News Archive

DMC completes review of BioSante LibiGel Phase III study
10 February 2012 The independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of BioSante Pharmaceuticals' LibiGel Phase III cardiovascular (CV) and breast cancer safety...

Tekmira begins TKM-Ebola Phase 1 clinical study
10 February 2012 Tekmira Pharmaceuticals, a developer of RNA interference (RNAi) therapeutics, has initiated patient enrollment in its Phase 1 clinical trial of...

Cariprazine monotherapy shows efficacy against bipolar I disorder
09 February 2012 Forest Laboratories and Gedeon Richter have reported preliminary top-line results from a Phase III clinical trial of Cariprazine (RGH-188), an investigational anti-psychotic agent, used to...

Avanir Pharmaceuticals reports Phase III data of AVP-923
09 February 2012 Avanir Pharmaceuticals has reported safety and efficacy results of its AVP-923 medication in the study entitled "Efficacy and Safety of Dextromethorphan/Quinidine (AVP-923) at Two Dosage Levels...

Anacor reports safety and tolerability results of AN2728 ointment
08 February 2012 Anacor Pharmaceuticals has reported positive preliminary results from two safety studies of AN2728 ointment,...

EpiCept files fast track status for AmiKet
08 February 2012 EpiCept Corporation has filed a fast track designation with the US Food and Drug Administration (FDA) for its AmiKet, used for the treatment of chemotherapy-induced peripheral neuropathy...

Cabozantinib shows efficacy in renal cancer patients
07 February 2012 Exelixis has reported the preliminary data from a cohort of heavily pretreated patients with metastatic refractory renal cell carcinoma (RCC) participating in an ongoing Phase 1b trial...

Ziopharm oral Palifosfamide gets FDA IND approval
07 February 2012 The US Food and Drug Administration (FDA) has accepted the investigational new drug application for Ziopharm Oncology's oral Palifosfamide (Zymafos or ZIO-201), which is used as a treatment...

Merck joins Threshold to co-develop TH-302 drug
06 February 2012 Merck and Threshold Pharmaceuticals have entered into a global agreement to jointly develop and commercialise Threshold Pharmaceuticals' hypoxia-targeted drug, TH-302, which is thought to...

OGX-427 plus prednisone found effective against prostate cancer
06 February 2012 OncoGenex Pharmaceuticals has announced the preliminary results from a Phase 2 study of its investigational compound OGX-427, designed for the treatment of chemotherapy-naive patients...

OBD drug meets Phase 3 trial primary endpoint: Sucampo, Takeda
03 February 2012 Sucampo Pharmaceuticals (SPI) and Takeda Pharmaceuticals have announced the results from the Phase 3 clinical trial of lubiprostone as a treatment of opioid-induced bowel dysfunction (OBD)...

Ipsen reports Q4 and full year 2011 sales
03 February 2012 Ipsen, a global specialty-driven pharmaceutical company, has reported its fourth quarter and full year results with total sales exceeding €1.1bn in...

MDV3100 shows efficacy against prostate cancer
02 February 2012 Medivation and Astellas Pharma have announced the positive results from the Phase 3 AFFIRM trial of the investigational drug MDV3100 in men with prostate cancer previously treated with...

Novartis Glivec wins extended FDA approval for three-year treatment
02 February 2012 The Novartis Glivec (imatinib) label has received an extended approval by the US Food and Drug Administration (FDA) to recommend 36 months of treatment for adult patients with KIT...

Boehringer, Eli Lilly diabetes drug wins FDA nod
01 February 2012 Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced that the US Food and Drug Administration (FDA) has approved Jentadueto (linagliptin / metformin hydrochloride) tablets, used...

Argos reports AGS-003 combination therapy trial data
01 February 2012 Argos Therapeutics' Arcelis immunotherapy, AGS-003, in combination with sunitinib has showed a correlation between anti-tumour memory T cell responses and overall survival in Phase 2 study...

Allos Therapeutics reports interim data of Folotyn combination therapy
31 January 2012 Allos Therapeutics has announced the interim results from the ongoing Phase 1 combination study of Folotyn (pralatrexate injection) and bexarotene in patients with relapsed or refractory...

FDA clears Pfizer Inlyta for kidney cancer
31 January 2012 The US Food and Drug Administration (FDA) has approved Pfizer's Inlyta (axitinib), a kinase inhibitor, intended for treating patients with advanced renal cell carcinoma (RCC) following failure...

Amylin and Alkermes diabetes drug wins FDA approval
30 January 2012 Amylin Pharmaceuticals and Alkermes have announced that the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) for the treatment...

Millennium announces Phase I trial data of Adcetris
30 January 2012 Millennium, part of the Takeda Group, has announced the interim results from a Phase I clinical trial of Adcetris (brentuximab vedotin) administered in combination with or sequentially...

Biogen Idec, Elan begins multiple sclerosis drug study
27 January 2012 Biogen Idec and Elan Corporation are conducting a global Phase 3b study, designed to evaluate the effectiveness of Tysabri as a treatment for secondary-progressive multiple sclerosis...

Chimerix reports Phase II trial data of CMX001
27 January 2012 Chimerix, a biotechnology company developing novel antiviral therapeutics, has announced the final data from Phase II study 201 evaluating CMX001 for the prevention of cytomegalovirus...

Merck Serono introduces Rebif in UK
26 January 2012 Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has introduced Rebif (interferon beta-1a) in the UK to treat people who have experienced clinically isolated syndrome (CIS), an...

Advaxis reports safety and survival data of cancer drug
26 January 2012 Advaxis has reported the preliminary data on the safety and clinical benefit of ADXS-HPV with or without cisplatin in Indian women with recurrent / refractory cervical cancer who have...

VentiRx announces positive TLR8 agonist preclinical data
25 January 2012 VentiRx Pharmaceuticals has announced preclinical data demonstrating that VTX-2337, the company's lead small molecule, is a novel, highly potent and selective TLR8...

Gilead begins Phase II study of HIV drug
25 January 2012 Gilead Sciences has begun a Phase II clinical trial of its GS-7340 drug, used as a treatment for HIV-1 infection in treatment-naive...

Immunomedics reports encouraging data from Phase Ib/II pancreatic cancer study
24 January 2012 Immunomedics has reported data from Phase Ib/II study of Yttrium-90-labelled clivatuzumab tetraxetan and gemcitabine in advanced pancreatic...

Spectrum announces positive results from Zevalin study
24 January 2012 Spectrum Pharmaceuticals has reported results from a randomised study comparing Zevalin (ibritumomab tiuxetan) injection for intravenous use plus high-dose BEAM chemotherapy with BEAM...

Cabozantinib found to treat patients with Hepatocellular Carcinoma
23 January 2012 Exelixis's cabozantinib has demonstrated positive effects in treating hepatocellular carcinoma (HCC) cohort patients during the ongoing Phase 2 randomized discontinuation trial...

Tesetaxel shows efficacy against gastric cancer in study
23 January 2012 Genta Incorporated has announced positive results from the Phase 2b confirmatory clinical trial, designed to evaluate tesetaxel in treating patients with advanced gastric...

Adeona begins Phase II study of multiple sclerosis drug
20 January 2012 Adeona Pharmaceuticals, a developer of synthetic DNA-based therapeutics, has commenced the Phase II clinical trial of its Trimesta drug, designed to treat cognitive dysfunction in...

Bristol-Myers reports Phase II data of DAA therapy against HCV
20 January 2012 Bristol-Myers Squibb has reported the Phase II clinical trial results of direct-acting antiviral (DAA) therapy in patients with hepatitis C virus (HCV) genotype 1 who had not responded to...

Regorafenib found to treat colorectal cancer: Bayer reports
19 January 2012 Bayer HealthCare's Regorafenib (BAY 73-4506) drug has demonstrated the efficacy in Phase 3 Colorectal cancer treated with Regorafenib or placebo after failure of standard therapy (CORRECT)...

Media-Soft develops new pharma CRM solution
19 January 2012 Media-Soft, a pharmacentric company, has developed new flagship product Sales Vision Android, an offline / online Android-based pharma CRM and SFE tool for...

Vivus Avanafil shows efficacy against erectile dysfunction
18 January 2012 Vivus has reported the results from its Phase III Revive study investigating the safety and efficacy of an investigational drug Avanafil, used for the treatment of erectile dysfunction...

Pergamum doses first patient in Phase II trial of DPK-060
18 January 2012 Sweden-based Pergamum has dosed the first patient in a randomised Phase II study of DPK-060, designed for the treatment of patients with external otitis (swimmers...

Lundbeck introduces new treatment for depressive disorder in UK
17 January 2012 Lundbeck, an international pharmaceutical company, has announced that Sycrest (asenapine) is being launched in the UK for treating moderate to severe manic episodes associated with bipolar...

Ganetespib with docetaxel found effective against lung cancer: Synta reports
17 January 2012 Synta Pharmaceuticals has reported the favourable safety profile of Ganetespib, a non-ansamycin inhibitor of Hsp90, in multiple non-small cell lung cancer (NSCLC) xenograft...

NovAliX and Teijin Pharma strike drug discovery alliance
16 January 2012 NovAliX SAS has entered into a multitarget integrated drug discovery collaboration with Tokyo-based Teijin Pharma to develop novel drug candidates against multiple targets across...

Ventrus Iferanserin ointment found to treat haemorrhoids
16 January 2012 Ventrus BioSciences has announced the results from the Phase IIb study of Iferanserin ointment (VEN 309), its novel investigational drug for the treatment of symptomatic...

CSL Behring begins phase II/III haemophilia study
13 January 2012 CSL Behring has initiated a global phase II/III, multi-centre study, designed to investigate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor...

BBR concludes preclinical trials of obesity compound
13 January 2012 Bridge Bioresearch (BBR) has completed the preclinical efficacy and safety trials of 2hydroxyoleic acid (2OHOA), a novel treatment for obesity and other metabolic...

Polaris doses first patient in Phase 1 prostrate cancer drug trial
12 January 2012 Polaris Group has dosed the first prostate cancer patient in its Phase 1 clinical trial investigating the cancer therapeutic pegylated arginine deiminase (ADI-PEG 20) in combination with...

Spherix concludes SPX-106 drug toxicology study
12 January 2012 Spherix, a developer of proprietary therapeutic products for the treatment of diabetes, metabolic syndrome and atherosclerosis, has successfully completed the 28-day rat toxicology study of...

Cynapsus reports positive results from Parkinson's drug trial
11 January 2012 Cynapsus Therapeutics, a Canada-based speciality pharmaceutical company, has reported positive top-line data from its human volunteer pilot proof-of-concept Phase I study of APL 130277 to treat...

LX4211 combination therapy found to treat type 2 diabetes
11 January 2012 Lexicon Pharmaceuticals has announced the top-line results from the first clinical study evaluating the combined effects of LX4211, a sodium glucose transporter 1 and 2 (SGLT1 and SGLT2)...

Idenix reports positive interim trial data for hepatitis C drug
10 January 2012 Idenix Pharmaceuticals has reported the positive interim data from a 12-week Phase IIb clinical trial of IDX184, a drug candidate for the treatment for hepatitis C virus...

BioCryst reports long-term results of BCX4208 therapy
10 January 2012 BioCryst Pharmaceuticals has reported positive results from the extension phase of its randomised Phase 2b study of BCX4208 added to allopurinol in patients with...

EyeGate enrols first patient in Phase III anterior uveitis study
09 January 2012 EyeGate Pharma has enrolled the first patient in a Phase III pivotal study of its EGP-437 product, a late-stage asset with multiple indications for inflammatory ocular indications used to...

Hypercholesterolaemia drug Lomitapide shows efficacy in trial
09 January 2012 Aegerion Pharmaceuticals drug candidate Lomitapide has demonstrated long-term safety and efficacy results in a 78-week Phase III clinical...

Ista begins Beposone nasal spray study
06 January 2012 Ista Pharmaceuticals' Beposone nasal spray has entered into a Phase II clinical study in conjugation with bepotastine besilate and a steroid for the treatment of the symptoms associated...

Baxter doses first patient in BAX 855 drug study
06 January 2012 Baxter International has begun dosing the first patients in a Phase I clinical trial of investigational candidate BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor...

Repros doses patient in low-dose oral Proellex trial
05 January 2012 Repros Therapeutics has completed patient dosing in its Phase II low-dose trial of oral Proellex, intended for the treatment of symptoms of uterine fibroids and...

Achillion HCV drug receives FDA fast track status
05 January 2012 The US Food and Drug Administration (FDA) has granted fast track designation to Achillion Pharmaceuticals' ACH-1625 drug, which is being evaluated in a Phase II clinical trial as a treatment...

CCS strikes license agreement with EMD Millipore
04 January 2012 Cell Culture Service has entered into a general license agreement with EMD Millipore, a division of...

Agile completes Phase III study of hormonal contraceptive patch
03 January 2012 Agile Therapeutics has concluded the final Phase III clinical trial of AG200-15, the company's hormonal contraceptive patch containing ethinyl estradiol in combination with...

Pfizer pneumonia vaccine receives FDA clearance
03 January 2012 The US Food and Drug Administration (FDA) has approved the extended use of Pfizer's pneumococcal conjugate vaccine- Prevnar 13 as a single-dose treatment for pneumonia in...

Season's Greetings from the editorial team
23 December 2011 We will be taking a short break over the holiday season. Our daily news service will return in full on 3...

Xoma commences Gevokizumab Phase II study
23 December 2011 Xoma has initiated patient dosing in its Phase II proof-of-concept study, designed to investigate the efficacy and safety of Gevokizumab (XOMA 052), an inhibitor of interleukin-1 beta, used...

Jennerex treats first patient in Phase IIa study of cancer drug
22 December 2011 Jennerex, a private clinical-stage biotherapeutics company, has treated the first patient in a Phase IIa clinical trial of JX-594, as a neoadjuvant therapy in patients who are undergoing surgery...

FDA clears Takeda Edarbyclor fixed-dose combination regimen
22 December 2011 The US Food and Drug Administration (FDA) has approved Takeda Pharmaceutical's Edarbyclor as a treatment for hypertension in...

Novartis concludes Altitude study with Rasilez/Tekturna
21 December 2011 Novartis has decided to conclude the Altitude study with Rasilez/Tekturna (aliskiren), on the recommendation of the independent data monitoring committee overseeing the...

Exparel shows efficacy against pain management
21 December 2011 Pacira Pharmaceuticals has reported the results from a placebo-controlled, pivotal Phase III trial of Exparel (bupivacaine liposome injectable suspension), a non-opioid local analgesic...

Galapagos GLPG0778 shows selective effects on biomarkers in Phase I study
20 December 2011 Belgium-based biotechnology company Galapagos has announced that its investigational medicine GLPG0778, a kinase target GT623 inhibitor, has demonstrated selective effects on a biomarker in a...

Raptor Pharmaceutical agrees RP104 research deal
20 December 2011 Raptor Pharmaceutical has entered into a cooperative research and development agreement with the National Institute of Diabetes and Digestive and Kidney Diseases to conduct a Phase IIb...

Pfizer Lyrica capsules meet co-primary endpoints
19 December 2011 Pfizer has announced that its Lyrica (pregabalin) capsules have met each of its three co-primary endpoints in the Phase III study evaluating it in patients with restless legs...

FDA clears Vertex Kalydeco NDA
19 December 2011 The US Food and Drug Administration (FDA) has granted Vertex Pharmaceuticals' New Drug Application (NDA) and its request for a six-month Priority Review of its Kalydeco (ivacaftor, VX-770)...

BioSante reports LibiGel efficacy trials data
16 December 2011 BioSante Pharmaceuticals has announced the top-line results from its two pivotal Phase III efficacy trials of LibiGel (testosterone gel), used for the treatment of postmenopausal women who...

Novartis multiple sclerosis drug shows positive clinical results
16 December 2011 A Phase III study conducted by Novartis has revealed that Gilenya (fingolimod) has demonstrated a 48% reduction in annualised relapse rates in patients with relapsing-remitting multiple...

MabThera combined with chemotherapy found to treat lymphoma patients
15 December 2011 A Cancer Research UK funded UK Phase III trial of MabThera, combined with chemotherapy in the treatment of newly diagnosed patients with Mantle Cell Lymphoma (MCL), has shown considerably...

TH-302 shows efficacy against leukemia: Threshold reports
15 December 2011 Threshold Pharmaceuticals' TH-302 drug has produced promising clinical trial results in the Phase I study performed at MD Anderson's Cancer Center in Houston, US, for treating patients...

FDA grants Celladon's Mydicar drug fast-track status
14 December 2011 The US Food and Drug Administration (FDA) has granted fast-track designation of Celladon's investigational product candidate Mydicar, which is designed to treat advanced heart...

Novartis reports Phase III study results of INC424
14 December 2011 Novartis has presented the supplementary results from two pivotal Phase III trials investigating its INC424 (ruxolitinib) drug, a Janus kinase (JAK) inhibitor that is used to treat patients...

Genmab reports first results from Phase I/II multiple myeloma study
13 December 2011 Genmab has reported encouraging preliminary safety and efficacy data from the first Phase I/II clinical study of daratumumab (HuMax-CD38) in multiple...

Abbott joins Reata to develop oral antioxidant inflammation modulators
13 December 2011 Abbott has signed a collaboration agreement with Reata Pharmaceuticals to develop and commercialise Reata's portfolio of second-generation oral antioxidant inflammation...

Celgene reports encouraging data from CLL investigational study
12 December 2011 Celgene International has announced interim results of CLL-009 followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who received at least one...

Arhalofenate combination therapy found to treat gout
12 December 2011 Metabolex has announced the positive results from its clinical study of Arhalofenate in combination with febuxostat (Uloric), used to treat patients with hyperuricemia and...

Enzon reports positive Phase II data of cancer drug
09 December 2011 Enzon Pharmaceuticals' PEG-SN38 (EZN-2208) has demonstrated positive results in a Phase II open-label study involving patients previously treated with metastatic breast...

Molecular Partners and Janssen enter research collaboration deal
09 December 2011 Molecular Partners has signed a strategic research collaboration with Janssen Biotech, for designed ankyrin repeat protein (DARPin) products for the treatment of immunological...

Genentech reports positive results of cancer drug
08 December 2011 Genentech, a member of the Roche Group, has presented the positive results from the first randomised Phase III study, designed to investigate HER2-targeted medicine...

Pharmathene presents Anthrax anti-toxin study results
08 December 2011 PharmAthene has announced the results of a Phase I clinical study of Valortim, a fully human monoclonal antibody, used as both post-exposure prophylaxis and therapeutic treatment for...

Peregrine Bavituximab therapy shows efficacy against NSCLC
07 December 2011 Peregrine Pharmaceuticals' Bavituximab, in combination with carboplatin and paclitaxel, has demonstrated 50% improvement in overall tumour response rates (ORR) in a Phase II trial...

Lixisenatide combination therapy found to treat type 2 diabetes
07 December 2011 Sanofi-aventis has presented the positive top-line results from a Phase III study, GetGoal Duo 1, designed to investigate the efficacy and safety of lixisenatide (Lyxumia) in combination...

Eylea injection found to improve visual acuity in wet age-related macular degeneration
06 December 2011 Regeneron Pharmaceuticals and Bayer HealthCare have announced that in an integrated analysis of two parallel Phase III studies, Eylea (aflibercept) injection has shown improvements in visual...

Achillion ACH-2928 drug shows efficacy against chronic hepatitis C
06 December 2011 The randomised, double-blind, placebo-controlled Phase Ia/Ib clinical trial is intended to evaluate the safety, tolerability, pharmacokinetic profile and antiviral activity of...

Amicus treats first patient in AT2220 study
05 December 2011 Amicus Therapeutics, a biopharmaceutical company that develops therapies for rare diseases, has infused the first patient in an Phase II drug-drug interaction study of AT2220 (duvoglustat...

Bristol-Myers Squibb and Tibotec to collaborate on daclatasvir trial
05 December 2011 Bristol-Myers Squibb has signed a clinical collaboration agreement with Medivir development partner Tibotec Pharmaceuticals for Phase II combination study in patients with chronic hepatitis C...

Boehringer and Aveo enter into manufacturing deal for ficlatuzumab
02 December 2011 Aveo Pharmaceuticals has signed a manufacturing agreement with Boehringer Ingelheim for large-scale process development and clinical manufacturing of ficlatuzumab (AV-299), used to treat...

Santarus Uceris tablet found to treat ulcerative colitis
02 December 2011 US-based specialty biopharmaceutical company, Santarus, has reported the clinical data from an open-label study, designed to investigate the efficacy and safety of eight weeks of treatment with...

Roche to present Pertuzumab combination therapy study results
01 December 2011 Switzerland-based biotech company Roche will present the study results of its investigational medicine, Pertuzumab, in HER2-positive breast cancer, at the 34th Annual CTRC-AACR San Antonio...

Cytokinetics reports positive study results of CK-2017357
01 December 2011 Cytokinetics' CK-2017357 drug has met all primary endpoints in the first cohort of an ongoing Phase II clinical trial in patients with amyotrophic lateral...

European Commission clears Novartis Rasilez-based triple combination pill
30 November 2011 The European Commission has approved Novartis Pharmaceuticals' Rasitrio, a Rasilez-based triple combination pill of aliskiren, amlodipine and hydrochlorothiazide that is used as a...

Komboglyze combination pill receives European marketing approval
30 November 2011 AstraZeneca and Bristol-Myers Squibb have announced that the European Commission has granted marketing approval for Komboglyze, used to treat adult patients with type 2 diabetes...

FDA accepts Amarin new drug application for AMR101
29 November 2011 The US Food and Drug Administration (FDA) has accepted Amarin's new drug application for AMR101 (icosapent ethyl), a drug to treat patients with very high...

Synairgen aerosolised IFN-beta shows efficacy against pneumonia
29 November 2011 UK-based respiratory drug discovery and development company, Synairgen has presented the positive data from its pre-clinical study investigating the effectiveness of aerosolised interferon...

Summit SMT C1100 secures FDA orphan drug status
28 November 2011 UK-based drug discovery company Summit has received the US Food & Drug Administration's (FDA) orphan drug status for SMT C1100, used to treat Duchenne muscular...

FDA approves Intermezzo sublingual tablet for insomnia
28 November 2011 The US Food and Drug Administration (FDA) has approved Transcept Pharmaceuticals' Intermezzo (zolpidem tartrate) C-IV, used to treat...

Prana given clearance to begin Alzheimer's drug trial
25 November 2011 The Austin Health Research Ethics Committee has granted approval to Prana Biotechnology to initiate a 12-month Phase II Imaging trial in Australia to evaluate PBT2, an Alzheimer's...

Pfizer to buy Excaliard Pharmaceuticals
25 November 2011 Pfizer has entered into a definitive agreement to acquire Excaliard Pharmaceuticals, gaining access to EXC 001, a skin scarring...

Celldex presents survival data from glioblastoma drug trial
24 November 2011 Celldex Therapeutics has presented mature overall survival data from a Phase II trial of rindopepimut (CDX-110) in patients with EGFRvIII-positive...

Portola secures financing for Phase III betrixaban study
24 November 2011 Portola Pharmaceuticals has secured $89m in preferred stock financing to advance its Phase III clinical programme of betrixaban, a once-daily, oral Factor Xa...

FDA grants clearance for Tonix to begin TNX-102 study
23 November 2011 Tonix Pharmaceuticals has received US Food Drug and Administration (FDA) approval to initiate a comparative pharmacokinetic and bioavailability study of TNX-102, an oral formulation...

Regeneron Eylea injection wins FDA nod
23 November 2011 The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals' Eylea (aflibercept) injection for the treatment of patients with neovascular (wet) age-related macular...

Imprime PGG combination therapy found effective against cancer
22 November 2011 Biothera's Imprime PGG in combination with cetuximab, carboplatin and paclitaxel has met all the endpoints in a Phase II non small cell lung cancer clinical...

FDA accepts new drug application for Northera
22 November 2011 Chelsea Therapeutics has received US Food and Drug Administration (FDA) acceptance for the filing of a new drug application for Northera (droxidopa), designed to treat symptomatic...

Virtify adds Kallik technology to labelling solution
21 November 2011 Software developer Virtify has integrated Kallik's Automated Artwork Generation technology to its labelling solution for pharmaceutical and life science...

Report highlights rising use of mental health medications in US
21 November 2011 A report from Medco Health Solutions revealed that more than one in five adult Americans took at least one medication to treat a psychiatric or behavioural disorder in...

Gilead and Tibotec to develop HIV medication
18 November 2011 Gilead Sciences has entered into a licence agreement with Tibotec Pharmaceuticals to develop and market a single-tablet regimen comprising Prezista (darunavir), Emtriva (emtricitabine, GS7340)...

Palifosfamide combination therapy found effective against small cell lung cancer
18 November 2011 Ziopharm Oncology's intravenous Zymafos (palifosfamide or ZIO-201) has demonstrated promising clinical results in an ongoing Phase Ib open-label dose escalation study in patients with small...

Lallemand, GM Pharmaceuticals launch Ismigen in Georgia
17 November 2011 Lallemand Pharma and GM Pharmaceuticals have introduced new oral vaccine Ismigen in Georgia, US, to prevent acute exacerbations in chronic obstructive pulmonary...

Bristol-Myers Squibb and Pfizer report apixaban trial results
16 November 2011 Bristol-Myers Squibb and Pfizer have presented the results of the Phase III trial to compare apixaban (Eliquis) to enoxaparin in acutely ill medical...

FDA approves IntelGenx anti-depressant
16 November 2011 The US Food and Drug Administration (FDA) has approved IntelGenxs' anti-depressant CPI-300 to treat patients with major depressive...

FDA grants orphan drug status to Santen Sirolimus drug
15 November 2011 The US Food and Drug Administration (FDA) has issued orphan drug status for Santen's sirolimus (DE-109, rapamycin) drug as a treatment for chronic / refractory anterior non-infectious...

Baxter International acquires Baxa
15 November 2011 Baxter International has acquired Baxa, the US-based developer of pharmacy technology, for a cash consideration of...

Anacor completes patient enrollment for AN2690 drug study
14 November 2011 Anacor Pharmaceuticals has concluded patient enrollment in the first of two Phase 3 trials of a topical anti-fungal product Tavaborole (AN2690), used to treat...

Alkermes' Vivitrol treats opioid dependence in study
14 November 2011 Alkermes' Vivitrol (naltrexone for extended-release injectable suspension) has demonstrated sustained efficacy and safety over 18 months of treatment and supported its clinical ability as...

Salix to acquire Oceana operating subsidiary
11 November 2011 Oceana Therapeutics has signed a definitive agreement for the sale of its operating subsidiary to Salix Pharmaceuticals for...

Opexa Tovaxin drug receives FDA fast-track designation
11 November 2011 The US Food and Drug Administration (FDA) has granted fast-track designation to Opexa Therapeutics' Tovaxin drug candidate, used to treat secondary progressive multiple...

UCB reports RAPID 1 post-hoc data of Cimzia
10 November 2011 UCB, a Belgium-based biopharmaceutical company, has announced the results from a Phase III double-blind placebo-controlled RAPID 1 post-hoc analysis designed to evaluate the efficacy...

DuoCort Plenadren drug receives European approval
10 November 2011 The European Commission has granted a European Marketing Authorisation for DuoCort Pharma's Plenadren, an orphan drug used to treat adrenal insufficiency in...

Acadia and Meiji Seika Pharma partner to advance AM-831 drug study
09 November 2011 Acadia Pharmaceuticals is to begin a Phase I clinical study of AM-831, an innovative small molecule for the treatment of schizophrenia, in collaboration with Meiji Seika...

Abbott announces results of Humira trials
09 November 2011 Abbott has announced the data from Premier and DE019 Phase III studies that investigated Humira (adalimumab) plus methotrexate for up to eight years in patients with early moderate to...

Sanofi submits marketing authorisation application for Lyxumia drug
08 November 2011 Danish biopharmaceutical firm Zealand Pharma has announced that its partner Sanofi has submitted a marketing authorisation application for Lyxumia (lixisenatide) in...

Aslan and Bristol-Myers Squibb partner for cancer drug development
08 November 2011 Aslan Pharmaceuticals has entered into an agreement with Bristol-Myers Squibb to develop an investigational small molecule inhibitor of MET receptor tyrosine kinase, BMS-777607, for treating...

Ligand Captisol-enabled melphalan meets trial goals
07 November 2011 Ligand Pharmaceuticals' Captisol-enabled, propylene glycol-free drug melphalan has met all the endpoints in a Phase II trial treating patients with multiple...

Vertex's Kalydeco shows efficacy against cystic fibrosis
07 November 2011 Data from a Phase III trial of Vertex Pharmaceuticals' Kalydeco (ivacaftor) has been published ion the New England Journal of...

Domainex wins grant to develop cancer drug
04 November 2011 The UK's Technology Strategy Board has awarded Domainex a £250,000 grant to develop of a new drug to treat several common...

Exelixis to commence prostate cancer drug trial
04 November 2011 Exelixis has announced that it will begin the pivotal Phase III '306 trial of cabozantinib in patients with metastatic castration-resistant prostate cancer by the end of...

Alios BioPharma and Versitech partner for influenza therapy
03 November 2011 Alios BioPharma has signed an exclusive worldwide licensing agreement with Versitech to develop, manufacture and market medication to combat influenza...

FDA clears Pacira post-surgical pain management therapy
03 November 2011 The US Food and Drug Administration (FDA) has approved Pacira Pharmaceuticals' Exparel (bupivacaine liposome injectable suspension) 1.3% for post-surgical pain...

FDA clears Vegenics VGX-100 drug trial
02 November 2011 The US Food and Drug Administration (FDA) has approved an investigational new drug application from Vegenics, a subsidiary of Circadian Technologies, to commence clinical trials of VGX-100 for...

Pfizer acquires Icagen
02 November 2011 Pfizer, through its wholly owned subsidiary Eclipse Acquisition, has completed the acquisition of biopharmaceutical company...

FDA approves Mylan pain drug
01 November 2011 Mylan's abbreviated new drug application for morphine sulphate extended-release tablets has been approved by the US Food and Drug Administration (FDA)...

Bristol-Myers and Gilead join forces to develop HIV drug
01 November 2011 Bristol-Myers Squibb and Gilead Sciences have entered a licensing agreement for the development and commercialisation of a new fixed-dose combination pill for HIV-infected...

Bionovo commences Menerba drug Phase 3 trial
31 October 2011 Biotech company Bionovo has begun a Phase 3 clinical trial designed to assess the safety and efficacy of two doses of oral estrogen receptor beta (ER-b) selective drug, Menerba (MF101), used...

KemPharm to develop new pain therapy
31 October 2011 KemPharm is planning to initiate the development of KP511, an oral prodrug of hydromorphone that is used to manage pain in patients where an opioid analgesic is...

Basilea completes BAL30072 antibiotic trial
28 October 2011 Basilea Pharmaceutical has completed a Phase I study to test the efficacy of its novel sulfactam antibiotic BAL30072 as a treatment of multi-drug resistant Gram-negative...

Atox Bio receives orphan drug designation for AB103
28 October 2011 Atox Bio has been granted orphan drug designation by US Food and Drug Administration (FDA) for AB103, used to treat necrotising soft tissue...

Gilead and GlobeImmune join forces to develop hepatitis B vaccine
27 October 2011 Gilead Sciences and GlobeImmune have entered into an exclusive worldwide licence and collaboration agreement to develop and market therapeutic vaccine products to treat chronic hepatitis B...

Encap partners Lena to develop new drug delivery technology
27 October 2011 Encap Drug Delivery has collaborated with Lena Nanoceutics to develop Nano-Capsules, a new drug delivery technology that integrates Lena's proprietary nano-particle engineering technology...

Alemtuzumab found superior to standard MS treatment
26 October 2011 Sanofi and its subsidiary Genzyme have reported new results from the CARE-MS I trial, comparing the investigational drug Lemtrada (alemtuzumab) to Rebif (high-dose subcutaneous interferon...

Xencor launches Phase I XmAb5871 study
26 October 2011 Xencor has begun the Phase 1 clinical trial of humanised monoclonal antibody XmAb5871 for the treatment of autoimmune...

FDA approves Sagent bupivacaine hydrochloride injection
25 October 2011 The US Food and Drug Administration (FDA) has granted approval for Sagent Pharmaceuticals' bupivacaine hydrochloride...

Allon completes patient enrolment for progressive supranuclear palsy drug trial
25 October 2011 Allon Therapeutics has completed the enrolment of 300 patients in a Phase II/III pivotal trial to evaluate neuroprotective drug candidate Davunetide as a treatment for progressive...

Tetraphase wins respiratory antibiotic contract
24 October 2011 The National Institute of Allergy and Infectious Diseases in the US has awarded a $36m contract to Tetraphase to develop TP-271, an antibiotic for respiratory...

Natco joins Mabxience to manufacture mAb finished dose formulations
24 October 2011 Indian firm Natco Pharma has signed an agreement with Mabxience, a unit of Swiss-based Chemo Sa Lugano, to purchase four mAb drug substances from Chemo and use them to manufacture finished...

Meloxicam depot injection proven to treat pain and inflammation
21 October 2011 Encore Therapeutics (ETI) has successfully completed a pre-clinical Proof of Concept (POC) study on ETI-511, its proprietary, extended release phospholipid gel depot formulation of the NSAID...

Servier partners Miragen to develop microRNA-targeting drugs
21 October 2011 European pharmaceutical company, Les Laboratoires Servier, has entered into a partnership agreement with Miragen Therapeutics, for advancing the research, development and commercialisation of...

Takeda begins type 2 diabetes drug Phase 3 trial
20 October 2011 Takeda Pharmaceutical and its wholly-owned subsidiaries have initiated the Phase 3 clinical trial of its TAK-875, an investigational therapy for type 2...

Oxford BioMedica gets FDA IND approval for UshStat therapy
20 October 2011 Oxford BioMedica has received US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for the Phase I/IIa clinical development of UshStat, a...

Roche to acquire Anadys
19 October 2011 Roche has signed a definitive merger agreement to acquire Anadys Pharmaceuticals, a manufacturer of antiviral drug compunds, for a total cash consideration of approximately...

Teva Pharmaceutical acquires Cephalon
19 October 2011 Teva Pharmaceutical Industries, a global generic drug maker, has acquired...

ChemoCentryx commences CCX168 drug trial
19 October 2011 ChemoCentryx has initiated a Phase II clinical trial for CCX168, an orally-administered small molecule for the treatment of anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis...

Galenica submits Injectafer NDA to FDA
19 October 2011 Galenica's US partner Luitpold Pharmaceuticals has submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Injectafer, used to treat iron deficiency...

Kissei Pharmaceutical to support MN-221 development programme
18 October 2011 Japan's Kissei Pharmaceutical said it will pay MediciNova $2.5m to support further clinical development of MN-221 for the treatment of acute exacerbations of asthma or chronic obstructive...

Pozen reports long-term safety study results of PA32540
18 October 2011 Pozen has reported long-term safety results of open-label study 303 of PA32540 in patients at risk for developing aspirin-associated gastric...

Intellikine commences INK1117 drug trial
17 October 2011 Intellikine has initiated a multicentre Phase I dose escalation study of INK1117 in patients with advanced solid...

NIH funds UCSF to develop antimalarial drugs
17 October 2011 The National Institutes of Health (NIH) has granted $718,136 in funding to the University of California San Francisco (UCSF) to discover and optimise oxaboroles as antimalarial drugs...

The Native Antigen Company launches new Bordetella pertussis toxin
14 October 2011 The Native Antigen Company, contract service provider to the in vitro diagnostics industry based in Oxford, UK, has launched a new purified Bordetella pertussis...

GlycoMimetics and Pfizer to further develop GMI-1070
14 October 2011 GlycoMimetics has entered into an exclusive worldwide licensing agreement with Pfizer for the advancement of GlycoMimetics' investigational compound,...

Aimspro proven effective to treat late-stage systemic sclerosis
13 October 2011 Daval International has reported positive results from a Phase II study, evaluating the safety and tolerability of Aimspro as a monotherapy to treat patients with late-stage established...

Roche Alzheimer's drug found to safely remove amyloid plaques
13 October 2011 Phase I clinical trials and ex vivo studies conducted by Roche have demonstrated that gantenerumab can safely remove amyloid plaques from the brain of patients with Alzheimer's...

BIT225 drug found effective against hepatitis C virus
12 October 2011 Biotron, an Australian drug development company, has reported positive results from a Phase IIa trial that evaluated the efficacy of BIT225 in patients infected with the hepatitis C...

Paladin Labs acquires Labopharm
12 October 2011 Canadian speciality pharmaceutical company Paladin Labs has completed the acquisition of all outstanding common shares of...

Teriflunomide shows efficacy against multiple sclerosis
11 October 2011 A Phase III study conducted by Sanofi healthcare has demonstrated positive results of a once-daily oral medication for the treatment of multiple...

FDA clears Merck type 2 diabetes medication
11 October 2011 The US Food and Drug Administration (FDA) has approved Merck's Juvisync, a once-daily therapy for type 2 diabetes that combines glucose-lowering medication sitagliptin, the active component...

CytRx reports preliminary efficacy results of bafetinib
10 October 2011 The CytRx ENABLE Phase II clinical trial has demonstrated positive results for bafetinib, a Bcr-Abl, Lyn and Fyn kinase inhibitor for the treatment relapsed or refractory B-cell chronic...

BioSante completes LibiGel efficacy trials
10 October 2011 BioSante Pharmaceuticals has completed its two pivotal LibiGel efficacy...

Santaris to report miravirsen drug trial results
07 October 2011 Santaris Pharma is set to release new clinical data results from the Phase 2a study of miravirsen, the microRNA-targeted drug designed to treat Hepatitis C virus (HCV) infected...

Auxilium doses first patient in Dupuytren's contracture multicord study
07 October 2011 Auxilium Pharmaceuticals has dosed its first patient in an open-label Phase IIIb trial of Xiaflex, used for treating adult Dupuytren's contracture patients with multiple palpable...

Novavax RSV vaccine Phase 1 trial shows efficacy
06 October 2011 A Phase I clinical study conducted by Novavax has demonstrated positive top-line results of its respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine...

Alkermes commences opioid-induced constipation drug trial
06 October 2011 Alkermes has started the Phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation...

Baxter seeks European approval for HyQ
05 October 2011 Baxter International has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking marketing authorisation for HyQ, the company's...

Vfend combination therapy shows positive results: Pfizer study
05 October 2011 Pfizer has reported the top-line results of a prospective Phase III, double-blind clinical trial which compared the combination of Vfend (voriconazole) and Eraxis (anidulafungin) to...

COG, Apeiron to jointly conduct APN301 trial
04 October 2011 Children's Oncology Group (COG) and Apeiron Biologics AG (Apeiron) will collaborate to evaluate Apeiron's APN301 in a clinical phase II study in pediatric neuroblastoma...

Horizon submits NDA for RA drug
04 October 2011 Horizon Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Lodotra, for the treatment of rheumatoid...

Lannett Loxapine capsules get FDA approval
03 October 2011 The US Food and Drug Administration (FDA) has approved Lannett's abbreviated new drug application (ANDA) of Loxapine Capsules in 5mg, 10mg, 25mg and 50mg...

Rexahn completes patient enrollment in cancer drug trial
03 October 2011 Rexahn Pharmaceuticals has completed patient enrollment in its Phase II clinical trial designed to investigate the ability of Archexinin to treat metastatic pancreatic...

BL-1020 effectively treats schizophrenia, says reveals
30 September 2011 BioLineRx has reported data from the Phase IIb EAGLE study of BL-1020, a first in class GABA-enhanced anti-psychotic for the treatment of...

MicroDose doses first patient in respiratory syncytial virus drug trial
30 September 2011 MicroDose Therapeutx has dosed its first patient in a Phase I clinical trial of MDT-637, an inhalable antiviral fusion inhibitor designed to treat respiratory syncytial...

Novartis reports positive results from breast cancer drug trial
29 September 2011 A Phase III study carried out by Novartis has demonstrated that Afinitor (everolimus) tablets coupled with exemestane can more than double the time women with breast cancer live without tumour...

AstraZeneca Faslodex wins Japanese regulatory approval
29 September 2011 AstraZeneca has received Japanese regulatory approval for Faslodex (fulvestrant) 500mg, an oestrogen receptor antagonist for the treatment of postmenopausal women with hormone...

Radium-223 chloride shows efficacy against castration-resistant prostate cancer
28 September 2011 Bayer HealthCare Pharmaceuticals' investigational radium-223 chloride has met the primary and secondary endpoints of a Phase III prostate cancer...

FDA clears Janssen Biotech paediatric ulcerative colitis drug
28 September 2011 The US Food and Drug Administration (FDA) has approved Janssen Biotech's Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients who...

Acetylon begins Phase I/IIa trial of ACY-1215 drug
27 September 2011 Acetylon Pharmaceuticals has initiated a Phase I/IIa clinical trial of ACY-1215, an oral Class II histone deacetylase inhibitor, in adults with relapsed and relapsed/refractory multiple...

NovImmune commences primary biliary cirrhosis drug study
27 September 2011 Swiss drug maker NovImmune has begun a proof-of-concept study to evaluate NI-0801 in patients with primary biliary...

Theraclone doses first patient in influenza A drug trial
26 September 2011 Theraclone Sciences has completed the dosing of the first patient in a randomised, double-blind, dose-escalation Phase I trial to investigate TCN-032 as a treatment for influenza A...

Viramune once-daily formulation receives EU approval
26 September 2011 Boehringer Ingelheim has received EU approval for its Viramune (nevirapine) prolonged-release once-daily formulation indicated for the treatment of HIV-1...

Tokai secures financing to advance TOK-001 drug study
23 September 2011 Tokai Pharmaceuticals has raised $23m in a Series D3 financing to support the ongoing clinical development of galeterone (TOK-001), a treatment for castration-resistant prostate...

FDA clears Amphastar enoxaparin sodium injection
23 September 2011 The US Food and Drug Administration (FDA) has approved Amphastar Pharmaceuticals' abbreviated new drug application (ANDA) for Enoxaparin Sodium...

Inhibitex begins patient dosing in hepatitis C drug trial
22 September 2011 Inhibitex has started dosing in a Phase II clinical trial to assess the safety, tolerability and antiviral activity of INX-189 in treatment naive patients who have chronic hepatitis C...

SK biopharmaceuticals joins Mayo Clinic to develop sclerosis drug
22 September 2011 SK biopharmaceuticals has signed an agreement to collaborate with the Mayo Clinic for the discovery of new drugs targeting amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. ...

BARDA funds Vaxin to develop anthrax vaccine
21 September 2011 Vaxin, a clinical-stage vaccine development company, has been awarded a $21.7m contract by the Office of Biomedical Advanced Research and Development Authority (BARDA) for the development of...

Novartis juvenile arthritis drug performs well in trial
21 September 2011 Novartis' ACZ885 (canakinumab) has demonstrated positive results in a Phase III trial involving patients with systemic juvenile idiopathic arthritis, a rare and serious childhood...

Teva signs antiviral drug development agreement with Cocrystal Discovery
20 September 2011 Teva Pharmaceutical Industries has signed a license and share purchase agreement with Cocrystal Discovery, a biopharmaceutical company focused on the discovery and development of novel...

KAI partners Ono to develop KAI-4169
20 September 2011 KAI Pharmaceuticals has entered into an agreement with Ono Pharmaceutical for the development and commercialisation of KAI-4169 in Japan. KAI-4169, an intravenous formulation for the...

AB Science receives FDA approval to commence asthma drug study
19 September 2011 AB Science has obtained investigational new drug status from the US Food and Drug Administration (FDA), allowing it to commence its Phase III study of masitinib in severe persistent...

ConjuChem commences diabetes drug trial
19 September 2011 ConjuChem has initiated patient enrolment in a Phase II clinical trial of its proprietary GLP-1 receptor agonist drug CJC-1134-PC in patients with type 2 diabetes who are receiving...

Technology Strategy Board to support healthcare research projects
16 September 2011 The Technology Strategy Board, in collaboration with the Engineering and Physical Sciences Research Council, is set to invest up to £9m to support collaborative research projects focused...

Acceleron begins anaemia drug study
16 September 2011 Acceleron Pharma has initiated a Phase I clinical study of ACE-536, a ligand trap that increases red blood cells and haemoglobin by inhibiting members of the TGF-beta super family for the...

Silence Therapeutics partners with InteRNA to develop cancer therapeutics
15 September 2011 Silence Therapeutics and InteRNA Technologies have agreed to combine the delivery capabilities of Silence's proprietary AtuPLEX delivery system with InteRNA's novel microRNAs to...

BioSante completes LibiGel pharmacokinetic study
15 September 2011 Speciality pharmaceutical company BioSante Pharmaceuticals has completed the pharmacokinetic study of LibiGel, a transdermal testosterone gel for the treatment of female sexual...

NKTR-102 shows efficacy against breast cancer
14 September 2011 Nektar Therapeutics has presented positive Phase II study results of NKTR-102 in patients with metastatic breast cancer. NKTR-102, a topoisomerase I inhibitor, is designed using...

FDA grants orphan drug status to Avedro VibeX solution
14 September 2011 The US Food and Drug Administration (FDA) has granted orphan drug designation to Avedro's VibeX (0.1.% riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for...

ADHD drug shows efficacy
13 September 2011 Teva Pharmaceutical and Alcobra have presented top-line results from a Phase II trial of MG01CI in adults with attention deficit hyperactivity disorder (ADHD). The six-week,...

Dynavax receives research grant
13 September 2011 Dynavax Technologies, a clinical-stage biopharmaceutical company that develops drugs to prevent and treat infectious and inflammatory diseases, has received a two-year small business...

US health department funds development of new antibiotic
12 September 2011 GlaxoSmithKline has been awarded a four-year contract by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to support the ongoing development...

Debiopharm partners Ascenta to develop cancer drug
12 September 2011 Swiss-based global biopharmaceutical group Debiopharm Group and Ascenta Therapeutics have entered into an exclusive licence agreement to develop and commercialise AT-406 (called Debio 1143...

AiCuris herpes drug shows efficacy
09 September 2011 AiCuris is set to present results of a resistance analysis from a Phase II clinical trial of AIC316 in patients with genital herpes. In the trial, 156 patients with genital herpes...

NOXXON commences NOX-H94 drug study
09 September 2011 Germany's NOXXON Pharma has started a Phase I trial to investigate NOX-H94 as a treatment for chronic anaemia. NOX-H94 is a Spiegelmer that targets peptide hormone hepcidin, the key regulator...

Afinitor approved for neuroendocrine tumour treatment
08 September 2011 Swiss drug manufacturer Novartis has received the European Commission approval for Afinitor (everolimus) tablets to treat adult patients with pancreatic neuroendocrine tumours. The drug has...

Gilead to make changes in hepatitis C drug trial design
08 September 2011 Gilead Sciences is set to terminate the dosing of GS 9190 in combination with pegylated interferon, ribavirin or other direct-acting antiviral agents in patients with hepatitis C in an...

AstraZeneca atherosclerosis drug trial shows tolerability and efficacy
07 September 2011 AstraZeneca has reported top-line results from a Phase IIIb trial evaluating a 40mg dose of Crestor (rosuvastatin) compared with a 80mg dose of atorvastatin on the progression of atherosclerosis...

Dr Reddy's commences type II dyslipidemia drug trial
07 September 2011 Indian drug firm Dr Reddy's Laboratories has started dosing in a randomised, double-blind, placebo-controlled and parallel-group Phase II trial of DRL-17822 in patients suffering from type...

FDA to review application for new erectile dysfunction drug
06 September 2011 The US Food and Drug Administration (FDA) will review Vivus' new drug application for avanafil as a treatment for erectile dysfunction. Avanafil, a highly selective phosphodiesterase type...

MorphoSys doses first patient in cancer drug trial
06 September 2011 MorphoSys has dosed the first patient dosing in a multicentre, open-label, dose- escalation Phase I/IIa trial evaluating cancer antibody MOR202. MOR202 is a fully human HuCAL antibody that...

FDA approves application for Perrigo's ketoconazole foam
05 September 2011 The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application for ketoconazole foam, 2%, a generic equivalent to Extina ketoconazole foam, 2%. ...

Bionovo reports positive results from Menerba trial
05 September 2011 Bionovo has presented positive results from an open-label, randomised trial evaluating Menerba (MF101) as a treatment for hot flashes associated with the menopause. The primary goal of the...

Adamis commences prostate cancer drug Trial
02 September 2011 Adamis Pharmaceuticals has enrolled the first patient in its Phase I/IIa clinical prostate study of APC-100 as a treatment for men with castration-resistant prostate cancer. APC-100 is an...

Actelion reports results of idiopathic pulmonary fibrosis drug study
02 September 2011 Actelion's Phase II study of macitentan has demonstrated positive results in patients with idiopathic pulmonary fibrosis. Macitentan, a tissue-targeting endothelin receptor antagonist,...

Aicuris human cytomegalovirus drug receives FDA fast-track designation
01 September 2011 The US Food and Drug Administration (FDA) has granted fast-track designation to AiCuris' Letermovir, an inhibitor of the human cytomegalovirus. Letermovir is currently being evaluated in...

Eisai reports anti-seizure drug study results
01 September 2011 Eisai has presented the results of its Phase III pivotal study into the investigational compound perampanel as a treatment of partial-onset seizures. Perampanel, discovered and developed...

FDA clears Pfizer lung cancer drug
31 August 2011 The US Food and Drug Administration (FDA) has approved Pfizer's Xalkori (crizotinib) capsules for the treatment of patients with locally advanced or metastatic ALK-positive non-small-cell...

Afexa presents over-the-counter flu drug efficacy results
31 August 2011 Afexa Life Sciences' multi-centre, randomised, placebo-controlled, double-blind study investigating the potential benefits of three-day dosing of COLD-FX in reducing cold and flu symptoms...

Helsinn recruits first patient in lung cancer drug trial
30 August 2011 Swiss-based pharmaceutical company Helsinn Therapeutics has recruited its first patient in a Phase III clinical programme evaluating Anamorelin HCl as a treatment of anorexia and cachexia...

NIH funds Alzheimer's drug development
30 August 2011 The National Institutes of Health (NIH) has awarded a five-year $1m grant to researchers at the University of California San Diego School of Medicine to accelerate the development of a...

Apceth commences Phase I/II peripheral arterial occlusive disease study
26 August 2011 Apceth has initiated the first Phase I/II clinical study of its somatic cell therapy for peripheral arterial occlusive disease after angioplasty. The study, being conducted in cooperation...

FDA awards Algeta's radium-223 chloride fast-track status
26 August 2011 The US Food and Drug Administration (FDA) has granted fast-track designation to Algeta's radium-223 chloride as a treatment for castration-resistant prostate cancer in patients suffering from...

Health Canada approves Vertex hepatitis drug
25 August 2011 Vertex Pharmaceuticals has received Health Canada approval for Incivek (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease,...

Celldex presents efficacy data of dense deposit disease drug
25 August 2011 Celldex Therapeutics, in collaboration with University of Iowa in the US, has demonstrated positive in vitro and in vivo animal efficacy data for CDX-1135, its drug for dense deposit...

Seattle Genetics lymphoma drug wins FDA approval
24 August 2011 The US Food and Drug Administration (FDA) has granted accelerated approval to Seattle Genetics' Adcetris (brentuximab vedotin) as a treatment for Hodgkin's lymphoma after failure of autologous...

Cytokinetics presents heart failure drug trial results
24 August 2011 Cytokinetics has presented results from Phase I and Phase IIa clinical trials of omecamtiv mecarbil, a novel cardiac myosin activator indicated for the potential treatment of heart failure...

Allos Therapeutics initiates Phase III lymphoma drug trial
23 August 2011 Allos Therapeutics has initiated a Phase III clinical trial (PDX-017) evaluating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma...

Krystexxa effective against RCG, reveals Savient study
23 August 2011 Savient Pharmaceuticals has demonstrated positive results from two pivotal Phase III clinical studies of Krystexxa (pegloticase) as a treatment for refractory chronic gout (RCG). Krystexxa is...

Emergent initiates lymphoma drug study
22 August 2011 Emergent BioSolutions has initiated a Phase 1b / 2 study (16011) to evaluate TRU-016 in conjunction with rituximab and bendamustine in patients with relapsed indolent non-Hodgkin's...

Boston Therapeutics completes Sugardown blood sugar management trial
22 August 2011 Boston Therapeutics has completed a trial evaluating the dietary supplement Sugardown at the University of Sydney. Sugardown is intended to help in the reduction of post-meal elevation of...

Curis doses first patient in cancer drug combination trial
19 August 2011 Curis has treated the first patient at the University of Colorado Cancer Center in a Phase I combination trial of CUDC-101, a first-in-class therapeutic to simultaneously inhibit epidermal...

RegeneRx commences patient enrollment in dry eye trial
19 August 2011 RegeneRx Biopharmaceuticals has commenced patient enrollment in a Phase 2 clinical trial of RGN-259, a sterile, preservative-free topical eye drop for the treatment of patients with dry...

NIAID Awards Grant to Fund Chikungunya Vaccine Development
18 August 2011 The National Institute of Allergy and Infectious Diseases (NIAID), a division of the US National Institutes of Health, has awarded a four-year grant of over $3m to the University of Texas...

AVI BioPharma Initiates Eteplirsen Trial in Duchenne Muscular Dystrophy Patients
18 August 2011 RNA-based therapeutics developer AVI BioPharma has initiated patient dosing in a Phase II study of Eteplirsen, an exon-skipping therapeutic candidate for the treatment of Duchenne...

Aeras and OETC Commence Tuberculosis Vaccine Trial
17 August 2011 Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC) have begun a Phase IIb proof-of-concept efficacy trial of MVA85A, an investigational tuberculosis vaccine for HIV patients. ...

Adolor Reports Positive Results from Opioid-Induced Constipation Drug Trial
17 August 2011 Adolor has reported positive top-line results from its two Phase II studies of ADL5945 in chronic non-cancer pain patients with opioid-induced constipation. ADL5945, a...

Lexicon's LX1031 Shows Efficacy Against IBS
16 August 2011 Lexicon Pharmaceuticals' Phase II clinical trial of the tryptophan hydroxylase inhibitor LX1031 in patients with non-constipating irritable bowel syndrome (IBS) has demonstrated positive results. ...

Nutra Pharma Pain Drug Receives Indian Regulatory Approval
16 August 2011 Nutra Pharma has received approval in India for Nyloxin, an over-the-counter pain reliever to treat moderate to severe (stage 2) chronic pain. Nutra Pharma chairman and CEO Rik J Deitsch...

FDA Approves Gilead Complera Regimen for HIV-1 Infection
15 August 2011 The US Food and Drug Administration (FDA) has approved Gilead Sciences Complera, a single-tablet regimen for the treatment of HIV-1 infection in treatment-naive adults. Complera combines...

LX1032 Shows Efficacy for Carcinoid Syndrome
15 August 2011 Lexicon Pharmaceuticals has reported positive, topline results from a Phase II study of LX1032 (telotristat etiprate) in carcinoid syndrome. LX1032 is designed to reduce serotonin...

Pfizer to Partner with UC for Drug Discovery and Development Programme
12 August 2011 Pfizer is set to partner with the University of California (UC) San Diego Health Sciences via its Centers for Therapeutic Innovation (CTI) network to accelerate and transform drug discovery...

Pharmacyclics and NCI Partner to Develop Blood Cancer Drug
12 August 2011 Pharmacyclics has signed a five-year cooperative research and development agreement (CRADA) with National Cancer Institute (NCI) to develop PCI-32765 for the treatment of haematologic...

FDA Allows Teva to File BDP Nasal HFA NDA
11 August 2011 The US Food and Drug Administration has allowed Teva to file a New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA) for the treatment of seasonal...

Unigene, GSK in Osteoporosis Drug Development Agreement
11 August 2011 Unigene Laboratories has entered into a development services and clinical supply agreement with GlaxoSmithKline (GSK), as part of an exclusive worldwide licensing agreement. Under the...

Healthpoint HP802-247 Therapy Shows Efficacy in Venous Leg Ulcers
10 August 2011 Healthpoint Biotherapeutics has presented positive results from its Phase IIb trial of cell-based therapy HP802-247 in venous leg ulcers. HP802-247 is an allogeneic living cell suspension...

FDA Grants ODD to Kamada Type 1 Diabetes Drug
10 August 2011 Biopharmaceutical company Kamada has been granted an orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for its Alpha-1 Antitrypsin (AAT) drug to treat type 1...

Dyax Treats First Patient in Angioedema Drug Trial
09 August 2011 Dyax has treated the first patient in a Phase II trial of Ecallantide for acute treatment of angiotensin converting enzyme inhibitor-induced angioedema. Ecallantide inhibits the...

AB Science Recruits First Patient in Rheumatoid Arthritis Drug Study
09 August 2011 AB Science has recruited the first patient in its Phase IIb/III study of masitinib in rheumatoid arthritis patients. Masitinib is a selective inhibitor of the c-Kit and Lyn kinases, which play...

US FDA Grants Orphan Drug Status to Merrimack MM-398
08 August 2011 The US Food and Drug Administration (FDA) has granted orphan drug status to Merrimack Pharmaceuticals' MM-398 as a treatment for pancreatic cancer. MM-398 is a stable...

Sobi Enrols First Patient in Kiobrina Study
08 August 2011 Swedish Orphan Biovitrum (Sobi) has enrolled the first patient in a Phase III trial to evaluate the safety, tolerability and efficacy of its Kiobrina medication in the treatment of...

Teva Oral Contraceptive Receives EU Approval
05 August 2011 Teva Pharmaceutical Industries has received EU approval for its new oral contraceptive tablet, Zoely. Zoely contains a monophasic combination of two steroid hormones, 17-beta estradiol...

SuppreMol and Protagen Partner for Lupus Study
05 August 2011 SuppreMol and Protagen are collaborating on a Phase IIa study to identify therapy-related biomarkers in patients with systemic lupus erythematosus. SM101, a recombinant,...

Cubist Begins CXA-201 Drug Phase III Trial
04 August 2011 Cubist Pharmaceuticals has initiated a pivotal phase III trial of CXA-201 in patients with complicated urinary tract infections (cUTI). CXA-201 will be used as a first-line intravenous...

FDA Approves Covidien Morphine Sulphate Oral Solution
04 August 2011 The US Food and Drug Administration (FDA) has approved Covidien's Mallinckrodt business for morphine sulphate oral solution as a treatment for moderate to severe acute and chronic pain...

US Food and Drug Administration Approves Bristol-Myers Orencia SC
03 August 2011 The US Food and Drug Administration has approved Bristol-Myers Squibb's subcutaneous formulation of Orencia (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis. ...

RegeneRx to Begin Patient Enrolment in Phase II Dry Eye Trial
03 August 2011 RegeneRx Biopharmaceuticals is set to begin a Phase II clinical trial of RGN-259 in 72 patients with dry eye syndrome. RGN-259 is a sterile, preservative-free topical eye drop for...

Irritable Bowel Syndrome Drug Shows Promise in Phase I Trial
02 August 2011 Lexicon Pharmaceuticals has successfully completed a Phase I clinical trial of LX1033, an orally-delivered small molecule drug candidate for the treatment of diarrhoea-predominant irritable...

Fujifilm and Dr Reddy's to Form Joint Venture in Japan
02 August 2011 Fujifilm and Indian drug maker Dr Reddy's have signed a memorandum of understanding to establish a joint venture in Japan. The joint venture, which will focus on developing, manufacturing...

Marshall Reports NV-128 Pre-Clinical Study Results
01 August 2011 Marshall Edwards has announced the pre-clinical study results of NV-128 in chemotherapy-resistant ovarian cancer stem cells. The study demonstrated that NV-128 can specifically target...

Ceridia Completes CER006 Drug Trial
01 August 2011 Australian-based Ceridia has completed the Phase I human clinical study of its LipoCeramic ibuprofen formulation, CER006. The four-arm, blinded study demonstrated the safety and...

Impax Completes Patient Enrolment for IPX066 Drug Trial
29 July 2011 Impax Pharmaceuticals has completed patient enrolment in a Phase III comparitive study of IPX066 versus immediate-release carbidopa-levodopa and entacapone in subjects with advanced...

Baxter Reports BAX 499 Study Results
29 July 2011 Baxter International has announced the pre-clinical data of BAX 499 for subcutaneous haemophilia therapy and final Phase I data on recombinant von Willebrand factor. The drug...

Eteplirsen Shows Efficacy for Duchenne Muscular Dystrophy
28 July 2011 AVI BioPharma has reported positive Phase Ib/II study results of eteplirsen, an exon-skipping therapy for the treatment of Duchenne muscular dystrophy. The genetic muscle-wasting disease...

Glenmark Completes Phase I Trial of Pain Drug
28 July 2011 Glenmark Pharmaceuticals has successfully completed a Phase I trial of GRC 15300, a first-in-class TRPV3 inhibitor for the treatment of pain. The study was conducted in the UK and showed...

FDA Approves Sulphur Colloid Injection
27 July 2011 Pharmalucence has received US Food and Drug Administration (FDA) approval for its Sulphur Colloid Injection, a radioactive tracer that can locate lymph nodes in breast cancer patients. ...

Dr Reddy's Acquires Assets of JB Chemicals & Pharmaceuticals
27 July 2011 Dr Reddy's Laboratories has entered into an agreement to acquire the pharmaceutical prescription portfolio of JB Chemicals & Pharmaceuticals in Russia and the Commonwealth of...

Bristol-Myers Squibb to Acquire Amira Pharmaceuticals
26 July 2011 Bristol-Myers Squibb has signed a definitive agreement to acquire US-based Amira Pharmaceuticals for a price of $325m, with additional payments totalling $150m. Under the...

Repligen Initiates RG1068 Drug Study
26 July 2011 Repligen has enrolled the first patient in a pilot study to evaluate the ability of RG1068 to improve detection and characterisation of pancreatic cancer. RG1068, a synthetic version of...

Synta Begins Phase IIb/III Ganetespib Study
25 July 2011 Synta Pharmaceuticals has initiated a Phase IIb/III GALAXY trial of ganetespib in combination with docetaxel in patients with non-small cell lung cancer. Ganetespib is a potent,...

Study Says Heplisav is Superior to Engerix-B
25 July 2011 A Phase III study of a hepatitis B virus vaccine Heplisav undertaken by Dynavax Technologies demonstrated superiority and safety compared to Engerix-B. Heplisav vaccine combines hepatitis...

Levomilnacipran Found Effective Against Major Depressive Disorder
22 July 2011 Forest Laboratories and Pierre Fabre Medicament have presented the preliminary top-line results from a Phase III study of once-daily Levomilnacipran as a treatment for major depressive disorder...

Tobira Combination Therapy Shows Promising Results
22 July 2011 A Tobira Therapeutics Phase I study of cenicriviroc in combination with tenofovir disoproxil fumarate has demonstrated promising results in healthy adults. Cenicriviroc is a potent...

FDA Clears Graceway Skin Cream
21 July 2011 Graceway Pharmaceuticals has received US Food and Drug Administration approval for Zyclara (imiquimod) cream, 2.5% for the treatment of actinic keratoses. Zyclara 3.75% cream is also...

American Regent Recalls Batch of Calcium Gluconate Injections
21 July 2011 American Regent has initiated a voluntary nationwide recall of a batch of calcium gluconate injections due to the presence of silicone particulates. The recall affects lot number 1,006...

Valeant to Acquire Ortho Dermatologics
20 July 2011 Valeant Pharmaceuticals North America and Valeant International (Barbados) have signed an agreement to acquire the assets of the Ortho Dermatologics division of Janssen Pharmaceuticals for $345m. ...

Genentech Cleopatra Phase III Study Meets Primary End Point
20 July 2011 Genentech's Cleopatra Phase III study of pertuzumab combined with Herceptin plus docetaxel chemotherapy in patients with HER2-positive metastatic breast cancer has met its primary...

US Researchers Say Antiretroviral Drugs Minimise HIV Risk
19 July 2011 Researchers from University of Washington's International Clinical Research Center have announced successful results from a pre-exposure prophylaxis study, which showed that...

BioMarin Initiates BMN 673 Drug Trial
19 July 2011 BioMarin Pharmaceutical has initiated a Phase I trial of a once-daily, oral poly-ADP-ribose polymerase inhibitor in patients with advanced haematological malignancies. The two-arm,...

Chimerix Initiates Patient Dosing in AdV HALT Study
18 July 2011 Chimerix has begun patient dosing in a randomised, placebo-controlled study of CMX001, which is being developed as a potential broad spectrum, oral antiviral product for the treatment...

OncoVista Begins Additional Safety Study of Cancer Drug
18 July 2011 OncoVista Innovative Therapies has initiated an additional safety study of cancer drug OVI-117 in a second animal species. OVI-117 is used for the treatment of solid tumours, such as...

Arena Drug Shows Efficacy Against Pulmonary Hypertension
15 July 2011 Arena Pharmaceuticals has announced results from a Phase I clinical trial of an orally bioavailable agonist of the prostacyclin receptor, APD811, as a treatment for pulmonary arterial...

Sanofi-Aventis and Regeneron Present Sarilumab Study Results
15 July 2011 Sanofi-Aventis and Regeneron Pharmaceuticals have reported clinical results from two Phase IIb studies of Sarilumab in rheumatoid arthritis and ankylosing spondylitis patients. Sarilumab is...

Alemtuzumab Shows Efficacy for Multiple Sclerosis
14 July 2011 Sanofi-Aventis and its subsidiary, Genzyme, have reported positive top-line results from CARE-MS I, the first of two Phase II clinical trials of alemtuzumab in patients with...

Advaxis Completes Patient Enrolment in Neoplasia Study
14 July 2011 Advaxis has concluded enrolment of the first 40-subject cohort in the dose-ranging Phase II study of ADXS-HPV, an immunotherapy for cervical intraepithelial neoplasia. The randomised,...

Onconova Partners SymBio to Develop Rigosertib
13 July 2011 Onconova Therapeutics and SymBio Pharmaceuticals have signed a licence agreement to develop and commercialise rigosertib in Japan and Korea. Rigosertib, a styryl benzyl sulfone, is a...

HyQ Found Effective for Primary Immunodeficiency
13 July 2011 Baxter and Halozyme Therapeutics have released top-line results from a Phase III study of a HyQ, a subcutaneous immune globulin product to treat primary immunodeficiency. The...

Synta Reports Positive Results from Ganetespib Trial
12 July 2011 Synta Pharmaceuticals has reported positive results from a Phase II single-agent clinical trial of ganetespib in patients with advanced non-small cell lung cancer who had failed prior...

Alkermes Reports ALKS 33 Phase II Results
12 July 2011 Alkermes has released the results of a Phase II trial designed to assess the safety and efficacy of daily oral administration of ALKS 33 in patients with binge eating disorder. ...

MSDC Receives Funding for Alzheimer's Drug Trial
11 July 2011 Metabolic Solutions Development Company (MSDC) has received a $773,000 grant from the Alzheimer's Drug Discovery Foundation to conduct a Phase IIa trial of MSDC-0160, used for the treatment...

Bristol-Myers and Innate Pharma to Develop Cancer Drug
11 July 2011 Bristol-Myers Squibb and Innate Pharma have signed a licence agreement for the development and commercialisation of cancer drug IPH2102. Under the agreement, Innate Pharma will...

Pfizer Reports Positive Results of Lyrica
08 July 2011 Pfizer has announced the top-line results from a Phase III study of Lyrica (pregabalin) as a treatment of fibromyalgia. The 16-week, randomised, double-blind, multicentre and...

BioLineRx Enrols First Patient for Neuropathic Drug Phase I Study
08 July 2011 BioLineRx has enrolled the first patient in a Phase I study of BL-1021, an oral drug to treat neuropathic pain. The first-in-human, single-site, double-blind and placebo-controlled study...

Talactoferrin Drug Found Effective for Sepsis
07 July 2011 Agennix has announced positive results from a Phase II trial to evaluate talactoferrin, an oral immunotherapy, as a treatment for severe sepsis. The randomised study evaluated 190 patients...

Bioniche to Acquire Assets of Plasvacc
07 July 2011 Canada's Bioniche has entered into a letter of intent to purchase the business and assets of Australia-based Plasvacc Holdings. The acquisition includes the inventories, properties,...

Ataluren Shows Efficacy for Cystic Fibrosis
06 July 2011 PTC Therapeutics has announced the successful clinical results from a Phase II study of ataluren, a drug to treat adults with nonsense mutation cystic fibrosis. The trial, an extension of...

Onbrez Inhalation Capsules Receive Japanese Regulatory Approval
06 July 2011 The Japanese Ministry of Health, Labour and Welfare has approved Novartis' once-daily Onbrez inhalation capsules (indacaterol), 150µg, for the treatment of chronic obstructive...

ALKS 9070 Drug Found Effective for Schizophrenia
05 July 2011 Alkermes has reported the positive top-line results from a Phase Ib study of ALKS 9070, a drug used to treat schizophrenia. The 20-week double-blind, randomised, multicentre...

Endo Reports Positive Results of Back Pain Drug
05 July 2011 Endo Pharmaceuticals has announced the successful clinical results from a Phase II study of axomadol, a drug to treat moderate-to-severe chronic low back pain. The drug was orally...

Lucentis Injection Shows Efficacy for Diabetic Macular Oedema
04 July 2011 Genentech has announced the successful clinical results from the two Phase III trials of Lucentis (ranibizumab injection) in people with diabetic macular oedema. The 36-month...

Zalicus Initiates Phase IIb Trial of Rheumatoid Arthritis Drug
04 July 2011 Zalicus has initiated a Phase IIb clinical trial of Synavive, a low-dose glucocorticoid to treat rheumatoid arthritis. The 12-week, five-arm, global, double-blind and placebo-controlled...

Scynexis and Anacor Report Positive Results for Sleeping Sickness Drug
01 July 2011 Anacor Pharmaceuticals and Scynexis have announced the successful completion of pre-clinical studies of oral drug candidate SCYX-7158 (AN5568), used to treat sleeping sickness. The...

TAK-875 Found Effective Against Type 2 Diabetes
01 July 2011 Takeda Pharmaceutical has reported positive results from a Phase II trial of investigational compound TAK-875, used for the treatment of type 2 diabetes. The randomised, double-blind,...

MIM-D3 Found Effective for Dry Eye Disease
30 June 2011 Mimetogen Pharmaceuticals has announced the positive data from a Phase II clinical trial of MIM-D3 for the treatment of dry eye. The 28-day Phase II study included 150 patients and...

Anacor Reports Positive Results of AN2728 for Psoriasis
30 June 2011 Anacor Pharmaceuticals has reported successful preliminary results from its Phase IIb trial of AN2728, used for the treatment of mild-to-moderate plaque-type psoriasis. The randomised...

Endo Pharmaceuticals Recalls Endocet Tablets
29 June 2011 Endo Pharmaceuticals has issued a voluntary nationwide consumer level recall of Endocet (oxycodone/acetaminophen) tablets, 10 mg / 325mg, in 100-count bottles, in the US. The affected lots...

Combination Therapy of Dapagliflozin and Metformin Found Effective in Type 2 Diabetes Patients
29 June 2011 Bristol-Myers Squibb and AstraZeneca have announced the successful clinical results from a long-term Phase III trial of dapagliflozin drug added to metformin, used to treat type 2 diabetes. ...

Arno's AR-67 Shows Efficacy in Glioblastoma Multiforme Trial
28 June 2011 Arno Therapeutics has reported the positive results from a Phase II clinical study of AR-67, used for treating patients with glioblastoma multiforme. The open-label and multicentre...

Rexahn Completes Patient Enrolment in Serdaxin Phase IIb Trial
28 June 2011 Rexahn Pharmaceuticals has completed patient enrolment in its Phase IIb clinical trial of Serdaxin as a treatment major depressive disorder. A total of 300 patients at about 40 sites have...

Ritter Enrols First Patient in Phase II Trial of Lactose Intolerance Drug
27 June 2011 Ritter Pharmaceuticals has enrolled the first patient in its Phase II clinical trial of RP-G28 as a treatment for lactose intolerance. The randomised, double-blind and placebo-controlled...

Ulcerative Colitis Drug Tests Well in Phase IIb Trial
27 June 2011 Lipid Therapeutics has announced positive clinical results from a Phase IIb trial of LT-02, a potential treatment for ulcerative colitis. The randomised, multicentre, double-blind,...

FDA Approves Generic Versions of Levaquin
24 June 2011 The US Food and Drug Administration (FDA) has approved the first generic versions of Sanofi-Aventis antibiotic Levaquin (levofloxacin). The drug is often used to treat bacterial infections...

Threshold Completes Patient Enrolment for Phase II Pancreatic Cancer Study
24 June 2011 Threshold Pharmaceuticals has completed patient enrolment for a Phase II trial of small molecule, tumour selective, hypoxia-activated prodrug TH-302 in patients with first line pancreatic cancer. ...

Cellceutix's Kevetrin Shows Promise as a Cancer Treatment
23 June 2011 Cellceutix Corporation has reported that Kevetrin has demonstrated anti-tumour activity in the treatment of a pancreatic carcinoma cell line in a xenograft tumour model. The three-week...

Momenta Cancer Drug Candidate Found to Inhibit Tumour Metastasis
23 June 2011 Momenta Pharmaceuticals has announced positive results from a pre-clinical study of oncology drug candidate M402. The study, the first to evaluate anti-tumour efficacy in an experimental...

Wipro Develops Cloud-Based Portal for Clinical Trials
22 June 2011 Wipro Technologies has developed a secure cloud-based solution to improve collaboration capabilities for multi-region clinical trials. The Wipro Clinical Collaboration Portal will cut...

Peripheral T-Cell Lymphoma Drug Performs Well in Trial
22 June 2011 Allos Therapeutics has reported successful clinical results from the PROPEL trial of single-agent Folotyn (pralatrexate injection), used as a second-line treatment for patients with relapsed...

Aradigm Reports Positive Results of Ciprofloxacin
21 June 2011 Aradigm has announced positive top line results from a Phase IIb study of ciprofloxacin (ARD-3100) for inhalation in patients with non-cystic fibrosis bronchiectasis, a progressive lung disease. ...

Revlimid and Rituximab Show Clinical Benefits in Mantle Cell Lymphoma Patients
21 June 2011 Celgene International has reported positive clinical data from a Phase I/II study evaluating the combination of Revlimid (lenalidomide) plus rituximab in patients with relapsed or...

Neurelis Reports Positive Results of Intranasal Diazepam
20 June 2011 Neurelis has announced the results of a Phase I clinical trial of NRL-01 (intranasal diazepam), which is used to control bouts of acute repetitive seizure activity. The randomised,...

Liraglutide Improves Glycaemic Control in Type 1 Diabetics
20 June 2011 Researchers at the University at Buffalo in New York, US, have announced the results of a study of type 2 diabetes medication liraglutide as a treatment to control blood-glucose levels in type...

CorMedix Completes Patient Enrolment in Kidney Disease Study
17 June 2011 CorMedix has successfully completed patient enrolment in a Phase II contrast-induced acute injury study for oral drug candidate CRMD001. The double blind, placebo-controlled and...

Deplin Combination Therapy Found to Improve Depressive Symptoms
17 June 2011 A multicentre, randomised and placebo-controlled clinical study has found that Deplin (L-methylfolate) combined with antidepressants reduces depressive symptoms. The data, collected from...

CytRx Reports Positive Results of Bafetinib in Leukaemia Patients
16 June 2011 CytRx has announced the preliminary results from its Phase II trial of bafetinib, used to treat patients with relapsed or refractory B-cell chronic lymphocytic leukaemia. Sixteen patients...

AC220 Monotherapy Found Effective in Acute Myeloid Leukaemia Patients
16 June 2011 Ambit Biosciences and Astellas Pharma have reported positive clinical results from the Phase II study of a selective FLT3 inhibitor, AC220, which is used to treat acute myeloid leukaemia. ...

Rozrolimupab Shows Efficacy in Immune Thrombocytopenia Patients
15 June 2011 Symphogen has reported the preliminary results from a Phase II clinical trial of rozrolimupab (SYM001) in RhD positive, non-splenectomised adults with immune thrombocytopenia. ...

Adcetris Found to be Effective in Hodgkin Lymphoma Patients
15 June 2011 Millennium and Seattle Genetics have announced successful clinical results from two Phase II trials of Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin's lymphoma patients. ...

Vertex Publishes Interim Results of Cystic Fibrosis Combination Therapy
14 June 2011 Vertex Pharmaceuticals has announced the interim results of combination regimens of VX-770 and VX-809, two drugs to treat cystic fibrosis, from the first part of a Phase II study. The first...

Abbott Reports Positive Results from Phase III Parkinson's Disease Gel Study
14 June 2011 Abbott has reported interim efficacy and safety results from a Phase III study of levodopa-carbidopa intestinal gel, used for the treatment of advanced Parkinson's disease. The...

Xoma 052 Shows Efficacy in Diabetic Patients
13 June 2011 Xoma has presented the successful six-month results from a Phase IIa clinical trial of Xoma 052 in patients with type 2 diabetes. The trial included 74 patients and showed the drug was safe...

4SC Reports Positive Results of Vidofludimus in Rheumatoid Arthritis Patients
13 June 2011 4SC has reported the positive results from a Phase IIb clinical trial of vidofludimus in patients with rheumatoid arthritis. The randomised, double-blind, placebo-controlled Phase IIb...

US Researchers Complete Study on Nerve Agent Treatment
10 June 2011 Researchers at the University of Pittsburgh Medical Center in the US have successfully completed a Phase I study with atropine sulphate delivered from a MicroDose proprietary dry powder inhaler...

CIP-Isotretinoin Shows Efficacy in Treating Nodular Acne
10 June 2011 Cipher Pharmaceuticals has presented the safety and efficacy results from a Phase III safety study of CIP-Isotretinoin, used for the treatment of severe nodular acne. The...

Eisai's Dacogen Injection Shows Efficacy in Acute Myeloid Leukaemia Patients
09 June 2011 Eisai has announced results from a Phase III study of DNA methylation inhibitor Dacogen (decitabine) in patients with acute myeloid leukaemia. The open-label, multi-centre DACO-016...

VTX-2337 Shows Promise as Advanced Solid Tumour Treatment
09 June 2011 VentiRx Pharmaceuticals has presented the results from the Phase 1 clinical trial of Toll-Like Receptor 8 (TLR8) agonist, VTX-2337 used to treat patients with advanced solid tumors. ...

Ganetespib Proven Effective for Non-Small Cell Lung Cancer
08 June 2011 Synta Pharmaceuticals has announced successful clinical responses from the Phase II trial of ganetespib in patients with advanced non-small cell lung cancer. The trial evaluated 76...

Cabozantinib Effective for Metastatic Ovarian Cancer
08 June 2011 Exelixis has reported positive results from the Phase II trial of Cabozantinib (XL184) in patients with metastatic ovarian cancer. The randomised trial enrolled 70 patients and indicated...

Relovair Shows Efficacy for COPD
07 June 2011 GlaxoSmithKline and Theravance have announced the results of two six-month Phase III studies of Relovair in patients with chronic obstructive pulmonary disease (COPD). The...

Teva Completes Patient Enrolment for Phase III Multiple Sclerosis Trial
07 June 2011 Teva Pharmaceutical has completed patient enrolment for the Glatiramer Acetate Low-Frequency Administration trial of Copaxone (glatiramer acetate injection) as a treatment for multiple sclerosis. ...

BioSante Completes Patient Enrolment in LibiGel Phase III Trial
06 June 2011 BioSante Pharmaceuticals has completed patient enrolment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. The gel is used for the treatment...

DPX-0907 Cancer Vaccine Successful in Phase I Trial
06 June 2011 Immunovaccine has announced successful immune responses from the Phase I clinical trial of a therapeutic cancer vaccine, DPX-0907. The open-label, dose-escalating trial was conducted at...

AMRI Drug Shows Efficacy Against Obesity
03 June 2011 AMRI has announced positive results from a Phase I clinical study of its MCH1 receptor antagonist, ALB-127158(a), used to treat obesity. The placebo-controlled study evaluated the...

Lomitapide Drug Found Effective for Homozygous Familial Hypercholesterolemia
03 June 2011 Aegerion Pharmaceuticals has reported the positive results from the Phase III clinical trial of lomitapide when used as a treatment for homozygous familial hypercholesterolemia. The Phase...

Thallion Enrols First Patient in High-Dose Cohort of SHIGATEC Trial
02 June 2011 Thallion Pharmaceuticals has enrolled the first patient in the high-dose cohort of its Phase II SHIGATEC trial, which will evaluate Shigamabs as a treatment for E coli infections that produce...

FDA Approves Oceana's Solesta Gel
02 June 2011 Oceana Therapeutics has received US Food and Drug Administration (FDA) approval for Solesta, its injectable gel treatment for faecal incontinence. The approval is based on the results from...

FDA Approves Dificid Tablets
01 June 2011 Optimer Pharmaceuticals has received US Food and Drug Administration (FDA) approval for Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhoea people aged...

Cixutumumab Found to be Effective in Five Sarcoma Subtypes
01 June 2011 Eli Lilly and Company has announced positive data from its Phase II study of cixutumumab in five subtypes of sarcoma, a cancer related to connective tissues. The Phase II trial included...

Basilea Reports Positive Results of BAL30072
31 May 2011 Basilea Pharmaceutica has reported positive top-line results from the Phase I study of its antibiotic BAL30072, used for the treatment of infections caused by multi-drug resistant...

NLX-P101 Proven Effective Against Parkinson's
31 May 2011 Neurologix has announced efficacy results from the Phase II clinical trial of gene therapy agent NLX-P101, used for the treatment of Parkinson's disease. The trial included 45 subjects...

Novartis ACZ885 Drug Treats Gouty Arthritis
27 May 2011 Novartis has announced positive results from the two pivotal Phase III studies of ACZ885 (canakinumab), a drug that could be used to treat gouty arthritis. The two Phase III,...

Avanafil Proven Effective for Erectile Dysfunction
27 May 2011 Vivus has reported the positive results from the Phase III clinical trial of Avanafil, a potential treatment for erectile dysfunction following a radical prostatectomy. The...

Pfizer's Tofacitinib Found to be Effective Against Rheumatoid Arthritis
26 May 2011 Pfizer has announced positive results from two studies of tofacitinib, an oral JAK inhibitor used to treat chronic inflammatory autoimmune disease rheumatoid arthritis. The first, the Phase...

KemPharm Drug KP201 Proven to Relieve Pain
26 May 2011 KemPharm has reported positive results from a Phase I clinical trial of its opioid-based drug candidate, KP201. The single dose, three-treatment, three-period, six-sequence and cross-over...

Inspra Found to Reduce New Onset Atrial Fibrillation
25 May 2011 Pfizer has announced positive results from the EMPHASIS-HF trial2, which revealed that Inspra (eplerenone) reduces the incidence of new onset atrial fibrillation or flutter in patients...

Tribenzor Proven Effective for Hypertension
25 May 2011 A study has reported positive findings of three-in-one combination product Tribenzor as a treatment for high blood pressure. The Phase III, multicentre, randomised, parallel-group study...

TMC435 Proven Effective for Hepatitis C
24 May 2011 Medivir has announced positive results from a Phase IIb study of TMC435 in patients with genotype 1 chronic hepatitis C. The randomised, placebo-controlled, double-blind study included...

Eliquis Receives European Commission Approval
24 May 2011 Eliquis, a new oral direct Factor Xa inhibitor, has received European Commission approval for the prevention of venous thromboembolic events in adult patients who have undergone elective hip...

Xgeva Drug Shows Positive Phase III Results
23 May 2011 Amgen has announced the primary results from a Phase 3 trial of Xgeva (denosumab), which prevents the spread of cancer to the bone in men with advanced prostate cancer. The...

CT-011 Effective for Treating DLBCL
23 May 2011 Teva Pharmaceutical and CureTech have announced the positive Phase 2 results for CT-011, an anti-PD-1 monoclonal antibody. The study included patients with diffuse large B cell lymphoma...

AstraZeneca's Olaparib Show Promise for Serous Ovarian Cancer
20 May 2011 AstraZeneca has reported positive results from a Phase II study of olaparib, a potential treatment for platinum-sensitive relapsed serous ovarian cancer. The Phase II, randomised,...

NovaBay Reports Positive Results of NVC-422
20 May 2011 NovaBay Pharmaceuticals announced beneficial results from a Phase II clinical study of NVC-422 ophthalmic solution, used for the treatment of adenoviral conjunctivitis, a contagious...

Takeda and Lundbeck Initiate Major Depressive Disorder Drug Trial in Japan
19 May 2011 Takeda Pharmaceutical and H Lundbeck have initiated a Phase III clinical trial for investigational multimodal antidepressant Lu AA21004 in patients with major depressive disorder. ...

FDA Approves Chronic Hepatitis C Drug Victrelis
19 May 2011 The US Food and Drug Administration (FDA) has approved Merck's Victrelis (boceprevir), in combination with peginterferon alfa and ribavirin, to treat chronic hepatitis C in patients...

AstraZeneca Inhalation Aerosol Effective for Asthma Patients
18 May 2011 AstraZeneca's Symbicort inhalation aerosol has demonstrated safety and efficacy results in African-American patients with moderate-to-severe persistent asthma. Symbicort is a combination...

Pacira Pain Drug Exparel Shows Positive Results
18 May 2011 Pacira Pharmaceuticals has reported positive results from a Phase III study of Exparel in patients who had undergone excisional hemorrhoidectomy using the Milligan-Morgan technique, a painful...

Pirfenidone Shows Positive Phase III Results
17 May 2011 InterMune has published positive results from two Phase III trials of pirfenidone on lung function, six-minute walking distance test and progression-free survival in patients with...

Otsuka OPC-34712 Effective for Major Depressive Disorder
17 May 2011 Otsuka Pharmaceuticals has said its OPC-34712 drug has shown efficacy when used as an adjunctive therapy in adults with major depressive disorder. In Phase II multicentre,...

Abbott's Humira Effective Against Ulcerative Colitis
16 May 2011 Abbott has announced that a Phase III study has shown its rheumatoid arthritis drug Humira (adalimumab) to be effective in treating ulcerative colitis, which causes inflammation and ulceration...

Can-Fite CF102 Proven Effective for Hepatocellular Carcinoma
16 May 2011 Can-Fite BioPharma has declared positive Phase I/II results of CF10, used in the treatment of hepatocellular carcinoma. The interim Phase I/II trial, which included 18 patients...

Swissmedic Approves Votubia for Subependymal Giant Cell Astrocytoma
13 May 2011 Swissmedic has announced that it has approved Votubia (everolimus) tablets for the treatment of subependymal giant cell astrocytoma associated with tuberous sclerosis in patients aged three...

Remicade Effective Against Paediatric Active Ulcerative Colitis
13 May 2011 Centocor Ortho Biotech has reported positive results from a Phase III study of Remicade (infliximab) as a treatment of moderate-to-severe active ulcerative colitis in paediatric patients. ...

Sucampo, Abbott Present Phase III Clinical Data of Lubiprostone
12 May 2011 Sucampo Pharmaceuticals and Abbott have said that lubiprostone capsules have been proven effective in Japanese chronic idiopathic constipation patients during a Phase III clinical...

Inovio Reports Positive Results from DNA Vaccine Study
12 May 2011 Inovio Pharmaceuticals has reported positive results from a Phase I study of VGX-3100, a DNA vaccine that achieved long-term durability of immune responses for treating cervical dysplasia...

Study Shows Efficacy of Nuvigil
11 May 2011 Cephalon has announced positive results from a Phase IV trial of Nuvigil (armodafinil) tablets for excessive sleepiness associated with shift work disorder. The six-week, double-blind...

Nexvax2 Proven Effective for Coeliac Disease
11 May 2011 The Phase I clinical trial of Nexvax2 vaccine has shown positive results for the treatment of coeliac disease, an autoimmune condition caused by a reaction to the gluten found in wheat, rye...

Study Demonstrates Velcade's Effectiveness Against Multiple Myeloma
10 May 2011 US-based Takeda Oncology Company has announced positive results from a randomised Phase III trial of Velcade (bortezomib) as a treatment of multiple myeloma in patients who have had an...

Cempra's Solithromycin Shows Excellent Systemic Tolerability
10 May 2011 Cempra Pharmaceuticals has announced that intravenous solithromycin demonstrated tolerability and a favourable pharmacokinetic profile in a Phase I study. The single-centre,...

Pfizer Announces Positive Results for Pristiq Drug
09 May 2011 Pfizer has announced positive results from a Phase III study of Pristiq (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor that reduces the number and severity of...

Strides Anaesthetic Drug Receives FDA Approval
09 May 2011 Strides Arcolab has announced that it has received US Food and Drug Administration (FDA) approval for Midazolam injection multiple-dose vials. Midazolam, a general anaesthetic, is given as...

Amira AM152 Proven Effective in Study
06 May 2011 Amira Pharmaceuticals has announced positive results from a Phase I clinical study of AM152, a LPA1 receptor antagonist for the treatment of idiopathic pulmonary fibrosis. Isabelle...

Bristol Recalls Coumadin Drug
06 May 2011 Bristol-Myers Squibb has initiated a voluntary recall of Coumadin (warfarin sodium) crystalline 5mg tablets, which are used to treat or prevent blood clots. The recall is a precautionary...

FDA Approves Tradjenta for Type 2 Diabetes
05 May 2011 Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced that the US Food and Drug Administration (FDA) has approved Tradjenta (linagliptin), a dipeptidyl peptidase-4 inhibitor used...

SARcode Announces Positive Clinical Results of SAR 1118
05 May 2011 SARcode has announced that its SAR 1118 molecule has shown positive results in a Phase II Study of dry eye disease. SAR 1118 is an integrin antagonist that inhibits T-cell...

AstraZeneca Receives FDA Clearance for Nexium IV
04 May 2011 AstraZeneca has received US Food and Drug Administration (FDA) approval for Nexium IV (esomeprazole sodium) injection for the short-term treatment of gastroesophageal reflux disease (GERD)...

XEN402 Ointment Proven Effective for Post-Herpetic Neuralgia
04 May 2011 Xenon Pharmaceuticals has announced that its novel ointment for post-herpetic neuralgia, XEN402, has demonstrated significant and clinically meaningful reductions in patient's pain during a...

PolyMedix PMX-30063 Effective Against NDM-1 Drug-Resistant Bacteria
03 May 2011 PolyMedix has said that its lead defensin-mimetic antibiotic, PMX-30063, has shown activity in an in vitro laboratory test against the New Delhi metallo-beta-lactamase-1 (NDM-1) drug...

Abbott Receives FDA Approval for AndroGel 1.62%
03 May 2011 Abbott Laboratories announced that the US Food and Drug Administration (FDA) has approved AndroGel (testosterone gel) 1.62%, a clear and odourless gel formulation shown to treat adult males...

Selumetinib Shows Positive Results Against Biliary Cancer in Phase II Trial
28 April 2011 A Phase II clinical trial led by cancer researchers at Ohio State University in the US has demonstrated the positive effects of selumetinib in people with advanced biliary cancer, a malignancy...

MonoSol and KemPharm Partner to Develop ADHD Drug
28 April 2011 PharmFilm drug delivery technology developer MonoSol Rx has announced a partnership with biopharmaceutical company KemPharm to develop new, safer therapies for the treatment of attention...

FDA Approves Vaccine to Treat Meningococcal Disease in Infants
27 April 2011 Menactra, a vaccine against meningococcal disease that is already approved for use in people aged two to 55 years old, has now been approved for children as young as nine months old by the US...

Anti-Inflammatory Drugs Found to Reduce Antidepressant Efficacy
27 April 2011 Scientists at Rockefeller University in the US have conducted a study and confirmed that anti-inflammatory drugs such as ibuprofen, aspirin and naproxen reduce the ability of...

Phase III Trial of Hyperphosphatemia Drug Begins in Japan
26 April 2011 Japan Tobacco and its subsidiary Torii Pharmaceutical have begun the Phase III clinical trial of ferric citrate in Japan to treat patients with hyperphosphatemia. The two firms...

Combination Therapy Effective Against Antibiotic Resistant Bacteria
26 April 2011 Researchers at McMaster University of Canada have discovered a combination therapy to fight against antibiotic resistant bacteria in patients with cystic fibrosis, the most common fatal...

Proteon Initiates Patient Enrolment for PRT-201 Phase II Study
21 April 2011 US-based Proteon Therapeutics has begun enrolment in a Phase 2 clinical trial of its lead product PRT-201 in in chronic kidney disease (CKD) patients preparing undergoing surgery for...

Inovio, Transgene and ChronTech Collaborate for HCV Vaccine
21 April 2011 Inovio Pharmaceuticals has signed an agreement with Transgene and ChronTech Pharma to jointly evaluate a therapeutic vaccination strategy against genotype 1 hepatitis C virus (HCV) in a phase...

L-Lysine Benefits Schizophrenia Patients, Study Reveals
20 April 2011 L-lysine treatment could improve symptom severity and cognitive deficits in patients with schizophrenia, according to a study conducted by a team of Swedish researchers. The study...

FDA Approves Taro's Imiquimod Cream
20 April 2011 Taro Pharmaceutical Industries has received US Food and Drug Administration (FDA) approval for Imiquimod cream 5%. Imiquimod cream, which is used for treatment of actinic keratosis and...

Debiopharm, Aurigene to Develop Oncology Drug
19 April 2011 Swiss-based Debiopharm Group has signed an agreement with Aurigene Discovery Technologies to develop and commercialise Debio 1142, a novel inhibitor of an undisclosed oncology...

Genentech Receives FDA Approval for Actemra
19 April 2011 The US Food and Drug Administration (FDA) has approved Genentech's Actemra (tocilizumab) as a treatment for active systemic juvenile idiopathic arthritis. The approval was based on...

S*BIO Initiates Lymphoma Drug Trial
18 April 2011 S*BIO has dosed the first ten patients in a Phase II clinical trial of its novel JAK2 inhibitor SB1518 for the treatment of advanced lymphoid malignancies. The multi-centre, open-label study...

Regulus and US University to Develop Treatments for Angiogenic Diseases
18 April 2011 Regulus Therapeutics has entered into collaboration with researchers at the University of California San Diego's school of medicine to develop novel treatments for angiogenic diseases...

Sanofi Reports Positive Results from Diabetes Drug Study
15 April 2011 Sanofi-Aventis has reported positive results from the Phase III study evaluating lixisenatide, a once-daily GLP-1 receptor agonist under development for people with type 2 diabetes. The...

Vanda Begins Schizophrenia Drug Study
15 April 2011 Vanda Pharmaceuticals has reported that Novartis Pharmaceuticals has initiated a Phase I clinical study to evaluate the safety and pharmacokinetic profiles of two long-acting...

Teva and Active Biotech Report Multiple Sclerosis Drug Success in Study
14 April 2011 Teva Pharmaceutical Industries and Active Biotech have reported positive results from the two-year Phase III of laquinimod, an oral, once-daily, investigational immunomodulator for the treatment...

Durect Low Back Pain Drug Fails in Study
14 April 2011 Durect has reported unsuccessful results from a Phase II clinical trial evaluating Eladur (transdur-bupivacaine), Durect's proprietary investigational transdermal bupivacaine pain patch,...

Pfizer and Medivation Huntington Drug Fails Study
13 April 2011 Pfizer and Medivation have reported unsuccessful results from a Phase III trial of investigational drug Dimebon (latrepirdine) in patients with Huntington's disease. The results revealed...

Biogen Multiple Sclerosis Drug Meets Study Goals
13 April 2011 Biogen has reported positive top-line results from the first of two Phase III clinical trials to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy...

Bayer and Regeneron Initiate Diabetic Macular Oedema Drug Trial
12 April 2011 Bayer HealthCare and Regeneron Pharmaceuticals have initiated the first of two Phase III trials evaluating the safety and efficacy of VEGF Trap-Eye (aflibercept ophthalmic solution) in...

Marina Initiates Dosing in Familial Adenomatous Polyposis Drug Trial
12 April 2011 Marina Biotech has initiated patient dosing in a Phase Ib/IIa trial evaluating CEQ508 in patients with familial adenomatous polyposis. The open-label, escalating-dose study is designed...

Lpath Initiates Retinal Detachment Drug Trial
11 April 2011 Lpath has initiated enrolment in Phase Ib/IIa trial of iSONEP, the company's ocular drug candidate, in patients with retinal pigment epithelium detachment. The Phase Ib/IIa trial will enrol...

Roche Reports Positive Results from Breast Cancer Drug Trial
11 April 2011 Roche has reported positive topline results from its first randomised trial of trastuzumab emtansine (T-DM1), an antibody-drug conjugate, in HER2-positive metastatic breast cancer. ...

FDA Clears AstraZeneca Medullary Thyroid Cancer Drug
08 April 2011 AstraZeneca has received approval from the US Food and Drug Administration (FDA) for vandetanib as a treatment for late-stage medullary thyroid cancer in adults who are ineligible for surgery...

Abbott and Enanta Report Positive Results from Hepatitis C Drug Study
08 April 2011 Abbott and Enanta Pharmaceuticals have reported positive 12-week results from a Phase II study of ABT-450/r, an investigational oral protease inhibitor being developed for the treatment...

Oncothyreon Initiates Enrolment in Brain Tumour Drug Study
07 April 2011 Oncothyreon has enrolled the first patient in a Phase II trial to evaluate PX-866 in patients with glioblastoma multiforme that has recurred during or following primary therapy. The...

Dara Begins Study of Diabetes Drug
07 April 2011 Dara BioSciences has initiated a Phase Ib clinical study of DB959, its peroxisome proliferator-activated receptor delta / gamma agonist for the treatment of type 2 diabetes. DB959...

Boehringer Moves Hepatitis C Drug into Phase III Trials
06 April 2011 Boehringer Ingelheim has announced the study outline for Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor to treat chronic...

Stealth Reports Positive Results from Ischaemia Reperfusion Injury Study
06 April 2011 Stealth Peptides has reported positive results from a Phase I clinical study to evaluate Bendavia, a novel compound that targets the mitochondria to treat ischaemia reperfusion injury. ...

Regado Reports Positive Results from Anticoagulation Drug Study
05 April 2011 Regado Biosciences has reported positive primary results from the Phase IIb RADAR clinical trial of its lead product, the REG1 anticoagulation system. REG1 is a two-component system...

Intercell and Novartis to Launch Pseudomonas Aeruginosa Vaccine Study
05 April 2011 Intercell and Novartis have agreed to advance Intercell's investigational Pseudomonas aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated intensive care unit...

Omeros Knee Surgery Drug Fails in Phase III Trials
04 April 2011 Omeros Corporation has reported unsuccessful results from the Phase III programme evaluating OMS103HP in patients undergoing arthroscopic anterior cruciate ligament reconstruction...

Enrolment Begins for Amyotrophic Lateral Sclerosis Drug Study
04 April 2011 Biogen and Knopp Biosciences have enrolled the first patient in a Phase III study to evaluate dexpramipexole as a treatment for amyotrophic lateral sclerosis. The randomised,...

Achillion Reports Positive Results from Hepatitis C Drug Study
01 April 2011 Achillion Pharmaceuticals has reported positive top-line results from its ongoing Phase IIa clinical trial evaluating ACH-1625 in patients with chronic hepatitis C. The results showed...

Medivation and Astellas Begin Prostate Cancer Drug Study
01 April 2011 Medivation and Astellas Pharma have announced that they have treated the first patient in a Phase II study of MDV3100, a triple-acting oral androgen receptor antagonist to fight advanced...

ViroPharma Trials Antibody-Mediated Rejection Drug
31 March 2011 ViroPharma has initiated a Phase II clinical study to evaluate Cinryze, a C1 esterase inhibitor, for the treatment of acute antibody-mediated rejection in donor-specific, cross-match...

Intercept Initiates Nonalcoholic Steatohepatitis Drug Trial
31 March 2011 Intercept Pharmaceuticals has initiated patient enrolment in a clinical trial to evaluate its first-in-class farnesoid X receptor agonist, obeticholic acid (OCA or INT-747), as a treatment...

Natco Cancer Medication Receives FDA Orphan Drug Designation
30 March 2011 Natco Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for anti-cancer drug NRC-AN-019 for glioma, pancreatic cancer and chronic myelogenous leukaemia. ...

Bionovo Begins Enrolment for Menopausal Hot Flushes Drug Trial
30 March 2011 Bionovo has initiated the Phase I clinical trial to evaluate the safety of two doses of Menerba as a treatment of menopausal hot flushes in postmenopausal women. The open-label and...

Genentech Diabetic Macular Oedema Drug Meets Primary Endpoint
29 March 2011 Genentech has reported that (ranibizumab injection) has met the primary endpoint of the second of two Phase III trials, which evaluated it in patients with diabetic macular oedema. The...

Mersana Initiates Cancer Drug Study
29 March 2011 Mersana Therapeutics has begun a Phase Ib extension study to evaluate its lead cancer product, XMT-1001, as a treatment for second-line gastric cancer and second-line and third-line non-small...

Targacept ADHD Drug Fails to Meet Primary Endpoint
28 March 2011 Targacept has announced that TC-5619 has failed to meet the primary efficacy outcome measure of a Phase II proof-of-concept trial to evaluate it as a treatment for attention...

FDA Approves Expanded Use of Merck Shingles Vaccine
28 March 2011 The US Food and Drug Administration (FDA) has approved the use of Zostavax, an attenuated vaccine, for the prevention of shingles in individuals aged 50 to 59. Zostavax, which is...

Gilead Sciences Reports Successful Trial for HIV Drug
25 March 2011 Gilead Sciences has reported positive results from a Phase III trial evaluating elvitegravir, its investigational anti-retroviral agent, as a treatment for HIV-1 infection in...

Xoma Diabetes Drug Fails to Meet Primary Endpoint
25 March 2011 Xoma has reported unsuccessful results from its Phase 2b trial of Xoma 052 in type 2 diabetes patients. The trial did not achieve the primary endpoint of reduction in glycosylated...

InSite Reports Positive Results from Eye Inflammation Drug Study
24 March 2011 InSite Vision has reported positive to top-line results from its Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation...

Cellerant Initiates Leukaemia Drug Trial
24 March 2011 Cellerant Therapeutics has announced the initiation of a Phase I/II clinical trial of CLT-008 in patients receiving intensive post-remission chemotherapy for high-risk leukaemia or myelodysplasia....

Bristol-Myers Melanoma Drug Meets Primary Endpoint
23 March 2011 Bristol-Myers Squibb has announced that ipilimumab, an investigational compound, has met the primary endpoint of a clinical trial by improving the overall survival of previously untreated...

XenoPort Gastroesophageal Reflux Disease Drug Fails to Meet Primary Endpoint
23 March 2011 XenoPort has reported unsuccessful preliminary top-line results from a Phase IIb clinical trial evaluating arbaclofen placarbil as an adjunctive therapy in patients with gastroesophageal...

Anacor and MMV to Develop Malaria Drug
22 March 2011 Anacor Pharmaceuticals has entered into a development agreement with Medicines for Malaria Venture (MMV) to develop its AN3661 compound for the treatment of malaria. Under the agreement,...

Quark Reports Results from Diabetic Macular Oedema Drug Study
22 March 2011 Quark Pharmaceuticals has reported results from a Phase II trial evaluating the safety and efficacy of PF-04523655 (RTP801I-14) in patients with diabetic macular oedema. Interim results at...

CytRx Initiates Solid Tumour Drug Study
21 March 2011 CytRx Corporation has initiated a Phase Ib safety and dose escalation clinical trial of INNO-206 in patients with advanced solid tumours. The clinical trial will enrol up to 24 patients...

Human Genome Sciences and FivePrime to Develop Cancer Drug
21 March 2011 Human Genome Sciences and FivePrime Therapeutics have entered into an agreement to develop and commercialise FivePrime's FP-1039 product for multiple cancers. Under the terms of...

Incyte Myelofibrosis Meets Primary Endpoint in Study
18 March 2011 Incyte has reported that ruxolitinib (INCB18424 or INC424) has met the primary endpoint of a second pivotal Phase III trial, reducing spleen size in patients with myelofibrosis compared to the...

Amylin and Takeda Suspend Obesity Drug Trial
18 March 2011 Amylin Pharmaceuticals and Takeda Pharmaceutical Company have suspended clinical activities in an ongoing Phase II study evaluating pramlintide/metreleptin for the treatment of obesity...

Anacor Completes Patient Enrolment in Psoriasis Drug Trial
17 March 2011 Anacor Pharmaceuticals has completed patient enrolment for a Phase IIb trial of AN2728, a topical anti-inflammatory product candidate for the treatment of psoriasis, a chronic skin disease. ...

Unigene Begins Osteoporosis Drug Study
17 March 2011 Unigene Laboratories has dosed the first subject in a Phase II study evaluating an experimental oral parathyroid hormone analogue as a treatment for osteoporosis in postmenopausal...

Biothera Initiates Leukaemia Drug Study
16 March 2011 Biothera has initiated a Phase I/II clinical trial to evaluate Imprime PGG in combination with alemtuzumab (Campath) and rituximab (Rituxan) in patients with earlier-stage, high-risk...

Supernus ADHD Drug Meets Primary Endpoints of Phase IIa Trial
16 March 2011 Supernus Pharmaceuticals has reported positive results from a Phase IIa trial to evaluate SPN-812 as a treatment for attention deficit hyperactivity disorder (ADHD) in adults. The...

Once-Monthly Injectable Exenatide Improves Glucose Control in Study
15 March 2011 Amylin Pharmaceuticals, Eli Lilly and Alkermes have reported positive results from a Phase II study that evaluated the effect of a once-monthly injectable suspension formulation of exenatide...

Genentech Diabetic Macular Oedema Drug Meets Primary Endpoint
15 March 2011 Genentech has reported positive two-year results from a pivotal Phase III trial evaluating the efficacy and safety of Lucentis (ranibizumab injection) in patients with diabetic macular...

FDA Approves Benlysta as Lupus Treatment
14 March 2011 The US Food and Drug Administration (FDA) has approved Benlysta (belimumab) as a treatment for active, autoantibody-positive lupus. Benlysta is the first new lupus drug approved in 56 years....

Lung Cancer Drug Fails Primary Endpoint of Phase III Trial
14 March 2011 Sanofi-Aventis and Regeneron Pharmaceuticals have announced negative results from a Phase III trial evaluating investigational agent aflibercept (VEGF Trap) as a second-line treatment of...

Plexxikon Begins Hodgkin Lymphoma Drug Trial
11 March 2011 Plexxikon has treated the first patient in a Phase II clinical trial evaluating PLX3397 as a treatment for Hodgkin's lymphoma. PLX3397 is an oral, selective inhibitor that down-modulates...

Oxford Researchers Receive Grant to Develop Meningitis Vaccine for Children
11 March 2011 UK charity Action Medical Research has awarded more than £148,000 to researchers in Oxford, UK, to develop a novel vaccine against meningitis B in children. The funds have been given to...

AstraZeneca and Galderma to Develop Drugs for Dermatological Disorders
10 March 2011 AstraZeneca and Galderma Pharma have entered into a five-year R&D collaboration to develop new treatments for dermatological conditions. The partnership will focus on...

Repligen Bipolar Depression Drug Fails Phase IIb Study
10 March 2011 Repligen Corporation has reported results from a Phase IIb clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. The study did not show a...

Anacor and Institute for OneWorld Health to Develop Antibiotics for Bloody Diarrhoea
09 March 2011 Anacor Pharmaceuticals and the Institute for OneWorld Health have entered into a joint research agreement to research antibacterial compounds to treat shigellosis, commonly known as...

Pfizer Rheumatoid Arthritis Drug Meets Primary Endpoint
09 March 2011 Pfizer has reported that tofacitinib, an investigational oral JAK inhibitor being evaluated in moderate-to-severe rheumatoid arthritis, has met the primary endpoints of a Phase III study. ...

Epilepsy and Migraine Drug Linked to Birth Defects
08 March 2011 New data indicates that children born to mothers taking Topamax (topiramate) or its generic versions during pregnancy have an increased risk of birth defects, according to the US Food and...

Infinity Begins Chondrosarcoma Drug Trial
08 March 2011 Infinity Pharmaceuticals has initiated a Phase II clinical trial to evaluate IPI-926 as a treatment for patients with metastatic or locally advanced inoperable chondrosarcoma, a rare bone cancer. ...

Allergan Initiates Trials of Endopeptidase Drug Candidate
07 March 2011 Syntaxin has reported that its partner, Allergan, has begun two Phase II trials to evaluate the safety and efficacy of its re-targeted endopeptidase drug candidate AGN-214868. The trials...

NovaBay Initiates Urinary Tract Infection Trial
07 March 2011 NovaBay Pharmaceuticals has initiated a Phase II trial of a compound to prevent urinary catheter blockage and encrustation (UCBE), a major factor behind urinary tract infections. ...

FDA Takes Action to Remove Unapproved Drugs from US Market
04 March 2011 The US Food and Drug Administration (FDA) has initiated action against companies that manufacture, distribute or market certain unapproved prescription oral cough, cold, and allergy...

Seattle Genetics and Millennium Begin Lymphoma Drug Trial
04 March 2011 Seattle Genetics and Millennium: The Takeda Oncology Company have begun a Phase I clinical trial to evaluate brentuximab vedotin (SGN-35) in combination with chemotherapy as a treatment for...

Forest Chronic Obstructive Pulmonary Disease Drug Receives FDA Approval
03 March 2011 Forest Laboratories has received approval from the US Food and Drug Administration (FDA) for Daliresp (roflumilast) as a treatment to reduce the risk of exacerbating chronic obstructive...

Bavarian Nordic Begins Prostate Cancer Drug Study
03 March 2011 Bavarian Nordic has initiated a Phase II study evaluating Prostvac as a treatment for patients with metastatic castration-resistant prostate cancer. The multicentre, randomised Phase II...

Regeneron Gout Drug Meets Primary Endpoint
02 March 2011 Regeneron Pharmaceuticals has reported that allopurinol therapy Arcalyst (rilonacept) has met has met all of the primary and secondary study endpoints of its second Phase III study, which...

Synta to Begin Lung Cancer Drug Trial
02 March 2011 Synta Pharmaceuticals has reported that it will initiate a Phase IIb/III clinical trial of ganetespib (STA-9090) in combination with docetaxel in non-small cell lung cancer in the second quarter...

Takeda Hypertension Drug Edarbi Approved in US
01 March 2011 Takeda Pharmaceutical has received approval from the US Food and Drug Administration (FDA) for Edarbi tablets (azilsartan medoxomil) to treat hypertension in adults. Results from...

Enobia Completes Patient Enrolment for Bone Disorder Drug Study
01 March 2011 Enobia Pharma has completed patient enrolment for a Phase II study evaluating ENB-0040 as a treatment for hypophosphatasia, a rare metabolic bone disorder. The study will evaluate ENB-0040...

Trevena Begins Heart Failure Drug Study
28 February 2011 Trevena has initiated a Phase IIa clinical trial to evaluate TRV120027 as a treatment for acute heart failure. The randomised, placebo-controlled, double-blind, dose-ranging trial will...

FDA Awards Sunesis Leukaemia Drug Fast-Track Status
28 February 2011 Sunesis Pharmaceuticals has received fast-track designation from the US Food and Drug Administration (FDA) for vosaroxin, a drug candidate for the treatment of relapsed or refractory acute...

TransPharma Reports Positive Results from Diabetes Patch Study
25 February 2011 TransPharma Medical has reported positive results from a Phase Ib trial of its ViaDor-GLP1 agonist, which is being developed for the treatment of diabetes mellitus type II. The...

Derma Sciences Receives Grant for Skin Injury Drug
25 February 2011 The US Government has awarded Derma Sciences a $4.5m grant to pre-clinically investigate the use of DSC127 in the treatment of skin injuries associated with acute radiation exposure. ...

Medivir Reports Positive Hepatitis C Drug Study Results
24 February 2011 Medivir has reported positive results from a Phase IIb study of TMC435, the company's investigational protease inhibitor, in treatment-naïve patients with hepatitis C virus genotype-1. ...

Pharming Initiates Angiooedema Drug Study
24 February 2011 Biopharmaceutical company Santarus and biotech specialist Pharming have announced the start of a Phase IIIb clinical study evaluating RHUCIN (recombinant human C1 inhibitor) for the treatment...

Genzyme Reports Positive Results from Gaucher Drug Study
23 February 2011 Genzyme Corporation has reported positive three-year follow-up data from a Phase II clinical trial of eliglustat tartrate, an investigational oral therapy for Gaucher disease type 1. The...

FDA Approves First Product to Treat Genetic Bleeding Disorder
23 February 2011 The US Food and Drug Administration (FDA) has approved CSL Behring's Corifact, the first product intended to prevent bleeding in people with congenital Factor XIII deficiency, a rare...

miRagen Receives FDA Orphan Drug Designation for Polycythemia Vera Drug
22 February 2011 miRagen Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for MGN-4893 as a potential treatment for polycythemia vera. MGN-4893 works by...

Conatus Begins Hepatitis C Drug Study
22 February 2011 Conatus Pharmaceuticals has dosed the first patient in a Phase IIb clinical trial evaluating CTS-1027 in patients who have previously been treated for hepatitis C with no response. The...

US Marshals Seize Unapproved Ear Infection Solution
21 February 2011 US Marshals have seized all of the ear infection drug Auralgan Otic solution, manufactured for Deston Therapeutics, as the product does not have FDA approval. The sale of Auralgan in the...

Halozyme and Roche Initiate Lymphoma Drug Trial
21 February 2011 Halozyme Therapeutics and Roche have dosed the first patient with subcutaneous (SC) MabThera (rituximab), an anti-cancer biologic, in a Phase III trial using Enhanze technology...

Oncolytics Reports Positive Results for Pancreatic Cancer Drug
18 February 2011 Oncolytics Biotech has reported positive preliminary results from a Phase II clinical trial evaluating the intravenous administration of Reolysin in combination with gemcitabine (Gemzar) as...

Jomaa Pharma and MMV to Develop Novel Malaria Treatment
18 February 2011 Jomaa Pharma and Medicines for Malaria Venture (MMV) have signed a memorandum of understanding to jointly development a fosmidomycin-based treatment for acute Plasmodium falciparum-induced...

Medivir and Janssen to Develop Dengue Drugs
17 February 2011 Medivir has entered into a partnership with Janssen Pharmaceutica to discover and develop drugs for the prophylaxis and treatment of dengue virus. Under the agreement, Medivir and Janssen...

Napo Reports Positive Results from Diarrhoea Drug Study
17 February 2011 Napo Pharmaceuticals has reported positive results from a Phase II study of crofelemer as a treatment of hospitalised adults with mild to moderate acute watery diarrhoea. The...

BrainStorm Stem Cell Treatment Receives Orphan Drug Designation
16 February 2011 BrainStorm Cell Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for NurOwn, the company's autologous adult stem cell product candidate for...

Genus Begins Tumour Drug Trial
16 February 2011 Genus Oncology has dosed the first patient in a Phase I trial to evaluate its GO-203-2c compound as a treatment for solid tumours. The prospective, open-label trial is designed to determine...

Inhibitex Receives Fast-Track Designation for Hepatitis C Drug
15 February 2011 Inhibitex has received fast-track designation from the US Food and Drug Administration (FDA) for INX-08189, a guanosine nucleotide polymerase inhibitor intended to treat chronic hepatitis...

Renovo Scar Revision Drug Fails to Meet Primary Endpoint
15 February 2011 Renovo Group's first EU Phase III trial to evaluate Juvista as a treatment for scar revision surgery has failed to meet its primary and secondary endpoints. The company has since said that...

Intellikine and PKD Foundation to Develop PKD Drugs
14 February 2011 Intellikine and the PKD Foundation have entered into a partnership to investigate novel, orally-available small molecule kinase inhibitors of the TORC1 and TORC2 complexes as a potential...

Genta Initiates Prostate Cancer Drug Trial
14 February 2011 Genta Incorporated has initiated a Phase II clinical of tesetaxel in patients with advanced prostate cancer to assess it as a first and second-line chemotherapy. The study will evaluate...

Targacept Initiates Two Studies of Anti-Inflammatory Drug
11 February 2011 Targacept has initiated two separate Phase II studies of its TC-6987 product candidate, one in patients with asthma and one in patients with type II diabetes. It is hoped that the trials...

Depomed Reports Positive Parkinson's Drug Study Results
11 February 2011 Depomed has reported positive results from the second Phase I trial of DM-1992, its investigative gastric-retentive, extended-release formulation of levodopa / carbidopa in patients...

Synta Doses First Patient in Leukaemia Drug Study
10 February 2011 Synta Pharmaceuticals has dosed the first patient in a Phase I single-agent trial of elesclomol, a potential treatment for acute myeloid leukaemia. The trial, which will enrol up to 36...

Rib-X Initiates Antibiotic Drug Trial
10 February 2011 Rib-X Pharmaceuticals has initiated a Phase IIb clinical trial to evaluate delafloxacin as a treatment of acute bacterial skin and skin structure infections, as well as infections caused by MRSA. ...

PharmaMar Initiates Solid Tumour Drug Study
09 February 2011 PharmaMar has initiated a Phase I clinical trial of PM060184 for patients with solid tumours. PM060184, which is a marine-derived, synthetically-produced compound, has demonstrated strong...

AstraZeneca Halts Prostate Cancer Drug Trial
09 February 2011 AstraZeneca has stopped its Phase III Enthuse Study 15 of zibotentan monotherapy in patients with non-metastatic, castration-resistant prostate cancer after a review found that the treatment...

FDA Approves First Drug to Reduce Preterm Delivery Risk
08 February 2011 The US Food and Drug Administration (FDA) has approved the Makena (hydroxyprogesterone caproate) injection, which can reduce the risk of preterm delivery. The drug is intended for use...

Anacor Initiates Psoriasis Compound Study
08 February 2011 Anacor Pharmaceuticals has dosed the first patient in a Phase IIb trial of AN2728, a topical anti-inflammatory product candidate for the treatment of psoriasis. The double-blind, randomised...

Shionogi Initiates Patient Enrolment for HIV Therapy
07 February 2011 Shionogi-ViiV Healthcare has enrolled the first patient in a clinical study to support a fixed-dose combination therapy to treat HIV. The investigational regimen, termed as 572-Trii,...

Derma Diabetic Ulcer Drug Meets Primary Endpoint
07 February 2011 Derma Sciences' diabetic foot ulcer treatment DC127 has met the primary and secondary endpoints of a Phase II clinical trial. The double-blind, placebo-controlled, and multi-centre...

US Firm Sues FDA for Importing Unapproved Lethal Injection Drug
04 February 2011 Law firm Sidley Austin has filed a lawsuit against the US Food and Drug Administration (FDA) on behalf of six death-row prisoners, seeking to prohibit the agency from importing or using...

Egen Receives FDA Orphan Drug Grant for Ovarian Cancer Treatment
04 February 2011 Egen has received a four-year grant from the US Food and Drug Administration (FDA) to develop EGEN-001 for the treatment of advanced, recurrent ovarian cancer. The company has completed...

Bellus Reports Positive Results of Alzheimer's Drug Study
03 February 2011 Bellus Health has reported positive results from the Phase I study evaluating NRM8499, a prodrug of tramiprosate, intended for the treatment of Alzheimer's disease. The randomised,...

BioMarin Begins Morquio Syndrome Drug Study
03 February 2011 BioMarin Pharmaceutical has initiated a Phase III study to evaluate N-acetylgalactosamine 6-sulfatase (GALNS) as a treatment for Morquio Syndrome type A, a lysosomal storage disorder. ...

Maxygen Initiates Arthritis Drug Study
02 February 2011 Maxygen has initiated a Phase I clinical study in the US to evaluate CTLA4-Ig therapeutic, which is being developed to treat rheumatoid arthritis and other autoimmune conditions. ...

VBL Initiates Two Cancer Drug Studies
02 February 2011 VBL Therapeutics has initiated two studies to evaluate the efficacy and safety of VB-111 in advanced cancers. The first, a Phase IIa study, will evaluate VB-111 in patients with...

Endo and Orion to Develop Cancer Drugs
01 February 2011 Endo Pharmaceuticals has entered into a collaboration agreement with Orion Corporation for the discovery, development and commercialisation of assets in oncology. The agreement allows...

Genentech Lymphoma Drug Receives FDA Approval
01 February 2011 Genentech has received approval from the US Food and Drug Administration (FDA) for Rituxan (rituximab) as a maintenance treatment for patients with advanced follicular lymphoma. The approval...

Plexxikon Begins Arthritis Drug Study
31 January 2011 Plexxikon has initiated dosing in the first of two Phase I clinical trials to evaluate PLX5622, an oral and highly selective FMS inhibitor targeted for the treatment of rheumatoid...

Sanofi-Aventis Breast Cancer Drug Fails Phase III Study
31 January 2011 Sanofi-Aventis and its BiPar Sciences subsidiary have reported that iniparib (BSI-201) has not met the co-primary endpoints of overall survival and progression-free survival in a Phase III...

Anadys Begins Dosing in Hepatitis C Drug Study
28 January 2011 Anadys Pharmaceuticals has initiated dosing in its Phase IIb study of ANA598, which is being tested in combination with pegylated interferon and ribavirin in hepatitis C patients. The...

Meda Arthritis Drug Receives Licence Extension
28 January 2011 Axorid, a symptomatic treatment of arthritis in patients who are at risk of developing gastric ulcers associated with non-steroidal anti-inflammatory drugs, has received an extension of...

GenVec Partners with NMRC to Develop Dengue Fever Vaccines
27 January 2011 GenVec has entered into a cooperative research and development agreement with the US Naval Medical Research Center (NMRC) to develop dengue fever vaccines. Under a contract with the Henry...

Rexahn Begins Patient Enrolment for Depressive Disorder Study
27 January 2011 Rexahn Pharmaceuticals has enrolled the first patient in a Phase IIb clinical trial to evaluate Serdaxin as treatment for major depressive disorder. The randomised, double blind...

Eisai Sepsis Drug Fails Study Goal
26 January 2011 Eisai has reported that eritoran, its potential treatment for severe sepsis, has failed to meet the primary endpoint of a Phase III trial. The company has decided not to submit...

Furiex Receives FDA Fast-Track Designation for IBS Drug
26 January 2011 Furiex Pharmaceuticals has received fast-track designation from the US Food and Drug Administration (FDA) for MuDelta, a novel diarrhoea-predominant irritable bowel syndrome (IBS)...

Sunshine and Binghamton University to Develop Cancer Drug
25 January 2011 Sunshine Biopharma has signed an agreement with The Research Foundation of the State University of New York, acting on behalf of Binghamton University, to develop Sunshine lead compound...

FDA Approves Depressive Disorder Drug
25 January 2011 The US Food and Drug Administration (FDA) has approved PGxHealth's Viibryd tablets (vilazodone hydrochloride) for the treatment of major depressive disorder in adults. Major...

BioMarin Begins Pompe Disease Drug Study
24 January 2011 BioMarin Pharmaceutical has initiated a Phase I/II trial to evaluate BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase, as a treatment for Pompe disease. ...

Targacept Reports Positive Schizophrenia Drug Study
24 January 2011 Targacept has reported positive top-line results from a Phase II proof-of-concept trial evaluating TC-5619 as an augmentation therapy to improve cognition in patients with...

Genentech Melanoma Drug Meets Co-Primary Endpoints
21 January 2011 Genentech has reported that a Phase III clinical study of RG7204 (PLX4032) has met its co-primary endpoints, demonstrating a significant survival benefit in people with previously untreated...

FDA Awards CureFAKtor Pancreatic Cancer Drug Orphan Status
21 January 2011 CureFAKtor Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for CFAK-C4, a potential pancreatic cancer treatment. CureFAKtor is planning...

Kyoto University and Takeda to Develop Drugs for Obesity and Schizophrenia
20 January 2011 Kyoto University and Takeda Pharmaceutical Company have formed a five-year research and development alliance to research drugs to treat obesity and schizophrenia. The two organisations will...

Ariad Soft Tissue Sarcoma Drug Meets Primary Endpoint
20 January 2011 Ariad Pharmaceuticals has reported that ridaforolimus, an investigational oral mTOR inhibitor, has met the primary endpoint of improved progression-free survival compared to placebo in a Phase...

Regeneron and Bayer Begin Retinal Disease Drug Study
19 January 2011 Regeneron and Bayer HealthCare have initiated a Phase III clinical to evaluate the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with myopic...

Merck Serono and Domain to Develop Parkinson's Drugs
19 January 2011 Merck Serono and Domain Therapeutics have entered into a development and licensing agreement to develop positive allosteric modulators of metabotropic glutamate receptor 4 to treat...

BioCryst Reports Good Results for Influenza Drug
18 January 2011 BioCryst Pharmaceuticals has reported topline results from one of its two Phase III studies evaluating intravenous peramivir to treat patients who have been hospitalised by influenza. ...

FDA Warns of Dronedarone Liver Injury Risk
18 January 2011 The US Food and Drug Administration (FDA) has notified health professionals and patients about the potential risk of liver injury associated with heart medication Multaq (dronedarone). ...

Cancer Research UK and AstraZeneca to Trial Cancer Drug Combinations
17 January 2011 Cancer Research UK has entered into a strategic combinations alliance with AstraZeneca to get combinations of experimental cancer drugs into early phase clinical trials more quickly. ...

MedImmune and Micromet Begin Gastrointestinal Cancer Drug Study
17 January 2011 MedImmune and Micromet have initiated a Phase I trial of MEDI-565 (MT111) in patients with advanced gastrointestinal cancers. The dose-escalation study is designed to evaluate the...

TransPharma Reports Positive Results for Musculoskeletal Disorder Patch
14 January 2011 TransPharma Medical has reported positive results from a Phase I study evaluating ViaDerm-Calcitonin, a self-applied transdermal calcitonin product for the treatment of musculoskeletal...

MMRF and Synta Pharmaceuticals to Develop Multiple Myeloma Drug
14 January 2011 The Multiple Myeloma Research Foundation (MMRF) has entered into a joint collaboration with Synta Pharmaceuticals to clinically develop ganetespib for patients with multiple myeloma. In...

Vicept Reports Positive Results for Rosacea Cream
13 January 2011 Vicept Therapeutics has reported positive results from a Phase II clinical trial evaluating V-101 cream, a topical cream for the treatment of facial redness known as Type I Rosacea (ETR). ...

Boehringer and Eli Lilly to Develop Diabetes Compounds
13 January 2011 Boehringer Ingelheim and Eli Lilly and Company have entered into a global alliance to jointly develop and commercialise a portfolio of diabetes compounds that are in mid- and...

Bayer Begins Enrolment for GIST Drug Trial
12 January 2011 Bayer HealthCare has initiated patient enrolment for an international Phase III trial evaluating investigational regorafenib (BAY 73-4506) as a treatment for metastatic or...

FDA Gives Exelixis Cancer Drug Orphan Drug Designation
12 January 2011 Exelixis has received orphan drug designation from the US Food and Drug Administration (FDA) for XL184 to treat follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or...

TGen and Oncoholdings to Develop Anti-Cancer Agents
11 January 2011 TGen Drug Development (TD2) and Oncoholdings have entered into a partnership to develop new anti-cancer agents. Under the agreement, TD2, a subsidiary of TGen, will be the exclusive...

ProStraken Abstral Approved to Manage Cancer Pain
11 January 2011 The US Food and Drug Administration (FDA) has approved ProStraken Abstral (fentanyl) transmucosal tablets for the management of breakthrough pain in adults with cancer. ...

Lexicon Reports Positive Diabetes Drug Study
10 January 2011 Lexicon Pharmaceuticals has reported positive results from a clinical trial and mechanistic study of a solid oral dose formulation of LX4211 as a treatment for type II diabetes patients. ...

Ziopharm and Intrexon to Develop DNA-based Oncology Therapeutics
10 January 2011 Ziopharm Oncology and Intrexon Corporation have entered into an exclusive channel partnership to develop DNA-based therapeutics to treat various cancers. Under the agreement, Ziopharm will...

Merck Completes Enrolment for Gastric Cancer Drug Trial
07 January 2011 Merck has completed patient enrolment for a pivotal Phase III clinical trial evaluating the efficacy of Erbitux (cetuximab) for the treatment of patients with advanced gastric cancer. The...

MacroGenics Initiates Trial of HER2-Expressing Tumour Drug
07 January 2011 MacroGenics has initiated a Phase I clinical trial of MGAH22 in patients with HER2-expressing solid tumours. The multi-dose, single-arm, multicentre, open-label, dose-escalation Phase I...

Anadys Begins HCV Drug Trial
06 January 2011 Anadys Pharmaceuticals has initiated a Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin in patients with HCV. The study will evaluate ANA598 in...

Almirall and Forest Report Positive Results from COPD Drug Studies
06 January 2011 Almirall and Forest Laboratories have reported positive results from the Phase III study of aclidinium bromide and the Phase IIb studies of fixed dose combination of aclidinium bromide...

Novavax Trials Respiratory Syncytial Virus Vaccine
05 January 2011 Novavax has initiated patient enrolment for Phase I clinical trial to evaluate the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus. ...

Senesco Multiple Myeloma Drug Gets Orphan Drug Designation
05 January 2011 Senesco Technologies has received orphan drug designation from the US Food and Drug Administration (FDA) for lead drug candidate SNS01-T for treatment of multiple myeloma. The decision...

Inspire Cystic Fibrosis Drug Fails to Meet Primary Endpoint
04 January 2011 Inspire Pharmaceuticals has revealed that a second Phase III clinical trial to evaluate denufosol tetrasodium as a treatment for cystic fibrosis has failed. The study did not attain...

Biotie Alcohol Dependence Drug Shows Positive Phase III Results
04 January 2011 Biotie's partner, H Lundbeck A/S, has reported positive results from two Phase III clinical trials (ESENSE1 and SENSE) evaluating nalmefene for the treatment of alcohol dependence. The...

BioCryst Initiates Gout Drug Study
24 December 2010 BioCryst Pharmaceuticals has initiated a Phase IIb study of BCX4208 as an add-on therapy in patients with gout who have not responded to allopurinol therapy alone. BCX4208 is a...

FDA Approves Merck's HPV Vaccine for Prevention of Anal Cancer and AIN
24 December 2010 The US Food and Drug Administration (FDA) has approved a new indication for Merck's Gardasil human papillomavirus (HPV) vaccine. The approval applies to the prevention of anal cancer caused...

Season's Greetings
24 December 2010 drugdevelopment-technology.com will be taking a short break over the holiday season. Our full daily news service will return on 4 January. Thank you for your support in 2010, and we wish you...

Isis Begins Phase I Hypertriglyceridemia Drug Study
23 December 2010 Isis Pharmaceuticals has initiated a Phase I study of ISIS-APOCIIIRx, an antisense drug designed to lower triglycerides to treat a variety of diseases associated with elevated...

FDA Grants Fast Track Designation for Clavis Leukaemia Drug
23 December 2010 Clavis Pharma ASA has been granted fast-track designation by the US Food & Drug Administration (FDA) for its clinical programme to test elacytarabine as a treatment for patients with acute...

Bristol-Myers and Oncolys Enter Licensing Agreement for HIV Compound
22 December 2010 Bristol-Myers Squibb and Oncolys BioPharma have signed a definitive agreement that will see Bristol-Myers obtain worldwide rights to manufacture, develop and commercialise festinavir, which is...

Icagen and Pfizer Initiate Phase I Trial of Pain Drug
22 December 2010 Icagen and Pfizer have initiated dosing of a sodium channel-based compound for the treatment of pain and related disorders in a Phase I study in healthy volunteers. In the first two cohorts...

EpiTherapeutics and Abbott to Develop Anti-Cancer Drugs
21 December 2010 EpiTherapeutics and Abbott have entered into a partnership to develop anti-cancer drugs by using small-molecule inhibitors against selected epigenetic oncology targets. Cancer epigenetics is...

MHRA Recalls Three Batches of Ranbaxy's Pravastatin
21 December 2010 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has asked Ranbaxy to recall three batches of Pravastatin as the company failed to update safety warnings on its...

European Medicines Agency Completes Avastin Review
20 December 2010 The European Medicines Agency has concluded that the balance of benefits and risks of Avastin in combination with docetaxel is negative and has recommended that this combination should no longer...

GSK and Impax to Develop and Commercialise Parkinson's Compound
20 December 2010 GlaxoSmithKline (GSK) and Impax Pharmaceuticals have entered into a global agreement for the development and commercialisation of IPX066, Impax's novel extended-release carbidopa-levodopa...

SciClone Discontinues Hepatitis C Drug Study
17 December 2010 SciClone Pharmaceuticals has reported topline results from the Phase IIb clinical trial of SCV-07 for the treatment of hepatitis C. The study was designed to evaluate the safety...

Jennerex and Transgene Initiate Colorectal Cancer Drug Study
17 December 2010 Jennerex and Transgene have initiated patient enrolment and treatment for a Phase Ib clinical trial to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer. ...

Tessalon Cough Capsules Pose Risk for Children
16 December 2010 The US Food and Drug Administration (FDA) has issued a warning that accidental ingestion of Tessalon (benzonatate) liquid cough capsules by children younger than ten years can lead to serious...

EpiCept Initiates Thyroid Cancer Drug Trial
16 December 2010 EpiCept Corporation has reported that the National Cancer Institute (NCI) has initiated a Phase II trial of crolibulin (EPC2407) in patients with anaplastic thyroid cancer (ATC). The trial...

Chimerix Reports Positive Antiviral Agent Study
15 December 2010 Chimerix has reported that antiviral agent CMX157 has demonstrated favourable safety, tolerability and a good drug distribution profile in a Phase I clinical trial. In addition, results from...

Anaphore and Mitsubishi Tanabe to Develop Autoimmune Drugs
15 December 2010 Anaphore has entered into a partnership with Mitsubishi Tanabe Pharma Corporation to research, develop and commercialise novel protein therapies for autoimmune diseases. The partnership will...

GlaxoSmithKline Breast Cancer Combo Improves Survival
14 December 2010 GlaxoSmithKline has reported positive results from Phase III study evaluating investigational combination Tykerb (lapatinib) plus paclitaxel in patients with in HER2-positive advanced...

Pfizer Withdraws Hypertension Drug
14 December 2010 Pfizer has voluntarily withdrawn pulmonary arterial hypertension drug Thelin (sitaxentan), after it was found to be associated with a risk of liver injury. Thelin will be withdrawn in...

Teva's Multiple Sclerosis Drug Meets Primary Endpoint
13 December 2010 Teva Pharmaceutical Industries and Active Biotech have reported positive initial results from a two-year Phase III study of oral laquinimod as a treatment for relapsing-remitting...

NIH Recommends Establishment of New Drug Development Centre
13 December 2010 The US National Institutes of Health (NIH) has recommended the establishment of a new centre dedicated to turning promising scientific discoveries into new drugs. The National Center...

Bavarian Receives FDA SPA for Prostate Cancer Vaccine Trial
10 December 2010 Bavarian Nordic has reached an agreement with the US Food and Drug Administration (FDA) under a special protocol assessment (SPA) for a Phase III trial of Prostvac for the treatment of...

Onyx Reports Myeloma Drug Study Success
10 December 2010 Onyx Pharmaceuticals has reported positive results from a Phase IIb study of single-agent carfilzomib, a next-generation proteasome inhibitor, in patients with relapsed and refractory...

Novartis Reports Positive Hodgkin Lymphoma Drug Study
09 December 2010 Novartis oral investigational drug LBH589 (panobinostat) has demonstrated substantial disease control and tumour reduction in extensively pre-treated Hodgkin's lymphoma patients, according to...

FDA Grants Orphan Drug Designation to QLT's Retinal Disease Drug
09 December 2010 QLT has received orphan drug designation from the US Food and Drug Administration (FDA) for QLT091001, an oral synthetic retinoid for the treatment of retinitis pigmentosa. It follows an...

Lundbeck Reports Positive Results for Seizure Drug
08 December 2010 Lundbeck has reported positive results from a Phase III study designed to determine the efficacy and safety of investigational compound clobazam as an adjunctive therapy to treat...

Pfizer's Leukaemia Drug Misses Primary Endpoint
08 December 2010 Pfizer has reported results from a Phase III study designed to evaluate investigational compound bosutinib as a first-line treatment for patients with Philadelphia chromosome positive...

Sirnaomics Enters into Partnership to Develop Wound-Healing Drug
07 December 2010 Sirnaomics has entered into a partnership with a Chinese pharmaceutical company to develop STP705, its small interfering RNA (siRNA) therapeutic for scarless wound healing. The partnership...

Roche Reports Positive Study Results of Lymphoma Drug
07 December 2010 Roche has reported positive results of a Phase III study of Rituxan/MabThera (rituximab) in patients with asymptomatic follicular lymphoma. The results showed that the immediate use...

FDA Grants Fast-Track Development Status to Octapharma Coagulation Drug
06 December 2010 The US Food and Drug Administration (FDA) has approved Octapharma's investigational new drug application for octaplex (human prothrombin complex, freeze dried) as a fast-track product for...

Geron Initiates Breast Cancer Drug Study
06 December 2010 Geron Corporation has initiated a randomised Phase II clinical trial of its telomerase inhibitor drug, imetelstat, for patients with locally recurrent or metastatic breast cancer. The...

ImmunoGen Initiates Lung Cancer Drug Trial
03 December 2010 ImmunoGen has initiated a Phase I/II clinical trial to evaluate proprietary product candidate IMGN901 (lorvotuzumab mertansine) for first-line treatment of small cell lung cancer in patients...

Merck Ends HIV Drug Study
03 December 2010 Merck has halted a Phase III study of Isentress (raltegravir) once-daily in treatment-naïve adult patients infected with HIV-1 after recording negligible safety and efficacy results. ...

APP Pharmaceuticals Receives US Approval for Cancer Drug
02 December 2010 APP Pharmaceuticals has received approval from the US Food and Drug Administration to market Topotecan for Injection, which is indicated for the treatment of small cell lung cancer and...

Sanofi Pasteur Initiates Study of Clostridium Difficile Vaccine
02 December 2010 Sanofi Pasteur has initiated a Phase II clinical study of a vaccine to prevent Clostridium difficile infections. The study is aimed at evaluating the prevention of the first episode...

Affymax and Takeda Confirm US Registration Strategy for Anaemia Drug
01 December 2010 Affymax and Takeda Pharmaceutical have announced that they plan to continue with their regulatory strategy for investigational drug peginesatide, a treatment for anaemia in patients who...

Gilead and Selcia Partner to Develop Liver Disease Drugs
01 December 2010 Selcia and Gilead Sciences have entered into a drug discovery partnership that will focus on medicines to treat liver diseases. Building on an established partnership, Selcia will provide...

FDA Extends Review Period for Merck Multiple Sclerosis Drug
30 November 2010 Merck has reported that the US Food and Drug Administration (FDA) has extended the review period for Cladribine tablets, indicated for the treatment of relapsing forms of multiple sclerosis,...

Jean-Marie Recalls Gastric Ulcer Drugs from Hong Kong Market
30 November 2010 Jean-Marie Pharmacal Company has initiated a recall of three stomach pain and gastric ulcer drugs in Hong Kong at the behest of the country's department of health, after one was found to...

Renovo Reports Positive Study Results for Scar Drug
29 November 2010 Renovo Group has reported positive trial results for Juvista Paediatric, a new formulation of Juvista for children indicated to improve the appearance of scars. The trial met its...

Convergence and Selcia to Develop Drugs for Chronic Pain
29 November 2010 Convergence Pharmaceuticals and Selcia have entered into a drug discovery partnership to identify and develop candidate molecules to treat chronic pain. Under the agreement, Convergence...

Winston Reports Positive Study Results of Migraine Solution
26 November 2010 Winston Pharmaceuticals has reported positive results from a Phase II study evaluating its Dolorac nasal solution as a prophylaxis for chronic migraines. The double-blind, multi-centre...

Evotec Partners with Merck to Develop Pre-Clinical Neurological Candidates
26 November 2010 Evotec has entered into an agreement with Merck to develop pre-clinical candidates for an undisclosed neurological disease. Evotec will provide its drug research expertise in the areas...

Mimetogen Initiates Dry Eye Disease Drug Study
25 November 2010 Mimetogen Pharmaceuticals has initiated a Phase II trial of MIM-D3, a mimetic of nerve growth factor, in patients with moderate to severe dry eye disease. Nerve growth factor is a protein...

Impax Gains Tentative FDA Approval for Cymbalta Generic
25 November 2010 Impax Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for a generic version of Cymbalta (duloxetine hydrochloride) in 20mg, 30mg and 60mg...

Reata and Abbott Report Positive Study Results of Kidney Disease Drug
24 November 2010 Reata Pharmaceuticals and Abbott Laboratories have reported positive results from a Phase IIb study of bardoxolone methyl, its investigational treatment for chronic kidney disease. The...

Xanodyne Withdraws Pain Medication Due to Heart Risks
24 November 2010 Xanodyne Pharmaceuticals has agreed to voluntarily withdraw Darvon and Darvocet, the branded versions of prescription pain medication propoxyphene, from the US market following a request from...

Intercell Reports Positive Phase II Trial Results of Staphylococcus Vaccine
23 November 2010 Intercell has reported positive Phase II clinical trial results of V710, an investigational vaccine for the prevention of Staphylococcus aureus infections. The randomised, double-blind...

Bristol-Myers and Pfizer Discontinue Coronary Disease Drug Study
23 November 2010 Bristol-Myers Squibb Company and Pfizer have discontinued a Phase III clinical trial of apixaban, an investigational oral factor Xa inhibitor, following safety concerns. The independent...

Proteostasis and Harvard to Develop Neurodegenerative Disease Drugs
22 November 2010 Proteostasis Therapeutics has entered into a research partnership with Harvard University to evaluate new therapeutic targets for neurodegenerative diseases. The collaboration will...

Merck Heart Disease Drug Meets Safety and Efficacy Endpoints
22 November 2010 Merck has reported that anacetrapib, its investigational CETP inhibitor, has met all safety and efficacy endpoints in a Phase III trial involving patients with coronary heart disease (CHD). ...

UCSF and Pfizer Form Research Partnership
19 November 2010 The University of California, San Francisco (UCSF) has entered into a partnership with Pfizer to reduce the time required to translate promising biomedical research into effective medications...

Eisai and Forma Enter into Drug Discovery Partnership
19 November 2010 Eisai and Forma Therapeutics have entered into a collaboration for strategic drug discovery. Under the agreement, Eisai will have non-exclusive access to Forma's cell-based screening...

Eisai Breast Cancer Drug Receives FDA Approval
18 November 2010 Eisai has received approval from the US Food and Drug Administration (FDA) for Halaven (eribulin mesylate) injections as a treatment for metastatic breast cancer in patients who have had at...

Rivaroxaban Reduces Stroke Risk, Study Finds
18 November 2010 Johnson & Johnson Pharmaceutical Research & Development has announced that rivaroxaban significantly reduced risk of stroke in patients with atrial fibrillation during a Phase III trial. ...

Pfizer Reports Positive Study Results of Chronic Heart Failure Drug
17 November 2010 Pfizer has reported that positive results from a Phase IIIb study of Inspra (eplerenone) in patients with chronic heart failure. The drug demonstrated a statistically significant...

Boehringer and Fresenius Partner for HESylated Pharmaceutical Production
17 November 2010 Boehringer Ingelheim and Fresenius Kabi have completed a project to produce robust HESylated pharmaceuticals on an industrial scale. HESylation technology allows the modification of...

Milestone and Ordway to Develop Drugs for Targeted Delivery
16 November 2010 Milestone Scientific and the Ordway Research Institute have entered into a partnership to develop drug formulations that will be suitable for targeted delivery using Milestone's patented...

Theratechnologies Receives US Approval for Lipodystrophy Drug
16 November 2010 Theratechnologies has received US regulatory approval for injections of Egrifta (tesamorelin) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. The US...

Novartis Discontinues Lung Cancer Drug Development
15 November 2010 Novartis has discontinued a Phase III clinical trial programme of investigational lung cancer treatment ASA404 (vadimezan), following interim study results that indicated the drug was not likely...

Arena Reports Positive Study Results of Weight-Loss Drug
15 November 2010 Arena Pharmaceuticals has reported positive results from a one-year trial of weight-loss drug lorcaserin. The study results showed that lorcaserin demonstrated statistically significant...

CytRx Initiates Brain Cancer Drug Trial
12 November 2010 CytRx Corporation has initiated a pharmacokinetic clinical trial designed to evaluate its oncology drug candidate bafetinib in patients with recurrent brain tumours. The trial will...

Biovista Enters Into Drug Repositioning Collaboration with Pfizer
12 November 2010 Biovista has entered into a drug repositioning collaboration with Pfizer. Under the agreement, Biovista will use its Clinical Outcome Search Space technology to identify new indications...

Nuvo Research Reports Positive Trial Results for Hayfever Drug
11 November 2010 Nuvo Research has reported that WF10, its immune modulating drug candidate, has met the primary endpoint a European Phase II clinical trial to evaluate it as a treatment for severe...

FDA Grants Orphan Drug Designation to Semafore Leukaemia Drug
11 November 2010 Semafore Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for SF1126, a product candidate for the treatment of B-cell chronic...

Genta Begins Breast Cancer Drug Trial
10 November 2010 Genta has initiated a Phase IIb clinical trial of tesetaxel, its investigational oral taxane, as first-line chemotherapy treatment for women with metastatic breast cancer. The trial is...

Immunologix and GenScript Unite to Develop Human Antibody Therapeutics
10 November 2010 Immunologix and GenScript have entered into a strategic partnership to offer a complete platform for producing human antibody therapeutics. The partnership will combine...

Cymbalta Receives FDA Nod for Chronic Musculoskeletal Pain Management
09 November 2010 Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for Cymbalta (duloxetine HCl) to manage chronic musculoskeletal pain. It has been established...

Positive Results from Pfizer's Rheumatoid Arthritis Drug Trial
09 November 2010 Pfizer has reported positive phase III study results of tasocitinib, an investigational, novel, oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). The six-month,...

Invarigen Receives Grants for Dengue and Chikungunya Vaccines
08 November 2010 Inviragen has received two grants from the US Government to continue ongoing programmes aimed at developing vaccines against dengue and chikungunya viruses. The two grants totalling...

Bristol-Myers and Simcere to Develop Oncology Compound
08 November 2010 Bristol-Myers Squibb Company and Simcere Pharmaceutical Group have entered into a strategic partnership to co-develop BMS-817378, a preclinical small molecule MET/VEGFR-2 inhibitor. ...

Ironwood and Forest Laboratories Report Positive Study Results for Constipation Drug
05 November 2010 Ironwood Pharmaceuticals and Forest Laboratories have reported positive top-line results of Phase III clinical trial of linaclotide, its investigational drug for the treatment of patients...

Neogenix Receives Orphan Drug Designation for Pancreatic Cancer Drug
05 November 2010 Neogenix Oncology has received approval from the US Food and Drug Administration (FDA) for ensituximab, a monoclonal antibody, for the treatment of pancreatic cancer. Neogenix had initiated...

Spencer and National Pharmaceutical to Develop Central Nervous Disease Treatments
04 November 2010 Spencer Pharmaceutical and National Pharmaceutical have signed a preliminary agreement to develop central nervous disease treatments. Under the agreement, the two companies will develop...

Inhibitex Initiates Clinical Trial of Hepatitis Drug
04 November 2010 Inhibitex has initiated a Phase 1b clinical trial of INX-189, its nucleotide polymerase inhibitor, for the treatment of chronic infections caused by hepatitis C virus (HCV). The trial, which...

FDA Approves Sunovion Schizophrenia Drug
03 November 2010 Sunovion Pharmaceuticals has received US Food and Drug Administration (FDA) approval for Latuda (lurasidone HCl) tablets to treat schizophrenia in adults. Four controlled studies...

Merck Hepatitis C Drug Meets Phase III Trial Goal
03 November 2010 Merck has reported positive results from two pivotal Phase III studies of boceprevir, an investigational oral hepatitis C protease inhibitor. The results showed that boceprevir...

Amira Begins Clinical Study of Fibrotic Disease Drug
02 November 2010 Amira Pharmaceuticals has initiated a Phase I clinical study to evaluate AM152, a novel LPA1 antagonist, as potential therapy for lung fibrosis of scleroderma and idiopathic pulmonary fibrosis. ...

Bristol-Myers Squibb Leukaemia Drug Approved in US
02 November 2010 Bristol-Myers Squibb and Otsuka Pharmaceutical have received US Food and Drug Administration approval for Sprycel (dasatinib) as a treatment for newly diagnosed chronic phase...

US Government Seizes Adulterated Drugs from Tri-Med Labs
01 November 2010 US Marshals have seized prescription and over-the-counter drug products from Tri-Med Laboratories as they were found to be unapproved and adulterated. According to the US Food and...

TransPharma Reports Positive Results of Transdermal Patch for Osteoporosis
01 November 2010 TransPharma has reported successful results of a four-week Phase I clinical trial of its self-applied ViaDerm-hPTH (1-34) for the treatment of osteoporosis. The blind,...

Boehringer and MacroGenics to Develop Antibody-Based Therapeutics
29 October 2010 Boehringer Ingelheim and MacroGenics have entered into a partnership to develop and commercialise antibody-based therapeutics covering multiple therapeutic areas such as immunology,...

Sanofi-Aventis Moves Multiple Sclerosis Drug to Phase III
29 October 2010 Sanofi-Aventis has initiated a Phase III Study of teriflunomide, a novel oral disease modifier for the treatment of relapsing multiple sclerosis (RMS). The multinational Phase III study...

Standard Homeopathic Company Recalls Teething Tablets
28 October 2010 Standard Homeopathic Company has reported that it is voluntarily recalling its Hyland's Teething Tablets after consulting the US Food and Drug Administration (FDA). The recall was initiated...

AstraZeneca Initiates Phase IIb Study of Sepsis Therapy
28 October 2010 AstraZeneca has reported that it has initiated patient dosing in a global Phase IIb study of AZD9773 (CytoFab), a first in class anti-TNF-alpha polyclonal antibody fragment product for...

Novartis Meningococcal Vaccine Meets Primary Endpoints of Phase III Study
27 October 2010 Novartis has reported positive Phase III study results for Menveo, a vaccine indicated for the prevention of invasive meningococcal disease. The randomised, open-label, multi-centre...

NeuroVive and to-BBB to Develop Neurodegenerative Disease Therapies
27 October 2010 NeuroVive Pharmaceutical and to-BBB have entered into a partnership to develop therapies for stroke and neurodegenerative diseases. The joint programme will combine to-BBB's...

Novartis Reports Good Results for Fluad Influenza Vaccine
26 October 2010 Novartis has reported positive Phase III study results of Fluad, a seasonal influenza vaccine containing the Novartis MF59 adjuvant. The study showed that Fluad was successful at...

NDAID Funds Four Clinical Trials to Tackle Antimicrobial Resistance
26 October 2010 The US National Institute of Allergy and Infectious Diseases (NIAID) has awarded four new contracts for large-scale clinical trials to reduce the risk of antimicrobial resistance. The trials...

Arena Reveals Narcolepsy Drug Phase I Results
25 October 2010 Arena Pharmaceuticals has reported Phase I clinical trial results of APD916, a novel drug for the treatment of narcolepsy with cataplexy. The double-blind, randomised and placebo-controlled...

US Approves First Anticoagulant for Half a Century
25 October 2010 Boehringer Ingelheim has received US Food and Drug Administration approval for Pradaxa (dabigatran etexilate), an oral direct thrombin inhibitor that is used to reduce the risk of stroke...

Diamyd Reports Phase I Results for Chronic Pain Drug
22 October 2010 Diamyd has reported positive Phase I study results of NP2 Enkephalin, an opioid peptide for the treatment of chronic pain. The study showed substantial and sustained reductions in pain...

Cytheris Begins HIV Drug Phase II Trial
22 October 2010 Cytheris has initiated a Phase II clinical study of investigative immunomodulatory agent CYT107 (rhIL-7) for the treatment of HIV, in combination with antiretroviral drugs raltegravir...

Eli Lilly Suffers Further Diabetes Drug Setback
21 October 2010 Pharmaceutical major Eli Lilly has suffered a further clinical setback with the failure of teplizumab, its investigational type I diabetes biologic. A data monitoring committee found that...

FDA Approves Chronic Hepatitis B Drug
21 October 2010 Bristol-Myers Squibb has received approval from the US Food and Drug Administration for Baraclude, a nucleoside analogue for the treatment of chronic hepatitis B in adults with decompensated...

GlaxoSmithKline to Collaborate on Genetic Disorder Treatments
20 October 2010 GlaxoSmithKline, Fondazione Telethon and Fondazione San Raffaele have entered into a strategic alliance to research and develop novel treatments for rare genetic disorders. The...

Sanofi-Aventis Reports Positive Results for Multiple Sclerosis Drug
20 October 2010 Sanofi-Aventis has reported positive Phase III study results of teriflunomide, an oral disease modifier for the treatment of relapsing multiple sclerosis. The double-blind,...

UCB and Synosia to Collaborate on Parkinson's Drugs
19 October 2010 UCB and Synosia Therapeutics have agreed a strategic collaboration to produce drugs for the treatment of Parkinson's disease. Synosia has granted UCB a licence for exclusive, worldwide rights...

Bavarian Nordic Receives Funding for Ebola Vaccine Development
19 October 2010 Bavarian Nordic has received funding from the US National Institutes of Health to develop a vaccine for filoviruses such as Ebola and Marburg. The company is investigating the use of core...

Pharmalink Receives Orphan Drug Designation for Berger's Disease Drug
18 October 2010 Pharmalink AB has been granted orphan drug designation by the US Food and Drug Administration (FDA) for Nefecon, its lead product candidate for the treatment of patients with IgA nephropathy,...

Geron Begins Spinal Cord Injury Stem Cell Study
18 October 2010 Geron Corporation has enrolled the first patient in the Phase I clinical trial of GRNOPC1, human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells for the treatment of spinal...

Johnson & Johnson Reports Positive Study Results of Prostate Cancer Drug
15 October 2010 Johnson & Johnson has reported positive Phase III study results for abiraterone acetate, its oral androgen biosynthesis inhibitor for the treatment of patients with metastatic advanced...

Alkermes Receives FDA Approval for Opioid Addiction Medication
15 October 2010 Alkermes has received approval from the US Food and Drug Administration (FDA) for Vivitrol, its extended-release injectable medication for the treatment of opioid dependence. Vivitrol is...

Eli Lilly Head and Neck Cancer Drug Fails Phase III Trial
14 October 2010 Eli Lilly and Company has reported that its global Phase III trial of Alimta (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell...

ImmunoGen and Novartis to Collaborate on Oncology Drugs
14 October 2010 ImmunoGen has entered into a collaboration with Novartis to discover and develop cancer drugs based on antibodies. Novartis will pay a $45m upfront fee to ImmunoGen to use its targeted...

Abbott to Withdraw Anti-Obesity Medication from US Market
13 October 2010 Abbott has decided to voluntarily withdraw anti-obesity prescription medicine Meridia (sibutramine) from the US market, following concerns that it raises cardiovascular risks. The move follows...

Kinaxo to Support Bristol-Myers Squibb in Drug Research
13 October 2010 Bristol-Myers Squibb has selected Kinaxo to support a number of its drug discovery programmes. Under the agreement, Kinaxo will use its chemical proteomics technologies to deconvolute...

Pfizer Psoriasis Drug Yields Positive Results
12 October 2010 Pfizer has reported positive Phase II study results of tasocitinib, its investigational oral Janus Kinase inhibitor for the treatment of psoriasis, a chronic autoimmune skin disease that...

NIAID Awards Funds for Bioterror Vaccine Development
12 October 2010 The US National Institute of Allergy and Infectious Diseases (NIAID) has announced three contracts to develop vaccines for infectious diseases and biological threats that could be used in a...

Tasly and ProteoTech to Co-Develop Alzheimer's Drug
11 October 2010 Tasly Pharmaceutical and ProteoTech are to co-develop Exebryl-1, ProteoTech's novel small molecule therapeutic for the treatment of mild-to-moderate Alzheimer's disease. Exebryl-1 has been...

Akebia Reveals Positive Anaemia Drug Study Results
11 October 2010 Akebia Therapeutics has reported positive study results for AKB-6548, a hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anaemia in patients with stage 3 and 4...

BioRelix and Merck to Collaborate on Antibacterial Drugs
08 October 2010 BioRelix has entered into a research collaboration with a subsidiary of Merck to identify new antibacterial drug candidates. Under the agreement, BioRelix will provide its proprietary...

Synergy Reveals Positive Constipation Drug Trial Results
08 October 2010 Synergy Pharmaceuticals has revealed positive Phase IIa trial results for plecanatide, a new treatment for chronic constipation. The double-blind, dose-escalation, randomised,...

Novartis Halts Development of Two Investigational Compounds
07 October 2010 Novartis has announced that it has discontinued the development of two investigational compounds in its pharmaceutical pipeline. The first discontinued drug is albinterferon alfa-2b,...

Shionogi Receives FDA Approval for ADHD Drug
07 October 2010 Shionogi has received US Food and Drug Administration (FDA) approval for Kapvay (clonidine hydrochloride), an extended release oral formulation for the treatment of attention deficit...

FDA Takes Action on Unapproved Single-Ingredient Oral Colchicine Drugs
06 October 2010 The US Food and Drug Administration (FDA) has taken action against companies that manufacture, distribute or market unapproved single-ingredient oral colchicine, a drug commonly used to treat...

Argenta and Janssen Partner to Develop Cancer Drugs
06 October 2010 Galapagos affiliate Argenta has entered into a drug research agreement with Janssen Pharmaceuticals to develop novel drug candidates for cancer. According to the agreement, Argenta will...

GlaxoSmithKline Halts Development of Herpes Simplex Vaccine
05 October 2010 GlaxoSmithKline has decided not to proceed with the worldwide development of Simplirix, its experimental vaccine for the prevention of genital herpes in women. The decision follows the results...

AstraZeneca Initiates Acute Coronary Syndrome Drug Study
05 October 2010 AstraZeneca has initiated a clinical study of ticagrelor, an oral antiplatelet treatment for the treatment of acute coronary syndrome. The double-blind, randomised, three-arm,...

ZymoGenetics Reveals Positive Study Results of Melanoma Drug
04 October 2010 ZymoGenetics has revealed the results of its Phase IIa clinical trial of recombinant Interleukin 21 (IL-21) for the treatment of metastatic melanoma. IL-21 is a cytokine that works by...

Visceral Leishmaniasis Treatment Receives Orphan Drug Status
04 October 2010 iCo Therapeutics has been granted orphan drug designation by the US Food and Drug Administration for iCo-009, an oral formulation of Amphotericin B for the treatment of visceral...

PolyMedix Initiates Bacterial Skin Infection Drug Trial
01 October 2010 PolyMedix has initiated a Phase II clinical trial of PMX-30063, its novel defensin-mimetic antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused...

Kinaxo and Daiichi Partner for Cancer Drug Research
01 October 2010 Daiichi Sankyo is to develop targeted cancer drugs using Kinaxo's technology platforms, following the announcement that the two companies have entered into a long-term partnership for...

OncoGenex Begins Prostate Cancer Drug Phase II Trial
30 September 2010 OncoGenex Pharmaceuticals has initiated a Phase II trial of OGX-427, an antisense drug for the treatment of metastatic prostate cancer. The randomised and controlled study will enrol up to...

Pfizer Discontinues Prostate Cancer Drug
30 September 2010 Pfizer has discontinued a Phase III trial of Sutent (sunitinib malate), an oral multi-kinase inhibitor for the treatment of castration-resistant prostate cancer (CRPC). The study evaluated...

AstraZeneca Prostate Cancer Drug Fails to Meet Primary Endpoint
29 September 2010 AstraZeneca has revealed that its Phase III study of zibotentan for the treatment of men with metastatic castration resistant prostate cancer (CRPC) did not meet its primary endpoint of...

Amgen Recalls Anaemia Drugs
29 September 2010 Amgen has voluntarily recalled certain lots of Epogen and Procrit over concerns that the products may contain lamellae, extremely thin glass flakes that are created by interactions between...

Dynavax Initiates Trial for Universal Flu Vaccine
28 September 2010 Dynavax Technologies Corporation has initiated a Phase Ib clinical trial of N8295, a universal flu vaccine candidate. The trial will assess the safety and efficacy of N8295 in combination...

Duchenne Muscular Dystrophy Therapy Receives Orphan Drug Status
28 September 2010 The US Food and Drug Administration has granted orphan drug designation to Amsterdam Molecular Therapeutics for AMT-080, a gene therapy for the treatment of Duchenne muscular dystrophy. A...

European Watchdog Recommends Avandia Suspension
27 September 2010 The European Medicines Agency has recommended that rosiglitazone-containing medicines Avandia, Avandamet and Avaglim are suspended over concerns that they could cause heart disease. The...

Novartis Receives FDA Approval for Multiple Sclerosis Drug
27 September 2010 Novartis has received US Food and Drug Administration (FDA) approval for Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis. Gilenya, which will be available in...

Abbott to Enter Asian Markets with Bardoxolone
24 September 2010 Abbott Laboratories has announced an exclusive rights deal to develop and commercialise the kidney disease drug bardoxolone in Asian markets. The $450m acquisition from Reata Pharmaceuticals...

Researchers Discover New Therapeutic Target for Alzheimer's
24 September 2010 Researchers at Rush University Medical Center in the US have identified a new therapeutic target which could help prevent the progression of Alzheimer's disease. The team found that...

US Regulator Approves New Atrial Fibrillation Drug
23 September 2010 The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has unanimously recommended the approval of dabigatran etexilate for stroke prevention in patients...

Celldex Initiates Study of Breast Cancer Drug
23 September 2010 Celldex Therapeutics has initiated a Phase IIb study of CDX-011, an antibody drug conjugate for the treatment of patients with advanced breast cancer. The randomised, controlled and...

BioCryst Gout Drug Shows Positive Phase II Results
22 September 2010 BioCryst Pharmaceuticals has revealed positive Phase II Study results for BCX4208, a purine nucleoside phosphorylase inhibitor for the treatment of gout. The double-blind,...

Boehringer Initiates Breast Cancer Drug Trial
22 September 2010 Boehringer Ingelheim has initiated a Phase III trial of afatinib for the treatment of advanced metastatic breast cancer. Afatinib is an oral compound that works by irreversibly inhibiting...

LigoCyte Initiates Norovirus Vaccine Trial
21 September 2010 LigoCyte Pharmaceuticals has initiated the first clinical trial of its bivalent intramuscular vaccine candidate for the treatment of stomach flu. The vaccine contains virus-like particle...

ISTA Initiates Phase III Dry Eye Disease Programme
21 September 2010 ISTA Pharmaceuticals has initiated a Phase III clinical programme for Remura, a bromfenac ophthalmic solution to relieve the symptoms of dry eye disease. The four double-blind, randomised...

Spirogen and Celtic Move Ovarian Cancer Drug to Phase II
20 September 2010 Spirogen and Celtic Therapeutics have initiated a Phase II trial of SG2000 for the treatment of ovarian cancer. The open-label study will enrol about 50 patients with resistant, recurrent...

Irritable Bowel Syndrome Drug Proven Effective in Phase III Trial
20 September 2010 Almirall and Ironwood Pharmaceuticals have released positive Phase III trial results of linaclotide, a treatment for irritable bowel syndrome (IBS) with constipation. The...

Oxigene Reveals Positive Results for Thyroid Cancer Drug
17 September 2010 Oxigene has announced positive results from a Phase II/III study of Zybrestat (fosbretabulin) for the treatment of anaplastic thyroid cancer. The randomised and controlled study involved...

Seattle Genetics Discontinues Development of Leukaemia Drug
17 September 2010 Seattle Genetics has halted the development of Lintuzumab for treatment of acute myeloid leukaemia in older patients following poor results in a Phase IIb trial. The monoclonal antibody, given...

Ariad Initiates Phase II Clinical Trial of Leukaemia Drug
16 September 2010 Ariad Pharmaceuticals has initiated a Phase II clinical trial of ponatinib, its investigational pan-BCR-ABL inhibitor for the treatment of patients with resistant or intolerant chronic...

Neurocrine's Depression Drug Fails Phase II Trial
16 September 2010 Neurocrine Biosciences has revealed that GSK561679, a corticotropin releasing factor (CRF1) receptor antagonist for the treatment of major depressive disorder, has failed to meet the primary...

FDA Approves Increased Metastatic Cancer Drug Dose
15 September 2010 AstraZeneca has received US Food and Drug Administration (FDA) approval for a 500mg dose of Faslodex (fulvestrant) injection for the treatment of metastatic breast cancer in postmenopausal women. ...

Noscira Receives Fast-Track Designation for Brain Disorder Drug
15 September 2010 Noscira has received US Food and Drug Administration (FDA) fast-track designation for tideglusib (Zentylor) for the treatment of progressive supranuclear palsy, a degenerative brain...

Cancer Research UK and AstraZeneca Sign Cancer Drug Trial Agreement
14 September 2010 Cancer Research UK and AstraZeneca have agreed to initiate a clinical trial of AZD-3965 as a cancer treatment. AZD-3965 targets the monocarboxylate transporter, which is essential in...

University Study Offers New Hope for Pancreatic Cancer
14 September 2010 A clinical trial carried out at the University of Liverpool has shown that a commonly used chemotherapy drug is equally effective as more expensive treatments for pancreatic cancer. The...

Octopharma Begins Phase II/III Study of Polyradiculoneuropathy Therapy
13 September 2010 Octopharma has initiated a Phase II/III Study of its intravenous immunoglobulin preparation (IVIG) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The...

Cempra Pharmaceuticals Begins Two Pneumonia Therapy Studies
13 September 2010 Cempra Pharmaceuticals has initiated two studies of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP). Solithromycin is a fluoroketolide with potent...

Jennerex and Transgene Partner to Develop Cancer Drug
10 September 2010 Jennerex and Transgene have entered into an exclusive partnership to develop and commercialise a promising new cancer drug known as JX-594. JX-594, Jennerex's lead cancer product,...

Roche and reMYND to Develop Parkinson's and Alzheimer's Drug
10 September 2010 Roche and reMYND have entered into a partnership to develop novel therapeutics that can slow down neurodegeneration in Parkinson's and Alzheimer's patients. The partnership will focus on two...

MSD Granted European Approval for Bipolar Disorder Drug
09 September 2010 MSD has received European approval for Sycrest (asenapine) sublingual tablets, an atypical antipsychotic for the treatment of moderate to severe manic episodes in bipolar I disorder in...

Cellerant Awarded BARDA Contract for Radiation Drug
09 September 2010 Cellerant Therapeutics has been awarded a $153m contract by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) for the development...

Transdel Pain Relief Candidate Performs Well in Phase III Study
08 September 2010 Transdel Pharmaceuticals has revealed positive Phase III study results of pain relief candidate Ketotransdel (TDLP-110), which uses a transdermal delivery platform to deliver ketoprofen. ...

Macleods Receives Tentative Approval for HIV Drug
08 September 2010 Macleods Pharmaceuticals has received tentative approval from the Food and Drug Administration (FDA) for a fixed dose combination formulation of lamivudine, nevirapine and stavudine tablets. ...

Santhera and Ipsen Partner to Commercialise Dyskinesia Drug
08 September 2010

ThromboGenics Vitreomacular Adhesion Therapy Tests Well
08 September 2010 ThromboGenics has announced positive second Phase III trial results of microplasmin, for the non-surgical treatment of vitreomacular adhesion (VMA). The Phase II trial was a...

Agensys Starts Phase I Trial of Metastatic Renal Cancer Drug
06 September 2010 Agensys, an affiliate of Astellas Pharma, has initiated a Phase I trial of AGS-16M8F, an antibody-drug conjugate (ADC) to treat metastatic renal cancer. An ADC uses its specific...

Stromedix Receives Orphan Drug Designation for Pulmonary Fibrosis Drug
06 September 2010 Stromedix has announced that it has received orphan drug designation by the Food and Drug Administration (FDA) for its lead clinical candidate STX-100 for the treatment of idiopathic...

Forest, Gedeon Announce Bipolar Depression Drug Trial Results
03 September 2010 Forest Laboratories and Gedeon Richter have announced the preliminary top-line results of the phase II clinical trial of cariprazine, an investigational antipsychotic agent for the treatment...

Glenmark Discovers NCE for Pain Disorders
03 September 2010 Indian firm Glenmark Pharmaceuticals has announced the discovery of novel chemical entity (NCE) GRC 17536, which targets TRPA1 receptor antagonists to treat pain and respiratory...

Trius Initiates Clinical Study of Skin Infection Drug
02 September 2010 Trius Therapeutics has announced the initiation of a Phase III clinical study of an oral form of torezolid phosphate for the treatment of acute bacterial skin and skin structure infections. ...

Sanofi-Aventis Multiple Sclerosis Drug Shows Reduced Annualised Relapse Rate
02 September 2010 Sanofi-aventis has announced that its investigational once-daily oral drug teriflunomide for the treatment of relapsing multiple sclerosis (RMS), has met the primary endpoint in its Phase...

BioMarin Receives Orphan Drug Designation for Pompe Disease Drug
01 September 2010 BioMarin Pharmaceuticals has announced that it has received orphan drug designation from the US Food and Drug Administration (FDA) for BMN-701 as a treatment of Pompe disease. Pompe disease...

Portola Announces Positive Results for Anti-Platelet Drug
01 September 2010 Portola Pharmaceuticals has announced positive Phase II study results for elinogrel, its investigational anti-platelet drug, which is intended to treat chronic coronary heart disease and...

Pharmasset Initiates Hepatitis C Drug Trial
31 August 2010 Pharmasset has announced the initiation of a Phase IIb clinical trial of PSI-7977, its nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (HCV) genotypes 1, 2 and 3....

Plexxikon Announces Positive Results of Melanoma Drug Study
31 August 2010 Plexxikon has announced positive Phase I trial results of PLX4032 (RG7204), confirming the drug significantly shrank tumours in the majority of metastatic melanoma patients with BRAF...

GlaxoSmithKline Begins Phase III Trials of Shingles Vaccine
27 August 2010 GlaxoSmithKline (GSK) has started Phase III clinical trials for a vaccine to prevent shingles. The trials will include more than 30,000 patients worldwide and will assess the...

Eisai Announces Positive Study Results for Epilepsy Drug
27 August 2010 Eisai has announced positive Phase III trial results of investigational compound perampanel (E2007), a first-in-class, highly selective and non-competitive AMPA-type glutamate receptor...

InSite Vision Initiates Ocular Anti-Inflammatory Clinical Trial
26 August 2010 InSite Vision has initiated a Phase I/II clinical trial of ISV-303, a topical anti-inflammatory product intended to relieve the pain and swelling associated with ocular surgery. ISV-303...

Pfizer Announces Mixed Lung Cancer Drug Results
26 August 2010

FDA Grants Tentative Approval for Generic HIV Drug
26 August 2010 The US Food and Drug Administration (FDA) has granted tentative approval for a generic form of atazanavir sulfate, which is indicated for HIV-I infection treatment in adults in combination...

Experimental Hepatitis E Vaccine Shows Positive Study Results
26 August 2010 A Phase III trial has shown that an experimental hepatitis E vaccine made by Xiamen Innovax Biotech of China is safe and effective. The vaccine, known as HEV 239, is a recombinant vaccine,...

Chelsea Therapeutics Initiates Study of Chronic Fatigue Syndrome Drug
24 August 2010 Chelsea Therapeutics has initiated an investigator-led Phase II study of Droxidopa as a treatment of chronic fatigue syndrome. The trial will be an open-label study that will evaluate...

BioMarin Initiates Phase IIIb Study of Phenylketonuria Drug
23 August 2010 BioMarin has initiated a Phase IIIb study to evaluate the safety and therapeutic effects of Kuvan (sapropterin dihydrochloride) on the neuropsychiatric symptoms of patients with...

FDA to Priority Review Bristol-Myers Squibb Melanoma Drug
23 August 2010 Bristol-Myers Squibb has received confirmation that the US Food and Drug Administration (FDA) has accepted its biologics licence application for ipilimumab for filing and review. The company...

Eli Lilly Halts Alzheimer's Drug Trials
20 August 2010 Eli Lilly has stopped development of semagacestat, a gamma secretase inhibitor for the treatment of Alzheimer's disease, as it has not shown favourable results in long-term Phase III studies. ...

Xenon Initiates Phase II Study of Topical Neuralgia Therapy
20 August 2010 Xenon Pharmaceuticals has initiated a Phase II clinical trial of its topical XEN402 therapy, a potential treatment for post-herpetic neuralgia. XEN402's Phase I study showed that the product...

Paracetamol Linked to Asthma in Teenagers
19 August 2010 Teenagers taking paracetamol are more than twice as likely to have asthma, according to a study by the Medical Research Institute of New Zealand. The study of 323,000 teenagers, aged 13 and...

Pharmasset Receives Fast-Track Designation for Hepatitis Drug
19 August 2010 Pharmasset has received a fast-track designation from the US Food and Drug Administration (FDA) for PSI-7977, a potential treatment for chronic hepatitis C. PSI-7977 is an oral uridine...

FDA Plans to Withdraw Approval of Blood-Pressure Drug
19 August 2010 The US Food and Drug Administration (FDA) could withdraw approval of midodrine hydrochloride, a drug used to treat orthostatic hypotension. The regulator is considering the move as...

Morphotek Begins Enrolment for Cancer Drug Study
19 August 2010 Morphotek, a subsidiary of Eisai, has begun enrolling patients with advanced melanoma on a Phase I clinical study of MORAb-028. MORAb-028 is a fully human recombinant IgM-type antibody,...

Agile Initiates Phase III Study of Contraceptive Patch
17 August 2010 Agile Therapeutics has begun a Phase III study of its AG200-15 contraceptive patch. The study, designed to evaluate the efficacy and tolerability of AG200-15 when compared to a low-dose...

FDA Warns of Lamictal and Aseptic Meningitis Link
17 August 2010 The US Food and Drug Administration (FDA) has announced that using Lamictal (lamotrigine), a treatment for seizures in children and bipolar disorder in adults, can result in aseptic...

Amgen Cancer Drug Fails to Improve Overall Survival
16 August 2010 Amgen has announced that Vectibix (panitumumab), its drug for metastatic squamous cell head and neck cancer, did not meet its primary endpoint of improving overall survival in a Phase III...

Alectos and Merck Collaborate to Develop Alzheimer's Drugs
16 August 2010 Alectos Therapeutics has entered into a research partnership with Merck to identify and develop compounds that could help to treat Alzheimer's disease. Under the terms of agreement, Merck will...

Scientists Begin Human Clinical Trials of Dengue Vaccine
13 August 2010 A Phase I clinical trial for a dengue virus vaccine has begun at the Johns Hopkins Bloomberg School of Public Health in Baltimore, US. No drug treatment or vaccine exists for the...

YM Biosciences Granted Orphan Drug Designation for Myelofibrosis Drug
13 August 2010 YM Biosciences has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to CYT387, its JAK1/2 inhibitor for the treatment of myelofibrosis. ...

Elan and Transition Announce Alzheimer's Drug Trial Results
12 August 2010 Elan Corporation and Transition Therapeutics have announced the results of a Phase II study for ELND005, a potential treatment for mild to moderate Alzheimer's disease. Participants...

Amarin Completes Patient Enrolment for Triglyceride-Lowering Drug Trial
12 August 2010 Amarin Corporation has completed enrolment for its Phase III clinical trial of triglyceride-lowering drug AMR101. The 12-week study is designed to evaluate the efficacy and safety of 2gm...

GenVec Signs Supply Agreement with Novartis
11 August 2010 GenVec has signed an agreement with Novartis to supply clinical trial materials for two lead candidates related to hearing loss and balance disorders. Under the agreement, GenVec could...

US Senate Passes Improving Access to Clinical Trials Act
11 August 2010 The US Senate has passed the Improving Access to Clinical Trials Act, which enables patients with rare diseases to take part in clinical trials and still be eligible to receive medical...

DUSA to Stop Clinical Trials of Skin Cancer Drug Levulan
10 August 2010 DUSA Pharmaceuticals is to halt the clinical trial of its skin cancer prevention drug for organ transplant patients after the US Food and Drug Administration (FDA) refused to grant it orphan...

Rotavirus Vaccine Proven Effective in Developing Countries
10 August 2010 A two-year follow-up study has shown that Rotateq rotavirus vaccine has reduced cases of severe rotavirus gastroenteritis in infants in developing countries by 48% in Asia and 39% in Africa. ...

Acceleron Receives Fast-Track Designation for DMD Drug
09 August 2010 Acceleron Pharma has received US Food and Drug Administration fast-track designation for ACE-031, its investigational protein therapeutic, for the treatment of Duchenne muscular dystrophy...

Merck Announces Positive Results of Phase III Hepatitis Drug Studies
09 August 2010 Merck has announced that boceprevir, its chronic hepatitis C virus treatment, has met its primary endpoints in a Phase III trial. It showed that boceprevir increased the number of patients...

Study Suggests Industry-Funded Drug Trials More Likely to be Positive
06 August 2010 Industry-funded drug trials are more likely to publish positive results than those funded by government or non-federal organisations, according to a study by Children's Hospital...

Cardioxyl Achieves Positive Trial Results for Cardiac Drug
06 August 2010 Cardioxyl Pharmaceuticals has announced positive results of a Phase I/IIa trial of CXL-1020 as a treatment for patients with acute decompensated heart failure. The trial was a...

First Human Embryonic Stem Cell Therapy Trial Given Approval
05 August 2010 The US Food and Drug Administration (FDA) has approved a Phase I clinical trial of Geron's GRNOPC1 drug in patients with acute spinal cord injuries. This trial will be the world's first...

TZDs Shown to Increase Fracture Risk in Type 2 Diabetes Patients
05 August 2010 Postmenopausal women who have type 2 diabetes and take thiazolidinediones (TZDs) have an increased risk of fractures, a study has shown. Men with type 2 diabetes taking loop diuretics and...

Asthma Drug Trial Gets FDA Approval
04 August 2010 N30 Pharma has received approval from the US Food and Drug Administration for its investigational drug application for N6022 to begin a first-in-man, Phase I trials to treat a variety of...

BioMarin Discontinues Duchenne Muscular Dystrophy Drug Development
04 August 2010 BioMarin Pharmaceutical has discontinued development of BMN 195 for the treatment of Duchenne muscular dystrophy (DMD) based on results from its Phase I clinical study. In the...

New Dosage Strengths Approved for Cholesterol Treatment Simcor
03 August 2010 Abbott has received US Food and Drug Administration approval for two new dosage strengths of Simcor, a prescription medication for cholesterol treatment. The new Simcor dosage strengths...

Schizophrenia Drug Shows Positive Trial Data
03 August 2010 Intra-Cellular Therapies has said a Phase Ib/II clinical trial has shown that investigational drug ITI-007 is safe and well-tolerated in patients with stabilised schizophrenia. Clinical...

Heart Attack Cell Therapy Shows Positive Results
02 August 2010 Heart attack cell therapy MultiStem is well tolerated when administered to damaged regions of the heart following acute myocardial infarction, according to the results of a Phase I clinical trial....

FDA Approves Treatment to Stop Chronic Drooling
02 August 2010 The US Food and Drug Administration (FDA) has approved Shionogi's Cuvposa for the treatment of chronic severe drooling in paediatric patients with neurological conditions such as cerebral...

Phase IIb Lung Cancer Injection Trial Shows Positive Results
30 July 2010 Allos Therapeutics has announced positive top-line results for a Phase IIb trial of Folotyn (pralatrexate injection) in patients with advanced non-small cell lung cancer. The objective of...

FDA Gives Cladribine Priority Review Treatment
30 July 2010 The US Food and Drug Administration (FDA) has accepted a new drug application for Cladribine tablets as a treatment for relapsing forms of multiple sclerosis. Manufacturer Merck KgaA said...

Good Results for Multiple Myeloma Drug Carfilzomib
29 July 2010 Onyx Pharmaceuticals has reported positive results from a Phase IIb study of single-agent carfilzomib in patients with relapsed and refractory multiple myeloma. The drug demonstrated a...

AG-707 Shows Potential as Genital Herpes Treatment
29 July 2010 Antigenics's AG-707 vaccine has shown positive results in a Phase I study to treat herpes simplex virus-2 (HSV-2). The vaccine triggered a cellular immune response, stimulating the CD4+ and...

Phase I Trial Begins for Hospira's Biosimilar Erythropoietin
28 July 2010 A Phase I clinical trial of Hospira's biosimilar erythropoietin (EPO) has begun in the US to treat anaemia associated with chronic renal failure and chemotherapy. The Phase I study will...

FDA Approves Aricept to Treat Alzheimer's
28 July 2010 Eisai and Pfizer said the US Food and Drug Administration has approved a once-daily, higher-dose Aricept 23mg tablet for the treatment of moderate-to-severe Alzheimer's disease. A study...

FDA Approves Generic Version of Sandoz Obesity Drug
27 July 2010 The US Food and Drug Administration (FDA) has approved an abbreviated new drug application for phentermine hydrochloride blue/white seed capsules USP 30mg for obesity management. The...

Sandoz Introduces Generic Lovenox Rival
27 July 2010 Sandoz, Novartis AG's generic drug unit, has announced the introduction of enoxaparin sodium injection, a generic version of Sanofi-Aventis's Lovenox drug, following approval from the US Food...

Once-Daily HIV Integrase Inhibitor Reaches Phase III Trials
26 July 2010 Shionogi-ViiV Healthcare has said it will progress its once-daily, unboosted integrase inhibitor into Phase III clinical trials for HIV treatment. The studies will further evaluate the...

Trial Shows Tenofovir Gel Reduces HIV Risk Among Women
26 July 2010 Tenofovir 1% vaginal gel provides moderate protection against sexually transmitted HIV, a Phase IIb trial has indicated. The CAPRISA 004 trial tested the safety and effectiveness of...

Pfizer Suspends Tanezumab Trials
23 July 2010 Pfizer has suspended two studies in its clinical programme for investigational compound tanezumab at the request of the US Food and Drug Administration (FDA). The FDA asked that the trials –...

Novartis's Rasilez Gets Regulatory Approval in China
23 July 2010 Rasilez has received regulatory approval in China as a treatment of high blood pressure, either alone or in combination with other high blood pressure medicines. Novartis' drug inhibits...

Geron Enrols First Patient in Phase II Lung Cancer Trial
22 July 2010 Geron Corporation has enrolled the first patient in its Phase II clinical trial of imetelstat as maintenance therapy following platinum-based induction therapy for patients with non-small cell...

Mylan's Clonidine Transdermal System Gets FDA Approval
22 July 2010 Mylan subsidiary Mylan Technologies has received final approval from the US Food and Drug Administration for its abbreviated drug application for its clonidine transdermal system (CTS). The...

Cytos to Work with A*STAR for Influenza Vaccine
21 July 2010 Cytos Biotechnology and Singapore's Agency for Science, Technology and Research (A*STAR) will collaborate to develop and commercialise a virus-like particle vaccine to manage influenza infections....

Voreloxin and Cytarabine Combination Gets EU Patent
21 July 2010 The European Patent Office (EPO) has issued a European patent covering combinations of Sunesis Pharmaceuticals' drug candidate voreloxin with cytarabine. Cytarabine is the...

FDA Approves Bacterial Vaginosis Drug Trial
20 July 2010 Starpharma Holdings has received US Food and Drug Administration (FDA) approval to begin a Phase II study to investigate VivaGel for the treatment of bacterial vaginosis. More than 130 women...

Keryx Receives Orphan Drug Status for Perifosine
19 July 2010 Keryx Biopharmaceuticals has received orphan drug designation for KRX-0401 (perifosine), a drug to treat neuroblastoma, by the US Food and Drug Administration (FDA). Neuroblastoma is a cancer...

Clinuvel Drug Could Offer Light Pain Relief
19 July 2010 A drug that could help people who suffer from a genetic disorder that causes them to feel pain when exposed to sunlight has performed well in its Phase III crossover trial. Scenesse was...

Gestiva Application Resubmitted to FDA
16 July 2010 K-V Pharmaceuticals has said that Hologic has resubmitted a new drug application for Gestiva (hydroxyprogesterone caproate injection), 250mg/ml to the US Food and Drug Administration (FDA). ...

Obesity Drug Shows Signs of Success
16 July 2010 Pre-clinical PET data in non-human primates has demonstrated the efficacy of drug candidate TM38837 in treating obesity, type 2 diabetes and related metabolic disorders. The drug, developed...

Pre-Clinical Trials Show Addex Drug Effective in Osteoarthritis
15 July 2010 Pre-clinical studies have shown Addex's drug candidate ADX71943 to be effective in reducing increased pain sensitivity in the monosodium iodoacetate model of osteoarthritis. The...

Imiquimod Cream Shows Positive Results for Genital Wart Treatment
15 July 2010 Two Phase III studies evaluating imiquimod 3.75% and 2.5% creams as a treatment of external genital warts have shown that both are well-tolerated and more efficacious than a placebo. In the...

Trials Show Positive Results for Ectoin Allergy Spray
14 July 2010 Studies have shown that Ectoin-containing nasal spray and eye drops significantly reduce symptoms of acute allergic rhinitis and conjunctivitis. A two-week crossover study on 50 patients...

Russia First to Approve RRMS Drug Cladribine
14 July 2010 The Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to Cladribine tablets as a treatment...

Biogen and Swedish Orphan Biovitrum Advance Haemophilia Drug Trial
13 July 2010 Biogen Idec and Swedish Orphan Biovitrum have decided to advance their fully-recombinant Factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial to treat people...

Orthopaedic Surgery Drug Tests Well
13 July 2010 A clinical trial has shown that an ultra-low-molecular-weight heparin known as semuloparin reduces incidences of venous thromboembolism (VTE) and all-cause death by 25% in orthopaedic...

Preventative Migraine Treatment Performs Poorly in Trial
12 July 2010 Prophylactic migraine treatment GSK1838262 (gabapentin enacarbil) has failed its Phase IIb trial, demonstrating no significant improvement compared to a placebo. In the 30-week trial, the...

Ofatumumab Shows Positive Results to Treat Multiple Sclerosis
12 July 2010 A Phase II study of ofatumumab has shown positive interim results for safety and pharmacokinetics in patients with relapsing-remitting multiple sclerosis (RRMS). Ofatumumab is a novel...

EC Approves Anti-Cholesterol Drug for Children
09 July 2010 The European Commission (EC) has approved a chewable version of anti-cholesterol drug Lipitor to treat adolescents and children with hypercholesterolaemia aged ten years or older. Lipitor is...

T-DM1 Proves Successful in Shrinking Breast Cancer Tumours
09 July 2010 A Phase II study has shown that trastuzumab-DM1 (T-DM1) shrank tumours in one-third of women who had already taken seven medicines on average for advanced HER2-positive breast cancer. The...

Daytrana Gets FDA Clearance to Treat ADHD Teens
08 July 2010 The US Food and Drug Administration (FDA) has approved Daytrana for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana is a...

ImmunoXel Studies Show Benefits for HIV Treatment
08 July 2010 Initial results from two studies of Stirling Products' ImmunoXel have shown the drug has immunomodulatory actions with clear effects on cytokine levels and lymphocyte profiles in HIV...

Evotec Trials NMDA Receptor Antagonist for Depression
07 July 2010 A proof-of-concept Phase II study is being carried out in the US to analyse the safety, efficacy and tolerability of EVT 101 in patients with treatment-resistant depression (TRD). EVT...

FDA Approves Heparin Sodium Injection
07 July 2010 The US Food and Drug Administration (FDA) has approved nine presentations of heparin sodium injection USP as a vital anticoagulant in surgical and dialysis settings. The injection is a...

FDA Approves Zuplenz Oral Soluble Film
06 July 2010 The US Food and Drug Administration (FDA) has approved an oral soluble form of Zuplenz, a drug to prevent nausea and vomiting induced by chemotherapy or radiotherapy. Zuplenz, a formulation...

Roche's Avastin Meets Ovarian Cancer Goals
06 July 2010 A second late-stage Phase III study has demonstrated that a combination of Avastin and chemotherapy improves progression-free survival in women with ovarian cancer compared to chemotherapy alone. ...

FDA Approves Generic Acne Drug
05 July 2010 The US Food and Drug Administration (FDA) has approved an abbreviated new drug application for adapalene gel 0.1% as a topical treatment for acne. The drug is an AB-rated generic equivalent...

Eisai to Market Arena's Weight Loss Drug
05 July 2010 The US operation of Tokyo-based Eisai has announced a market and supply agreement with Arena Pharmaceuticals Gmbh for exclusive rights to commercialise Lorcaserin in the US. The drug,...

Pre-Diabetes Drug Shows Positive Clinical Results
02 July 2010 GENFIT will advance the development of GFT505 after two Phase IIa trials successful demonstrated the drug's ability to treat the symptoms of pre-diabetes. The first study involved 47...

Roche and IBM to Develop New DNA Sequencing Technology
02 July 2010 Roche has announced that it is working with IBM to develop a nanopore-based technology, which could lead to cost-effective personalised healthcare. The technology is designed to read and...

Diabetic Pain Drug Fails to Meet Phase II Trial Endpoint
01 July 2010 Forest Laboratories' investigational drug for treating neuropathic pain associated with diabetic peripheral neuropathy has failed to meet the primary endpoint of its Phase II trial. ...

Diabetic Gastroparesis Drug Shows Positive Phase II Results
01 July 2010 A Phase II study of Tranzyme Pharma's TZP-102 capsules in diabetic patients with gastroparesis has demonstrated clinically significant improvements in critical symptoms. The study, conducted...

InNexus Develops Non-Invasive Treatment for Vascular Eye Diseases
30 June 2010 InNexus Biotechnology has developed a non-invasive topical therapy for age-related macular degeneration and diabetic retinal dysplasia. Antibody fragment IXS312 targets vascular...

FDA Approves Generic Version of Antidepressant Effexor
30 June 2010 The US Food and Drug Administration (FDA) has approved Venlafaxine HCl ER, a generic version of Wyeth's antidepressant medication Effexor XR. Israel-based Teva Pharmaceutical Industries has...

FDA Approves Generic Version of Pfizer's Procardia Tablets
29 June 2010 The US Food and Drug Administration (FDA) has approved an abbreviated new drug application for a generic version of Pfizer's Procardia XL tablets as a treatment for angina and...

Trial Data Shows Raloxifene Improves Bone Quality
29 June 2010 Daiichi Sankyo's EVISTA osteoporosis treatment for post-menopausal women is effective at improving bone quality, according to Phase II trial data. The results, based on high-resolution...

Merck Joins Fight Against Chagas Disease
28 June 2010 Merck has announced that it will initiate a Phase II investigational proof-of-concept clinical study to evaluate posaconazole, its oral anti-fungal agent, as a potential treatment for...

New Combination Asthma Treatment Approved by FDA
28 June 2010 The US Food and Drug Administration (FDA) has approved a fixed-dose combination asthma treatment for patients aged twelve years and older. Dulera combines an inhaled corticosteroid with...

New Alzheimer's Drug Approved in US
25 June 2010 The US Food and Drug Administration has approved Namenda XR (memantine hydrochloride) for the treatment of moderate to severe Alzheimer's disease. The drug is a 28mg, extended-release...

Diabetes Drug Dapagliflozin Shows Further Promise
25 June 2010 Investigational drug dapagliflozin can improve glycaemic control in treatment-naive adults with type 2 diabetes when used as a monotherapy, a Phase III study carried out at Princeton...

Takeda Pays Affymax $30m After Phase III Hematide Trial Success
24 June 2010 Takeda Pharmaceutical Company has paid Affymax $30m for meeting development milestones for Hematide (peginesatide), an investigational drug to treat anaemia in patients with chronic renal failure....

US Companies Inject Record Amounts into Pharma and Biotech R&D
24 June 2010 Despite the economic recession, US pharmaceutical research and biotechnology companies invested a record $65.3bn in medicine and vaccine R&D during 2009. An industry-wide analysis...

Chugai Anti-Cancer Antibody Receives Priority Review Status in Japan
23 June 2010 Chugai Pharmaceutical Co has been granted priority review designation for its trastuzumab anti-cancer antibody by the Japanese Ministry of Health, Labour and Welfare. The designation was...

Pfizer to Withdraw Leukaemia Drug from US Market
23 June 2010 Pfizer has said it plans to withdraw acute myeloid leukaemia drug Mylotarg from the US market, after a clinical study indicated it had few benefits for patients. The Food and Drug...

European Drug Companies Lead Access to Medicine Index
22 June 2010 European pharmaceutical companies are doing better then their US counterparts when it comes to making their drugs available in the developing world, according to the second Access to...

Curis's Colorectal Cancer Drug Fails Phase II Study
22 June 2010 Curis's GDC-0449, a new first-line metastatic colorectal cancer drug, has failed to meet its Phase II study primary endpoint of sufficiently inhibiting disease progression. The trial,...

Advanced Prostate Cancer Drug Approved in US
21 June 2010 The US Food and Drug Administration (FDA) has approved Jevtana (cabazitaxel), a chemotherapy drug to treat men with prostate cancer. Jevtana, produced by Sanofi-Aventis, is the first...

Pfizer and Trubion Halt Development of Rheumatoid Arthritis Drug
21 June 2010 Pfizer will discontinue development of one of the two investigational rheumatoid arthritis drugs it is working on with Trubion Pharmaceuticals. The companies decided to halt development...

Bayer and OncoMed Team Up to Develop Anti-Cancer Stem Cell Therapeutics
18 June 2010 Bayer Schering Pharma AG and OncoMed Pharmaceuticals have announced a global strategic alliance to discover, develop and commercialise novel anti-cancer stem cell therapeutics. The two...

FDA Approves Generic Version of Keppra Injection
18 June 2010 The US Food and Drug Administration (FDA) has given Sun Pharmaceuticals approval to market a generic version of UCB's Keppra epilepsy injection. The generic injection - levetiracetam - is used...

Phase I Clinical Study Shows Positive Results for Octreolin
17 June 2010 A Phase I clinical study to evaluate the safety of Octreolin – an oral therapy for acromegaly patients manufactured by Chiasma - found no serious adverse events among treated...

Bayer's Lung Cancer Drug Fails Trials
17 June 2010 Nexavar has not met its Phase III trial primary endpoint of improving the overall survival of patients with advanced non-small cell lung cancer in the first-line setting. The drug was...

FDA Fast-Tracks Collegium Chronic Pain Drug
17 June 2010 The US Food and Drug Administration (FDA) has granted fast-track designation to Collegium Pharmaceutical's COL-172, a tamper-resistant, extended-release oral opioid treatment for pain. COL-172...

Raptor Wins EU Orphan Status for Kidney Disease Drug
17 June 2010 The European Medicines Agency (EMA) has granted Raptor Pharmaceutical orphan medicinal product designation for DR Cysteamine to treat cystinosis, a genetic condition that affects the kidney. ...

Epilepsy Treatment Linked to Birth Defects
16 June 2010 A drug used to treat epilepsy could triple the risk of birth defects, a study suggests. Researchers at the University of Ulster in the UK found that taking valproic acid in the first...

Pfizer Establishes Rare Disease Research Unit
16 June 2010 Pfizer has established a research unit to find new medicines for rare diseases that affect fewer than 200,000 patients. The Rare Disease Research Unit is expected to pursue treatments across...

Pixantrone Manufacture Approved in Italy
15 June 2010 Manufacture of experimental antineoplastic drug Pixantrone will begin at NerPharMa DS' facility in Nerviano, Italy, after the site was given approval by the Italian Medicines Agency. The...

Patheon Q2 Revenues Increase
15 June 2010 Patheon Inc has reported revenues of $175.4m for the second quarter of 2010 (ending 30 April), compared to $167.4m for the same period in 2009. The company, which provides contract...

Fingolimod Gets Initial Approval from FDA Committee
14 June 2010 Multiple sclerosis drug fingolimod (FTY720) has received approval from a US Food and Drug Administration (FDA) expert advisory committee as a treatment for relapsing/remitting multiple sclerosis. ...

Insomnia Drug Trials Show Improved Sleep Efficiency
14 June 2010 Clinical results from a Phase IIb study conducted on 254 patients with primary insomnia showed positive effects for Merck's MK-4305. MK-4305 is Merck's investigational dual-orexin...

Sprycel Study Shows High Survival Rates in Leukaemia Patients
11 June 2010 Results of a Sprycel phase III study showed 82% overall survival for patients with chronic phase chronic myeloid leukaemia (CML - CP) resistant to alternative treatment Gleevec. The...

Study Shows Positive Results for Macugen Treatment
11 June 2010 A phase III trial of Macugen injection treatment for patients with diabetic macular edema (DME), a complication of chronic diabetes that causes blindness, showed maintained and expanded...

Northwest Biotherapeutics' Cancer Vaccine Get Positive Review
10 June 2010 Northwest Biotherapeutics' DCVax personalised cancer vaccine can improve survival for patients with brain cancer and prostate cancer, according to a report by the Matrix Group. There was also...

New Amgen Combo Shows Antitumour Activity
10 June 2010 Amgen has announced that clinical trials of AMG 386 combined with paclitaxel are showing promising antitumour activity and extended progression-free survival in recurrent ovarian cancer patients. ...

Ascenta Therapeutics and Sanofi-Aventis Collaborate on Cancer Drugs
09 June 2010 Ascenta Therapeutics and sanofi-aventis have announced a new collaboration to develop compounds that can restore the p53 tumour suppressor function in cancer cells or tumour cell...

Phase III Avastin Trial Suggests Long-term Benefit for Ovarian Cancer Patients
09 June 2010 A Phase III clinical trial has found that long-term treatment with cancer drug Avastin may help keep advanced ovarian cancer in check. The study showed that women who took Avastin for up to...

FDA Approves Generic Version of Neurontin
08 June 2010 The US Food and Drug Administration has approved a generic version of Pfizer's Neurontin tablets to treat postherpetic neuralgia. The abbreviated new drug application will allow...

Good Results for Eisai's Breast Cancer Drug
08 June 2010 Eisai revealed its single-agent Phase III trial of eribulin mesylate showed improved overall survival in patients with locally recurrent or metastatic breast cancer. The phase III Embrace...

Teva Receives FDA Approval for Generic Differin
07 June 2010 Teva Pharmaceutical Industries has received US Food and Drug Administration approval for its generic version of Galderma's Differin Gel. Following the approval, Teva has announced the...

Single-Dose Fosaprepitant as Effective as Three-Day Regimen for CINV
07 June 2010 Merck has revealed the results of a non-inferiority trial of an anti-emetic regimen containing fosaprepitant dimeglumine administered as a single-dose along with 5-HT3 antagonist and...

Orexigen Files NDA for Obesity Drug
04 June 2010 The US Food and Drug Administration (FDA) has accepted a new drug application from Orexigen for its investigational drug Contrave to treat obesity. The application is based on four...

Philips, RXi to Explore New RNAi Drugs
04 June 2010 Royal Philips Electronics and RXi Pharmaceuticals Corporation have entered into a joint research agreement to explore the benefits of the targeted delivery of experimental therapeutics based on...

FDA Approves Prolia to Treat Osteoporosis in Menopausal Women
03 June 2010 The US Food and Drug Administration (FDA) has approved Amgen's Prolia, an injectable treatment for menopausal women with osteoporosis. Prolia decreases destruction of bone and increases...

Lorus Files IND for Anti-Cancer Drug Candidate
03 June 2010 Lorus Therapeutics has filed an investigational new drug (IND) application with the US Food and Drug Administration for LOR-253, an anti-cancer drug candidate. The application is for...

Novartis Ovarian Cancer Drug Fails Phase III Study
02 June 2010 Novartis' drug patupilone (EPO906) did not demonstrate overall survival to patients with advanced ovarian cancer, resistant to platinum-based therapy, in a Phase III trial. The company is...

Iron Replacement Drug Improves Renal Function
02 June 2010 Correcting iron deficiency with Vifor Pharma's Ferinject can improve renal function in chronic heart failure patients, according to a subanalysis study. The study indicated that the...

AstraZeneca Won't Develop Recentin for Metastatic Colorectal Cancer
01 June 2010 AstraZeneca has decided not to file regulatory submissions for Recentin (cediranib) to treat first-line metastatic colorectal cancer. The decision followed the results of a Phase III study...

Hong Kong Researchers Locate Influenza Drug Target
01 June 2010 A research team at The University of Hong Kong has found that a viral structural protein can be used as a drug target to combat the influenza virus. The team identified and validated...

Bayer Meets Efficacy Goals in Gadobutrol Phase III Study
28 May 2010 Bayer HealthCare Pharmaceuticals has released Phase III clinical trial results confirming the efficacy of Gadobutrol, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA) in...

Malaria Drug Restanza Shows Good Trial Results
28 May 2010 Advanced Life Sciences Holdings has announced positive results from in-vitro and in-vivo studies to evaluate the efficacy of Restanza (cethromycin), an anti-malarial oral antibiotic. The...

Clovis and Avila Sign Lung Cancer Drug Development Deal
27 May 2010 Clovis Oncology and Avila Therapeutics have signed an agreement to develop and commercialise Avila's epidermal growth factor receptor (EGFR) to treat non-small cell lung cancer (NSCLC). Under...

FDA Approves New Drug to Treat Pompe Disease
27 May 2010 The US Food and Drug Administration has approved Lumizyme (alglucosidase alfa) to treat patients aged eight years and older with Pompe disease. The genetic disorder is characterised by...

Repligen Wins Orphan Drug Status for Friedreich's Ataxia Drug
26 May 2010 Repligen Corporation has been granted orphan drug designation by the US Food and Drug Administration (FDA) for RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor to treat...

Anadys Announces Positive Results for Hepatitis C Drug
26 May 2010 Anadys Pharmaceuticals has achieved complete early virological response (cEVR) from a ongoing 12-week Phase II study of ANA598, a new drug candidate to treat hepatitis C. The...

Lilly Releases Positive Phase II Results for Melanoma Drug
25 May 2010 Lilly Oncology, a division of Eli Lilly and Company, has released positive Phase II study results for its anti-cancer agent, Tasisulam, in patients with metastatic melanoma, a form of skin cancer....

Ablynx and Pfizer Extend Anti-TNF-Alpha Nanobody Collaboration
25 May 2010 Ablynx has extended its research collaboration, which forms part of its licence agreement for the anti-tumour necrosis factor alpha (TNF-alpha) nanobody, with Pfizer for another year. ...

Quintiles and Kaiser Permanente to Collaborate on Drug Development
24 May 2010 Quintiles and Kaiser Permanente's Southern California Permanente Medical Group (SCPMG) have signed an agreement to accelerate the development of new medicines. SCPMG will join Quintile's...

Bayer to Establish Innovation Centre in US
24 May 2010 Bayer Schering Pharma will establish an innovation centre in San Francisco, US, to build a specialty pharmaceutical pipeline and expand its global research network. The centre will focus...

Roche and Biogen to Discontinue Ocrelizumab Clinical Development
21 May 2010 Roche and Biogen Idec will discontinue the ocrelizumab clinical development programme for patients with rheumatoid arthritis (RA). The companies concluded that the drug candidate did not...

New Therapy Class Successful Against Blood Cancer
21 May 2010 A first-in-class drug SNS-032, being tested by a team of industry experts and academics, has demonstrated safety and clinical action against advanced chronic lymphocytic leukaemia (CLL). The...

New Peptides Identified for Cancer Treatment
20 May 2010 ImmunoCellular Therapeutics and the Torrey Pines Institute for Molecular Studies have identified peptides that can generate CD-133 T-cells suitable for immunological targeting. The partners...

Washington University to Use Pfizer's Compound Library
20 May 2010 As part of a new collaboration between academia and industry, Pfizer has granted scientists at Washington University School of Medicine in St Louis access to information regarding more than...

RegeneRx Awarded NIH Grant to Develop Cardiac Drug
19 May 2010 RegeneRx Biopharmaceuticals has been awarded a $3m grant from the National Institute of Health's National Heart, Lung and Blood Institute for heart attack drug. The grant is to...

Teva's Lou Gehrig's Drug Fails Phase II Trials
19 May 2010 Teva Pharmaceutical Industries did not meet its primary endpoint from its Phase II trial to evaluate efficacy, safety and tolerability of Talampanel to reduce disease-related...

Nile Enrols Patients for Cardiac Drug Phase II Study
18 May 2010 Nile Therapeutics has begun a placebo-controlled Phase II clinical study of its lead compound, CD-NP, for patients with acute decompensated heart failure. The study is being conducted...

Celsion to Continue Enrolment for Phase III ThermoDox Trials
18 May 2010 The Data Monitoring Committee (DMC) has advised Celsion Corporation to continue enrolling patients for its liver cancer drug candidate, ThermoDox. The recommendation follows the DMC's review...

Galapagos and Roche Expand Drug Discovery Partnership on COPD
17 May 2010 Galapagos NV has expanded its global multi-year strategic alliance with Roche to develop new drugs against chronic obstructive pulmonary disease (COPD). The partners have added more...

Novavax Publishes Pre-Clinical Report on VLP Influenza Vaccine
17 May 2010 Novavax has published the first pre-clinical study report of its Pandemic 2009 H1N1 influenza virus-like particle (VLP) vaccine. Novavax and the Centres for Disease Control and Prevention...

Repligen Files NDA for Friedreich's Ataxia Drug
14 May 2010 Repligen Corporation has filed an Investigational New Drug Application with the US Food and Drug Administration (FDA) for a phase 1 study of what could be the first drug to treat the deadly...

Amarin to Complete Phase 3 AMR101 Trial Enrolment
14 May 2010 Amarin Corporation is expecting to complete enrolment in 2011 for two pivotal Phase 3 clinical trials for its lead drug candidate, AMR101, to treat elevated triglyceride levels. ...

Evotec and Genentech Enter into Drug Discovery Collaboration
14 May 2010 Evotec AG has entered into a multi-year integrated drug discovery partnership with Genentech, a wholly owned subsidiary of Roche Group. The partners will discover novel small molecule...

FDA Nod for Cipher Chronic Pain Drug
13 May 2010 Cipher Pharmaceuticals has received US Food and Drug Administration approval for its extended-release tramadol product CIP-TRAMADOL ER to treat chronic pain in adults. The product is...

Sanofi-Aventis Starts Phase IIIb Mustaq Trials
13 May 2010 Sanofi-aventis has initiated PALLAS, a double-blind, multinational, randomised phase-IIIb trial to assess the clinical benefit of Multaq in over 10,000 patients with permanent atrial...

Dynavax Immunise first Patients in Hepatitis B Vaccine Study
12 May 2010 Dynavax Technologies Corporation has immunised the first of over 2,000 subjects enrolled in its Phase III clinical study of investigational adult hepatitis B vaccine HEPLISAV. The...

Nile Completes Dose Escalation in Phase II Cardiac Drug Study
12 May 2010 Nile Therapeutics has completed the dose escalation stage of an ongoing Phase II study of CD-NP in patients with acute decompensated heart failure. Nile said it reached a maximum tolerated...

Intercell Acquires Antibody Technology Platform from Cytos
11 May 2010 Intercell AG has signed an agreement with Cytos Biotechnology to acquire its monoclonal antibody discovery platform technology. The technology facilitates anti-infective antibody...

Adeona Enters to Develop Fibromyalgia Drug with Meda
11 May 2010 Adeona Pharmaceuticals has entered into a development and commercialisation agreement with Meda AB to develop flupirtine to treat fibromyalgia syndrome. Adeone has granted Meda an...

FDA Approves Four-phasic Oral Contraceptive
10 May 2010 The US Food and Drug Administration has approved Natazia, a combination hormonal oral contraceptive from Bayer HealthCare Pharmaceuticals. The drug contains oestrogen and progestin and is...

Asterand Enters BioMAP Collaboration Agreement with Eisai
10 May 2010 BioSeek, a subsidiary of Asterand, has signed a two-year collaboration agreement with Eisai to advance the discovery of oncology and inflammation agents. BioSeek will apply its...

Newron Clinical Study Fails to Yield Positive Results
07 May 2010 A phase IIb / III study of ralfinamide in patients with at least moderate neuropathic low back pain (NLBP) conducted by Newron Pharmaceuticals has failed to yield positive results. The...

Newron Clinical Study Fails to Yield Positive Results
07 May 2010 A phase IIb / III study of ralfinamide in patients with at least moderate neuropathic low back pain (NLBP) conducted by Newron Pharmaceuticals has failed to yield positive results. The...

FDA Finds Increased Disease Risk with Prostrate Cancer Drugs
06 May 2010 The US Food and Drug Administration (FDA) has found Gonadotropin-Releasing Hormone (GnRH) agonists to be associated with a minor risk of diabetes, heart attack, stroke and sudden death in...

Oral Gaucher Therapy Shows Success in Trials
06 May 2010 A multi-national, open-label phase II study of 26 patients with Gaucher disease type 1 to evaluate the efficacy, pharmacokinetics and safety of eliglustat tartrate as an oral therapy has...

Angelini Labopharm to Commericalise Oleptro
05 May 2010 Labopharm and Angelini have entered into a joint venture agreement to commercialise Oleptro, an antidepressant drug used to treat major depressive disorders in adults in the USA. The...

FDA Approves Denderon Prostrate Cancer Drug
05 May 2010 The US Food & Drug Administration (FDA) has approved Dendreon Corporation's PROVENGE for the treatment of men with advanced prostrate cancer. The drug, designed to induce an immune...

Combination Antiviral Therapy Pilot Study Shows Encouraging Results
04 May 2010 A triple combination antiviral drug (TCAD) developed by Adamas Pharmaceuticals has been well tolerated in a pilot clinical study of immunocompromised patients with influenza A. The...

Bill Gates Invests in Schrodinger
04 May 2010 Schrodinger, a scientific leader in chemical simulation for pharmaceutical research, has received an equity investment from Bill Gates' private investment company, Cascade Investment, to...

Takeda Gets NDA Clearance for Diabetes Drug in Japan
30 April 2010 Takeda Pharmaceutical Company has received approval from the Japanese Ministry of Health, Labour and Welfare for its new drug application for NESINA (alogliptin), a DPP-4 inhibitor for...

Dr Reddy’s Launches Amlodipine Benazepril in USA
30 April 2010 Dr Reddy's Laboratories has launched amlodipine benazepril capsules, a generic version of Novartis's drug Lotrel, in the US market. Amlodipine benazepril is indicated for the treatment...

Evotec to Receive German Grant for H3 Receptor Antagonist Programme
29 April 2010 Evotec AG will receive €1.5m from the German Federal Ministry of Education and Research as a research grant to advance its H3 receptor antagonist programme. Evotec has identified...

BioSante Enters Agreement to License 2A/Furin Technology
29 April 2010 BioSante Pharmaceuticals has entered into an option agreement with an undisclosed pharmaceutical company to obtain a non-exclusive worldwide licence to use the former’s 2A/Furin technology in...

Clavis and Partners Develop Diagnostic Partner for Cancer Drug
28 April 2010 Clavis Pharma, Clovis Oncology and Ventana Medical Systems have entered into a collaboration agreement to develop a companion diagnostic to CP-4126, Clavis's lead cancer drug candidate. ...

Genentech Submits Herceptin Chemo Application to FDA
28 April 2010 Genentech, a wholly owned subsidiary of Roche Group, has submitted a supplemental biologics licence application to the US FDA for Herceptin plus chemotherapy for patients with...

MMV and Anacor Collaborate to Develop Antimalarial Drugs
28 April 2010 Medicines for Malaria Venture (MMV) and Anacor Pharmaceuticals have entered into a research collaboration to develop new therapeutics to treat malaria. Anacor will lead the research effort...

Nycomed, Merck Sign to Commercialisation COPD Drug
27 April 2010 Nycomed and Merck & Co have entered into a commercialisation agreement for Daxas, an investigational once-daily tablet for patients with chronic obstructive pulmonary disease. Under the...

Charles River, WuXi Propose $1.6bn Merger
27 April 2010 Charles River and WuXi PharmaTech have announced a definitive agreement under which the companies will merge in a cash and stock transaction valued at $1.6bn. The merged entity will retain...

Pfizer and MMV to Develop Treatment for Pregnant Women
26 April 2010 Pfizer and Medicines for Malaria Venture (MMV) have entered into an agreement for the development, access and delivery of a fixed-dose combination treatment. The treatment will consist...

EC Grants Novartis Pharma New Pediatric Indication For Diovan
26 April 2010 The European Commission (EC) has granted Diovan (valsartan) a new pediatric indication for the treatment of hypertension in children and adolescents between 6-18 years of age. Novartis...

Novartis Receives FDA Nod for Immunosuppressant Drug
23 April 2010 Novartis has received US FDA approval for its immunosuppressive drug Zortress to prevent organ rejection in adult kidney transplant recipients. The new drug is approved to prevent...

Lotus to Receive China SFDA Approval for Asthma Drug
23 April 2010 Lotus Pharmaceuticals' asthma drug Laevo-Bambutero will receive fast-track approval from China's State Food & Drug Administration (SFDA) to begin clinical trials. Laevo-Bambutero completed...

Prana to Begin Phase IIb Alzheimer's Drug Trial
22 April 2010 Prana Biotechnology has announced plans to initiate a Phase IIb trial of its the drug PBT2, the company's lead candidate to treat Alzheimer's disease, before the end of 2010. The...

Cornerstone to Begin Phase I Cancer Drug Trials
22 April 2010 Cornerstone Pharmaceuticals has received US FDA clearance to initiate Phase I human clinical trials of the anticancer agent, CPI-613. The trial, to be conducted at Wake Forest University...

Array Signs Oncology Drug Agreement with Novartis
21 April 2010 Array BioPharma said it has signed an agreement with Novartis to develop small-molecule MEK inhibitors ARRY-162, ARRY-300 and other inhibitors. Long-term preclinical safety studies have...

Wellcome Extends Drug Discovery Initiative
21 April 2010 Global Charity the Wellcome Trust has injected £110m to extend its seeding drug discovery (SDD) programme for an additional five years. The decision was made following an internal review of...

FDA Approves Wider use of Tarceva
20 April 2010 The US FDA has approved the wider use of OSI Pharmaceutical's Tarceva, a once-a-day pill to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The drug...

PhytoMedical and Medicilon to Advance Brain Cancer Drug
20 April 2010 PhytoMedical Technologies has signed a letter of intent with Shanghai Medicilon to advance its brain cancer drug candidate, D11B. Under the proposal, Shanghai Medicilon will...

Mylan Gets FDA Nod for Antidepressant Generics
16 April 2010 Mylan Pharmaceuticals has received US FDA approval for its abbreviated new drug application for Bupropion Hydrochloride Extended-Release Tablets. The drug is the generic version...

Albany and Navigen Enter into Drug Research Collaboration
16 April 2010 Albany Molecular Research has entered into a research collaboration with Navigen Pharmaceuticals to develop new drug therapies. Albany will provide fully integrated drug discovery services...

Mylan Receives FDA Approval for Hyzaar Generics
15 April 2010 Mylan Pharmaceuticals has received the final approval for its abbreviated new drug application (ANDA) for losartan potassium and hydrochlorothiazide (HCTZ) tablets 100mg / 12.5 mg from the US FDA....

FDA Approves New Digestive Pancreaze
15 April 2010 The US FDA has approved Pancreaze delayed-release capsules, a pancreatic enzyme product (PEP) manufactured by Johnson & Johnson. PEPs improve food digestion in patients whose bodies do...

Sanofi Pasteur, US Naval Centre to Develop Diarrhoea Vaccine
14 April 2010 Sanofi Pasteur has entered into a four-year strategic partnership with the US Naval Medical Research Center to develop a diarrhea vaccine. The core enterotoxigenic Escherichia coli...

Research Grants Awarded for Frontotemporal Dementia
14 April 2010 The Alzheimer's Drug Discovery Foundation (ADDF) and the Association for Frontotemporal Dementias (AFTD) has awarded $300,000 to three academic scientists as part of the Frontotemporal...

Seattle Genetics, Takeda and Millennium Begin Brentuximab Vedotin Phase III Trials
13 April 2010 Seattle Genetics, Takeda Pharmaceutical Company and its wholly owned subsidiary Millennium announced the beginning of the Phase III trial of brentuximab vedotin for post-transplant Hodgkin...

Genzyme and Arecor Collaborate on Advanced Protein Therapeutics
13 April 2010 Genzyme and Arecor will work together on developing advanced formulations for protein therapeutics. Both companies say they want to develop stable, high-strength formulations of...

Penwest and Alvogen Sign Drug Development Agreement
13 April 2010 Penwest Pharmaceuticals said it has signed a drug development and commercialisation agreement with Alvogen, under which the partners will develop five compounds. Penwest will formulate...

ChemoCentryx Identifies Drug Candidate to Treat Inflammatory Diseases
12 April 2010 ChemoCentryx said it has identified a novel drug candidate to treat inflammatory skin diseases. The investigational new drug-coded CCX832 is an orally administered small molecule...

Genta's Tesetaxel Gets Fast Track Status
12 April 2010 Genta has received fast-track designation for its advanced gastric cancer drug candidate tesetaxel from the US FDA, the company said. Following positive results from a phase 2a trial, Genta...

Pfizer, MDRNA to Study RNAi Drug Discovery Platform
09 April 2010 MDRNA said it is conducting a study with Pfizer to evaluate its proprietary di-alkylated amino acids (DiLA2) platform and UsiRNA constructs for RNA interference (RNAi). MDRNA will...

Approval for Teva's Antihypertensive Generics
09 April 2010 Teva Pharmaceutical Industries has received final approval from the US FDA for its generic versions of Merck's anti-hypertensive agents Hyzaar (losartan potassium-hydrochlorothiazide) and...

Daiichi Sankyo Submits NDA for Edoxaban in Japan
08 April 2010 Daiichi Sankyo said it has submitted a new drug application for edoxaban for the treatment of venous thromboembolism (VTE) following orthopedic surgeries, in Japan. Edoxaban is an...

Allon Receives Fast-Track Status for Davunetide
08 April 2010 Allon Therapeutics has received US FDA fast-track status for its drug candidate davunetide as a treatment for progressive supranuclear palsy (PSP), a degenerative brain disease. ...

Æterna Receives Fast-Track Designation for Perifosine
07 April 2010 Æterna Zentaris and its partner Keryx Biopharmaceuticals have received fast-track designation from the US Food and Drug Administration (FDA) for perifosine (KRX-0401). Perifosine is...

FDA Approves Re-formulated OxyContin
07 April 2010 The US FDA has approved a reformulated version of OxyContin that slowly releases the potent opioid oxycodone to make the drug less open to abuse. OxyContin is used to treat patients who...

Ikraia Acquires Lucassin Orphan Therapeutics
06 April 2010 Ikaria Holdings is reporting that it has acquired the new drug application and the investigational new drug application for Lucassin from Orphan Therapeutics. Through the acquisition,...

Antisoma Halts NSCLC Drug Trial
06 April 2010 Antisoma has said it will halt trials of its non-small cell lung cancer drug candidate ASA404 following poor interim data analysis from Phase III trials. The interim analysis indicated that...

FDA Approves Asclera Varicose Vein Treatment
01 April 2010 The US Food and Drug Administration (FDA) has approved Asclera (polidocanol) injection for the treatment of swollen or twisted varicose veins. Asclera is indicated for the treatment of...

Access Signs Agreement to Develop Oral Insulin
01 April 2010 Access Pharmaceuticals has signed a collaborative agreement with bioRASI to facilitate clinical development for its Cobalamin-based oral insulin and other products. The partners will focus...

GenVec Discontinues Phase III Pancreatic Cancer Drug Trial
31 March 2010 GenVec said it will discontinue its Phase III trial of TNFerade in advanced pancreatic cancer patients after interim analysis did not provide enough persuasive evidence to continue. ...

Novavax Completes Pivotal Stage of Mexican A/H1N1 Study
31 March 2010 Novavax has announced positive results from the 1,000-subject Stage A of its two-stage pivotal study to evaluate the safety and immunogenicity of its 2009 A/H1N1 VLP pandemic influenza...

Biovail Acquires Assets from Cortex Pharmaceuticals
30 March 2010 Biovail Laboratories, a subsidiary of Biovail Corporation has acquired compounds and intellectual property in the field of respiratory depression from Cortex Pharmaceuticals. The...

Eisai to Enrol Patients in Phase III Eritoran Trial
30 March 2010 Eisai will continue Phase III trials for its investigational sepsis drug eritoran with the enrolment of 2,000 patients. The trial is a global, double-blind, placebo-controlled, randomised...

Xifaxan Approved for Advanced Liver Disease
29 March 2010 The US Food and Drug Administration (FDA) has approved the use of Xifaxan for patients with advanced liver disease to reduce the risk of overt hepatic encephalopathy (HE). HE is a reduction...

Arena Initiates Phase I Trial of Narcolepsy and Cataplexy Drug
26 March 2010 US firm Arena Pharmaceuticals has initiated patient screening in a Phase I clinical trial of APD916, an oral drug that targets the histamine H3 receptor for the treatment of narcolepsy...

Vical to Trial Navy Swine Flu Vaccine
26 March 2010 US firm Vical will carry out a Phase I clinical trial of its Vaxfectin-formulated DNA vaccine for A/H1N1 pandemic influenza, also called swine flu, for the US Navy. The funds will be provided...

Ono and BioSeek Collaborate on Bioactive Lipid Drug Discovery
25 March 2010 Japanese firm Ono Pharmaceuticals and US company BioSeek have entered into a drug discovery agreement based on bioactive lipids. Under the agreement, Ono will pay research funds and...

Merck Serono Suspends Stimuvax Clinical Programme
25 March 2010 Merck Serono, a division of Merck KGaA, has temporarily suspended all clinical programmes for Stimuvax (BLP 25 liposome vaccine) following a suspected serious adverse reaction. The...

Mirapex Approved For Early and Advanced Parkinson's
24 March 2010 Boehringer Ingelheim Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved once-daily Mirapex ER for early and advanced Parkinson's disease (PD). Mirapex...

Positive Trials Clear Path for Cannabis-Based Cancer Drug
24 March 2010 Positive preliminary results from a Phase II study of GW Pharmaceuticals' chronic cancer pain drug Sativex should result in regulatory approval for the world's first cannabis-based...

Drug Industry Lifted on the Back of US Healthcare Reform
23 March 2010 The passing of landmark healthcare reform in US House of Representatives will extend health insurance to an estimated 36 million Americans, providing a welcome lift to the pharmaceutical and...

Multidrug-Resistant Tuberculosis on Rise, Says WHO Report
23 March 2010 An estimated 440,000 people worldwide fell ill with multidrug-resistant tuberculosis (MDR-TB) in 2008, with around a third of them dying, according to a World Health Organization (WHO)...

Novelos Discontinues Lung Cancer Drug Programme
22 March 2010 Novelos Therapeutics has discontinued the development programme for its non-small cell lung cancer (NSCLC) candidate drug NOV-002 as the primary and secondary endpoints were not met in the...

FDA Approves New Insomnia Treatment Silenor
22 March 2010 The US Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Somaxon Pharmaceuticals' Silenor (doxepin) to treat insomnia characterised by difficulty with...

Ipsen Initiates Two Studies to Evaluate Carcinoid Drug
19 March 2010 Ipsen has initiated two Phase II clinical studies to evaluate the efficacy and safety of BIM 23A760, a new drug to treat patients suffering from carcinoid syndrome due to neuroendocrine tumours. ...

Physiomics Simulations to Boost Cancer Drug Development
19 March 2010 UK firm Physiomics has signed an agreement with Sareum, The Institute of Cancer Research and Cancer Research Technology to provide silico simulations to support cancer drug...

Nuvo Research Begins Allergic Rhinitis Phase II Trial
18 March 2010 Nuvo Research has enrolled the first patient in its European Phase II clinical trial evaluating the immune modulating drug candidate WF10 for the treatment of allergic rhinitis, also known as...

LLS and Forma Collaborate on Lymphoma Drug
18 March 2010 The Leukemia & Lymphoma Society (LLS) and Forma Therapeutics have entered into a collaboration to discover and develop small molecule compounds for the treatment of B cell lymphoma. ...

GSK and Cellzome Collaborate on Anti-Inflammatory Drugs
17 March 2010 UK firm GlaxoSmithKline (GSK) and Anglo-German biotech firm Cellzome have partnered to jointly identify selective small-molecule drug candidates for anti-inflammatory drugs. The research will...

Pancreatic Cancer Vaccine Wins Orphan Drug Status
17 March 2010 The US Food and Drug Administration (FDA) has awarded orphan drug status to BioSante Pharmaceuticals for its GVAX pancreas vaccine to guard against pancreatic cancer. The Orphan Drug Act...

IBS Drug Market to Triple by 2018
16 March 2010 The irritable bowel syndrome (IBS) drug market in the US, Europe and Japan will more than triple from $459m in 2008 to $1.52bn in 2018, according to a new report. The Decision Resources...

Pfizer Halts Lung Cancer Treatment Trial
16 March 2010 Pfizer has suspended a Phase III trial of the investigational drug figitumumab in patients with advanced non-small cell lung cancer (NSCLC) after a safety comitee found that the drug is unlikely...

AstraZeneca's Cancer Drug Fails Trial
15 March 2010 Anglo-Swedish firm AstraZeneca's cancer drug Recentin has failed to meet its primary endpoint in a Horizon Phase III trial, to assess the drug as a treatment for metastatic colorectal...

Sigma-Aldrich to Sell Pfizer's Bioactive Small Molecules
15 March 2010 Sigma-Aldrich has reached a deal with Pfizer to sell approximately 100 Pfizer-developed small molecule compounds to life science researchers to help advance understanding of biological...

Watson's Long-Acting Prostate Cancer Agonist Approved
12 March 2010 Watson Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a new twice-yearly formulation of TRELSTAR, making the drug the only six-month intramuscular...

Roche and Biogen Halt Ocrelizumab Trials
12 March 2010 Swiss firm Roche and US firm Biogen Idec have suspended the ongoing clinical trials of a new rheumatoid arthritis (RA) drug ocrelizumab, following deaths caused by infection. The decision...

ImmunoGen's Skin Cancer Treatment Wins Orphan Drug Status
11 March 2010 The US Food and Drug Administration (FDA) has granted orphan drug designation to ImmunoGen's investigational skin cancer drug IMGN901. In an early-stage trial, the drug is being developed...

iToxFX Platform to Predict New Drug Safety
11 March 2010 US firms Entelos and RegeneMed have released a new software platform, iToxFX, which they claim will help pharmaceutical companies quickly analyse a new drug's potential safety profile. ...

Isis To Trial ALS Antisense Drug
10 March 2010 US firm Isis Pharmaceuticals has initiated a Phase I study of the antisense drug ISIS-SOD1Rx in patients with an inherited and aggressive form of Lou Gehrig's disease, also known as...

Good Results for Nektar's Ovarian Cancer Drug
10 March 2010 US firm Nektar Therapeutics' initial trial of its NKTR-102 drug has been shown to slow down the progression of ovarian cancer in women who are resistant to platinum-based chemotherapy. ...

Sanofi-Aventis's Prostate Cancer Drug Passes Trial
09 March 2010 A Phase III trial of Sanofi-Aventis's investigational treatment cabazitaxel has shown significantly increased survival for metastatic hormone-refractory prostate cancer patients. The...

US Researchers to Develop Bioterror Antidote
09 March 2010 Scientists from the US Department of Energy and Stony Brook University have been selected to receive up to $1.4m in applied research funds from the Department of Defense to develop drugs that...

Good Results for Investigational Anticoagulant Apixaban
08 March 2010 Apixaban, an anticoagulant being jointly developed by Bristol-Myers Squibb and Pfizer has shown good results as an agent to reduce the incidence of venous thromboembolism (VT) in...

CombinatoRx's Chronic Painkiller Gets FDA Approval
08 March 2010 The US Food and Drug Administration (FDA) has approved CombinatoRx's New Drug Application for the painkiller tablet Exalgo for use by opioid-tolerant patients. The hydromorphone HCl...

FDA and EPA Simplify Orphan Drug Development Process
05 March 2010 The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic...

Abbott and Enanta Initiate Phase II HCV Antiviral Trials
05 March 2010 US drug firms Abbott and Enanta have moved their jointly developed hepatitis C (HCV) drugs to Phase II clinical trials. The trial will evaluate three HCV antiviral agents, ABT-450, ABT-333...

Cleveland Offers Army Radiation Antidote
04 March 2010 US firm Cleveland BioLabs has offered its radiation protection drug candidate CBLB502 as a potential medical radiation countermeasure (MRC) to the Department of Defense (DoD). The submission...

FDA Approves Generic Flomax for BPH
04 March 2010 The US Food and Drug Administration (FDA) has approved the first generic version of Flomax capsules 0.4mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a common...

APT Begins Phase III Lung Transplant Trials
03 March 2010 US firm APT Pharmaceuticals has finished the enrollment in a Phase III trial of inhaled cyclosporine for preventing chronic rejection in lung transplant patients. The CYCLIST trial will...

FDA to Review Arena's Obesity Drug Application
03 March 2010 The US Food and Drug Administration (FDA) has accepted an application from Arena Pharmaceuticals for its newly developed obesity drug Lorcaserin, to treat weight management. Lorcaserin is a...

Regulus and GlaxoSmithKline Collaborate for HCV
02 March 2010 US firm Regulus Therapeutics and GlaxoSmithKline have partnered to develop and commercialise therapeutic targets for hepatitis C viral infection (HCV) using microRNA therapeutics targeting...

Evotec to Assist Cubist's Antibacterial Targets for Drug Development
02 March 2010 German firm Evotec AG said it will provide its proprietary fragment-based drug discovery platform EVOlution to US company Cubist Pharmaceuticals until 2010 for its drug discovery against...

FDA and NIH to Speed up Biomedical Innovation
01 March 2010 The US Food and Drug Administration (FDA) has partnered with the National Institutes of Health (NIH) to speed up the process whereby biomedical discoveries become therapies available for patients....

Sunesis to Begin Phase III AML Trials
01 March 2010 US firm Sunesis Pharmaceuticals is set to conduct Phase III trials of its drug voreloxin to treat acute myeloid leukaemia (AML), a type of blood cancer characterised by uncontrolled...

Genentech and UCSF Team Up on Drug Development
26 February 2010 The University of California, San Francisco (UCSF) has partnered with biotechnology firm Genentech to discover and develop drug candidates for neurodegenerative diseases. Roche Group...

Breath Test to Detect Pulmonary Tuberculosis
26 February 2010 A new breath test is being developed by US-based Menssana Research to easily detect active infection in pulmonary TB patients by detecting volatile organic compounds (VOC) in the breath of...

New Technology Can Help Doctors Find Melanoma
26 February 2010 A new technology known as photoacoustics, or a laser-induced ultrasound is being developed by US researchers to help doctors identify the stage of a patients melanoma with more accuracy. ...

EGF Trap-Eye Shows Positive Results in Phase II Study
26 February 2010 A team of US and German scientists have announced good results for vascular endothelial growth factor (VEGF) Trap-Eye, a new protein that could provide a alternative to laser therapy for...

Trana to Develop tRNA Identification-Based Diagnostic
25 February 2010 US firm Trana Discovery has begun proof-of-concept studies on a rapid diagnostic platform that it says could detect the presence of a variety of infectious micro-organisms in less than an...

Karus Adds HDAC-6 Inhibitors to Development Pipeline
25 February 2010 UK firm Karus Therapeutics has included selective HDAC-6 inhibitors in its HDAC drug discovery programme. A series of these small molecules recently developed by Karus have displayed...

Aptuit Develops Proprietary Production Screen
24 February 2010 US firm Aptuit has unveiled a new production screen that it claims will help speed up scale-up processes by enabling better understanding of active pharmaceutical ingredients (APIs) and...

Tioga's Asimadoline to Undergo Phase III Trial
23 February 2010 US firm Tioga Pharmaceuticals will begin Phase III clinical trials in March for Asimadoline to treat patients with diarrhoea predominant irritable bowel syndrome (D-IBS). Asimadoline is...

Seasonal Flu Vaccine Should Have H1N1 Strain, Says WHO
23 February 2010 The World Health Organization (WHO) has recommended including the pandemic influenza A(H1N1) virus in the seasonal flu vaccine mixture for the northern hemisphere in 2010–2011. WHO...

UK Tentatively Backs Diabetes Drug Victoza
15 February 2010 UK Health watchdog NICE has recommended Novo Nordisk's diabetes drug Victoza for limited use on Britain's state-run health service the NHS. NICE has agreed that a 1.2mg once-daily injection of...

Shire Presents Positive Gaucher Trial Data
15 February 2010 Shire has presented positive results from a first Phase III study evaluating velaglucerase alfa as an investigational enzyme replacement therapy for the treatment of Type 1 Gaucher...

Catalysis Receives Gates Grant for TB Biomarker
11 February 2010 The Catalysis Foundation for Health has received a $5m grant from the Bill & Melinda Gates Foundation to discover new tuberculosis (TB) biomarkers that will be used to improve diagnostic tests...

Good Results for Roche’s Type 2 Diabetes Drug
11 February 2010 Results from the first five Phase III studies to evaluate Roche;s weekly type 2 diabetes drug taspoglutide have shown good results in reducing blood glucose compared with other diabetes...

Amgen Announces Positive Prostate Cancer Drug Trials
10 February 2010 Amgen has announced positive results from a Phase III trial evaluating denosumab vs Zometa (zoledronic acid) for the treatment of bone metastases in 1,901 men with advanced prostate...

UK Company to Begin First Stroke Stem Cell Trial
10 February 2010 The UK Gene Therapy Advisory Committee (GTAC) has given the go-ahead to UK company ReNeuron to go ahead with the first-ever clinical trial to test its ReN001 stem cell therapy as a treatment...

Vantia's Nocturia Candidate Enters Stage Two Trials
09 February 2010 Vantia Therapeutics has announced the start of a Phase IIb trial of its lead development compound VA106483 for nocturia, a sleep-disturbing condition caused by having to urinate at night. ...

Addex Pain Drug Shows Broad Effects
09 February 2010 Addex Pharmaceuticals has announced that its investigational pain drug ADX71943 has demonstrated statistically significant analgesic-like effects in three preclinical models of pain. ...

Biosimilars Market Driven by Pharma Spending Cuts, Study Says
04 February 2010 The high cost of biological drugs, combined with the need to cut spending in the pharmaceutical market, has led to considerable momentum in the biosimilars market, according to a new report. ...

Ipsen and Debiopharm Launch New Cancer Drug in France
04 February 2010 Ipsen and Debiopharm have launched Decapeptyl, a sustained-release treatment for locally advanced or metastatic hormone-dependent prostate cancer in France. Marketing authorisation was granted...

Daiichi Sankyo Initiates VTE Trials
04 February 2010 Daiichi Sankyo has begun dosing patients in its largest Phase III trial to test its factor Xa inhibitor edoxaban for the treatment and prevention of recurrent venous thromboembolism (VTE), or...

Teva Files Application for New Neutropenia Drug
04 February 2010 Teva Pharmaceutical Industries is filing a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for XM02, a new drug to prevent neutropenia, a condition...

Conatus Trials Triple-Combo Hepatitis C Treatment
29 January 2010 Conatus Pharmaceuticals has begun Phase II clinical trials to evaluate a triple-combination drug for patients with the hepatitis C virus (HCV) who have not responded to single treatment. ...

ChemoCentryx Initiates Novel Autoimmune Trials
29 January 2010 ChemoCentryx has initiatied Phase I clinical trials of CCX168, a novel orally administered small molecule designed to treat autoimmune diseases. According to the company, CCX168 is a...

Pacgen Forms Tie with New Summit to Target Chinese Market
28 January 2010 Pacgen Biopharmaceuticals has entered into collaboration research and development agreements with New Summit Biopharma to develop PAC-113 for the treatment of oral candidiasis for...

Rotavirus Vaccines Can Save Two Million Lives, Studies Show
28 January 2010 Vaccines against rotavirus, which can kill infants by causing severe diarrhoea, have the potential to save the lives of 2 million children over the next ten years, new research has found. ...

Teva Attempts to Launch Generic Version of Gilead Drug
28 January 2010 Teva Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration requesting permission to manufacture and market a generic version of...

Novartis Names New CEO
27 January 2010 Novartis welcomed a new CEO on Tuesday 26 January, who will take over from Daniel Vasella, one of the most well-known and longest serving CEOs in the European industry, with 14 years under...

Trials Start on Renal Cancer Drug
27 January 2010 Australian biotech firm Bionomics has started a clinical trial of BNC105 in patients with renal cell carcinoma at three sites in the US. Up to 12 sites and a total of 152 patients are likely...

Threshold to Continue Trialling Tumour Drug
27 January 2010 Threshold Pharmaceuticals has released the results of its clinical trial of TH-302 for patients with advanced solid tumours and said the data supports the need for an additional study. ...

UK Under Pressure to Allow Heart Drug on NHS
27 January 2010 The National Health Service (NHS) in the UK is being pressured to accept a heart drug that could cost £2 a day onto its list for the treatment of atrial fibrillation. About 6,000 people in...

Biogen Kicks off Haemophilia B Trials
26 January 2010 Biogen Idec and Swedish firm Orphan Biovitrum have begun dosing the first patient in a multicentre trial to evaluate the companies' long-acting, recombinant Factor IX Fc fusion protein (rFIXFc)...

US Approves New Type 2 Diabetes Drug
26 January 2010 The US Food and Drug Administration (FDA) has granted approval to Novo Nordisk's Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults. Victoza is in a class...

Inspire Drug for Dry Eye Disease Fails Late-Stage Trial
22 January 2010 Biotechnology company Inspire Pharmaceuticals said its drug candidate for dry eye disease did not meet its key treatment goals in a Phase III clinical trial. Inspire said it is reviewing...

Roche Drug Helps Elderly Be Cancer-Free for Longer
22 January 2010 Elderly patients taking Roche's drug Xeloda for colorectal cancer live disease-free for longer, the company said. Patients older than 65 and 70 taking Xeloda (capecitabine) with...

Latest Trials Show Hope for MS Drug
22 January 2010 Two trials have shown positive results for an oral treatment developed by Novartis for multiple sclerosis (MS). Results of the TRANSFORMS(1) and FREEDOMS(2) Phase III clinical trials with...

Leading Obesity Drug Suspended in UK
22 January 2010 The leading obesity drug Reductil (sibutramine) has been suspended from use in the UK over concerns it increases the risk of heart attacks and strokes. The drug works by controlling...

Healthcare Fraud Costs $260bn Each Year
19 January 2010 Each year $260bn is lost globally to fraud and errors in healthcare, equal to more than 5% of annual global health spending, a new report has found. The study by the European Healthcare Fraud...

Study Finds Need for Dose Variation in Psoriasis Drugs
19 January 2010 A clinical trial testing the effectiveness of two prescription drugs for the skin condition psoriasis found significant differences in the doses needed to treat patients with the condition. ...

AstraZeneca and Dako Join to Develop Cancer Treatments
19 January 2010 AstraZeneca and Dako Denmark have entered into an agreement to develop companion diagnostic tests for multiple AstraZeneca oncology projects. The projects cover biologics and small molecules...

MorphoSys Enrolls First Patient in Arthritis Trial
19 January 2010 MorphoSys has enrolled the first patient in its Phase Ib/IIa clinical trial of its lead drug targeting rheumatoid arthritis (RA). Its MOR103 antibody is being developed in the area of...

Sorrento Springs for Scripps MRSA Technology
13 January 2010 Sorrento Therapeutics has announced antibody discovery and development collaboration with the Californian Scripps Research Institute, which will allow the company exclusive access to...

Amarin's Cardio Drug Moves to Phase III Trials
13 January 2010 Amarin Corporation has enrolled patients for two Phase III clinical trials to assess AMR101, the company's lead product candidate for treating cardiovascular disease. The MARINE and ANCHOR...

Novartis Launches Schizophrenia Treatment Fanapt
11 January 2010 Novartis has announced the launch of its new schizophrenia treatment Fanapt as a proven alternative to existing medications available in the US. Fanapt is a twice-daily, oral antipsychotic...

EU Opens Official Lundbeck Investigation
11 January 2010 The European Commission has announced the opening of official antitrust proceedings against Danish drugmaker H Lundbeck over potential breaches of EU rules and allegations that the company...

US Psychiatric Patients Likely to be Given Combination of Drugs
08 January 2010 Adults in the US are more likely to be given a combination of two or more drugs today than ten years ago, according to a new report. Psychiatric drug combinations are regularly given to...

NexBio Starts Flu Drug Trial in Mexico and US
08 January 2010 NexBio has started trials in Mexico and the US of DAS181 (Fludase) for the treatment of laboratory-confirmed influenza. DAS181 is an investigational drug candidate that blocks the entry of...

US Has Made No Decision about Selling H1N1 Vaccines
08 January 2010 The US has made no decision as to whether it will sell or cancel some of its orders of the H1N1 vaccine, according to a federal official. The announcement comes after some European...

First Phase of Huntington's Drug Trial Begins in EU
08 January 2010 Elixir Pharmaceuticals said its partner Siena Biotech has begun the Phase I clinical trial of its inhibitor for the treatment of Huntington's Disease. Its first-in-class SIRT1...

Eisai Acquires AkaRx and Blood Drug Rights
07 January 2010 Eisai has announced the successful acquisition of the biopharmaceutical company AkaRx for approximately $255m, and the resulting rights to develop the investigational drug AKR-501. AkaRx is...

Ensemble and Pfizer to Develop Novel Drug Candidates
07 January 2010 Ensemble Discovery and Pfizer have entered a strategic alliance, to discover and develop a new class of oral drugs developed by Ensemble to address diseases that cannot be modulated effectively...

Japan's Dainippon Submits New Schizophrenia Drug to FDA
05 January 2010 Dainippon Sumitomo Pharma America, a US subsidiary of Japan's Dainippon Sumitomo Pharma has submitted a new drug application to the US Food and Drug Administration (FDA) for lurasidone, an...

EU Approves Pfizer's Injectable PAH Treatment
05 January 2010 The European Commission has approved Pfizer's Revatio (sildenafil) in an injectable solution for patients affected with rare and incurable pulmonary arterial hypertension (PAH) who cannot take...

Positive Results for Medicago's Avian Flu Jab
22 December 2009 Medicago has reported positive interim results from a Phase I human clinical trial of its H5N1 avian influenza vaccine candidate. The vaccine was found to be safe, well tolerated and...

Nine Deaths Halt Elan's High-Dose Alzheimer's Trial
15 December 2009 Elan and Transition Therapeutics have announced that they will immediately withdraw patients from the two higher dose groups in the Phase II AD201 study for Alzheimer's disease after nine...

Addex Stops Migraine Study Due to Liver Problems
15 December 2009 Addex Pharmaceuticals has prematurely ended the trial of its lead drug candidate against migraine due to reports of liver problems. Routine safety monitoring of blinded data in study 206...

FDA Allows Roche to Resume Avastin Trial
14 December 2009 The US Food and Drug Administration (FDA) has said Roche can resume enrolment for a phase three Avastin trial after cases of clinical congestive heart failure (CHF) caused it to be suspended. ...

US Must Spend More on Vaccine Safety, Report Says
14 December 2009 The US should spend more on ensuring the safety of vaccines and establish a permanent working group to advise the government on these issues, according to a report by the Institute of...

Roche Sees Positive Results in Arthritis Drug
11 December 2009 Roche said the late-stage study of its arthritis drug indicated that ocrelizumab could help ease symptoms of a type of rheumatoid arthritis. Roche said its phase III trial found that...

Targacept Starts Schizophrenia Drug Trial
11 December 2009 Targacept has initiated a Phase II clinical proof of concept trial of its TC-5619 drug compound for cognitive dysfunction in schizophrenia. The study will be carried out in the US and...

Oncothyreon Shares Up on News of Lung Cancer Trial
11 December 2009 Shares of Oncothyreon rose on 10 December following the announcement that its partner Merck had started a late-stage study on Stimuvas as a potential lung cancer treatment. The Phase III...

Roche Cancer Trials Show Positive Results
10 December 2009 Roche said that results from drug trials in three different therapies may offer a better future to women with early and very advanced breast cancer. Roche will present results on all three...

Major Child Cancer Study to Begin in UK
10 December 2009 A new trial looking into whether boosting the immune system will help children with an aggressive form of cancer is to be carried out by scientists from Cancer Research UK. Cancer Research...

Asthma Sufferers Could be Helped by Cancer Drug
10 December 2009 A cancer drug could also help patients with asthma, according to new research from experts at Edinburgh University, Scotland. Researchers said the drug R-Roscovitine helps kill certain...

Bionomics to Launch Anti-Cancer Drug Trial in Australia
10 December 2009 Bionomics will carry out a Phase II clinical trial of its BNC105 anti-cancer drug on mesothelioma patients across Australia. Mesothelioma is a cancer usually associated with asbestos...

GSK Expands Heart Drug Trials
10 December 2009 GlaxoSmithKline (GSK) has initiated its second large-scale Phase III clinical trial with experimental heart drug darapladib as a treatment for clogged arteries. The latest trial will...

GE and Covidien MRI Drugs May Pose Higher Risk, Advisers Warn
09 December 2009 MRI imaging drugs produced by GE Healthcare (GE) and Covidien appear to have a higher risk of a serious skin disease than similar products, advisers to the US Food and Drug Administration...

Effectiveness of Flu Antiviral Tamiflu in Question
09 December 2009 The effectiveness of H1N1 flu antiviral Tamiflu has been questioned in a new report that has stated there is no clear evidence that the drug prevents complications such as pneumonia. ...

Micromet's Leukaemia Drug Shows Positive Results
09 December 2009 Micromet said data from its completed Phase II clinical trial showed a high response rate of blinatumomab in patients with acute lymphoblastic leukaemia (ALL). A total of 21 patients with...

New Database to Boost European Cancer Research
07 December 2009 The UK National Institute for Health and Clinical Excellence (NICE) has launched a new database that will help with the identification and prioritisation of future cancer research projects...

Good Results for DermaGen's New Skin Treatment
04 December 2009 DermaGen AB has announced promising results from a clinical Phase I/IIa study to test a novel antimicrobial peptide (AMP) treatment for atopicdermatitis, a chronic inflammatory skin...

US Fast Tracks New Multiple Myeloma Drug
03 December 2009 AEterna Zentaris has announced that the US Food and Drug Administration has granted fast-track status to step up development of its new treatment for relapsed/refractory multiple myeloma. ...

Hereditary Angioedema Treatment Approved in the US
03 December 2009 The US Food and Drug Administration (FDA) has approved Kalbitor (ecallantide), to treat the potentially life-threatening fluid build-up that can occur in people with the rare genetic...

J&J Seeks Approval for New Chronic Pain Treatment
02 December 2009 Johnson & Johnson (J&J) Pharmaceutical Research & Development has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for tapentadol extended release (ER)...

WHO Prequalifies GSK's Pandemic Flu Drug
02 December 2009 The World Health Organization (WHO) has awarded prequalification for global use of GlaxoSmithKline's (GSK) Arepanrix adjuvanted H1N1 influenza pandemic vaccine. The WHO prequalification...

Drug-Resistant Bacterial Infection on the Rise in US
27 November 2009 Recent research has found cases of the drug-resistant bacterial infection known as methicillin-resistant Staphylococcus aureus (MRSA) outside of hospitals have increased by 90% in the US...

FDA Approves Treatment for Resistant HIV Patients
26 November 2009 The US Food and Drug Administration (FDA) has granted approval for Intelence, a treatment specifically indicated for treatment-experienced patients who have experienced virologic failure...

Idera and Merck Extend Vaccine Adjuvant Alliance
26 November 2009 Idera Pharmaceuticals and Merck & Co have extended their collaboration to research, develop and commercialise vaccine products based on new investigational agonist compounds for a fourth year....

Merck Serono Extends Chinese Footprint
24 November 2009 Merck Serono has announced plans to extend its global research and development footprint in China by investing more than €150m and building an R&D centre in Beijing. The centre will...

New Once-Daily Launched for Parkinsons Disease
24 November 2009 Boehringer Ingelheim has announced the launch of Mirapexin (pramipexole) of a new once-daily prolonged-release tablet for the treatment of Parkinson's disease (PD). The new treatment is...

Positive Results for Genta's Leading Oncology Drug
23 November 2009 Genta has announced its lead oncology product Genasense shows a high response rate when administered as an intravenous infusion for the treatment of advanced melanoma. Preliminary results of...

Hungary Declares Swine Flu a National Epidemic
23 November 2009 Hungary has declared H1N1 influenza a national epidemic with more than 22,000 swine flu cases reported in the country over the past week, a 30% increase compared to the previous week. ...

Morphine Linked to Spread of Cancer
23 November 2009 Morphine, commonly used to manage pain, may encourage the spread of cancer, according to US researchers. Speaking at the American Association for Cancer Research in Boston scientists said...

Pfizer's Geodon Approved for Bipolar Disorder
23 November 2009 Pfizer has received approval from the US Food and Drug Administration (FDA) for Geodon capsules as part of a combination maintenance treatment for bipolar disorder in adults. The FDA...

Adamas Expands Triple-Combo Flu Trial
20 November 2009 Adamas Pharmaceuticals has expanded its Phase II clinical study of a new proprietary investigational triple-combination antiviral drug therapy for influenza to include centres in the United...

EU Approves Advanced Gastric Cancer Treatment
20 November 2009 Taiho Pharmaceutical has received the go-ahead to market S-1, a treatment for advanced gastric cancer, a deadly disease designated as an area of significant unmet medical need. S-1 when...

Jennerex and Lee's to Develop New Cancer Drug in Asia
19 November 2009 Jennerex and Lee's Pharmaceutical Holdings have forged a collaboration and licence agreement to develop JX-594, a breakthrough biotherapeutic product for the treatment of hepatocellular...

Drug Industry Positive About 2010
19 November 2009 Around 50% of senior players in the drug manufacturing industry are optimistic about economic recovery between Q3 2009 and Q2 2010, according to a new report. The new "Global Drug...

FDA Approves Chilli Treatment for Shingles Pain
18 November 2009 The US Food and Drug Administration (FDA) has approved NeurogesX's Qutenza (capsaicin) 8% patch, which uses the same substance that gives chillis their heat to manage neuropathic pain...

Cancer Pain Market to Reach $3.7bn by 2018
18 November 2009 According to a new Pharmacor report the global market for cancer pain drugs, driven by the continued dominance of novel opioids, will soar from $2.3bn in 2008 to $3.7bn by 2018. The new...

GSK Announces Deal for Potential Nicotine Vaccination
17 November 2009 GlaxoSmithKline (GSK) Biologicals has agreed a licensing deal to market an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse. The...

Dementia Drugs Contribute to Patient Deaths, Report Shows
13 November 2009 Controversial anti-psychotic drugs are prescribed to dementia patients needlessly and contribute to many deaths, according to a new report. Four in five of the 180,000 patients in the UK...

WHO Pushes Early Antiviral Treatment for H1N1
13 November 2009 Antivirals should be given to pregnant women and young children as early as possible to prevent severe H1N1 influenza, the World Health Organization (WHO) said. WHO clinical expert Niki...

Allergy Drug Also Reduces Nasal Congestion
13 November 2009 The allergy drug desloratadine has been proven to reduce nasal congestion and the common symptoms of hayfever, a study has shown. The second-generation drug that has a brand name of...

Record Number of Drugs Being Developed for Women
13 November 2009 Pharmaceutical and biotechnology companies are working on a record number of medicines for diseases affecting women, according to a new report. Details of a new report by Pharmaceutical...

Novartis Launches Prevacid 24HR OTC Across US
12 November 2009 Novartis has launched its over-the-counter (OTC) heartburn drug Prevacid 24HR across the US with the pharmaceutical company's largest-ever advertising campaign. Prevacid 24HR received US...

Merck and Isofol Sign Agreement for Cancer Drug
12 November 2009 Merck Eprova has signed an exclusive license agreement with Isofol Medical for it to use Merck's proprietary folate compound Modufolin in oncology. The use of Modufolin is expected to...

Sanofi Confirms Safety of H1N1 Vaccine
12 November 2009 Sanofi Pasteur has released the final data from trials of the US-licensed influenza A H1N1 vaccine that confirm its immunogenicity and safety profile. The trial confirmed that one dose of...

Pfizer Skewed Positive Data from Neurontin Trials, Researchers Say
12 November 2009 Researchers said trials of Pfizer's Neurontin epilepsy treatment for uses that are yet to be approved may have been emphasised to indicate that the drug worked better than internal...

New Treatment Combo Reduces Breast Cancer Recurrence
11 November 2009 The results of a large Phase III randomised study in women with early breast cancer has shown that adding capecitabine (Xeloda) to a standard treatment regimen significantly increased the amount...

Teva Wins Right to Market Heartburn Generic
11 November 2009 Teva Pharmaceutical Industries has won a decision in the US District Court that should allow the company to begin marketing Prevacid (lansoprazole), a generic version of Takeda...

Novartis Three-in-One Blood Pressure Drug Approved in EU
11 November 2009 Novartis has been granted authorisation from the European Commission to market Exforge HCT, its new three-in-one once-daily treatment for high blood pressure. Exforge HCT is a combination...

Bristol-Myers and Alder to Research New Arthritis Biologic
11 November 2009 Bristol-Myers Squibb and Alder Biopharmaceuticals have announced a global agreement to develop and commercialise ALD518, a promising biologic for the treatment of rheumatoid arthritis. Under...

Novel Epilepsy Treatment Zebinix Launched in the UK
10 November 2009 Zebinix, a novel once-daily treatment option for adults suffering from epilepsy, has been launched in the UK as an adjunctive therapy for patients with partial-onset seizures. The novel...

GSK to Donate H1N1 Vaccine to Developing World
10 November 2009 GlaxoSmithKline (GSK) has signed an agreement with the World Health Organization (WHO) to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to developing countries. ...

Novexel Begins Advanced Skin Infection Treatment Trials
06 November 2009 Novexel has begun phase II trials on an advanced oral antibacterial NXL103 designed to treat adults with acute bacterial skin and skin structure infections. The multi-centre,...

Lymphoma Drug Could Fight Deadly Bone Cancer
06 November 2009 A new study of Bortezomib, a drug already approved for the treatment of Lymphoma, has shown that it may also slow the growth of the most deadly form of bone cancer in young children...

Inspire Completes Patient Enrollment in Late-Stage Trials
05 November 2009 Inspire Pharmaceuticals has completed patient enrollment in three of its late-stage clinical trials. The milestones have been reached in its TIGER-2 phase III trial testing...

Novartis Gets German Approval for Celtura Flu Vaccine
05 November 2009 Novartis has received approval from the German regulatory authorities for its adjuvanted cell culture-based influenza A (H1N1) 2009 monovalent vaccine, Celtura. Clinical trials of the drug...

Largest Malaria Vaccine Trial Underway across Africa
04 November 2009 The world's largest-ever malaria vaccine trial is being undertaken in seven African countries by GlaxoSmithKline (GSK). A pivotal efficacy trial of the GSK Biologicals RTS,S is expected...

New Study Raises Concerns Over Antibiotic Use During Pregnancy
04 November 2009 A new study from the Archives of Pediatrics & Adolescent Medicine has reportedly identified that some antibiotics used to treat urinary tract infections may increase the risk of birth...

StemEx Could Provide Bone Marrow Alternative
03 November 2009 Scientists at a symposium in Herzliya, Israel have identified StemEx, a stem cell product derived from part of the umbilical cord as an exciting new treatment for leukaemia and...

Groundbreaking Lupus Treatment Makes Progress
03 November 2009 Human Genome Sciences (HGS) and GlaxoSmithKline have announced that their groundbreaking new lupus treatment Benlysta has met its primary endpoints in trials and will be submitted for...