Drug Development Technology-Updates The latest content updates from the www.drugdevelopment-technology.com web site http://www.drugdevelopment-technology.com/ en-us http://www.drugdevelopment-technology.com/ Drug Development Technology-Updates http://www.drugdevelopment-technology.com/content/images/logo_big.gif Chi-Med commences Phase I/II trial of HMPL-453 for solid tumours http://www.drugdevelopment-technology.com/news/newschi-med-commences-phase-iii-trial-of-hmpl-453-for-solid-tumours-5851726 http://www.drugdevelopment-technology.com/news/newschi-med-commences-phase-iii-trial-of-hmpl-453-for-solid-tumours-5851726 Hutchison China MediTech (Chi-Med) has commenced a Phase I/II clinical trial of HMPL-453 in China for the treatment of solid tumours in patients carrying fibroblast growth factor receptor (FGFR) genetic alteration. Thu, 22 Jun 2017 23:00:00 GMT Deals this week: Dova Pharmaceuticals Inc, Gamida Cell Ltd, Onxeo SA http://www.drugdevelopment-technology.com/news/newsdeals-this-week-dova-pharmaceuticals-inc-gamida-cell-ltd-onxeo-sa-5850110 http://www.drugdevelopment-technology.com/news/newsdeals-this-week-dova-pharmaceuticals-inc-gamida-cell-ltd-onxeo-sa-5850110 US-based clinical-stage pharmaceutical company Dova Pharmaceuticals Inc is intending to raise between $60.93m and $69.06m through an initial public offering (IPO) of 4,062,500 shares of its common stock. Thu, 22 Jun 2017 23:00:00 GMT Novartis reports positive top-line data from Phase III trial of cardiovascular drug http://www.drugdevelopment-technology.com/news/newsnovartis-reports-positive-top-line-data-from-phase-iii-trial-of-cardiovascular-drug-5852177 http://www.drugdevelopment-technology.com/news/newsnovartis-reports-positive-top-line-data-from-phase-iii-trial-of-cardiovascular-drug-5852177 Novartis has reported positive top-line results from the Phase III CANTOS clinical trial of ACZ885 (canakinumab) and standard-of-care combination to address cardiovascular risk in patients who survived a heart attack. Thu, 22 Jun 2017 23:00:00 GMT M&As this week: Shanghai ChemPartner Co, Cell Medica, BBI Group Holding http://www.drugdevelopment-technology.com/news/newsmas-this-week-shanghai-chempartner-co-ltd-cell-medica-ltd-bbi-group-holding-ltd-5850717 http://www.drugdevelopment-technology.com/news/newsmas-this-week-shanghai-chempartner-co-ltd-cell-medica-ltd-bbi-group-holding-ltd-5850717 ShangPharma Corporation's contract research subsidiary Shanghai ChemPartner Co Ltd is set to merge with Quantum Hi-Tech (China) Biological Co Ltd. Thu, 22 Jun 2017 23:00:00 GMT CTD Holdings starts enrolment in Phase I/II trial of Trappsol Cyclo for NPC http://www.drugdevelopment-technology.com/news/newsctd-holdings-starts-enrolment-in-phase-iii-trial-of-trappsol-cyclo-for-npc-5851717 http://www.drugdevelopment-technology.com/news/newsctd-holdings-starts-enrolment-in-phase-iii-trial-of-trappsol-cyclo-for-npc-5851717 US-based biotechnology firm CTD Holdings has started patient enrolment in the Phase I/II clinical trial of Trappsol Cyclo to treat patients suffering from Niemann-Pick disease type C (NPC) in Europe. Thu, 22 Jun 2017 23:00:00 GMT Breaking Down Complex Generics http://www.drugdevelopment-technology.com/contractors/regulatory-affairs/pharmaceutical-developmentgroup/pressbreaking-down-complex-generics.html http://www.drugdevelopment-technology.com/contractors/regulatory-affairs/pharmaceutical-developmentgroup/pressbreaking-down-complex-generics.html Pharmaceutical consulting and generic drug professionals: What is your hedge against the increasingly crowded traditional drug markets? Thu, 22 Jun 2017 15:34:00 GMT ePAT Automated Lab Reactor Optimised for 24/7 Data Capture http://www.drugdevelopment-technology.com/downloads/whitepapers/delivery/epat-automated-lab-reactor/ http://www.drugdevelopment-technology.com/downloads/whitepapers/delivery/epat-automated-lab-reactor/ Systag Systems presents ePAT, a cost-effective device for automation in the laboratory. Thu, 22 Jun 2017 14:37:00 GMT Paradigm Shift Regarding API and Formulation Components http://www.drugdevelopment-technology.com/downloads/whitepapers/organic/paradigm-shift-api/ http://www.drugdevelopment-technology.com/downloads/whitepapers/organic/paradigm-shift-api/ This whitepaper will provide an introduction to high-purity carbohydrates often used for applications such as stabilisation, modulation, and cryopreservation, comparing the old paradigm that formulation components are inactive ingredients with limite… Thu, 22 Jun 2017 14:37:00 GMT Immune Pharma starts enrolment in Phase I/II trial of Ceplene for CMML http://www.drugdevelopment-technology.com/news/newsimmune-pharma-starts-enrolment-in-phase-iii-trial-of-ceplene-for-cmml-5850240 http://www.drugdevelopment-technology.com/news/newsimmune-pharma-starts-enrolment-in-phase-iii-trial-of-ceplene-for-cmml-5850240 Immune Pharmaceuticals has started patient recruitment for Phase I/II clinical trial of Ceplene (histamine dihydrochloride) to treat chronic myelomonocytic leukaemia (CMML) patients.  Wed, 21 Jun 2017 23:00:00 GMT InDex initiates enrolment for Phase IIb trial of cobitolimod to treat ulcerative colitis http://www.drugdevelopment-technology.com/news/newsindex-initiates-enrolment-for-phase-iib-trial-of-cobitolimod-to-treat-ulcerative-colitis-5850250 http://www.drugdevelopment-technology.com/news/newsindex-initiates-enrolment-for-phase-iib-trial-of-cobitolimod-to-treat-ulcerative-colitis-5850250 Sweden-based InDex Pharmaceuticals has started patient enrolment in Phase IIb CONDUCT clinical trial of cobitolimod for treatment of patients with ulcerative colitis. Wed, 21 Jun 2017 23:00:00 GMT New Phase I/II trial indicates positive outcome for Astellas' cancer drug http://www.drugdevelopment-technology.com/news/newsnew-phase-iii-trial-indicates-positive-outcome-for-astellas-cancer-drug-5850404 http://www.drugdevelopment-technology.com/news/newsnew-phase-iii-trial-indicates-positive-outcome-for-astellas-cancer-drug-5850404 US researchers at the University of Pennsylvania’s (Penn) Perelman School of Medicine and Abramson Cancer Centre have reported positive data from a Phase I/II clinical trial of Astellas Pharmaceuticals’ new drug gilteritinib in patients with acute my… Wed, 21 Jun 2017 23:00:00 GMT Hansa Medical begins IdeS dosing in Phase II trial for anti-GBM antibody disease http://www.drugdevelopment-technology.com/news/newshansa-medical-begins-ides-dosing-in-phase-ii-trial-for-anti-gbm-antibody-disease-5849044 http://www.drugdevelopment-technology.com/news/newshansa-medical-begins-ides-dosing-in-phase-ii-trial-for-anti-gbm-antibody-disease-5849044 Swedish biopharmaceutical firm Hansa Medical has begun dosing patients in its Phase II clinical trial of drug candidate IgG degrading enzyme of Streptococcus pyogenes (IdeS), to treat patients with severe anti-GBM antibody disease / Goodpasture’s dis… Tue, 20 Jun 2017 23:00:00 GMT Effector, Pfizer and Merck to initiate Phase II combination trial for colorectal cancer http://www.drugdevelopment-technology.com/news/newseffector-pfizer-and-merck-to-initiate-phase-ii-combination-trial-for-colorectal-cancer-5849391 http://www.drugdevelopment-technology.com/news/newseffector-pfizer-and-merck-to-initiate-phase-ii-combination-trial-for-colorectal-cancer-5849391 Effector Therapeutics has signed a clinical collaboration and supply agreement with Pfizer and Merck to initiate a Phase II clinical trial of immuno-oncology drugs combination to treat microsatellite stable colorectal cancer (CRC) patients. Tue, 20 Jun 2017 23:00:00 GMT Genexine to conduct Phase Ib/II combination trial of cervical cancer drug GX-188E http://www.drugdevelopment-technology.com/news/newsgenexine-to-start-phase-ibii-combination-trial-of-cervical-cancer-drug-gx-188e-5849036 http://www.drugdevelopment-technology.com/news/newsgenexine-to-start-phase-ibii-combination-trial-of-cervical-cancer-drug-gx-188e-5849036 Biotechnology firm Genexine has secured approval from the South Korean Ministry of Food and Drug Safety (MFDS) to conduct a Phase Ib/II trial of GX-188E vaccine in combination with Keytruda (pembrolizumab) in patients with non-resectable cervical can… Tue, 20 Jun 2017 23:00:00 GMT Seattle Genetics stops Phase III trial of leukaemia drug due to high death rate http://www.drugdevelopment-technology.com/news/newsseattle-genetics-stops-phase-iii-trial-of-leukaemia-drug-due-to-high-death-rate-5848223 http://www.drugdevelopment-technology.com/news/newsseattle-genetics-stops-phase-iii-trial-of-leukaemia-drug-due-to-high-death-rate-5848223 Biotechnology firm Seattle Genetics has stopped the Phase III CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in older patients with frontline acute myeloid leukaemia (AML). Mon, 19 Jun 2017 23:00:00 GMT GSK’s Benlysta shows positive outcome in Phase II continuation trial for SLE http://www.drugdevelopment-technology.com/news/newsgsks-benlysta-shows-positive-outcome-in-phase-ii-continuation-trial-for-sle-5847710 http://www.drugdevelopment-technology.com/news/newsgsks-benlysta-shows-positive-outcome-in-phase-ii-continuation-trial-for-sle-5847710 GlaxoSmithKline (GSK) reported positive data from the Phase II ten-year continuation clinical trial of Benlysta (belimumab) in combination with standard-of-care for patients suffering from systemic lupus erythematosus (SLE). Mon, 19 Jun 2017 23:00:00 GMT Synlogic begins dosing in Phase I trial of SYNB1020 to treat hyperammonemia http://www.drugdevelopment-technology.com/news/newssynlogic-begins-dosing-in-phase-i-trial-of-synb1020-to-treat-hyperammonemia-5847714 http://www.drugdevelopment-technology.com/news/newssynlogic-begins-dosing-in-phase-i-trial-of-synb1020-to-treat-hyperammonemia-5847714 Synlogic has begun dosing healthy volunteers in its Phase I clinical trial of SYNB1020 for the treatment of hyperammonemia associated with diseases such as urea cycle disorders (UCD) and hepatic encephalopathy (HE). Mon, 19 Jun 2017 23:00:00 GMT Galera enrols last patient in Phase IIb trial of GC4419 to treat oral mucositis http://www.drugdevelopment-technology.com/news/newsgalera-enrols-last-patient-in-phase-iib-trial-of-gc4419-to-treat-oral-mucositis-5846549 http://www.drugdevelopment-technology.com/news/newsgalera-enrols-last-patient-in-phase-iib-trial-of-gc4419-to-treat-oral-mucositis-5846549 US-based biotechnology company Galera Therapeutics has concluded enrolment in the Phase IIb clinical trial of GC4419 for the treatment of oral mucositis (OM) in patients with head and neck cancer. Sun, 18 Jun 2017 23:00:00 GMT Novartis reports favourable data from Phase III extension trial of Cosentyx for AS http://www.drugdevelopment-technology.com/news/newsnovartis-reports-favourable-data-from-phase-iii-extension-trial-of-cosentyx-for-as-5846564 http://www.drugdevelopment-technology.com/news/newsnovartis-reports-favourable-data-from-phase-iii-extension-trial-of-cosentyx-for-as-5846564 Novartis has reported positive results from the Phase III MEASURE 1 extension trial of Cosentyx (secukinumab) to treat patients with active ankylosing spondylitis (AS). Sun, 18 Jun 2017 23:00:00 GMT Xencor reports interim positive results from Phase II trial of XmAb5871 for IgG4-RD http://www.drugdevelopment-technology.com/news/newsxencor-reports-interim-positive-results-from-phase-ii-trial-of-xmab5871-for-igg4-rd-5846918 http://www.drugdevelopment-technology.com/news/newsxencor-reports-interim-positive-results-from-phase-ii-trial-of-xmab5871-for-igg4-rd-5846918 Biopharmaceutical firm Xencor has reported interim positive results from the Phase II clinical trial of XmAb5871 for the treatment of patients with active IgG4-Related Disease (IgG4-RD). Sun, 18 Jun 2017 23:00:00 GMT