News, views and contacts from the global Drugdevelopment industry
Weekly Round Up
22 October 2016
Latest Companies

Malvern Instruments - Biopharmaceutical and Drug Development

Pharmaceutical Development Group - Pharmaceutical Consultant and FDA Regulatory Strategist

SYSTAG Systems Technik - Automation Systems for Small-Molecule Drug and API Development

Pfanstiehl - Injectable and HPLE Carbohydrates for Protein Stabilisation and Optimisation

Softigel - Contract Development Services and Drug Delivery Systems

Press Releases

Biovian to Present at Bio-Europe in Germany
Biovian has announced it will be present at the biotechnology partnering Conference Bio-Europe in Cologne, Germany.

Malvern to Demonstrate New Nanoparticle-Size and Concentration Measurer in Webinar
Malvern has announced it will be demonstrating the NanoSight NS3000, which uses Nanoparticle Tracking Analysis (NTA) to measure nanoparticles and concentrates.

Drug Labeling Types
Understanding the various types of drug product labeling is an essential component of maintaining labeling compliance. Our most recent paper describes the different types of Drug Labeling and includes reference to the regulatory basis for each.

Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?
Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions, so this should be easy?

Biovian's CEO will be Available for Discussions at Three Events in Europe
Biovian will be present at Nordic Life Science Days, BioTalk, and Bio-Europe.

White Papers

Using FlexyCUBE in Risk and Quality Analysis
In the first reaction step, an acid is added with constant thermal reduction (TR) control and stirrer...

Benefits of Trehalose
Products such as monoclonal antibodies (mAb), fusion proteins, peptides, vaccines, antibody drug conjugulates (ADC) and stem cells benefit from the stabilising effects of...

From Gene to Finished Vial
Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals, covering services from early development to finished...

Stability Analysis of Proteins for the Biopharmaceutical Industry
The biggest class of biopharmaceuticals on the market is monoclonal antibodies (mAb) and their specific binding nature provides an opportunity to use them to modulate...

Using Differential Scanning Calorimetry in Lipid Bilayer Membranes to Characterise Thermotropic Phase Transitions
Proteins and other constituents are bound or incorporated into cell membrane surface bilayers formed by...


eptember's top stories: Oncternal begins dosing TK216 trial, Trial of medical cannabis begins, Canada
Oncternal Therapeutics has begun dosing patients in its Phase I clinical trial of TK216 to treat Ewing sarcoma and Tilray and University of British Columbia have begun patient enrolment in Canada’s first Phase II clinical trial of medical cannabis to treat post-traumatic stress disorder. Drugdevelopment-technology.com wraps up the key headlines from September 2016.

August's top stories: Gradalis' Phase I breast cancer trial, Biothera and Merck conducted combination cancer immunotherapy trials
Gradalis dosed the first patient in its pilot Phase I trial of a combination of Vigil Engineered Autologous Tumour Cells (EATCs) and durvalumab to treat advanced breast cancer, and Biothera collaborated with Merck to expand the ongoing clinical programme of Merck’s KEYTRUDA and Biothera’s Imprime PGG. Drugdevelopment-technology.com wraps up the key headlines from August 2016.

Pharma Technology Focus – Issue 50
In this issue: Maximising investment by cancer megafunds, positive clinical trials for an antibody to treat lupus, how copper can be used to tackle obesity, whether day and night should influence our drug regimes, a device to soak up excess drugs and more.

July's top stories: GBT's Phase II1 trial GBT440, Merck's Phase III trial ONCEMRK of Isentress
Global Blood Therapeutics (GBT) began the Phase IIa trial (GBT440-007) of GBT440 in adolescents with sickle cell disease (SCD), and Merck reported positive results from its ongoing Phase III pivotal trial ONCEMRK of Isentress (raltegravir) to treat adults with HIV-1 infection. Drugdevelopment-technology.com wraps up the key headlines from July 2016.

June's top stories: Bayer reported positive results of RESORCE trial, TapImmune initiated Phase II trial of TPIV 200
Bayer reported positive results from the Phase III RESORCE trial of Stivarga (regorafenib) tablets to treat unresectable hepatocellular carcinoma, and TapImmune initiated its Phase II trial of cancer vaccine TPIV 200. Drugdevelopment-technology.com wraps up the key headlines from June 2016.


Exondys 51 (eteplirsen) for the Treatment of Duchenne Muscular Dystrophy (DMD)
Exondys 51 (eteplirsen) is an injectable solution developed by Sarepta Therapeutics.

Carnexiv (carbamazepine) for the Treatment of Partial, Generalised Tonic-clonic Seizures in Adults
Carnexiv (carbamazepine) is an injectable formulation developed by Lundbeck for partial, generalised tonic-clonic seizures in adult patients who are unable to temporarily take oral medication.

Dupixent (dupilumab) for the Treatment of Atopic Dermatitis
Dupixent (dupilumab) is an investigational drug being developed by Sanofi and Regeneron as a treatment for moderate to severe atopic dermatitis in adult patients.

Ocrevus (ocrelizumab) for the Treatment of Multiple Sclerosis
Ocrevus (ocrelizumab), developed by Genentech, a member of Roche Group, is indicated for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis.

Ibrance (palbociclib) for the Treatment of Metastatic Breast Cancer
Ibrance (palbociclib) is an oral formulation developed by Pfizer for the treatment of metastatic breast cancer in women with disease progression post endocrine therapy.

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