Bayer HealthCare Pharmaceuticals Inc. said that the Food and Drug Administration will conduct a fast track review of its cancer drug candidate regorafenib.
Avanir Pharmaceuticals Inc. reported a bigger loss for its fiscal second quarter due to costs to launch the drug Nuedexta. Nuedexta is the first and only FDA-approved treatment for pseudobulbar affect.
Johnson & Johnson said that its drug Remicade met key goals in treating pediatric patients with moderate to severe ulcerative colitis in a late-stage study.
Immunologix, Inc., Charleston, S.C., and DavosPharma, Upper Saddle River, N.J. have formed a strategic alliance whereby DavosPharma, a provider of discovery, chemistry, and formulation services, will represent and market 100% human antibodies produced by Immunologix.
The company is currently enrolling a Phase 3 clinical trial referred to as SYNERGY, to be conducted in approximately 123 cancer centers to evaluate a survival benefit for custirsen in combination with first-line docetaxel treatment in approximately 800 patients with castration-resistant prostate cancer (CRPC).
The Ontario Genomics Institute (OGI) has been awarded $23.8 million to support genomics research. $11.3 million from Genome Canada and $12.5 million from co-funding.
Kancera AB and has launched a collaborative research effort with Mary Hendrix and her research group at The Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Feinberg School of Medicine.
Heptares Therapeutics signed an exclusive option agreement granting Shire Pharmaceuticals an exclusive option, upon completion of certain preclinical studies, to license worldwide development and commercial rights to the Heptares novel adenosine A2A antagonist.
Cellzome and Neusentis, Pfizer’s Pain & Sensory Disorders and Regenerative Medicine unit, will collaborate to characterize epigenetic factors involved in stem cell differentiation using Cellzome’s EpisphereTM technology.
Researchers with the Faculty of Medicine & Dentistry at the University of Alberta discovered that some “protective” T-cells can kill neurons.
Biotech company Rhythm announced results that demonstrated RM-131 were effective in restoring normal gastric function in animal models of delayed gastric emptying owing to a direct prokinetic effect.
Basic research conducted at the University of California, San Francisco (UCSF) into botulism has translated into a novel antitoxin to protect against bioterrorism and the first clinical trials to assess the resulting vaccine’s safety may launch soon.
Instead of viewing proteins in a two-dimensional textbook, students at the University of Arkansas in Fayetteville are working with a three-dimensional display to study proteins from the inside out.
U.S. regulatory approvals for new biopharmaceuticals nearly doubled in the last decade, compared to the 1990s, but drug developers "face substantial challenges" if they are to maintain that pace.