Fresh off of a better-than-expected launch with Clostridium difficile-associated diarrhea (CDAD) drug Dificid (fidaxomicin), Cubist Pharmaceuticals Inc. disclosed plans to move into pivotal testing with its own CDAD candidate, CB-183,315, in the first half of next year. Read More
For industry observers who think biosimilars won't stand much of a chance against long-time market dominators in the U.S., Hospira Inc. has one word: Europe. Read More
Three biotechs and a U.S. university will share $39.6 million in new funding from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to progress drugs designed to treat injuries associated with acute radiation syndrome (ARS). Read More
Proximagen Group plc, of London, partnered three of its developmental central nervous system (CNS) programs with H. Lundbeck A/S, of Valby, Denmark, in exchange for a stock purchase worth £10.3 million (US$16.2 million). The companies will work together to develop the three programs in the areas of epilepsy, pain and inflammatory disorders. Read More
CorMedix Inc., of Bridgewater, N.J., is requesting a pre-investigational new drug meeting with the FDA to discuss next steps for Neutrolin, which is being developed for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients. Read More
Otonomy Inc., of San Diego, presented positive data from a Phase Ib study of OTO-104, its lead candidate, in patients with Meniere's disease. The data suggested patients treated with OTO-104 experienced clinically meaningful reductions in vertigo frequency and improvements in tinnitus compared to placebo. Read More
