On March 9, 2011 – 56 years after the FDA OK'd the last drugs to treat systemic lupus erythematosus (SLE) – the agency approved Benlysta (belimumab). Read More
Cell Therapeutics Inc., of Seattle, will sell approximately $16 million worth of shares of series 12 preferred stock and warrants to purchase shares of common stock in a registered offering to three of its institutional investors. Read More
Otonomy Inc., of San Diego, reported positive data from a Phase Ib study of the company's lead product candidate, OTO-104, in patients with Ménière's disease. Study results showed OTO-104 to be well-tolerated at both doses tested when delivered via a single intratympanic injection. Additionally, while not powered to demonstrate statistically significant clinical activity, data from the trial showed that patients receiving OTO-104 experienced greater reductions in vertigo frequency and tinnitus compared to patients receiving placebo. Read More
The unanimous support of the FDA's Antiviral Drugs Advisory Committee Thursday for telaprevir as a treatment for hepatitis C virus (HCV) genotype 1 is good news for Vertex Pharmaceutical Inc., but it could change the game for HCV clinical trials that are ongoing or just getting started. Read More
PolyMedix Inc., of Radnor, Pa., announced that its lead defensin-mimetic antibiotic, PMX-30063, has shown activity in an in vitro laboratory test against the NDM-1 drug-resistant strain of Klebsiella pneumonia. PMX-30063 also is in a Phase II trial in patients for treatment of acute bacterial skin and skin structure Infections caused by staph bacteria, the company said. Read More
Almost exactly a year after Dendreon Corp. set the prostate cancer space abuzz with the approval of immunotherapy Provenge (sipuleucel-T), Centocor Ortho Biotech Inc. scored another win with an FDA nod for abiraterone, an oral androgen biosynthesis inhibitor, roughly two months ahead of schedule. Read More
