In an agency first, the FDA is rescinding an orphan drug exclusivity, saying it made a mistake two years ago in determining that Octapharma USA Inc.'s Wilate was superior to CSL Behring LLC's previously approved Humate-P. Read More
While the rest of the biotech world seems to embrace the arrival of nanotechnology in drug development, the FDA is still seeking to understand the nuances of products that contain nanoscale materials. Read More
Following a decision to terminate development of saridegib under its alliance with Mundipharma International Corp., and subsequent 20 percent headcount reduction, Infinity Pharmaceuticals Inc. said Thursday it would raise about $76.85 million through a public offering of 5.3 million shares of common stock at $14.50 per share. Net proceeds from the offering will be funneled into clinical development of cancer candidates IPI-145 and retaspimycin. Read More
• ViroPharma Inc., of Exton, Pa., posted second quarter 2012 net sales of $94.6 million as compared to $128.8 million in the comparative period of 2011. The company attributed the decrease to the impact of generic oral vancomycin entries into the market. Read More
• Curetis AG, of Holzgerlingen, Germany, and Cempra Inc., of Chapel Hill, N.C., signed a research and development collaboration to incorporate Curetis' molecular diagnostic system into Cempra's global Phase III trial of oral solithromycin in community-acquired bacterial pneumonia. The randomized, double-blind Phase III trial comparing solithromycin against a comparator drug is expected to begin in the fourth quarter. Read More
• Vanda Pharmaceuticals Inc., of Washington, said the Israeli Ministry of Health granted market approval for Fanapt (iloperidone) for the treatment of schizophrenia. Vanda will commercialize the drug in Israel through its partner Megapharm Ltd., of Raanana, Israel. Read More
