An FDA advisory committee began priming the pipeline Wednesday for new hepatitis C virus (HCV) treatments, voting unanimously to recommend approval of Merck & Co. Inc.'s boceprevir in conjunction with the current standard of care (SOC), pegylated interferon and ribavirin, to treat chronic HCV genotype 1. Read More
Regeneron Pharmaceuticals Inc.'s (Nasdaq:RGEN) stock surged 28 percent on news that its Phase III VELOUR trial of Zaltrap (aflibercept) for metastatic colon cancer hit its primary endpoint of improving overall survival. Regeneron and partner Sanofi-Aventis will waste no time preparing marketing approval applications for the FDA and European Medicines Agency for submission in the second half of 2011. Read More
Like many cancer treatments, recently approved melanoma drug ipilimumab (Yervoy, Bristol Myers Squibb Co.), is great for those patients in whom it works – meaning, not that many. In Yervoy's case, the response rate is about 15 percent. (See BioWorld Today, March 28, 2011, and March 23, 2011.) Read More
After nearly a decade of effort, biopharmaceutical development company Cytogel Pharma LLC recently moved its lead candidate – a chemically stabilized analogue of endomorphin (EM) 1 designed to treat acute and chronic pain – into the clinic. Read More
• BioInvent International AB, of Lund, Sweden, and ThromboGenics NV, of Leuven, Belgium, dosed their first patient in a Phase IIb trial of TB-402 (anti-factor VIII) for thromboembolism after hip surgery. The trial will enroll 600 patients and compare two dose levels of the drug with rivaroxaban. Results are expected in the second half of 2012. Read More
• Beactica AB, of Uppsala, Sweden, has entered into an agreement with Janssen Pharmaceutica NV, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson, under which Beactica will use its Sprint drug discovery platform to generate small-molecule lead compounds against undisclosed targets of therapeutic interest to Janssen. Financial details were not disclosed. Read More
