Bristol-Myers Squibb Co. shut down development of its hepatitis C virus (HCV) drug, BMS-986094, following a fatality and nine hospitalizations in a Phase II trial of the drug. The trial was suspended on Aug. 1, and the FDA placed the compound on clinical hold. BMS and the FDA are working together to follow up on the incidents, which involve heart and lung toxicity. Read More
An appeals court Friday upheld federal funding of human embryonic stem cell (hESC) research and, in a case involving cigarette labeling, gave a boost to corporate free speech rights that could encourage biopharma to challenge restrictions on off-label promotion. Read More
Early Friday, Eli Lilly and Co. reported that Phase III Alzheimer's candidate solanezumab missed both the cognitive and functional endpoints in its two double-blind, placebo-controlled EXPEDITION trials in patients with mild-to-moderate disease. Read More
Over the past two years, the advent of protease inhibitors launched a paradigm shift that is changing the landscape of hepatitis C treatment. Now, 2009 biotech start-up Novira Therapeutics Inc. is looking to foster a similar revolution in hepatitis B, and its capsid-targeting approach got a boost last week with the closing of a $23 million Series A financing. Read More
Agennix AG is cutting more than half of its work force and shutting down a small drug development facility in Houston, in the wake of the recent failure of its lead drug talactoferrin in a Phase III trial in non-small-cell lung carcinoma (NSCLC). Read More
• Forest Laboratories Inc., of New York, said that the final voting tally for its annual meeting, Aug. 15, resulted in nine of the company's 10 director nominees being elected to the Forest board of directors together with Pierre Legault, one of Carl Icahn's four nominees for a board seat. Read More
• Seattle Genetics Inc., of Bothell, Wash., initiated a Phase Ib trial evaluating SGN-75 in combination with everolimus (Afinitor, Novartis AG) in advanced metastatic renal cell carcinoma (RCC). Read More
• The FDA approved an abbreviated new drug application for a generic equivalent to Chadds Ford, Pa.-based Endo Pharmaceuticals Inc.'s Lidoderm (lidocaine topical patch 5 percent) by Watson Laboratories Inc., a subsidiary of Watson Pharmaceuticals Inc., of Parsippany, N.J. Read More
Scientists from the University of California at San Francisco and Memorial Sloan-Kettering Cancer Center have used sequencing data from a single patient to identify mutations in the tuberous sclerosis complex 1 gene as a biomarker that can predict the response to the mTOR inhibitor Afinitor (everolimus, Novartis AG). Read More
