Shares in Idenix Pharmaceuticals Inc. sank 47 percent as the FDA placed a clinical hold on studies of IDX184 and IDX320 for hepatitis C virus due to elevated liver enzymes in three healthy volunteers. (BioWorld Today)
Another Japanese firm has partnered for an obesity compound that is under review by the FDA. This time, Takeda Pharmaceutical Co. Ltd. has agreed to pay at least $1.05 billion to market Orexigen Therapeutics Inc.'s Contrave in North America. (BioWorld Today)
The FDA sent a refuse-to-file letter to Genentech Inc., a member of the Roche Group, rejecting the company's application for accelerated approval of trastuzumab-DM1 (T-DM1) and catching investors and the company off guard. (BioWorld Today)
San Diego-based Somaxon Pharmaceuticals Inc. plans to launch its Silenor insomnia drug in September with the help of Proctor & Gamble Co., which will co-promote the prescription drug in the U.S. (BioWorld Today)
Abbott Respiratory LLC, as expected, handed back U.S. rights to Flutiform to London-based SkyePharma plc. It was no surprise that the two firms parted ways on the asthma drug candidate after the FDA in January said further clinical trials were needed to file for regulatory approval and later the Flutiform new drug application was transferred back to SkyePharma. Still, Abbott lost out on potential future milestone payments in excess of $150 million. (BioWorld International)
Achillion Pharmaceuticals Inc. plans to raise about $50 million through the sale of stock and warrants to a select group of investors, money that would be used to advance the company's early stage pipeline of drug candidates for hepatitis C virus (HCV). (BioWorld Today)