When Halozyme Therapeutics Inc. received word that the FDA was issuing a complete response letter for HyQ, the news wasn't isolated to just the program that it's developing with Baxter International Inc. The FDA also put a temporary clinical hold on a subcutaneous version of ViroPharma Inc.'s Cinryze (C1 esterase inhibitor [human]). (See BioWorld Today, Aug. 3, 2012.)
Visterra Inc. made a splash at this year's Interscience Conference on Antimicrobial Agents and Chemotherapy. The company has developed an antibody, VIS410, that neutralizes a broad spectrum of influenza A strains in a preclinical animal model. (See BioWorld Today, Sept. 12, 2012.)
MedImmune is taking its new YTE technology to China. Last week, the biologics arm of AstraZeneca plc established a joint venture with WuXi AppTec to develop its anti-inflammatory drug MEDI5117 for the China market.
The demise of Bristol-Myers Squibb Co.'s hepatitis C drug BMS-986094, which BMS discontinued development of after patients in its Phase IIb study experienced heart and kidney toxicity, stretched further than just the big pharma. The FDA put a partial clinical hold on Idenix Pharmaceuticals Inc.'s related nuc IDX184 and then slapped a hold on its next-generation nuc, IDX19368, as well.
Earlier this month, the U.S. Court of Appeals for the Federal Circuit upheld the validity of Myriad Genetics Inc.'s patent claims based on the composition of isolated DNA. (See BioWorld Today, Aug 17, 2012.)
In April, Arrowhead Research Corp. bought Alvos Therapeutics Inc. in an all-stock deal valued at about $2.1 million plus additional stock worth up to $23.5 million based on the achievement of clinical and regulatory milestones.
After gaining FDA approval for its obesity drug Qsymia (phentermine/topiramate) last month, Vivus Inc. went to work preparing for a fourth-quarter launch of the drug. (See BioWorld Today July 19, 2012.)
Amarin Corp. plc got a green light from the FDA to market its triglyceride-lowering drug Vascepa (icosapent ethyl) last month. Now the biotech needs to give a red light to potential generic competitors.