Could the steady trickle of generics approvals out of the FDA suddenly become a rapid stream? The agency is touting an initiative, called Generic Initiative for Value and Efficiency (GIVE), to speed up generic approvals. The FDA says it will hire more staff to review generic apps, use computers to streamline the process, and "when possible," divert resources from other departments to the effort. Report
> France-based Genfit has launched two Phase II clinical trials for its GFT505, an experimental treatment for type IIb dyslipidemia and atherogenic dyslipidemia in pre-diabetic patients with abdominal obesity. Release
> OXiGENE announced Interim results from a Phase Ib study of zybrestat-bevacizumab, a treatment for advanced solid tumors. Release
> Novartis got the EU's approval to sell its new osteoporosis drug Aclasta, known in the U.S. as Reclast. But on the flip side, Canadian regulators pulled the pain pill Prexige because of the same liver-damage fears that brought it down in Australia in August. Report
And Finally... University of Florida doctors treated their first patient enrolled in a new study designed to test whether injecting stem cells into the heart helps restore blood flow to the organ by prompting new blood vessels to grow. Release