ALSO NOTED: FDA to speed up generic approval; Genfit starts Phase II trials; and much more...

Fri, 05 Oct 2007 06:59:50 -0400

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

ALSO NOTED: Knopf tapped to run Acceleron; FDA clears Samaritan IND; Wockhardt in hunt for Par; and much more...

Tue, 18 Sep 2007 06:59:50 -0400

> Chutes & Ladders: Acceleron Pharma has named John L. Knopf, Ph.D., as its new CEO. Dr. Knopf, a founder of Acceleron, has served as the executive vice president of corporate development and recently, as president. Release

> The FDA has cleared Samaritan Pharmaceuticals' IND for SP-6300, a treatment for Cushing's syndrome. Samaritan can proceed with its proposed Phase II clinical study of Cushing's syndrome SP-6300's efficacy in patients experiencing Hypercortisolism. Release

> Rumor Mill: Ranbaxy, Wockhardt, and Sun Pharma are all said to be courting U.S.-based Par Pharmaceuticals. Report

> New York State and New York City have sued Merck to recoup more than $100 million they spent on Vioxx, joining six other states suing on behalf of their Medicaid plans. Report

> The feds will investigate whether ADHD drugs actually increase the risk of heart problems. Report

> Big kudos to the Novartis osteoporosis drug Reclast: A New England Journal of Medicine study showed that patients with broken hips were more likely to survive if they were given a yearly dose of the drug. Report

And Finally... It's not by chance that the lonely tend to get sick and die younger. Researchers say that the lonely are statistically much more likely to suffer from dysfunctional immune systems. Report