In Brief: Cephalon Myotrophin
Executive Summary
Cephalon Myotrophin: Studies in support of a Treatment IND for the amyotrophic lateral sclerosis drug will be reviewed by FDA's Peripheral & Central Nervous System Drugs Advisory Committee on June 7. FDA put the company's treatment protocol on hold due to concerns about data from a European study showing a trend toward higher mortality for Myotrophin compared to placebo. Cephalon plans to file an NDA for Myotrophin later this year. The meeting will be held at the Holiday Inn in Bethesda, Md. starting at 8 a.m...