FDA panel votes against Prochieve

FDA's Reproductive Health Drugs Advisory Committee voted 13-4 that the benefit-risk profile of Prochieve vaginal progesterone gel from Columbia Laboratories Inc. (NASDAQ:CBRX) does not support its approval in reducing the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. The panel said data did not show sufficient efficacy in the U.S. population and suggested Columbia conduct an additional trial in the U.S. The NDA has a Feb. 26 PDUFA date. ...