Columbia Laboratories (NASDAQ:CBRX) is cutting 42 percent of its staff and reviewing strategic options following a complete response letter that delays the approval of a vaginal gel for high-risk pregnancies it has developed with Watson Pharmaceuticals (NYSE:WPI). The Livingston, New Jersey drug developer is reducing its workforce from 24 to 14 and the cuts will […]
Watson Pharmaceuticals (NYSE:WPI) faces a delay in the approval of a vaginal gel that addresses high-risk pregnancies because it received a complete response letter from U.S. regulators. The letter from the U.S. Food and Drug Administration said the results of phase 3 clinical trial for progesterone vaginal gel 8% did not meet the level of […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A U.S. Food and Drug Administration panel has voted against Columbia Laboratories‘ (Nasdaq: CBRX) and Watson Pharmaceuticals’ (NYSE: WPI) progesterone vaginal gel 8% to reduce preterm birth in women, saying the panel requires more information. The Advisory Committee for Reproductive Health Drugs said the gel did not produce a statistically significant reduction in preterm births […]