FDA's Arthritis Advisory Committee will review Merck's COX-2 inhibitor Vioxx (rofecoxib) on April 20 for treatment of acute or chronic signs and symptoms of osteoarthritis and management of pain. The meeting will begin at 8 a.m. at the Holiday Inn in Gaithersburg, Md. The Vioxx NDA (21-042) was submitted on Nov. 23 and is receiving a six-month priority review at FDA
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth