FDA’s Endocrinologic & Metabolic Drugs Advisory Committee
Will review Merck's Proscar (finasteride) on Feb. 4 for the treatment of benign prostatic hypertrophy. Merck Chairman Roy Vagelos, MD, reported in November that Proscar would receive an early February advisory committee review ("The Pink Sheet" Nov. 11, T&G-2). On Feb. 3, the committee will be joined by "worldwide urological experts" to discuss "state-of-the-art efficacy endpoints to be used for testing drugs" for BPH. The issues to be discussed will include the effect of BPH on urodynamic parameters, efficacy criteria used in BPH trials, current BPH therapy, and "the potential for masking prostatic cancers during anti-BPH therapy." The Feb. 3-4 meeting will be held at NIH's Building One, Wilson Hall, beginning at 8:30 a.m. each day....
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