Serono Ovidrel
Executive Summary
Filing for approval of the recombinant human chorionic gonadotropin is expected in both the U.S. and Europe by the end of the year, VP-Investor Relations & Scientific Affairs Andrew Galazka, MD, told the Warburg Dillon Read Conference Sept. 29. Phase III studies were completed in the second quarter (1"The Pink Sheet" Oct. 11, p. 22)
You may also be interested in...
Ares-Serono Initiates Rebif v. Avonex Trial, May Beat Exclusivity Clock
Ares-Serono has initiated a 600-patient trial to test the efficacy of Rebif against Biogen's Avonex.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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