Agouron Viracept combo study press release called misleading by FDA.
Executive Summary
AGOURON VIRACEPT COMBINATION PILOT STUDY PRESS RELEASE DRAWS FDA OBJECTION that the study of Agouron's protease inhibitor Viracept (nelfinavir) with Glaxo Wellcome's Retrovir (zidovudine) and Epivir (lamivudine) is not included in Viracept labeling. "This study (study 509) was a pilot study and was not included in Viracept's labeling because it was very small and did not add meaningful information to the use of Viracept," FDA's Division of Drug Marketing, Advertising & Communications said in an April 18 letter to the company.
You may also be interested in...
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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