In Brief: Serono Labs' Serostim for AIDS wasting
Executive Summary
Serono Labs' Serostim for AIDS wasting: NDA submitted Sept. 11 for the mammalian cell-derived recombinant human growth hormone. Results and analysis of two Phase III trials and an open-label continuation study were included in the NDA. Patients receiving Serostim gained lean body mass while losing fat and performed better on treadmill endurance tests than placebo patients, and "there is sufficient data in the NDA showing Serostim impacts a number of immunological parameters," Serono said. Serostim has been available under a Treatment IND since December 1994; a total of over 500 patients have been treated through study protocols or expanded access...
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