GI NEUMEGA HAS "MODEST" BENEFIT IN REDUCING CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA -- FDA REVIEWER; LABEL SHOULD CAUTION ABOUT VOLUME EXPANSION
Executive Summary
Therapy with Genetics Institute's Neumega at the recommended dose sought by the company led to a 28% platelet transfusion avoidance rate compared to 7% for placebo, Center for Biologics Evaluation & Research reviewer Richard Steffen, MD, told FDA's Biological Response Modifiers Advisory Committee July 24.
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
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: