In Brief: Univax' WinRho SD
Executive Summary
Univax' WinRho SD: Rho(D) immune globulin intravenous approved March 24 for the treatment of idiopathic thrombocytopenic purpura, and for the suppression of Rh isoimmunization in Rho(D) negative pregnant women and Rho(D) negative women being transfused with Rho(D) positive blood. The RhIVIG orphan product requires less volume and less time for administration than other immune globulins used to treat the conditions. WinRho SD, which uses a solvent detergent step to inactivate viral particles, was recommended for approval by an FDA advisory committee in March 1994 ("The Pink Sheet" March 28, 1994, T&G-9). The WinRho SD PLA has been pending since June 1993. Winnipeg, Canada-based Rh Pharmaceuticals will manufacture the product for Univax...
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