In Brief: Bristol-Myers Squibb Pravachol
Executive Summary
Bristol-Myers Squibb Pravachol: Liver function testing frequency decreased in revised labeling for the HMG-CoA reductase inhibitor pravastatin. Testing at six weeks and semiannual testing in patients with normal test results at 12 weeks is no longer recommended. The changes are based on safety data from the five-year Pravastatin Primary Prevention Study. "Pravachol is the only HMG to receive clearance from FDA for less frequent liver function testing," Bristol said...
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