ORPHAN DRUG AMENDMENT COMPROMISE BILL CLEARS SENATE LABOR CMTE. UNCHANGED; KEY TO HOLDING TOGETHER BIO AND NORD COMPROMISE MAY BE PREVENTING CHANGES
Executive Summary
An orphan drug bill cleared the Senate Labor Committee without amendment May 11 by a 134 vote, marking the first step toward potential passage of the bill after six years of debate. Forged from discussions with the Biotechnology Industry Organization and the National Organization for Rare Disorders, the legislation (S 1981) enjoys the endorsement of both groups as a "true compromise." The bill was introduced March 24 by Sens. Kassebaum (R-Kans,), Metzenbaum (D-Ohio) and Committee Chairman Kennedy (D- Mass.) ("The Pink Sheet" March 28, p. 3).
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