Business Updates And Product Approval News, In Brief
Executive Summary
FDA approves Tykerb expanded indication: FDA cleared GlaxoSmithKline's Tykerb (lapatinib) Jan. 29 for use in combination with Novartis' Femara (letrozole) to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. Though overall survival data is not mature from the trial, women treated with Tykerb plus Femara had nearly double benefit in progression-free survival, 35 weeks versus 13 weeks for Femara alone; that finding was the basis for the approval. The application had been slated for review at the Dec. 16 meeting of the Oncologic Drugs Advisory Committee, but FDA dropped Tykerb from the agenda, with the explanation that it had resolved the issue for which it was seeking discussion
You may also be interested in...
Warner Chilcott Transformation Underway With Integration Of P&G's Pharma Biz
With the acquisition of Procter & Gamble's pharma business complete, the specialty drug maker adds 1,900 employees.
Three AWP Verdicts Overturned By Alabama Supreme Court; Ruling Could End 70 Other Suits
AstraZeneca, Novartis and GlaxoSmithKline get verdicts totaling $274 million reversed.
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