In Brief: Sequus Amphotec
Executive Summary
Sequus Amphotec: Liposomal amphotericin B product adds safety data to labeling showing less renal creatinine increase than regular amphotericin B in a study of febrile neutropenic patients. The study's efficacy results were found insufficient to support an indication by an FDA advisory committee ("The Pink Sheet" April 21, T&G-6). Revised labeling notes that "Amphotec is NOT approved for empirical treatment in febrile neutropenic patients." Sequus withdrew the sNDA for the indication in June. Dosing language revised to state "3-4 mg/kg as required"...
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