Pregabalin
Executive Summary
NDA filing for Neurontin (gabapentin) successor compound will not take place until mid-2001 so that Pfizer can "enrich" the application in the area of neuropathic pain, firm reports. The company had been projecting a filing as early as year-end. Pfizer maintains that a recently issued patent covering bulk gabapentin will extend the exclusivity of Neurontin until at least 2003 ("The Pink Sheet" July 31, p. 23).
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