LILLY FORESEES CECLOR CD IN U.S. "SOON,"
Executive Summary
LILLY FORESEES CECLOR CD IN U.S. "SOON," Chairman Randall Tobias told the Hambrecht & Quist 12th Annual Life Sciences Conference in San Francisco Jan. 11. The sustained-release, twice- daily formulation of the broad spectrum antibiotic cefaclor has been launched in Spain and the U.K. and is being reviewed by regulatory authorities in several other countries. The NDA has been pending at FDA since November 1991. The CD approval prediction is the first venture by Tobias, since joining Lilly, into the imprecise realm of FDA approval guestimates.
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