Below is a summary of updates to the
BioMedReports.com database of over 200 entries included in the
FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) Wyeth (NYSE:WYE), Pfizer (NYSE:PFE): WYE announced today that the FDA granted a priority (six-month) review for the Company's pending BLA for Prevnar (Pneumococcal 13-valent Conjugate Vaccine) which was filed at the end of March. The proposed indication in the U.S. for Prevnar 13 is for the prevention of invasive pneumococcal disease (IPD) and otitis media (ear infections) caused by the 13 serotypes included in the investigational vaccine in children aged two months through five years. Prevnar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.
2.) Savient Pharma (NASDAQ: SVNT): SVNT announced today that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA in January to further strengthen and clarify the overall filing. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA decision date by three months to 8/1/09.
3.) Amarin Corp. (NASDAQ:AMRN): AMRN announced today that it has agreed to a Special Protocol Assessment (SPA) with the FDA for its planned Phase 3 registration clinical trial of AMR101 (ethyl-EPA) in patients with hypertriglyceridemia (very high triglyceride levels).
