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 t