Tuesday, 28 April 2009 19:21

Below is a summary of updates to the

BioMedReports.com database of over 200 entries included in the

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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.

Watson Pharma (NYSE:WPI) confirmed the filing of an Abbreviated New Drug Application (ANDA), with Paragraph IV litigation underway, which is seeking marketing approval of a generic version of an overactive bladder drug called Enablex (darifenacin). Novartis (NYSE:NVS) has filed a lawsuit to prevent generic competition before the patent expires, causing a stay of final FDA approval for the ANDA for a period of 30 months or court resolution (whichever occurs first). According to IMS Health data, Enablex posted U.S. sales of $220M in 2008.

United Therapeutics (NASDAQ:UTHR) announced on 4/28/09 that the FDA has extended the PDUFA decision date deadline for the Companys Tyvaso (inhaled treprostinil) NDA which is pending at the agency. The new PDUFA date is 7/30/09 and UTHR anticipated the delay (which was announced in a PR in mid-March) due to the submission of additional clinical trial data to the FDA, which was considered a major amendment by the agency. The additional data was related to human factors testing to validate the instructions for using the Optineb nebulizer device which delivers the medication.

Auxilium Pharma (NASDAQ:AUXL) filed a BLA in early march and today announced that a priority review request was granted for XIAFLEX (clostridial collagenase for injection) as a novel, first-in-class, orphan-designated biologic for the treatment of Dupuytren's contracture, which is a progressive condition that affects the connective tissue that lies beneath the skin in the palm, resulting in collagen deposits which impair normal hand function. The PDUFA decision date deadline for the BLA is 8/28/09.

Dendreon (NASDAQ:DNDN) announced today that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option Taxotere. DNDN expects to file an amendment to its existing BLA during 4Q09 and Provenge has a high likelihood for approval since the results met FDA requirements with a good safety profile and survival advantage over Taxotere.

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