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FDA Calendar Updates: KG, PTIE, DRRX, ALTH, TRIB, CBST, DYAX

 July 07, 2009 03:16 PM
 


Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 243 entries as of 7/7/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/7/09, kg and ptie announced that KG met with the FDA on 7/2/09 to discuss the Complete Response Letter (CRL) for the Remoxy NDA.KG expects the resubmission of the NDA to occur mid-year 2010 and believes that the rate limiting step is the generation of six-month stability data, and no new clinical trials are required.

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Remoxy is based on Durect's (NASDAQ:drrx%20) Oradur technology as a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for Remoxy was accepted by the FDA and granted Priority Review. In December 2008, PTIE received a CRL from the FDA, and subsequently, KG assumed full control of all activities related to the development of Remoxy.

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On 7/7/09, Allos Therapeutics (NASDAQ:alth) announced the completion of patient enrollment in the Company's randomized Phase 2b clinical trial comparing pralatrexate to erlotinib (Tarceva) in patients with Stage IIIB/IV non-small cell lung cancer (NSCLC) who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen. This randomized, open-label, international, multi-center Phase 2b trial was initiated in January 2008 and enrolled 201 patients.

The objective of the trial is to compare the efficacy of pralatrexate to that of erlotinib in patients with Stage IIIB/IV NSCLC who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen, including subsets of light and heavy smokers, as well as current and former smokers. Per the protocol, the primary endpoint is overall survival. Response rate, progression-free survival and the safety and tolerability of pralatrexate will also be assessed.


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