FDA Calendar Updates: Acorda, Roche Print
Wednesday, 06 May 2009 09:50

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.

1.) Acorda Therapeutics (NASDAQ:ACOR): On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS). Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on March 30, 2009, which cited the need to correct formatting issues with the application and requested additional supporting information before the NDA could be accepted for review. On 5/6/09, the FDA accepted the NDA with a priority review designation and PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS.

2.) Roche (VTX:ROG) (OTC:RHHBY): Following the recommendation of an advisory panel, the FDA approved Avastin for use against an aggressive and deadly form of brain cancer known as glioblastoma based on encouraging early clinical trial data on an accelerated approval basis since there have been no new treatments for this condition in the past decade.                                     

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