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Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. 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 02/07/09, Eisai (OTC:ESALY) (TYO:4523) announced that it plans to submit a new drug application (NDA) with the FDA on a new (sustained-release or SR) form of its Alzheimer's disease drug Aricept (donepezil) in August or September as Aricept faces U.S. patent expiration in 2010 and will face generic competition for the standard formulation. Eisai has completed a Phase 3 study of Aricept 23 mg SR in patients with moderate to severe Alzheimer's disease.
On 02/07/09, Acura Pharma (NASDAQ:ACUR) and King Pharma (NYSE:KG) announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Acurox (oxycodone and niacin) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain. The CRL raises issues regarding the potential abuse deterrent benefits of Acurox. Acura and King are currently evaluating the CRL and at this stage believe they can respond to the issues raised without conducting any additional studies and plan to meet with the Agency after submitting their response to the CRL.
On 01/07/09, Myriad Pharma (NASDAQ:MYRX) announced that it has completed its previously announced spin-off from Myriad Genetics (NASDAQ:MYGN).MYRX is focused on discovering, developing and commercializing novel, small molecule drugs that address severe medical conditions, including cancer and HIV infection. MYRX expects to report data from Azixa efficacy trials by the end of 2009 and begin a Phase 2b trial for its HIV maturation inhibitor later in 2009.
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/fda-calendar.html
Disclosure: No positions.
About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
For more biomedical sector and investment news, go to www.BioMedReports.com
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