CADX, JNJ, TRGT, WPI

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FDA Calendar Updates: CADX, JNJ, TRGT, WPI

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 260 entries as of 7/15/09. 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.
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Cadence painkiller gets priority review, shares up

BANGALORE, July 15 (Reuters) - Cadence Pharmaceuticals Inc. (Nasdaq: CADX) said U.S. health regulators assigned a priority review status for its painkiller Acetavance, sending its shares up as much as 9 percent.
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U.S. panel votes to reject cancer drug

NEW YORK, July 15 (Reuters) - A Johnson & Johnson and Zeltia SA drug for ovarian cancer should not be approved, as risks of heart and liver toxicity outweigh its limited ability to keep the disease in check, an advisory panel to the U.S. Food and Drug Administration said on Wednesday.
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EXACT Sciences (NASDAQ:EXAS): Back on Track, Report Available

EXACT Sciences (NASDAQ:EXAS) provides a timely case study on the current debate over healthcare reform in the U.S. Our current "sick-care" system focuses on the treatment of disease rather than preventative medicine initiatives through investments in wellness programs and improved diagnostic screening tests - particularly in the area of cancer screening since this represents a fast-growing, costly disease.
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Access Pharma (OTC:ACCP): Deep Pipeline, Shallow Valuation

Access Pharma (OTC:ACCP)(ACCP.OB) is an emerging bio-pharmaceutical company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to a treatment for a common side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining) which has already received FDA 510(k) marketing clearance and European CE Mark approval. On 7/13/09, Access announced that it would be among the LifeTech Capital Group companies presenting at Jesup & Lamont's 2009 Growth Stock & National Sales Conference to be held at the Waldorf Astoria Boca Beach Club on 7/30/09 in Boca Raton, FL, which will also include former FDA Commissioner Dr. Lester M. Crawford D.V.M., Ph.D., as the keynote speaker for the event.
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