Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the 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.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

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Highlighted companies include Genentech, inc. (DNA), Amgen, Inc. (AMGN) and Wyeth (WYE).Waxman's Bill Bad for Biotech Companies (and Doctors, Patients and America)California Representative Henry Waxman (D-CA), Chairman of the House Energy and Commerce Committee, has proposed legislation, along with his colleagues, that would give the U.S. Food and Drug Administration (FDA) the authority to approve generic (bioequivalent) versions of biotech drugs. As of now, there exists no path to approval for so called follow-on biologics as there is with small-molecule pharmaceutical products.According to the Wall Street Journal, the main contention on the bill remains how many years of market exclusivity a product would receive after approval. Mr. Waxman is calling for 5 years, whereas the biotech companies and trade organizations are asking for 14 years.This is a serious issue for investors in biotechnology stocks, in our view. Allowing ...

Sonus Pharma (SNUS) is on the verge of a major catalyst in the form of pivotal Phase 3 clinical trial results