FDA Calendar Updates for AZN, MIPI, MELA, IMGN

Pasadena, CA, May 12, 2009 --(PR.com)-- There are new updates to BioMedReports.com's database of FDA and Clinical Trial Calendars.

The site's 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.

AstraZeneca (AZN): On 5/11/09, AZN announced top line results from the phase III trial involving a treatment for acute coronary syndromes (ACS).

Molecular Insight Pharma (MIPI): The FDA has indicated that a single Phase 3 trial, with robust results, would be sufficient to support Zemiva's approval. The Company's goal is to obtain FDA agreement on a Phase 3 study protocol by the end of 2009 and to begin the trial in early 2010.

Electro-Optical Sciences (MELA): MELA has a binding Protocol Agreement with the FDA for MelaFind as a new diagnostic screening device for melanoma, which includes expedited review (180 days expected) for the Company's pre-market approval (PMA) application, would receive expedited review.

ImmunoGen (IMGN): Final results from a 100-patient "second-line plus" Phase II trial for T-DM1 will be reported at the upcoming ASCO annual meeting. Patient enrollment in this trial began in mid-2007 and was completed by mid-2008. ASCO is the American Society of Clinical Oncology Annual Meeting being held May 29 - June 2, 2009.

A full, very detailed report on the developments and how they affect upcoming FDA decisions and approvals is available at:

http://biomedreports.com/articles/most-popular/953-fda-clinical-trial-calendar-updates-azn-imgn-mipi-mela.html

A full report on these developments appears today at BiomedReports.com.

Below are also some recent articles to generate new trade ideas for investors and traders looking for the next big mover in the biomedical financial space.

FDA, Clinical Trial Calendars: Nine Cash Plus Catalyst Trades - 5/10/09
http://biomedreports.com/articles/most-popular/938-fda-clinical-trial-calendars-nine-cash-plus-catalyst-trades.html

Access Pharma (ACCP): Low Valuation, Big Potential - 5/6/09
http://biomedreports.com/articles/most-popular/912-access-pharma-otcaccp-low-valuation-big-potential.html

An Extreme Trade That Paid: Vanda Pharma, Nine More To Go - 5/6/09
http://biomedreports.com/articles/most-popular/915-an-extreme-fda-trade-that-paid-vanda-pharma-nasdaqvnda.html

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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.

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