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Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour! Releases FDA Calendar Updates for GlaxoSmithKline and Genmab - There are new updates to's database of FDA and Clinical Trial Calendars (NYSE: GSK) (CPH: GEN) (PINK: GNMSF) Releases FDA Calendar Updates for GlaxoSmithKline and Genmab


PRZOOM - /newswire/ - Pasadena, CA, United States, 2009/05/05 - There are new updates to's database of FDA and Clinical Trial Calendars (NYSE: GSK) (CPH: GEN) (PINK: GNMSF).

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AstraZeneca (NYSE: AZN) submitted a NDA seeking FDA approval for a combination of low-dose aspirin and esomeprazole (the generic name for the stomach medicine better known as Nexium or the purple pill). AZN is filing for approval of the combination product to reduce the risk of gastric (stomach) and/or duodenal (small intestinal) ulcers in patients at risk for this side effect of aspirin therapy.

AZN also submitted a sNDA for Nexium to expand its label to include the risk reduction of low-dose aspirin gastric and/or duodenal ulcers. Nexium is already approved for reducing the risk of stomach ulcers associated with regular use of non-steroidal anti-inflammatory drugs (NSAIDs - e.g. ibuprofen and naproxen) in patients at risk for developing gastric ulcers.

GlaxoSmithKline (NYSE: GSK) and Genmab (CPH: GEN) (PINK: GNMSF) announced today that a FDA Advisory panel will review the Company's pending BLA for cancer drug Arzerra (ofatumumab) on 5/29/09. The BLA was filed in January and the FDA accepted the filing in April with priority review (six-month) status.

Sanofi-Aventis (NYSE:SNY) has not yet received a final decision from the FDA on its pending NDA for heart drug Multaq (dronedarone) in the treatment of atrial fibrillation (a type of irregular heartbeat). In March, a FDA panel of cardiology experts recommended that Multaq should be approved with a 10-3 vote. The original PDUFA decision date was 4/30/09, but a decision is now expected to occur some time during 2Q09 based on a company update on 5/4/09.

A full report on the developments is available on the BiomedReport's FDA Calendar, which 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.

About 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.

Disclosure: No positions.
Certain sections of this report contain forward-looking statements that are based on our reporters' expectations, estimates, projections and assumptions. Words such as "expects," "anticipates," "plans," "believes," "scheduled," "estimates" and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, FDA announcements, trial and drug approvals, and company stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors including but not limited to the status or outcome of legal and/or regulatory proceedings.

All forward-looking statements speak only as of the date of this report or, in the case of any document incorporated by reference, the date of that document. All subsequent written and oral forward-looking statements attributable to the company or any person acting on the company's behalf are qualified by the cautionary statements in this section. BiomedReports.Com does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this report.

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