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BiomedReports: FDA Calendar Updates for Trinity Biotech (NASDAQ:TRIB), Cubist Pharma (NASDAQ:CBST), NexMed, Inc. (NASDAQ:NEXM), and Amgen (NASDAQ:AMGN)

Wed. July 08, 2009; Posted: 09:02 AM
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Pasadena, CA, Jul 08, 2009 (M2 PRESSWIRE via COMTEX) -- TRIB | Quote | Chart | News | PowerRating -- BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors has new updates to its calendar database of Clinical Trials and upcoming FDA approvals & decisions.

Below are companies which have either pending FDA decisions or pending clinical trial results that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades.

A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com

On 7/7/09, Trinity Biotech (NASDAQ:TRIB) announced the FDA approval and U.S. launch of its high throughput haemostasis (blood clot) analyzer, the Destiny Max. On 9/3/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.

On 6/7/09, Cubist Pharma (NASDAQ:CBST) announced that it began dosing in the CONSERV-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate ecallantide's effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects. Ecallantide is a potent inhibitor of plasma kallikrein, and CONSERV-2 will evaluate the effects of plasma kallikrein inhibition in the trial population. CBST stated that it remains on track for a mid-2010 end-of-phase 2 meeting with the FDA and anticipates that the results of this trial and the ongoing CONSERV-1 trial will provide meaningful insights into the optimal design of subsequent Phase 3 trials. In April 2008, Cubist announced an exclusive North American and European license and collaboration agreement with Dyax Corp. (NASDAQ: DYAX) for the development and commercialization of the intravenous formulation of ecallantide for surgical indications. The first indication being sought by Cubist for ecallantide is the reduction of blood loss during on-pump cardiac surgery.

On 7/07/09, NexMed, Inc. (NASDAQ:NEXM) announced the mutual decision with Novartis to terminate the licensing agreement for NM100060, a topically-applied treatment for onychomycosis, commonly known as nail fungus. NexMed entered into the exclusive, worldwide agreement with Novartis AG (NYSE:NVS) in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.

On 7/07/09 Amgen, Inc.(NASDAQ:AMGN) announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa.

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/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

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.

CONTACT: Mike Havrilla, Managing Editor, BiomedReports.Com e-mail: mike@biomedreports.com Tel: +1 323 472 4480 Fax: +1 888 210 3556

((M2 Communications disclaims all liability for information provided within M2 PressWIRE. Data supplied by named party/parties. Further information on M2 PressWIRE can be obtained at http://www.presswire.net on the world wide web. Inquiries to info@m2.com.

For full details on Amgen Inc (AMGN) click here. Amgen Inc (AMGN) has Short Term PowerRatings of 6. Details on Amgen Inc (AMGN) Short Term PowerRatings is available at This Link.

    


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