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NewswireTODAY - /newswire/ -
Pasadena, CA, United States, 2009/05/14 - Biomedical news portal tracks several companies with FDA decisions, clinical trial results, or pending FDA submissions [NASDAQ: CADX] [NYSE: NVS] [NASDAQ: ALTH].
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There are new updates to BioMedReports.com's database of FDA and Clinical Trial Calendars.
Below are brief summary 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.
Cadence Pharma (NASDAQ: CADX): Announced the 505(b)(2) NDA submission for Acetavance (the Company's proprietary intravenous formulation of acetaminophen) for the treatment of acute pain and fever in adults and children. If approved, Acetavance would become the first new intravenous analgesic approved in the U.S. in more than 20 years and the only approved intravenous agent for the treatment of fever in this country.
Novartis (NYSE: NVS): Novartis announced today that Prevacid 24HR (lansoprazole delayed-release capsules 15 mg) has been approved by the FDA as the first over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn since 2003 (Prilosec OTC). Prevacid 24HR is expected to be available over-the-counter later this year.
Osmetech (LON: OMH) announced today that it has submitted a request to the FDA for Emergency Use Authorization for its Respiratory Pathogen Test Panel test to be used to screen for the swine flu virus.
Allos Therapeutics (NASDAQ: ALTH) announced today that updated data from its pivotal Phase 2 PROPEL study of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) on 5/30/09.
A full, detailed report on the developments and how they affect upcoming FDA decisions and approvals is available online.
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.
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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