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POZEN Submits New Drug Application For VIMOVO™ (PN 400)
POZEN Inc. (NASDAQ:POZN), announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO™ (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers.
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Sancuso(R) Clinical Trial Application Filed In China
Solasia Pharma K.K., a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the filing of clinical trial application (CTA) of SP-01 (long-acting transdermal granisetron patch; brand name: Sancuso®) to the China State Food and Drug Administration (SFDA). This represents the first regulatory-related filing in China made by Solasia. Upon SFDA approval of the application expected in the 1st quarter of 2010, Solasia will initiate Sancuso clinical trials in China through Excel PharmaStudies Inc. (http://www.excel-china.com), China"s largest Clinical Research Organization (CRO).
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GP Dies After Contracting Swine Flu - British Medical Association Statement
Commenting on the news that a GP has died after contracting swine flu, Dr Laurence Buckman, Chairman of the BMA"s GPs Committee, said:
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Columnist Discusses Lifting Of Needle Exchange Funding Ban

"The heavy lifting" for garnering Congressional support for eliminating the federal ban on funding for needle exchange programs "was left to David Obey, the Democrat from Wisconsin who chairs both the House Appropriations Committee and the Subcommittee on Labor, Education, Health and Human Services," Boston Globe columnist Derrick Jackson writes in response to the introduction of legislation by the House Appropriations Committee last week that would lift the ban. Jackson also notes that while President Obama addressed needle exchange during the campaign, his FY 2010 budget continued the ban and that a "White House spokesmen said [President] Obama need[ed] time to "build support" with Congress and the public to get rid of the ban." In discussing the history behind the ban and the science supporting the use of needle exchange programs, Jackson says, "It is time, with the House having taken the lead, for [President] Obama to get out front and say once and for all that science takes the front seat to ideology," concluding, "Some issues are too critical to the very lives of Americans to wait to "build support"" (7/14). This information was reprinted from dailyreports.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily U.S. HIV/AIDS Report, search the archives and sign up for email delivery at dailyreports.kff.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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