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Pharmaceutical News

• Pharmaceutical Companies Seek Clarity On Evidence Needed For Drug Label Change
  Tue, 06 January 2009
  With the discovery of a growing number of predictive biomarkers for existing drugs, the question of when and how to add pharmacogenetic information to drug labels has taken on greater urgency. On December 16 the Oncologic Drug Advisory Committee (ODAC) of the Food and Drug Administration (FDA) met in Gaithersburg, MD with re ...
• DNA Nanotubes May Soon Find Their Way Into A New Generation Of Ultra-Tiny Electronic And ...
  Tue, 06 January 2009
  Arizona State University researchers Hao Yan and Yan Liu imagine and assemble intricate structures on a scale almost unfathomably small. Their medium is the double-helical DNA molecule, a versatile building material offering near limitless construction potential.
• American Medical Student Association Applauds Pharmaceutical Industry For Voluntary Ban; ...
  Tue, 06 January 2009
  The American Medical Student Association (AMSA), the nation's oldest and largest, independent association for physicians-in-training, applauds the pharmaceutical industry for implementing a voluntary ban on gifts to physicians, which began on January 1, 2009. Enacted by the Pharmaceutical Research and Manufacturers of Americ ...
• FDA Approves Most Comprehensive System To Test Donated Blood For HIV, Hepatitis B & Hepa ...
  Tue, 06 January 2009
  The United States Food & Drug Administration (FDA) approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for co ...
• Bionovo Publishes Discoveries In Predictable Tissue Selectivity For Selective Estrogen R ...
  Tue, 06 January 2009
  Bionovo, Inc. (Nasdaq: BNVI) announced results describing predictable estrogen regulatory elements that can be used to identify estrogenic drugs that are safer. The data, published in Molecular and Cellular Endocrinology, showed that the new regulatory elements can distinguish the estrogenic pharmacological activity exerted ...
• Schering-Plough Announces European Submission Of Fertility Medicine Corifollitropin Alfa
  Sun, 04 January 2009
  Schering-Plough Corp., (NYSE: SGP), a leading provider of fertility treatments, announced today that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS). This applicatio ...
• FDA Issues Complete Response Letter To Ipsen For Dysport Biologics License Application F ...
  Sun, 04 January 2009
  Ipsen (Paris:IPN) today announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport. The application, submitted by the Group in late 2007, seeks approval to market Dysport for the treatment of cervical dystonia. ...
• Cleveland BioLabs Reports Advances In Curaxin Anticancer Program
  Sat, 03 January 2009
  Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced several advances in the development of Curaxins, the leading class of drug candidates in the Company's anticancer drug discovery program. Curaxins are synthetic small molecules designed to simultaneously target major stress response pathways that are frequen ...
• Pegloticase BLA Filing Accepted For Priority Review By FDA
  Fri, 02 January 2009
  Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted the Company's BLA with a priority review s ...
• Pfizer Tops Annual Most Effective Sales Force Ranking, According To Study By GfK Market ...
  Fri, 02 January 2009
  For the fifth year in a row, Pfizer has claimed the top spot as the industry's most effective sales force, as ranked by GfK Market Measures in a study with more than 800 physicians across 12 specialties.