Industry News

• European Commission issues positive decision for approval of Seroquel XR  AstraZeneca announced the European Commission issued a positive decision for the approval of once-daily SEROQUEL XR Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder who had sub-optimal response to antidepressant monotherapy.
  AstraZeneca September 02, 2010  
• New England Journal of Medicine reports Xpert MTB/RIF a faster Tuberculosis test  New England Journal of Medicine reports Xpert MTB/RIF a faster, more Cepheid announced that its Xpert(R) MTB/RIF test was the subject of a study published in the latest edition of the New England Journal of Medicine (NEJM), "Rapid Molecular Detection of Tuberculosis and Rifampin Resistance."
  Cepheid September 02, 2010  
• Allergan resolves investigation of past sales and marketing practices related to BOTOX(R)  Allergan announced a resolution with the U.S. Department of Justice regarding Allergan's past U.S. sales and marketing practices relating to therapeutic uses of BOTOX. Allergan pled guilty to a single misdemeanor "misbranding" charge covering the period 2000 through 2005 and will pay $375 million.
  Allergan, Inc. September 01, 2010  
• Merck and Cardiome annoumnce BRINAVESS for infusion approved in the European Union  Merck and Cardiome Pharma Corp. announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial fibrillation.
  Merck & Co., Inc. September 01, 2010  
• BARDA funds development of new way to treat illness from acute radiation  The HHS Biomedical Advanced Research and Development Authority awarded a $153 million contract to Cellerant Therapeutics of San Carlos, Calif., to continue developing a new way to treat an illness caused by exposure to high levels of ionizing radiation which can damage the body’s cells.
  U.S. Health & Human Services September 01, 2010  
• U.S. Court of Appeals upholds validity of Lilly's Evista patents through March of 2014  Eli Lilly and Company announced that the U.S. Court of Appeals for the Federal Circuit has affirmed a prior ruling by the U.S. District Court for the Southern District of Indiana that the company's method-of-use patents for Evista are valid in the U.S. through March of 2014.
  Eli Lilly and Company September 01, 2010  
• Abbott receives FDA approval for first automated molecular test for assessing Hepatitis B   Abbott announced it has received FDA approval to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.
  Abbott September 01, 2010  
• Emergent BioSolutions awarded NIAID contract for development of anthrax vaccine  Emergent BioSolutions announced that it has signed a contract valued at up to $28.7 million with NIAID, an institute within the NIH, for advanced development of the company's third generation anthrax vaccine candidate. For a complete listing of our news releases, please click here
  Emergent BioSolutions Inc. September 01, 2010  
• FDA launches new organizational performance management system   The FDA launched an innovative performance management system designed to advance transparency, public participation, and collaboration. The system, called FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year.
  U.S. Food and Drug Administration September 01, 2010  
• NIAID Grant to Fund Dynavax Research on Hepatitis B Vaccination and Individual Variations   Dynavax announced a grant from NIAID to take a systems biology approach to study the differences between individuals that do or do not respond to vaccination against the Hepatitis B virus. This study will be one of several projects covered in a five-year, $17.6 million grant to Baylor Institute.
  Dynavax Technologies Corporation August 31, 2010  

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