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  
• Pivotal Phase 3 study compares tapentadol extended release tablets to placebo  Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation.
  Johnson & Johnson August 30, 2010  

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