Industry News

• 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  
• Nebraska tracking system assesses developmental needs for premature infants  Risks for premature babies can include heart and lung complications, cerebral palsy, blindness and deafness. Because of a unique Nebraska program called Tracking Infants Progress Statewide (TIPS), infant needs for development services are identified earlier, at just 16 months of age.
  University of Nebraska Medical Center 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  
• Monsanto projects solid conclusion of fiscal year  Monsanto Company confirmed the drivers of its fourth-quarter operating plan have tracked well with management expectations, positioning the company to conclude the fiscal year within its previous guidance ranges for ongoing earnings per share (EPS) and free cash flow.
  Monsanto Company August 31, 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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