Industry News

• FDA approves Envoy Medical 's first totally implanted hearing system   The FDA announced the approval of the Esteem – an implanted hearing system used to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss. As a condition of FDA approval, Esteem manufacturer, Envoy Medical of St. Paul, Minn., must conduct two post-approval studies.
  U.S. Food and Drug Administration March 18, 2010  
• The Medicines Company expands a nationwide recall for certain lots of Cleviprex(R)  The Medicines Company announced that it is voluntarily expanding the recall of Cleviprex (R) (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials.
  The Medicines Company March 17, 2010  
• U.S. Food And Drug Administration accepts New Drug Application  Bristol-Myers Squibb and AstraZeneca announced that the FDA has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA(TM) (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets.
  Bristol-Myers Squibb Company March 17, 2010  
• Alkermes announces initiation of multidose Phase 1 clinical study of ALKS 37  Alkermes announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).
  Alkermes, Inc. March 17, 2010  
• Study shows Prevenar 13* is immunogenic in young children previously vaccinated  According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13* was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed).
  Pfizer Inc. March 17, 2010  
• Anika Therapeutics reports 18% revenue drowth in fourth-quarter 2009  Anika Therapeutics reported product revenue increased by 20% to $9,944,000 for the fourth quarter of 2009, compared with $8,285,000 in the same period last year, and net income for the fourth quarter of 2009 was $697,000 versus $1.0 million for the fourth quarter of 2008.
  Anika Therapeutics, Inc. March 16, 2010  
• The Medicines Company announces decision in PTO and FDA litigation  The Medicines Company announced that the District Court for the Eastern District of Virginia set aside the PTO's denial of the Company's patent term extension application and sent the matter back to the PTO for reconsideration.
  The Medicines Company March 16, 2010  
• Molecular Insight reports fourth quarter and year-end 2009 financial results  Molecular Insight resported a net loss of $13.2 million for the quarter ended December 31, 2009 versus a net loss of $15.8 million or $0.63 per share for the fourth quarter of 2008. At December 31, 2009, the Company had approximately $64.0 million in cash, and cash equivalents.
  Molecular Insight Pharmaceuticals, Inc. March 16, 2010  
• Covidien declares quarterly cash dividend and announces share repurchase program  Covidien announced that its Board of Directors has declared a quarterly cash dividend of $0.18 per ordinary share. The dividend is payable on May 14, 2010, to shareholders of record on April 15, 2010. Covidien also announced a program to purchase up to $1 billion of the Company's ordinary shares.
  Covidien plc March 16, 2010  
• Boston Scientific completes enrollment in PLATINUM trials  Boston Scientific announced completion of patient enrollment in the Small Vessel and Long Lesion trials of its PLATINUM clinical program that are designed to compare the platinum chromium PROMUS® Element Everolimus-Eluting Stent System to matched historical control groups of patients.
  Boston Scientific Corporation March 16, 2010  

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