Local News

• FDA approves tapentadol immediate-release tablets for relief of acute pain  Johnson & Johnson Pharmaceutical Research & Development, announced that the U.S. Food and Drug Administration (FDA) approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.
  Johnson & Johnson November 21, 2008  
• New antibiotic against serious infections  The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the antibiotic, ZEVTERA(TM) (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections.
  Johnson & Johnson November 21, 2008  
• EMEA recommends suspension of marketing authorisation for IONSYS(R)  Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended suspension of the marketing authorisation for IONSYS(R), indicated for the management of pain for use in a hospital setting only.
  Johnson & Johnson November 21, 2008  
• Independent scientists determine study conclusions are flawed  On November 11, 2008, the Austrian Ministry of Health, Family and Youth released a report on three studies designed to assess the impact of GM corn on reproduction. One finding in one of the studies was interpreted as a possible impact on reproduction in the test mice.
  Monsanto Company November 21, 2008  
• Nplate(TM) (Romiplostim) receives positive opinion for marketing authorisation in the EU  Amgen announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate(TM) (romiplostim) in the European Union (EU).
  Amgen November 21, 2008  
• CHMP recommends approval of new indication for Enbrel(R)  The European Committee for Medicinal Products for Human Use (CHMP) announced its positive recommendation for the approval of Enbrel(R) (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis.
  Wyeth November 21, 2008  
• Lilly completes cash tender offer for ImClone Systems  Eli Lilly and Company and ImClone Systems announced the successful completion of the previously announced tender offer by Lilly's wholly-owned subsidiary, Alaska Acquisition Corporation, for all outstanding shares of ImClone at a price of $70.00 per share in cash.
  Eli Lilly and Company November 21, 2008  
• Number of biotech jobs grow in N.C.  Years of investment paid off for North Carolina with the highest five-year growth rate in biotechnology jobs nationwide. Considered the third largest U.S. biotech hub by number of companies, North Carolina increased its biotech work force by about 18.5 percent from 2001 to 2006.
  The News & Observer (Raleigh, N.C.) November 20, 2008  Sabine Vollmer
• FDA approves Promacta(R) (eltrombopag)  GlaxoSmithKline announced that the FDA granted accelerated approval for Promacta(R) (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
  GlaxoSmithKline November 20, 2008  
• Wyeth names Michael Kamarck President, Technical Operations & Product Supply  Wyeth announced that Michael Kamarck, Ph.D., 57, has been promoted to President, Technical Operations & Product Supply (TO&PS). Dr. Kamarck will be responsible for all aspects of technical operations and product supply for Wyeth.
  Wyeth November 20, 2008  

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