Thursday, March 28, 2013

Biogen's multiple sclerosis drug Tecfidera gets FDA approval

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March 28, 2013
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  Today's Top Story 
  • Biogen's multiple sclerosis drug Tecfidera gets FDA approval
    The FDA approved Biogen Idec's oral drug Tecfidera to treat patients with multiple sclerosis. Tecfidera activates the Nrf2 chemical pathway and is intended to shield nerve cells from damage and inflammation. Biogen is days from commercializing the drug. Reuters (3/27) LinkedInFacebookTwitterEmail this Story
  Health Care & Policy 
  • FDA approves Eisai's Aciphex Sprinkle for pediatric GERD
    The FDA has approved the use of Eisai's Aciphex Sprinkle delayed-release capsules, or rabeprazole sodium, for up to 12 weeks in children ages 1 to 11 with gastroesophageal reflux disease. The approval was based on results of a multicenter trial in which 81% of Aciphex-treated pediatric patients responded during the 12-week treatment period. Zenopa.com (U.K.) (3/27), Drug Store News (3/27) LinkedInFacebookTwitterEmail this Story
  • Former FDA official: Biosimilar pathway won't bring a revolution
    The FDA's abbreviated pathway for most biosimilars will not have a considerable effect on costs nor cause a major change in the drug development landscape, writes Henry I. Miller, a former FDA biotechnology official. The high costs of planning and conducting clinical trials and analyzing the results will inhibit the rush to produce biosimilars. Each biosimilar has to be considered effectively as a novel treatment, making for a much more expensive process than the development of small-molecule generics. Forbes (3/27) LinkedInFacebookTwitterEmail this Story
 
  • Aastrom switches focus of development for ixmyelocel-T
    Aastrom Biosciences said it would stop a late-stage trial of ixmyelocel-T for critical limb ischemia. Aastrom will continue developing the treatment candidate, which is made from a patient's bone marrow, against dilated cardiomyopathy. Treatment in a Phase II trial is expected to start within weeks. Yahoo/Reuters (3/27) LinkedInFacebookTwitterEmail this Story
  • Gene discoveries open treatment targets for 2 blood disorders
    An international team of researchers says the discovery of two genetic mutations has yielded the possibility of new ways to treat beta-thalassemia and hemochromatosis. Blocking the macrophages that attach to erythroblasts could reduce red blood cell production, and changing the Tmprss6 gene could halt the body's use of iron. The findings were published in Nature Medicine and the Journal of Clinical Investigation. MedicalDaily.com (3/26) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
  Industry Deals 
  Food & Agriculture 
  Industrial & Environmental 
  • NSF-backed research seeks to improve butanol production process
    A researcher at Auburn University is seeking to develop a more cost-effective way of converting farm and woody biomass into butanol. Butanol is a promising advanced biofuel, but technical issues, such as hydrolysate inhibition, present barriers to cost-effective production, said researcher Maobing Tu. The project is supported by a five-year, $401,155 award from the National Science Foundation. Biofuels-News.com (U.K.) (3/26) LinkedInFacebookTwitterEmail this Story
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