Thursday, April 18, 2013

GSK-Theravance's COPD drug wins support of FDA panel

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April 18, 2013
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  Today's Top Story 
 
  • Theravance-GSK's COPD drug wins support of FDA panel
    A panel of FDA advisers endorsed the approval of GlaxoSmithKline and Theravance's Breo Ellipta as a treatment for chronic obstructive pulmonary disease. The once-daily inhaled treatment, a combination of fluticasone furoate and vilanterol, would compete with GSK's Advair and AstraZeneca's Symbicort. The FDA could issue a decision by May 12. Reuters (4/17), Bloomberg Businessweek (4/17) LinkedInFacebookTwitterEmail this Story
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  Health Care & Policy 
  • BioFire seeks FDA clearance for blood culture ID system
    BioFire Diagnostics has filed a 510(k) clearance application with the FDA for a device that can screen positive blood cultures simultaneously for about 90% of the yeast microbes and gram-positive or gram-negative bacteria tied to bloodstream infections. The FilmArray Blood Culture Identification, or BCID, system could be released in the summer if cleared by the FDA. GenomeWeb Daily News (free registration) (4/16) LinkedInFacebookTwitterEmail this Story
  • Stem cells from bone marrow do well in Mayo heart failure trial
    Heart function improved for all patients who received autologous, bone marrow-derived stem cells in a trial conducted by the Mayo Clinic's Center for Regenerative Medicine in Minnesota, according to a study in the Journal of the American College of Cardiology. The stem cells were modified to act as cardiac cells before being injected into the patients, who were being treated for heart failure. Daily Express (London) (4/12) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
 
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  Industry Deals 
  Food & Agriculture 
  Industrial & Environmental 
  • International Energy Agency: More biofuel needed to fight warming
    The world is lagging behind the goal of limiting the increase in global temperatures by 2020 to 2 degrees Celsius, according to a new report by the International Energy Agency. To make up for lost time, the agency recommends at least doubling biofuel production annually while raising advanced biofuel capacity sixfold through targeted government support and other measures. "We agree with the IEA that biofuels offer real GHG emissions reductions today and that we must increase biofuel usage if we want to mitigate the impacts of climate change," said Bliss Baker, spokesman for the Global Renewable Fuels Alliance. DomesticFuel.com (4/17) LinkedInFacebookTwitterEmail this Story
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