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November 19, 2012
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at

  Today's Top Story 
  • EU backs approval of Sanofi's diabetes and colorectal cancer drugs
    A European Medicines Agency committee has recommended approval of Sanofi and Zealand Pharma's Lyxumia as a therapy for type 2 diabetes. Sanofi and Regeneron Pharmaceuticals' anti-angiogenic agent Zaltrap also won approval recommendation from the Committee for Medicinal Products for Human Use as a treatment for advanced colorectal cancer with chemotherapy. CNBC/Reuters (11/16), Bloomberg (11/17) LinkedInFacebookTwitterEmail this Story
FDA on Hot Seat as Congress Probes Compounding Imbroglio
In stinging questioning by members of the House Energy and Commerce Committee, FDA Commissioner Margaret A. Hamburg was hammered for more than 4 hours about the agency's failure to communicate proactively with Massachusetts Department of Public Health or to provide adequate oversight of the New England Compounding Center. Find out the details.

  Health Care & Policy 
  • Bristol obtains option to license Biocon's insulin drug
    Biocon and Bristol-Myers Squibb signed a deal that gives the latter the option to acquire global rights to Biocon's oral insulin, IN-105. Bristol can choose to take on the drug's development if it succeeds in a Phase II trial. The agreement entitles Biocon to a license payment plus sales-based milestone and royalty fees. Reuters (11/16) LinkedInFacebookTwitterEmail this Story
  • FDA panel: Data on effects of Dynavax's hep B vaccine insufficient
    The FDA's Vaccines and Related Biologics Advisory Committee voted 13-1 in support of the efficacy of Dynavax's hepatitis B vaccine Heplisav, but they questioned its safety and asked whether more trial data was needed involving blacks, Asians and Hispanics. The FDA could decide on the application by Feb. 24. MedPage Today (free registration) (11/15) LinkedInFacebookTwitterEmail this Story
  • Pfizer's Lyrica misses goal in Phase III seizure trial
    Pfizer's pregabalin CR, a long-lasting version of seizure drug Lyrica, was not associated with a significant reduction in seizure frequency in epilepsy patients compared with a placebo during a late-stage study. The response rate for participants receiving the placebo was higher than expected, which could have affected results. Trials of the drug are also being conducted for fibromyalgia and post herpetic neuralgia. The Washington Post/The Associated Press (11/17), Reuters (11/16) LinkedInFacebookTwitterEmail this Story
  • Roche's Avastin forestalls progression, death in brain cancer study
    Roche Holding's Avastin, in combination with radiation and chemotherapy, lowered the risk of cancer progression or death in patients with a common form of brain cancer during a Phase III trial. The drug, however, failed to significantly improve overall survival rates. Avastin is approved for treatment of several cancers including kidney and breast cancers. CNBC/Reuters (11/17) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
  • Diagnostics maker pulls in $9M
    Metamark Genetics said in a regulatory filing that it secured $9 million as part of a $13 million Series B funding round. The company plans to use the proceeds to complete final clinical validation of two prognostic tests for prostate cancer. Mass High Tech (Boston) (11/16) LinkedInFacebookTwitterEmail this Story
  Food & Agriculture 
  • Why Proposition 37 lost in California
    Proposition 37 lost in California not because of money spent on advertisements against the initiative but because it contained a list of contradictory exceptions and because of flaws reported on by independent news media, writes Richard Cornett, director of communications for the Western Plant Health Association. A majority of the state's daily newspapers, which have millions of readers, came out with editorials opposing the proposal, Cornett writes. Western Farm Press (11/15) LinkedInFacebookTwitterEmail this Story
  Hot Topics 

Top five news stories selected by BIO SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Industrial & Environmental 
  • Firm eyes Ala. bay to test NASA-developed algae technology
    Nevada-based Algae Systems is looking at Alabama's Mobile Bay as a potential pilot-testing area for a process that uses algae to produce biofuels while treating wastewater. Developed at NASA's Ames Research Center, the "algae photo-bioreactor" process requires growing algae in floating, wastewater-filled containers. The system uses wave action and sunlight to "keep the algae solution stirred up," yielding clean water and an "algae solution that they can convert into a jet fuel," said Rob McElroy, general manager of Daphne Utilities in Daphne, Ala. (Alabama)/Live blog (11/16) LinkedInFacebookTwitterEmail this Story
  News from BIO 
  • BIOtechNOW
    BIOtechNOW is the first in a number of new products from BIO intended to enhance our communications with the biotech community -- not only with our members, but with other stakeholders as well. This e-newsletter, combined with its website, serves as our flagship in that effort. BIOtechNOW will offer original content that emphasizes the business needs of the industry; highlight BIO's advocacy efforts; and provide a portal to all BIO activities and events. Most importantly, it will spotlight for those outside the industry the value of biotechnology. Sign up for the e-newsletter. LinkedInFacebookTwitterEmail this Story
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