- 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)       | 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) - 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) - 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) - 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) | 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) | 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) | 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. AL.com (Alabama)/Live blog (11/16) | News from BIO | | | | - BIOtechNOW
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