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| Today's Top Story |  |  | | - Hamburg: FDA turns attention to lab-developed diagnostics
The FDA could use its regulatory discretion to increase its scrutiny of laboratory-developed diagnostics, including those that are tools for personalized medicine, FDA Commissioner Dr. Margaret Hamburg said at a conference. Tests developed and offered by labs are becoming more complex, and the FDA wants to ensure that "the accuracy and clinical validity of high-risk tests are established before they come to market," she said. Forbes (6/2)       | Health Care & Policy | | | | - Amgen's melanoma drug T-Vec extends survival in pivotal trial
Amgen's investigational drug talimogene laherparepvec, or T-Vec, improved survival by 21% in advanced-melanoma patients compared with standard treatment, an interim analysis of a trial found. Amgen is in talks with the FDA on how to move forward, said David Chang, the firm's leader of global oncology development. Reuters (6/1) - Sanofi halts development of 2 late-stage drugs
Sanofi said it would no longer develop its lung cancer drug candidate iniparib and anticoagulant otamixaban after the two did not meet primary endpoints in trials. Both drugs were in late-stage development. Reuters (6/3) - Stem cells and drug show potential against type 1 diabetes
After finding that type 1 diabetes destroys blood vessels in the pancreas as well as insulin-producing cells, scientists at the University of Missouri are developing a drug called Ig-GAD2 for use in combination with adult stem cells from bone marrow. Lead author Habib Zaghouani said "the bone marrow cells led to growth of new blood vessels, and it was the blood vessels that facilitated reproduction of new beta cells" in preclinical tests. The results appear in the journal Diabetes. Business Standard (India)/Asian News International (5/30) | Company & Financial News | | | | - ISB secures $7.7M sepsis-biomarker contract from Pentagon
The Institute for Systems Biology landed a nearly $7.7 million contract from the Department of Defense to use advanced sequencing to find biomarkers in peripheral blood that predict post-surgical sepsis. "With this approach, we aim to produce biomarker tests to guide therapeutic intervention at the earliest possible stage after infection and thereby prevent the onset of potentially dire systemic sequelae," institute scientist Kai Wang said. GenomeWeb Daily News (free registration) (5/31) - Valerion gets $1.2M from Muscular Dystrophy Association
Valerion Therapeutics is getting $1.2 million from the Muscular Dystrophy Association to advance the preclinical development of 3E10Fv-MTM1, an experimental drug for myotubular myopathy. Preclinical tests indicate that the drug may improve muscle strength, structure and function. The funding will permit Valerion to continue animal trials and proceed with pharmaceutical-grade development. Genetic Engineering & Biotechnology News (5/31) | Food & Agriculture | | | | - Monsanto won't push for biotech-seed approval in Europe
Monsanto said it has no plans to seek regulatory approval for its new biotech seeds in Europe due to weak demand and strong public opposition in the region. "We've come to the conclusion that this has no broad acceptance at the moment," said Ursula Luettmer-Ouazane, a spokeswoman for Monsanto Germany. Reuters (5/31) | 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 | | | | - New bioprocessing research center is planned in Ill.
The University of Illinois at Urbana-Champaign is planning to break ground this fall on a research facility dedicated to biomass-based biofuels. The Integrated Bioprocessing Research Laboratory will provide "a niche between the bench scale study, which can ferment approximately a kilogram of corn, and the large scale, such as the National Corn-to-Ethanol Research Center at Southern Illinois University at Edwardsville," said professor Vijay Singh. EthanolProducer.com (5/30)  | |  | | The Buzz(CORPORATE ANNOUNCEMENTS)
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