| Today's Top Story |  |  | | - FDA could speed approval process for certain drugs
Treatments whose public health benefits outweigh their risks, including drugs for drug-resistant bacteria, infectious diseases and obesity, could be fast-tracked for approval under plans being considered by the FDA. Commissioner Dr. Margaret Hamburg said such drugs could be labeled for "special medical use" after faster, smaller clinical trials to get them to the people who need them most. "A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Allan Coukell of Pew Health Group, who has been involved in the FDA talks. Bloomberg Businessweek (10/11)       | | Health Care & Policy | | | | - Lilly chief: TPP must set standard for biologic data exclusivity
Not all participants in the Trans-Pacific Partnership trade negotiations share the U.S.' commitment to 12 years of data exclusivity for biologics, and that's why it's necessary that the eventual agreement set a standard that will encourage biopharmaceutical investment and innovation, writes Eli Lilly and Co. chairman, president and CEO John C. Lechleiter. "Furthermore, TPP will set the standard for countries such as China that are not part of the trade agreement, so America must stand firm: we cannot sacrifice the fundamental incentives that drive biomedical R&D investments," he writes. Forbes (10/10) - Vaccine shows promise in wiping out HPV-infected cells in women
Inovio Pharmaceuticals' vaccine VGX-3100 shows promise in helping women with human papillomavirus infections and are at risk for cervical cancer, according to a study in Science Translational Medicine. Researchers found that the vaccine, which contains DNA pieces, helps women develop an immune system that could attack and wipe out HPV-infected cells. The study also showed the vaccine's potential in hindering precancerous cells from becoming cancerous. MyHealthNewsDaily.com (10/10) - Genome interpreter keeps data local for better privacy
The Knome knoSYS 100 can interpret one sequenced genome per day based on current knowledge and keeps the analysis local, appealing to patients and clinicians who worry about keeping personal genomic data private. The device can help bridge the gap between the lab and the clinic by helping clinicians understand sequencing data, Knome CEO Martin Tolar says. Nature (10/9) | Company & Financial News | | | | - Kythera obtains $70.4M in IPO to advance double-chin drug
Kythera Biopharmaceuticals secured around $70.4 million from selling 4.4 million shares in an initial public offering. Almost all proceeds will go toward the Phase III trials of ATX-101, an experimental treatment for double chin. Kythera and partner Bayer Consumer Care plan to file an application in Europe for ATX-101 next year. CNBC/The Associated Press (10/11) - MedGenesis receives grant for experimental Parkinson's drug
Deutsche Parkinson Vereinigung e.V. awarded MedGenesis Therapeutix a grant to support midstage development of glial-cell-line-derived neurotrophic factor, a potential treatment for Parkinson's disease. "GDNF has the potential to become the first disease-modifying treatment in Parkinson's disease and could significantly change the quality of life of the affected patients," MedGenesis Chairman and CEO Erich Mohr said. Pharmaceutical Business Review Online (10/11) | Food & Agriculture | | | | | Industrial & Environmental | | | | - RFS waiver won't improve economy and corn prices, BIO says
Waiving the Renewable Fuel Standard would harm biotech employers without helping the economy, BIO said in a letter to the EPA. "The petitions, as presented for comment, fail to demonstrate that continued implementation of the RFS would severely harm the economy or the environment of a State, a region, or the United States as a whole during the waiver period," according to the letter. BIO cites two studies showing an RFS waiver won't reverse the economic damage caused by drought. BiofuelsDigest.com (10/10)  | |  | | The Buzz(CORPORATE ANNOUNCEMENTS)
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