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- FDA shifts review date for Biogen MS drug to March
The FDA has added three months to the review of Biogen Idec's multiple sclerosis drug BG-12, or dimethyl fumarate. Biogen said the agency asked for more time to evaluate the application but didn't ask for additional studies. The review date moves to March with the extension, which analysts said were not rare. Reuters (10/18)        | White Paper: Improving Total Cost of Ownership with EQMS
Companies are looking for ways to improve product quality, customer satisfaction and profitability while dealing with rising costs, competition and regulatory pressures. This white paper details how utilizing an EQMS backbone enables a broader organizational view of these issues, allowing for increased revenues and margins, operational efficiencies and global standardization for stakeholders. Read it now! | |
| Health Care & Policy |  |  | | - TNI BioTech strikes cancer drug development deal in China
Hubei Qianjiang Pharmaceutical and TNI BioTech agreed to jointly develop new cancer drugs using the latter's patents for Methionine Enkephalin. Under terms of the deal, TNI will be in charge of preclinical and clinical development in China while Hubei Qianjiang will provide $1.6 million for preclinical work. Methionine Enkephalin showed signs of fighting tumors and had a positive toxicity profile in early and midstage studies in the U.S. Pharmaceutical Business Review Online (10/19) - Pfizer's kidney cancer drug Inlyta comes close to key target
Pfizer's Inlyta, or axitinib, "narrowly missed" its main goal of significantly enhancing progression-free survival in treatment-naïve patients with advanced renal cell carcinoma compared with Bayer and Onyx Pharmaceuticals' Nexavar, or sorafenib, in a late-stage trial. Pfizer said the difference in overall median PFS between the Inlyta and Nexavar groups was not statistically significant. PharmaTimes (U.K.) (10/18) | Company & Financial News | | | | - Neurovance raises $7M to advance ADHD drug
Neurovance secured $7 million in a Series A1 financing round from several investors including Novartis Venture Fund and H&Q Life Sciences Investors. Proceeds will go toward the development of the firm's EB-1020, an experimental drug for attention deficit-hyperactivity disorder. Mass High Tech (Boston) (10/18) | Food & Agriculture | | | | - 6 French academies slam biotech corn study
Six scientific academies in France have released a joint statement dismissing a study linking biotech corn with increased risk of tumors and early mortality in rats as a "a scientific non-event." The study was led by Gilles-Eric Séralini of the University of Caen. "Given the numerous gaps in methods and interpretation, the data presented in this article cannot challenge previous studies which have concluded that NK603 corn is harmless from the health point of view, as are, more generally, genetically modified plants that have been authorised for consumption by animals and humans," the academies' statement said. The New York Times (tiered subscription model)/Dot Earth blog (10/19) | 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 | | | | - Congressional leaders are urged to leave RFS alone
BIO and other biofuel groups asked congressional leaders to preserve the Renewable Fuel Standard as they craft drought-relief measures. "This is not the time to kick the legs out from under renewable fuels. And we should not turn our backs on the 400,000 Americans whose jobs are supported by the biofuels industry. As the advanced biofuel industry grows, good employment opportunities will be within reach for many more Americans," BIO President and CEO Jim Greenwood said. The Hill/E2 Wire blog (10/18) | News from BIO | | | | - Ship with FedEx
FedEx is now offering member companies discounts of up to 35% off select FedEx services, both U.S. and international services. The BIO program with FedEx is one of the many cost-savings programs offered by BIO through its Business Solutions program. There is no charge for BIO member companies to participate in any of the BIO Business Solutions programs -- it is a benefit of membership. Learn more about the BIO and FedEx program.
| SmartQuote | | | |  | The importance of money flows from it being a link between the present and the future."
--John Maynard Keynes,
British economist  |
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