Soligenix gains fast-track status for Crohn's disease drug

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November 12, 2012 BIO has teamed up with FedEx to offer member companies discounts of up to 35% off select FedEx Express, FedEx Ground and FedEx Home Delivery services through the BIO Business Solutions cost-savings program. Learn more. 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 bio@smartbrief.com.   Today's Top Story  Soligenix gains fast-track status for Crohn's disease drug Soligenix's SGX203, an experimental drug for Crohn's disease in children, secured fast-track designation from the FDA. The drug contains beclomethasone 17,21-dipropionate, an active corticosteroid, that targets local inflamed tissue. The FDA previously granted the drug orphan-drug status for the same indication. Pharmaceutical Business Review Online (11/9)        Health Care & Policy  Merck submits insomnia drug suvorexant for FDA approval The FDA received Merck & Co.'s application for suvorexant as treatment for insomnia. As part of the process, the drug will be reviewed by the agency's controlled substances staff. Drug Store News (11/8)      Ironwood seeks FDA approval for anti-anxiety drug trial Ironwood Pharmaceuticals filed an investigational new-drug application with the FDA to conduct a clinical study of IW-2143, an experimental drug for anxiety. A study involving healthy volunteers would assess the treatment's pharmacokinetic profile. Pharmaceutical Business Review Online (11/9)      Celgene's Abraxane extends survival in pancreatic cancer study Patients with pancreatic cancer who received Celgene's Abraxane, or paclitaxel, plus gemcitabine survived longer than those treated with gemcitabine alone during a clinical trial. Celgene didn't quantify the improvement but said the difference was statistically significant; details are expected to be reported in January. The firm plans to submit the drug for approval as a treatment for pancreatic, lung and breast cancer. MedCityNews.com/Reuters (11/9)      Boehringer plans late-stage trial of hepatitis C drugs Boehringer Ingelheim plans to begin a Phase III study of its hepatitis C regimen after obtaining positive results from a midstage trial. The SOUND-C2 study found that 69% of patients who received a combination of BI-201335, a protease inhibitor, and BI-207127, a polymerase inhibitor, plus ribavirin, were virus-free 12 and 24 weeks after completing therapy. CNBC/Reuters (11/10)      Blood stem cell trigger gene could increase transplant supply Canadian and Italian researchers said they have pinpointed what they call "a master control" gene that plays a role in switching on dormant blood stem cells. The findings could lead to methods that increase the amount of stem cells from cord blood available for transplantation. The study was reported in the journal Cell: Stem Cell. The Globe and Mail (Toronto) (tiered subscription model) (11/8)        Company & Financial News  Gates Foundation joins $26M round for developer of flu drug Visterra secured an additional $13 million in a Series A funding round from existing and new investors, bringing the total raised to $26 million. The biotech startup will use the money to advance VIS410, an antibody to prevent and treat influenza, into clinical development. Mass High Tech (Boston) (11/9), Xconomy/Boston (11/9)      Epigenetic analysis tool project wins $640K grant from NIH The NIH awarded New England Biolabs a grant worth $640,000 to expand its study into the development of new enzymatic tools for use in epigenetic analysis. New England Biolabs said the grant will allow them to carry out additional studies that could lead to "a deeper understanding of epigenetic marks in the mammalian genome." GenomeWeb Daily News (free registration) (11/8)        Food & Agriculture  CLCV-resistant cotton plant developed in Pakistan A team of Pakistani scientists, in collaboration with researchers from University of Toronto, developed a cotton plant that is resistant to cotton leaf curl virus using transgenic RNA interference technology. The biotech seeds could be commercialized in three years. The News - International (Pakistan) (11/10)        Hot Topics  Top five news stories selected by BIO SmartBrief readers in the past week. Pioneering gene therapy gains approval in Europe (BioWorld Online) Proposition 37's biotech labeling rule trails in Calif. voting (San Jose Mercury News (Calif.)) Lipitor, Plavix lead list of 10 most-sold drugs since 2000 (Genetic Engineering & Biotechnology News) LinkedIn brings the biotech world down to size (Xconomy) J&J-Bayer's anti-clotting drug Xarelto wins expanded FDA approval (PharmaTimes (U.K.)) Results based on number of times each story was clicked by readers.   Industrial & Environmental  KiOR flips switch on advanced-biofuels plant in Miss. KiOR has started production at its commercial-scale cellulosic gasoline and diesel plant in Columbus, Miss. The facility could be fully operational in nine months to a year. Bloomberg Businessweek (11/9)        News from BIO  Are you taking full advantage of your membership? BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. 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