Drug firms call on FDA to add to guidance on trial enrichment

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March 27, 2013 Are you part of a BD or licensing team and want to improve your skills in contracts, intellectual property, valuation and deal structuring? Register for BIO's Executive Training Courses, April 19-21, in Chicago. 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  Drug firms call on FDA to add to guidance on trial enrichment Large drug firms including Merck & Co., Eli Lilly and Co. and Pfizer urged the FDA to bolster its draft guidance on enrichment measures for clinical trials with additional examples involving various therapeutic areas. Pharmaceutical companies also called for increased guidance involving diagnostics. OutSourcing-Pharma.com (3/25)        Health Care & Policy  Gilead's HIV combination drug Stribild wins EU panel support Gilead Sciences' Stribild has received an endorsement from the European Medicines Agency's Committee for Medicinal Products for Human Use as a treatment for HIV-1 infection in previously untreated adults and those with no known mutations related with resistance to any of the three antiretroviral agents in Stribild. The drug, which contains cobicistat, elvitegravir and Truvada, has been approved by the FDA. Pharmaceutical Business Review Online (3/26)      Clinigen pays $33M to acquire Novartis' Cardioxane Novartis agreed to sell Cardioxane, or dexrazoxane, a support treatment for the prevention of cardiotoxicity of anthracycline chemotherapy for metastatic breast cancer, to Clinigen Group for $33 million. Clinigen will take over production, distribution and marketing. Fox Business/Dow Jones Newswires (3/26), Genetic Engineering & Biotechnology News (3/26)      Firms ally to create platform for immunotherapy production Sanofi and Transgene will invest $12.9 million to create a new industrial platform for immunotherapy production. The platform will belong to Sanofi. Sanofi and Genzyme will use the platform to manufacture clinical and commercial batches of Transgene's MVA1 therapeutic vaccines and other immunotherapy products. Genetic Engineering & Biotechnology News (3/26), RTT News (3/25)      FDA again turns down United Therapeutics' oral PAH drug The FDA has again denied United Therapeutics' application for a treprostinil extended-release tablet as treatment for pulmonary arterial hypertension. The firm plans to meet with the FDA to discuss its decision. "We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," CEO Martine Rothblatt said. Reuters (3/25), Bloomberg Businessweek/The Associated Press (3/25)        Company & Financial News  Mass. biotech gets $26M boost from 35 investors RXi Pharmaceuticals, which specializes in developing treatments based on RNA-targeted technologies, secured $26 million from 35 investors, according to an SEC filing. The Westborough, Mass.-based firm's product pipeline includes an early-stage anti-scarring treatment and a preclinical ophthalmology drug. American City Business Journals/Boston/bioflash blog/Mass High Tech (3/26)      CNS drug developer raises $12M from 82 angel investors Reviva Pharmaceuticals, which develops drug for central nervous system diseases, secured $12 million from 82 angel investors in its latest financing round. The firm has finished a midstage trial for RP5063, its lead candidate for schizophrenia. MedCityNews.com (3/26)      Pa. biotech closes Series A round with additional $7.5M Novira Therapeutics obtained an additional $7.5 million in a Series A funding round from Versant Ventures, bringing the total raised to $25 million. The Radnor, Pa.-based firm is developing hepatitis B treatments, and plans to initiate clinical trials next year. MedCityNews.com (3/25)        Food & Agriculture  Crop genomics studies get up to $15M funding from U.K., India The U.K. Biotechnology and Biological Sciences Research Council and India's Department of Biotechnology agreed to provide as much as $7.8 million each to support research intended to enhance crop breeding using genomics and bioinformatics technologies. The studies will focus on wheat, solanaceae plants such as tomato, potato, and eggplant, and the brassica or mustard family. GenomeWeb Daily News (free registration) (3/26)        Industrial & Environmental  Discovery makes CO2-based biofuels possible, researcher says A scientist at the University of Georgia and colleagues found a way to convert carbon dioxide into biofuels and other products with the help of a biotech form of the Pyrococcus furiosus. "We can take carbon dioxide directly from the atmosphere and turn it into useful products like fuels and chemicals without having to go through the inefficient process of growing plants and extracting sugars from biomass," biotechnologist Michael Adams said. United Press International (3/26)      The Buzz(CORPORATE ANNOUNCEMENTS) GLOBAL BIOENERGIES receives 740,000 euros from OSEO to create a pre-industrial strain Interested in learning more about advertising in BIO SmartBrief? Contact Meryl Harold at (202) 407-7828 or mharold@smartbrief.com.    News from BIO  Are you taking full advantage of your membership? 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