FDA permits Acadia to file NDA for psychosis drug without additional trial

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April 12, 2013 Win an Apple TV, $100 Visa gift card, Keurig brewing system and more while learning to save your company money! Try your luck at the BIO Partner Pavilion raffle at the BIO International Convention, April 22-25, Chicago -- Booth No. 3651. 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  FDA permits Acadia to file NDA for psychosis drug without additional trial The FDA has allowed Acadia Pharmaceuticals to submit a new drug application for pimavanserin, its experimental drug for psychosis related to Parkinson's disease, without conducting an additional late-stage trial. Data from an initial Phase III trial and supporting studies is enough to support a regulatory filing, the agency said. Acadia, however, said it still needs to carry out more studies, and may not submit the new drug application until the end of 2014. Fox Business/Dow Jones Newswires (4/11), Reuters (4/11)        Health Care & Policy  Pfizer wins fast-track status for breast cancer drug palbociclib The FDA granted breakthrough therapy designation to Pfizer's palbociclib as possible treatment for breast cancer patients. The decision was based on preliminary midstage trial results showing palbociclib's efficacy in improving median progression free survival in patients, in combination with letrozole. PharmaTimes (U.K.) (4/11)      Merck submits tablet form of Nozafil for FDA approval The FDA received Merck's new drug application for a tablet form of antifungal posaconazole, or Nozafil. The liquid formulation of the drug is already available to treat "severely immunocompromised" patients at high risk of developing Aspergillus and Candida infections. PharmaTimes (U.K.) (4/11)      EU officials to review Sanofi's quadrivalent flu vaccine Sanofi said European regulators have accepted its marketing application for a quadrivalent version of its Vaxigrip flu vaccine. The new vaccine is designed to fight the four strains of flu virus anticipated in the coming season. Sanofi plans to apply for marketing approval in all countries where the three-strain Vaxigrip is currently marketed. Reuters (4/11)      Merck licenses West Nile vaccine technology rights to Hawaii Biotech Merck & Co. granted Hawaii Biotech rights to a family of patents to West Nile virus vaccine technology and nonexclusive license to related technologies. The deal will allow Hawaii Biotech to continue work on its West Nile virus vaccine, said CEO Elliot Parks. Honolulu Star-Advertiser (4/11)      Quest secures license to Matrix-Bio's VeraMarker system Quest Diagnostics has licensed the rights to Matrix-Bio's VeraMarker metabolite profiling system. Quest will use the technology to develop a clinical test for breast cancer recurrence. Matrix-Bio says its method combines mass spectrometry and NMR spectroscopy to detect metabolic changes in cancerous cells. GenomeWeb Daily News (free registration) (4/11)        Company & Financial News  $250M expansion planned for Bristol's Mass. biologics facility Bristol-Myers Squibb plans to invest $250 million to expand its biologics manufacturing plant in Devens, Mass. The firm wants to add biologics development and capabilities for clinical trial production at the site while adding employees. American City Business Journals/Boston/bioflash blog/Mass High Tech (4/11)      Mass. startup gets $30M boost to advance gene regulators A Series A funding round led by Arch Venture Partners and Flagship Ventures has brought in $30 million to Syros Pharmaceuticals, which is developing treatment techniques based on advanced genetic sequencing and insights into how proteins control genetic expression in stem cells. The Watertown, Mass.-based biotech startup will use the money to expedite the discovery and development of proteins it calls super enhancers. American City Business Journals/Boston/bioflash blog/Mass High Tech (4/11), Xconomy/Boston (4/11)        Food & Agriculture  Dow, Monsanto sign corn technology cross-licensing deal Monsanto obtained the rights to Dow AgroSciences' Enlist corn technology, which includes a trait that makes corn resistant to herbicide 2,4-D. In exchange, Monsanto granted Dow AgroSciences rights to a rootworm-resistant corn trait it is developing. Both firms are entitled to receive sales royalties on seeds containing their technology. The Wall Street Journal/Dow Jones Newswires (4/11)        Industrial & Environmental  Calif.-based biofuel startup gets $3.1M offer to move to Colo. The Colorado Economic Development Commission cleared the way for California-based Cool Planet Energy Systems to receive $3.1 million in tax incentives for relocating to the state. The biofuel startup is considering either Colorado or Texas as the site for its future headquarters and its first commercial-scale biomass-to-gas biorefinery. The Denver Post (4/12)      The Buzz(CORPORATE ANNOUNCEMENTS) Chefitz to Join PCAsso's Advisory Board Interested in learning more about advertising in BIO SmartBrief? 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