Science and Enterprise

Tag: FDA

  • FDA Funds Evaluation of Pain Drug Clinical Trial Methods

    The Food and Drug Administration is funding a study by researchers at University of Rochester in New York and University of Washington in Seattle to find different ways of evaluating drugs designed to relieve acute and chronic pain. The grant of up to $4.5 million over five years aims to better understand why few new…

  • ACADIA, Meiji Seika Advance Schizophrenia Drug to Trials

    ACADIA Pharmaceuticals, a biotechnology company in San Diego, says its drug AM-831 developed with Meiji Seika Pharma Co. Ltd. in Japan to treat schizophrenia has received clearance from the Food and Drug Administration to begin phase 1 clinical trials. The clinical study will test the drug’s safety, tolerability, and interaction with the body. AM-831 was…

  • FDA Approves Anti-Clotting Drug for Stroke Prevention

    The U.S. Food and Drug Administration today approved the anti-clotting drug rivaroxaban to reduce the risk of stroke in people with abnormal heart rhythms from atrial fibrillation due to problems other than faulty heart valves. The drug is marketed under the name Xarelto in the U.S. by Janssen Pharmaceuticals in Raritan, New Jersey, a subsidiary…

  • FDA Approves Post-Surgical Pain Medication

    Pacira Pharmaceuticals Inc. in Parsippany, New Jersey says the Food and Drug Administration has approved its drug Exparel for the management of post-surgical pain. The non-opioid local analgesic, says the company, can provide pain relief for surgical patients of up to 72 hours. Exparel combines the compound bupivacaine in the company’s DepoFoam drug delivery platform.…

  • FDA Grant Funds Georgetown University Regulatory Center [Updated]

    Update, 26 October 2011:  A similar center of excellence will be established at University of Maryland in College Park, also funded by a $1 million  FDA grant. Georgetown University in Washington, D.C. will establish a Center of Excellence in Regulatory Science and Innovation (CERSI), with initial funding from the U.S. Food and Drug Administration. The…

  • FDA Approves Advance of ALS Stem Cell Trial

    Neuralstem Inc. in Rockville, Maryland says the Food and Drug Administration has approved the progression of a clinical trial to broaden treatment of amyotrophic lateral sclerosis (ALS) with neural stem cells. Based on the FDA’s approval, the trial at Emory University in Atlanta can expand stem cell transplant region for treating ALS, also known as…

  • National Academies Urge Single, Simple Food Rating System

    A study by the National Academy of Sciences recommends federal agencies develop an easy-to-understand point system that rates the nutritional value of packaged food and beverages. The point system, says the study authors, should reflect a single numerical rating that reflects calorie counts with saturated and trans fats, sodium, and added sugars. The study was…

  • Atlanta Network to Boost Pediatric Medical Devices

    The Food and Drug Administration (FDA) has awarded four Atlanta-area institutions a $1.8 million grant to encourage development of new medical devices to meet the special needs of children. Georgia Institute of Technology, Children’s Healthcare of Atlanta, Emory University and Saint Joseph’s Translational Research Institute will take part in the Atlanta Pediatric Device Consortium. Barbara…

  • Study to Assess Regulations’ Impact on Tobacco Users

    The Food and Drug Administration and National Institutes of Health today announced a joint national study of tobacco users to gauge the behavioral and health impacts of new government tobacco regulations. The Tobacco Control Act National Longitudinal Study of Tobacco Users is the first large-scale collaboration on tobacco regulatory research since Congress granted FDA the…

  • Survey: VCs Pulling Back from Biopharma, Devices Companies

    A survey of venture capital (VC) companies investing in health care enterprises says they have shifted funding away from businesses that develop drugs and medical devices toward less regulated services and information technology firms. The survey, conducted by the National Venture Capital Association (NVCA) from July to September 2011, covers 156 of its members with…