Science and Enterprise

Tag: FDA

  • FDA, Industry Group to Partner on Medical Device Regulation

    The Food and Drug Administration will collaborate with LifeScience Alley, an industry association based in Minneapolis, in the Medical Device Innovation Consortium, to advance regulatory science for medical devices. Medical Device Innovation Consortium is expected to create scientific tools for assessing the safety and effectiveness of medical devices. The consortium has nine corporate members, including…

  • Stem Cells Devised for Rare Disease Boost Personal Medicine

    Medical researchers at Johns Hopkins University in Baltimore and Memorial Sloan-Kettering Institute in New York developed a method of screening treatments for a rare genetic disorder that the authors say could be applied to tests of stem-cell derived personalized medicines. The team led by Gabsang Lee at the Johns Hopkins Institute for Cell Engineering published…

  • FDA Approves Cell Culture Seasonal Flu Vaccine

    The Food and Drug Administration approved yesterday Flucelvax, the first seasonal influenza vaccine cleared for use in the U.S., produced with cultured animal cells, instead of fertilized chicken eggs. Flucelvax is made by the  global pharmaceutical company Novartis, based in Basel, Switzerland. The virus strains in the vaccine are grown in animal cells of mammalian…

  • FDA Approves Drug to Treat Seizures in Epilepsy Patients

    The U.S. Food and Drug Administration approved the drug perampanel, given in tablet form to treat partial onset seizures in patients with epilepsy ages 12 years and older. Perampanel is marketed under the brand name Fycompa by Eisai Inc. of Woodcliff Lake, New Jersey, and headquartered in Tokyo. Epilepsy is a brain disorder characterized seizures…

  • Trial to Test Branded vs. Generic Anti-Rejection Drugs

    Researchers at University of Cincinnati will lead a clinical trial testing a brand-name drug to reduce rejection of transplants against generic versions. The $2.7 million study, funded by the Food and Drug Administration, includes colleagues from University of Colorado and Cincinnati Children’s Hospital Medical Center. The trial will test the drug tacrolimus, an immunosuppressant compound…

  • Clinical Trial Under Way Testing Stem Cell Heart Treatment

    Cytori Therapeutics, a biotechnology company in San Diego, reports the first patient received treatment in its clinical trial using stem cells derived from body fat to treat severe heart failure. The patient was treated in September at the Minneapolis Heart Institute Foundation in Minneapolis, one of six sites for the trial, and completed a seven-day…

  • Artificial Kidney Project Lands New $750,000 Funding

    The Kidney Project, an academic-corporate initiative led by University of California in San Francisco to develop an implantable device to replace failed kidneys, secured a new $750,000 grant from the John and Marcia Goldman Foundation. The funding supplements a $2.25 million grant received this summer from National Institutes of Health (NIH). The artificial kidney aims…

  • FDA Approves Colorectal Cancer Treatment

    The U.S. Food and Drug Administration approved the drug regorafenib to treat patients with metastatic colorectal cancer, where the cancer has progressed after treatment and spread to other parts of the body. Regorafenib is marketed under the brand name Stivarga by Bayer HealthCare Pharmaceuticals, in Wayne, New Jersey. Stivarga blocks several enzymes that promote cancer…

  • FDA Approves Inhaled Aerosol Asthma Maintenance Drug

    Acton Pharmaceuticals Inc. in Marlborough, Massachusetts reports the U.S. Food and Drug Administration approved its drug Aerospan, an orally inhaled corticosteroid for the prevention of asthma attacks. The FDA approval, says Acton, came in response to a supplemental new drug application, and will enable the company to launch the drug in the U.S. during the…

  • Pharmas to Collaborate on Improving Clinical Trial Process

    Ten of the world’s larger pharmaceutical companies formed a non-profit organization to improve the way clinical drug studies, a major time and financial expense, are conducted. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech (a division of the Roche Group), and Sanofi will take part in the…