Science and Enterprise

Tag: FDA

  • BARDA Contract Awarded for Antiviral Influenza Drug

    The U.S. Biomedical Advanced Research and Development Authority (BARDA) awarded a contract to Biota Scientific Management Pty in Melbourne, Australia for an antiviral drug to combat influenza. The contract for advanced development and testing of the drug is valued at $231 million over five years. The drug, CS-8958, is a long-acting neuraminidase inhibitor, which prevents…

  • FDA Approves Melanoma Immunotherapy Drug

    The U.S. Food and Drug Administration (FDA) approved Yervoy — ipilimumab — to treat patients with late-stage metastatic melanoma, a dangerous type of skin cancer. Yervoy is marketed by Bristol-Myers Squibb, in Princeton, New Jersey. Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in…

  • Public-Private Research Helps Oyster Growers Meet FDA Regs

    Researchers at the Virginia Institute of Marine Science (VIMS) in Gloucester Point joined with local oyster growers to sharply reduce a bacterium harmful to humans found in farmed oysters. Their findings may offer a lower-cost solution to new Food and Drug Administration (FDA) regulations that many growers believe can affect the oyster industry in Chesapeake…

  • FDA Approves Improved Laser Eye Surgery Technology

    The U.S. Food and Drug Administration approved an enhanced technology for refractive (laser) eye surgery, based on research conducted at University of Rochester in New York. The Rochester Nomogram, as the technology is called, is licensed to Technolas Perfect Vision, a cataract and refractive laser company formed through a joint venture of lens manufacturer Bausch…

  • Report: Pharma Research Productivity Undercounted

    In a new analysis, pharmaceutical market research company EvaluatePharma in London, U.K. says current methods of measuring productivity of the industry miss a big part of the industry’s output and thus give a misleading picture. The report suggests the pharma industry is in better shape than most observers indicate. EvaluatePharma says most industry watchers count…

  • Trial Shows Drug Improved Vision For Macular Edema Patients

    A clinical trial of the drug Lucentis made by Genentech indicates patients with diabetic macular edema (DME) who received the drug had improved vision compared to patients who received a placebo. Genentech, a division of the Roche Group in South San Francisco, California, says vision improvements among those receiving Lucentis began to occur within seven…

  • Agencies Use Robotics to Test Chemicals for Toxicity

    National Institutes of Health (NIH) today unveiled a new robotic screening system that will test 10,000 different chemicals for potential toxicity. The system is a result of a collaboration among several federal agencies known as Tox21. The  system is located at NIH’s Chemical Genomics Center in Rockville, Maryland. Tox21 is a joint effort started in…

  • Georgetown Univ., FDA to Partner on Regulatory Science

    Georgetown University Medical Center (GUMC) in Washington, D.C. and the U.S. Food and Drug Administration (FDA) in Rockville, Maryland signed a new agreement to encourage research and education in the fields of regulation and public health. The memorandum of understanding (MOU) signed today covers regulatory science, ethics, education, and training. The five-year agreement is expected…

  • Pharma Companies Developing 460 Orphan Drugs

    A report from the Pharmaceutical Research and Manufacturers of America (PhRMA) says there are now 460 medicines for rare  or “orphan” diseases in late stages of the pipeline, either in clinical trials or awaiting Food and Drug Administration (FDA) review. The group says this is the largest number of drugs for orphan diseases in development…

  • FDA Approves Hepatitis C Virus Test

    OraSure Technologies Inc. in Bethlehem, Pennsylvania says that the U.S. Food and Drug Administration (FDA) has approved its OraQuick HCV Rapid Antibody Test to detect hepatitis C virus (HCV) antibodies with a fingerstick whole blood sample. The test, says the company, provides results in 20 minutes. OraSure says the OraQuick HCV test is the only…