Science and Enterprise

Tag: FDA

  • Wireless Security Devised for Implanted Medical Devices

    Engineers at Massachusetts Institute of Technology in Cambridge and University of Massachusetts in Amherst have designed a system that shields implanted medical devices like heart pacemakers and defibrillators from unauthorized wireless access or sabotage. Their findings will be presented at the ACM Special Interest Group on Data Communication (SIGCOMM) conference in Toronto, Canada in August.…

  • Diagnostics Company Gets State Grant for Blood Platelet Test

    Immunetics Inc. in Boston, Massachusetts, received a Small Business Matching Grant (SBMG) to commercialize its BacTx test for detecting bacterial contamination in blood platelets. The Massachusetts Life Sciences Center made the $500,000 award. Platelets enable clotting, and patients suffering from trauma, surgical procedures, cancer, or chemotherapy must receive platelet transfusions to survive. The company says…

  • FDA Approves HIV Drug in Combination Treatment

    The U.S. Food and Drug Administration approved today the drug Edurant (rilpivirine) as a treatment for HIV infection in adults, when used in combination with other antiretroviral drugs. Edurant is manufactured by Tibotec Therapeutics, a subsidiary of Johnson & Johnson, in Raritan, New Jersey. FDA approved the drug for the treatment of HIV-1 — the…

  • Regulatory Agency Funding Increases in Federal Budgets

    A new report from researchers at Washington University in St. Louis, Missouri and George Washington University in Washington, DC describe increases in funding and staff at federal regulatory agencies over the two most recent fiscal years. Fiscal Stalemate Reflected in Regulators Budget: An Analysis of the U.S. Budget for Fiscal Years 2011 and 2012, by…

  • FDA Approves Staph Bacteria Resistance Test

    The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus (S.aureus) infections that can identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA). The KeyPath MRSA/MSSA Blood Culture Test is made by Microphage Inc. of Longmont, Colorado. According to the Centers for Disease Control and Prevention, MRSA is…

  • FDA Approves Type 2 Diabetes Treatment

    The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, which when used with diet and exercise, can improve blood glucose control in adults with Type 2 diabetes. Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut, and Eli Lilly Company in Indianapolis, Indiana. People with Type 2 diabetes do not produce or…

  • FDA Approves Drug for Rare Blood Vessel Disorders

    The U.S. Food and Drug Administration today approved Rituxan (rituximab) as a therapy for two rare disorders that cause severe vasculitis or blood vessel inflammation. The drug was developed by Biogen Idec in Weston, Massachusetts, and is manufactured by Genetech in South San Francisco, California. The diseases approved for treatment by Rituxan — Wegener’s granulomatosis…

  • U.S. Meat, Poultry Found with Drug-Resistant Staph Bacteria

    A study in five cities by the Translational Genomics Research Institute in Phoenix, Arizona finds drug-resistant strains of Staphylococcus aureus (S. aureus) in meat and poultry from U.S. grocery stores at unexpectedly high rates. The study’s findings appear in today in the journal Clinical Infectious Diseases. S. aureus is a bacteria linked to a wide…

  • FDA Approves Drug for Restless Legs Syndrome

    The U.S. Food and Drug Administration approved Horizant Extended Release Tablets, a once-daily treatment for moderate-to-severe restless legs syndrome (RLS). The drug was developed by Xenoport of Santa Clara, California and GlaxoSmithKline of Research Triangle Park, North Carolina. Horizant’s compound is gabapentin enacarbil that uses the body’s nutrient transport mechanisms that are believed to help…

  • FDA Adverse Drug Event Reports Jump in Past Decade

    Researchers at University of Maryland School of Pharmacy in Baltimore found a sharp increase in reports of adverse drug events to the Food and Drug Administration in the years 2000 through 2009, but the reasons for the jump may be more complex than the quality of the drugs. Their findings appear in the March issue…