Science and Enterprise

Tag: FDA

  • FDA Approves Electronic Artificial Retina Implant Device

    The U.S. Food and Drug Administration approved the first implant device to restore some visual perception for adults with retinitis pigmentosa, a genetic disease that damages the retina. The Argus II Retinal Prosthesis System is made by Second Sight Medical Products Inc. in Sylmar, California. Retinitis pigmentosa is an eye disease caused by genetic defects…

  • Report: Common Action Needed Against Fake, Substandard Drugs

    A report from the Institute of Medicine, part of the National Academies in the U.S., calls for a new agreement on an international code of practice on drug quality to counter the growing health risks from illegimiate medicines. Among the recommendations in the report are a mandatory drug tracking system and tightening the licensing requirements…

  • FDA Grants Accelerated Multiple Myeloma Drug Approval

    The U.S. Food and Drug Administration approved pomalidomide to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is marketed under the brand name Pomalyst by the pharmaceutical company Celgene Corporation in Summit, New Jersey. Multiple myeloma is a blood cancer that affects mainly older adults and arises…

  • Clinical Trials To Test More Tamiflu Effects, Plasma on Flu

    National Institutes of Health plans three new clinical trials of influenza therapies, two trials involving the current flu drug oseltamivir, and a third trial testing plasma enriched with anti-influenza antibodies. The clinical studies, for which NIH is seeking volunteers, are being held at NIH in Bethesda, Maryland and at 36 other sites elsewhere in the…

  • FDA Approves Acute Migraine Treatment Patch System

    The U.S. Food and Drug Administration approved a battery-powered patch system made by Nupathe Inc. of Conshohocken, Pennsylvania for the treatment of migraine. The patch, marketed as Zecuity, is a single-use system that delivers the drug sumatriptan, and was approved by FDA for treating migraine headaches and nausea after symptoms occur, known as acute treatments.…

  • FDA Approves Flu Vaccine Based on Engineered Viruses

    The U.S. Food and Drug Administration approved a new seasonal flu vaccine using a technology that engineers flu virus proteins, rather than the traditional methods of growing inactive viruses in eggs. Flublok, developed by Protein Sciences Corp. of Meriden, Connecticut was approved by the FDA for adults age 18 through 49. Flublok is based on…

  • New Company Formed to Create Engineered Corneal Tissue

    Wake Forest Baptist Medical Center, North Carolina Eye Bank, and the company Ocular Systems Inc., all in Winston-Salem, are forming a new company to create bioengineered tissue for cornea transplants. The startup company, HCEC LLC (for human cultured endothelial cells), is expected first to advance the technology to the point of an FDA submission for…

  • Covidien to Acquire Blood Vessel Device Developer

    Covidien — a maker of medical devices, pharmaceuticals, and health care supplies based in Dublin, Ireland — agreed to acquire CV Ingenuity in Fremont, California, a developer of a device to treat peripheral artery disease. Financial terms of the deal, expected to be completed in the first quarter of 2013, were not disclosed. Peripheral artery…

  • FDA Extends Flu Therapy Approval for Infants

    The U.S. Food and Drug Administration on Friday approved the prescription of oseltamivir phosphate to treat acute, uncomplicated influenza in children as young as two weeks in age. Oseltamivir phosphate, developed by Genentech, a division of the pharmaceutical company Roche in South San Francisco, California, is marketed under the brand name Tamiflu. Tamiflu blocks the…

  • Safety Info Variations Found between Branded, Generic Drugs

    Researchers at the Regenstrief Institute and Indiana University School of Medicine in Indianapolis found safety warnings on drug labels vary on a large majority of drugs between their brand-name and generic equivalents. The findings of the team led by Regenstrief professor of internal medicine Jon Duke appear online in the journal Pharmacoepidemiology and Drug Safety…