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Regulatory and Washington

  • FDA approves Medtronic continuous glucose monitoring system

    MINNEAPOLIS — The Food and Drug Administration has approved a professional glucose monitoring system made by Medtronic, the company said.

  • Shire seeks approval to make Gaucher disease drug at new plant

    LEXINGTON, Mass. — British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.

    The company said Tuesday that it had filed with the Food and Drug Administration and the European Medicines Agency for approval to produce the Gaucher disease drug Vpriv (velaglucerase alfa) at its Lexington, Mass., plant. The company expects to win approval to make the drug there early next year.

  • FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep

    SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

  • Provider groups file lawsuit to battle Medi-Cal reimbursement rate cuts

    SACRAMENTO, Calif. — The recent approval of a 10% reimbursement rate cut in California’s Medicaid program, known as Medi-Cal, by the Centers for Medicare and Medicaid Services has prompted provider groups to file a lawsuit against the California Department of Healthcare Services and the U.S. Department of Health and Human Services, alleging that the cuts did not follow proper legal channels.

  • Impax Labs looks to market generic cancer pain drug

    HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

    Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

  • Mylan granted license to market generic menopause drug

    PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

    Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.

  • CRN adds food and drug law policy expert to staff

    WASHINGTON — The Council for Responsible Nutrition on Monday announced that Rend Al-Mondhiry has joined CRN’s staff to serve as the trade association’s regulatory counsel.

    “This is a new position for our association and [Al-Mondhiry's] skill set and experience provide a perfect match for what we need," CRN president and CEO Steve Mister said. "Her knowledge of food and drug law will make her a tremendous asset for our staff and for our members."

  • FDA approves Eylea

    SILVER SPRING, Md. — After being unanimously recommended for approval by a Food and Drug Administration panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals.

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