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  • Novo Nordisk-organized cyclist team to tour Canada

    MISSISSAUGA, Ontario — An athletic team consisting entirely of people with diabetes will take part in several professional competitions and speaking events in Canada.

    Team Novo Nordisk, organized by the Danish drug maker, includes 17 professional bike riders from 10 countries, including winners and podium finishers from professional races. The team will take part in the Tour de Beauce in Quebec, with three cyclists, and will compete in BC Superweek in British Columbia, as well as other competitions around the country.

  • FDA approves Astellas drug for fungal infections in children

    NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

  • Health Canada approves Actavis drug for uterine fibroids

    PARSIPPANY, N.J. — Canadian regulators have approved a drug for treating a condition that affects up to three-quarters of women and causes excessive bleeding from the uterus.

  • Drug for nephropathic cystinosis receives seven years' exclusivity

    NOVATO, Calif. — The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.

  • Takeda applies for approval of ulcerative colitis, Crohn's disease drug

    DEERFIELD, Ill. — Takeda Pharmaceutical Co. is seeking Food and Drug Administration approval for an experimental treatment for inflammatory bowel disease, the drug maker said.

    Takeda announced that it had submitted a biologics license application to the FDA for vedolizumab in patients with severe Crohn's disease and ulcerative colitis. IBD is estimated to affect more than 4 million people worldwide, and ulcerative colitis and Crohn's disease affect as many as 700,000 Americans each, according to Takeda.

  • Former J&J, Advandx executive appointed as Mylan Specialty president

    PITTSBURGH — Mylan Specialty has appointed Roger Graham as president, the Mylan subsidiary said Monday.

    Graham previously worked for Advandx, a privately owned company that develops in-vitro diagnostic tests for infectious diseases and will report to Mylan North America president Tony Mauro. Mylan Specialty markets the EpiPen auto-injector for emergency treatment of severe allergic reactions, among other products.

  • FDA approves Plan B One-Step OTC switch

    SILVER SPRING, Md. — The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

    The FDA said the new approval of Teva Women's Health's Plan B One-Step (levonorgestrel) was to comply with an April 5 federal court order to make emergency contraceptives containing levonorgestrel available over the counter without age or point-of-sale restrictions.

  • BD launches needle aimed at diabetics

    FRANKLIN LAKES, N.J. — Becton, Dickinson and Co. has launched a needle that it said would make insulin injections easier and faster for people with diabetes.

    BD subsidiary BD Medical announced Friday the BD Ultra-Fine Nano 4-millimeter pen needle. The needle includes technology called EasyFlow, designed to aid faster and more comfortable injections, and product demonstrations will take place at the American Diabetes Association's 73rd annual Scientific Sessions in Chicago, lasting through next Tuesday.

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