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  • Upsher-Smith buys British drug maker

    MAPLE GROVE, Minn. — Upsher-Smith Labs has finalized its purchase of a British company that makes drugs for central nervous system and inflammatory disorders, the former said Tuesday.

  • FDA approves formulation for 2012-2013 flu vaccines

    SILVER SPRING, Md. — The Food and Drug Administration has approved the formulation for the 2012-2013 flu vaccine, the agency said Monday.

    The agency's approval is for all six licensed flu vaccines for the 2012-2013 season: Afluria, made by CSL; Fluarix, made by GlaxoSmithKline; FluLaval, made by ID Biomedical; FluMist, made by MedImmune Vaccines; Fluvirin, made by Novartis; and Fluzone, made by Sanofi.

  • Novartis drug appears effective in liver transplant patients

    EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

    A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

  • Pfizer will shepherd OTC Nexium through switch process

    NEW YORK — Pfizer will be the next consumer healthcare company to reach the market with a switched proton-pump inhibitor. Pfizer on Monday afternoon announced that it has entered into an agreement with AstraZeneca for the over-the-counter rights to Nexium.

  • FDA approves Genentech's Lucentis for diabetic macular edema

    SILVER SPRING, Md. — Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

    The Food and Drug Administration approved Lucentis (ranibizumab) for diabetic macular edema, a cause of vision loss in people with diabetes. The drug already was approved for age-related macular degeneration.

  • FDA accepts Teva contraceptive pill application

    FRAZER, Pa. — The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

    Teva Women's Health, part of Israeli drug maker Teva Pharmaceutical Industries, announced the FDA's acceptance of its application for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol), which the company called the first ascending-dose, extended regimen oral contraceptive for preventing pregnancy.

  • FDA approves Sanofi voice-guided auto-injector for allergic reactions

    PARIS — The Food and Drug Administration has approved a voice-guided injection device made by Sanofi for severe allergic reactions, the drug maker said Monday.

    The French drug maker announced the approval of Auvi-Q (epinephrine), calling it the first epinephrine auto-injector with audio and visual cues that guides users through the injection process. Sanofi US licensed the North American commercialization rights to Auvi-Q from Intelliject, which has retained commercialization rights for the rest of the world.

  • Bristol-Myers Squibb, AstraZeneca expand diabetes deal

    PRINCETON, N.J. — AstraZeneca paid $3.2 billion to Amylin Pharmaceuticals Thursday following the latter's acquisition by Bristol-Myers Squibb, AstraZeneca and Bristol said.

    The payment was made as part of the expansion of a deal between the drug manufacturers made in 2007 to develop diabetes drugs. Bristol announced Wednesday that it had completed its acquisition of Amylin, making the San Diego-based drug maker a wholly owned subsidiary.

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