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Specialty Pharmacy

  • FDA accepts NDA for Aricept patch

    WOODCLIFF LAKE, N.J. The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said Friday.

     

    The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.

     

     

  • Seattle Genetics, Genmab to develop cancer therapeutics

    BOTHELL, Wash. Biotech companies Seattle Genetics and Genmab will collaborate to develop antibody treatments for cancer, the two companies announced Tuesday.

     

    Seattle Genetics, based in the Seattle suburb of Bothell, Wash., and Denmark-based Genmab will develop the treatments using Seattle Genetics’ antibody-drug conjugate technology. Seattle Genetics received an undisclosed upfront payment and will have the right to exercise a co-development option for any products at the end of early-stage clinical development.

     

     

  • FDA accepts approval application for Fluzone Intradermal

    SWIFTWATER, Pa. The Food and Drug Administration has accepted a regulatory approval application for a flu vaccine administered in the skin.

     

    Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis, announced Monday that the FDA had accepted its application for Fluzone Intradermal (influenza virus vaccine). The company expects the FDA to take action on the vaccine in the first half of next year.

     

     

  • FDA clarifies position on low blood pressure drug

    PHILADELPHIA The Food and Drug Administration did not completely withdraw from the market a drug used to treat a dangerous low blood pressure condition, but merely proposed to do so as a “step in the regulatory process,” according to a document posted on the agency’s website Monday.

    The agency said its proposal last month to withdraw approval for Shire’s drug ProAmatine (midodrine) did not represent the actual withdrawal of the drug from the market, while calling for more data on the drug to verify its clinical benefit.

     

  • Gilead: 'Quad' anti-retroviral drug as effective as competitor

    FOSTER CITY, Calif. An investigational treatment for HIV by Gilead Sciences that combines four drugs in one tablet works as well as a drug already on the market, Gilead said Monday.

     

  • PhRMA: Drug, vaccine development for infectious diseases grows

    BOSTON Close to 400 drugs and vaccines are in development for fighting infectious diseases, according to one of the pharmaceutical industry’s largest lobbying groups.

     

    The Pharmaceutical Research and Manufacturers of America announced Friday that drug makers have 395 new medicines and vaccines in clinical development or under review by the Food and Drug Administration. These include five vaccines and six drugs for malaria, as well as agents for infections like cholera, methicillin-resistant Staphylococcus aureus and the Ebola virus.

     

  • The Apothecary Shops earns spot on Inc.'s fastest-growing private companies list

  • GSK, Genmab begin late-stage clinical trial for cancer drug

    NEW YORK British drug maker GlaxoSmithKline and biotech company Genmab have started a late-stage trial of a biotech drug for treating cancer, the two companies said.

     

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