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Specialty Pharmacy

  • URAC revises accreditation programs

    WASHINGTON — A healthcare accrediting organization is revising three products in its Pharmacy Quality Management suite of programs.

    URAC said its pharmacy committee approved revisions to its mail service, specialty pharmacy, and workers' compensation and property and casualty for pharmacy benefit management accreditation programs. The products revised include:

    • Mail-service pharmacy, version 2.0;

    • Specialty pharmacy, version 2.0; and

  • Biogen acquires rights to neuro disease programs

    WESTON, Mass. and ZURICH — In a deal that will bolster its drug development capabilities, Biogen Idec has acquired a subsidiary of Swiss-based Neurimmune Holding AG.

    Among other assets, the agreement gives Biogen the worldwide rights to three preclinical immunotherapy programs. The three programs are focused on the discovery and development of novel human antibodies that address three central nervous system targets: alpha-synuclein, tau and TDP-43.

  • Dey Pharma settles DoJ suit

    BASKING RIDGE, N.J. — A Mylan subsidiary has settled a lawsuit brought on by the Department of Justice four years ago.

  • AstraZeneca discontinues development of RSV drug

    LONDON — An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

    AstraZeneca has requested the withdrawal of its pending biological license application for motavizumab from the Food and Drug Administration. Motavizumab is an investigational monoclonal antibody that could prevent serious respiratory syncytial virus disease.

    AstraZeneca said it will incur a financial impairment charge of $445 million in fourth quarter 2010.

  • In pact with Oncolys, Bristol-Myers Squibb snags rights to investigational HIV compound

    NEW YORK and TOKYO — Bristol-Myers Squibb has signed a definitive licensing pact with Oncolys BioPharma, a privately held Japanese biotech company, that will give it control of a promising new HIV treatment.

  • Novo Nordisk, Emisphere enter insulin deal

    PRINCETON, N.J. — A biopharmaceutical company exclusively will develop and commercialize oral formulations of a drug maker's insulins.

    Emisphere will be paid $57.5 million in potential product development and sales milestone payments by Novo Nordisk — of which $5 million dollars will be payable upon signing — as well as royalties on sales. Further financial details of the agreement were not disclosed.

  • Amylin's lipodystrophy treatment granted orphan-drug, fast-track designations

    SAN DIEGO — Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

  • King, Acura seek regulatory approval for Acurox

    BRISTOL, Tenn. — Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

    The two drug makers announced Tuesday the submission for Acurox (oxycodone hydrochloride), an immediate-release tablet for relief of moderate to severe pain.

    The tablets use Acura’s aversion technology, designed to deter abuse of the drug by dissolving or crushing the pills.

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