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Regulatory and Washington

  • NACDS announces support of enactment of Minnesota PBM audit legislation

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores has expressed its support for enactment of the Pharmacy Audit Integrity Program (HF 1236/SF 973) by Minnesota governor Mark Dayton. The law will establish standards in the pharmacy audit process conducted by pharmacy benefit management companies in the state of Minnesota.

    NACDS sent a letter of support to Dayton prior to enactment, emphasizing the importance of this legislation in ensuring transparency in the PBM audit process.
     

  • NRF: FTC should move cautiously on mobile payments

    WASHINGTON — The National Retail Federation on Thursday urged the Federal Trade Commission to move cautiously in establishing regulations for mobile payments and said any rules that are adopted should parallel those for the underlying form of payment and not be specific to the technology.

  • Mylan, Pfizer, Teva reach deal over generic version of EpiPen

    NEW YORK — Two companies have settled with Teva over the latter's efforts to launch a generic version of an emergency treatment for allergic reactions.

    Under the agreement, involving Mylan and Pfizer's Meridian Medical Technologies subsidiary, Teva will be allowed to launch a generic version of EpiPen (epinephrine) auto-injector in June 2015, assuming it wins approval from the Food and Drug Administration. Mylan Specialty markets the EpiPen, which Meridian manufactures.

  • FDA approves GlaxoSmithKline's Votrient for soft tissue sarcomas

    PHILADELPHIA — The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

  • PhRMA report lists almost 300 vaccines under development

    WASHINGTON — Drug makers in the United States are developing nearly 300 vaccines for preventing and treating diseases, according to a new report by a drug industry trade group.

  • FDA declines to approve Takeda diabetes drug

    DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

    Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

  • NACDS expresses support of 'chairman's mark' of Senate bill to reauthorize PDUFA

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.

  • Report: Preliminary injunction to block ESI-Medco merger denied

    PITTSBURGH — The U.S. District Court for the Western District of Pennsylvania on Wednesday denied a preliminary injunction filed by pharmacy trade groups in an effort to block the merger between pharmacy benefit managers Express Scripts and Medco.

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