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  • FDA approves Merck’s Keytruda for patients who have a specific biomarker

    WASHINGTON — The Food and Drug Administration on Tuesday granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

  • FDA approves first drug targeting giant cell arteritis

    WASHINGTON — The Food and Drug Administration on Monday expanded the approved use of Hoffman La Roche’s subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.

  • Diplomat dispensing Novartis’ Rydapt

    FLINT, Mich. — Diplomat Pharmacy on Thursday announced that it had added a new drug to the roster of its oncology treatments. The specialty pharmacy chain will be dispensing Novartis’ Rydapyt (midostaurin), a treatment for newly diagnosed acute myeloid leukemia that is positive for an FLT3 mutation detected by a test approved by the Food and Drug Administration.

  • Analyst: An Amazon entry into the pharmacy business would not be ‘market disruptive’

    SEATTLE — A Wall Street analyst believes the potential for Amazon’s entry into the pharmacy business would not be “market disruptive.” These are the words of Mizuho Securities analyst Ann Hynes.

    According to Barron’s, a major reason for this line of thinking is that ordering drugs by mail is not a new innovation. “CVS and Walgreens have been in this business for years and have relationships with drug companies and insurers that give them an early advantage,” the newspaper wrote.

  • Meijer opens first upper peninsula stores

    GRAND RAPIDS, Mich. — Meijer on Thursday opened new supercenters in Escanaba and Sault Ste.

  • Bloomberg: FDA reorganizes to optimize industry oversight

    NEW YORK — The Food and Drug Administration is reorganizing its field team within the FDA’s Office of Regulatory Affairs with a new focus on specific product areas vs. oversight of activities based on geographic regions, Bloomberg reported Monday.

  • FDA expands approval for Vertex Pharmaceuticals’ cystic fibrosis drug

    WASHINGTON — The Food and Drug Administration on Wednesday expanded the approved use of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for treating cystic fibrosis. According to the FDA, the approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33, adding it based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials.

  • Amazon reportedly exploring pharmacy options

    NEW YORK — Amazon.com may be on the cusp of entering the pharmaceutical dispensing business, according to a report published by CNBC Tuesday. The company reportedly has hired a general manager whose role is said to be helping the online retailer explore how to hang a pharmacy shingle.

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