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Specialty Pharmacy

  • FDA proposes regulations for meetings between agency, biosimilar makers

    SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

  • Diplomat VP clinical services participates in HCV 'think tank'

    FLINT, Mich. — An executive from Diplomat Specialty Pharmacy recently participated in a program on hepatitis C therapy, the company said.

  • FDA approves Novartis antibacterial treatment for cystic fibrosis

    EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

    Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

  • Drug makers ramp up treatments for chronic conditions in the elderly, PhRMA report finds

    WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

  • AstraZeneca, Moderna Therapeutics to develop drugs using RNA technology

    NEW YORK — AstraZeneca will pay $420 million to Moderna Therapeutics in a deal to develop drugs for a variety of diseases using a technology developed by Moderna, AstraZeneca said.

  • Genzyme drug shows improvement in MS patients

    CAMBRIDGE, Mass. — Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

    Genzyme, a division of French drug maker Sanofi, announced results of an extension study of the drug Lemtrada (alemtuzumab). The study was a follow-up to two other late-stage clinical studies of the drug, finding that relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug.

  • FDA commissioner calls for power to regulate compounding pharmacies

    SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

  • Va. governor signs first state bill to limit biosimilars

    WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

    McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

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