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Specialty Pharmacy

  • 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.

  • Dr. Reddy’s earns FDA approval for Doxil generic

    PRINCETON, N.J. — Dr. Reddy’s Laboratories announced on Wednesday that it has received Food and Drug Administration approval to launch doxorubicin hydrochloride liposome injection, a therapeutic equivalent generic version of Janssen Products’ Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market.

    The product is indicated to treat ovarian cancer.

  • Q&A: Transcript Pharmacy president discusses company’s growth

    Jackson, Miss.-based Transcript Pharmacy has enjoyed stellar growth for several years running, culminating the company being named to Inc. Magazine’s top growth lists five times. Drug Store News reached out Transcript Pharmacy president Cliff Osbon for an exclusive interview to learn more about the company and its impressive year-over-year growth. 

  • 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.

  • J&J: 10 products with “blockbuster potential” to be filed by 2021

    NEW BRUNSWICK, N.J. — Johnson & Johnson and its Janssen Pharmaceutical Cos. will announce plans to launch or file for regulatory approval more than 10 new products with “blockbuster potential” between 2017 and 2021, as well as 50-plus line extensions of new medicines, senior executives said Wednesday during an industry analysts meeting.

    Among the late-stage blockbusters projected to file for regulatory approvals between 2017 and 2021, include:

  • Fresenius Kabi introduces pediatric cancer generic

    LAKE ZURICH, Ill. — Fresenius Kabi announced on Tuesday the immediate availability in the United States of its first-to-market generic of Genzyme’s Clolar (clofarabine injection). Fresenius Kabi’s clofarabine injection is available as a single dose vial containing 20 mg per 20 mL clofarabine.

  • FDA fast-tracks Sangamo/Pfizer hemophilia A treatment

    WASHINGTON —  Sangamo Therapeutics announced on Tuesday that the Food and Drug Administration has granted Fast Track designation to SB-525, the company's clinical stage cDNA gene therapy candidate for hemophilia A, which is being developed as part of an exclusive, global collaboration and license agreement with Pfizer.

    The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill an unmet medical need.

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