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  • FDA approves Novartis acute myeloid leukemia drug

    WASHINGTON — The Food and Drug Administration on Friday approved Novartis’ Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.

  • FDA approves first drug for specific form of Batten disease

    WASHINGTON — The Food and Drug Administration on Thursday approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. BioMarin Pharmaceuticals’ Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.

  • Branded thiotepa shipped by Amneal

    PATERSON, N.J. — Amneal Biosciences, the exclusive U.S. distributor for Tepadina, on Thursday began shipping the branded thiotepa. The product is available for purchase through major wholesalers and distributors.

  • Stivarga receives expanded approval to include hepatocellular carcinoma

    WASHINGTON — The Food and Drug Administration on Thursday expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. The drug, manufactured by Bayer HealthCare Pharmaceuticals, is the first FDA-approved treatment for a liver cancer in almost a decade.
     

  • Rite Aid CEO: Ongoing Walgreens merger affected Q4 earnings

    CAMP HILL, Pa. — Although Rite Aid affirmed it believes its acquisition by Walgreens Boots Alliance is in the “best interest of Rite Aid shareholders, customers and associates,” Chairman and CEO John Standley acknowledged “the extended duration of the merger process is having a negative impact on our results.

  • Teva simultaneously launches AirDuo RespiClick and its authorized generic

    JERUSALEM — Teva Pharmaceutical Industries on Thursday announced the simultaneous launch of AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist (LABA) combination.

  • Upsher-Smith to sell generics business for $1.05B

    MAPLE GROVE, Minn. — Japanese generic pharmaceutical manufacturer Sawai Pharmaceutical will purchase the generic pharmaceuticals business of Upsher-Smith Laboratories, from its parent, Acova, for $1.05 billion.

    Under Thursday’s agreement, expected to close near the end of June 2017, Rusty Field, the current President of Upsher-Smith, will continue leading the company. Following the closing, Upsher-Smith’s non-generic pharmaceuticals businesses will remain with Acova.

  • Allergan, Argentum reach Restasis settlement

    NEW YORK — Generic pharmaceutical manufacturer Argentum Pharmaceuticals announced that it has reached a settlement and license agreement with Allergan related to Argentum's generic version of Restasis (0.05% cyclosporine ophthalmic emulsion).

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