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Specialty Pharmacy

  • Sandoz launches authorized generic shampoo for severe scalp psoriasis

    PRINCETON, N.J. — Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said.

    Sandoz announced the introduction of clobetasol propionate shampoo in the 0.05% strength, an authorized generic version of Galderma Labs' Clobex. An authorized generic drug is a branded drug sold under its generic name, usually by a third-party company at a reduced price.

    Various versions of the shampoo had sales of about $54.9 million during the 12-month period ended in October 2011, according to IMS Health.

     

  • Achillion receives fast-track designation for hepatitis C drug

    NEW HAVEN, Conn. — The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

  • Biogen Idec, Isis to develop spinal muscular atrophy drug

    WESTON, Mass. — Biogen Idec and Isis Pharmaceuticals will work together on a drug invented by Isis for spinal muscular atrophy, the two companies said.

    According to the companies, SMA is the most common genetic cause of infant mortality and causes muscle atrophy and weakness, occurring in 1-in-10,000 births. While children with the condition appear normal at birth, symptoms can develop within a few months and significantly shorten their lifespan. The drug, ISIS-SMNRx, is designed to compensate for the underlying genetic defect that causes SMA.

  • FDA panel to review resubmitted NDA for pixantrone

    SEATTLE — The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

    The company said that the panel will review the NDA for pixantrone, which is designed to treat relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.

  • FDA accepts application for Gilead HIV drug

    FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

    Gilead said the FDA planned to review the application for the Quad by Aug. 27.

    The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.

  • FDA approves new REMS for fentanyl-based painkillers

    SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

  • FDA panel to review potential new use for Xgeva

    THOUSAND OAKS, Calif. — Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

  • Baxter, Momenta partner on biosimilar development

    NEW YORK — Baxter and Momenta have agreed to partner to develop and market biosimilar  drugs to treat cancer, autoimmune disorders and other chronic conditions.

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