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Specialty Pharmacy

  • FDA approves J&J HIV drug in children

    TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.

    J&J's Janssen Therapeutics division announced Tuesday the FDA approval of Intelence (etravirine) in patients ages 6 years to younger than 18 years with HIV-1 who have taken other therapies but whose infection has become resistant to treatment. The drug already was approved for adults.

  • Impax Labs, Tolmar enter collaboration agreement

    HAYWARD, Calif., and FORT COLLINS, Colo. — Impax Labs has partnered with a pharmaceutical research, development, manufacturing and commercial operations company on a multiproduct agreement.

    Impax Labs and Tolmar will develop, supply and distribute alternative dosage form products. The products and terms of the agreement were not disclosed; however, Impax Labs president and CEO Larry Hsu said the new agreement "represents an ideal extension of [our] initial product agreement."

  • Reports: Congressmen accuse companies of drug price gouging

    NEW YORK — Lawmakers are going after companies that they say have sought to take advantage of drug shortages by buying drugs in short supply and then reselling them at higher prices, according to published reports.

  • FDA opens dialogue of incorporating technology, pharmacy into switch paradigm

    SILVER SPRING, Md. — The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing held here.

  • Teva to list shares on New York Stock Exchange

    JERUSALEM — Israel-based Teva Pharmaceutical Industries is switching stock exchanges, the company said.

    The world's largest generic drug manufacturer — and increasingly a player in branded and specialty drugs — announced Wednesday that it would transfer the listing of its shares from the Nasdaq to the New York Stock Exchange, with plans to start trading on the NYSE on May 30 under its current ticker symbol, "TEVA."

  • FDA advisory committee votes in favor of GSK's Votrient

    PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

    GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

  • Patients taking oral cancer drugs may risk drug interactions, study finds

    WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

  • Late-stage trial of MS drug shows positive results

    JERUSALEM — A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

    Teva and Active announced the publication of results of the phase-3 "Allegro" study of oral laquinimod in the March 15 issue of the New England Journal of Medicine. The study was conducted in 24 countries and enrolled 1,106 patients with MS who received 0.6 mg of laquinimod per day or placebo.

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