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  • Bayer gastrointestinal cancer drug extends progression-free survival in trial

    WAYNE, N.J. — An experimental drug made by Bayer HealthCare extended the length of time that patients with gastrointestinal tumors survived without their disease getting worse, according to results of a late-stage clinical trial released Monday.

  • Pharmacy groups oppose hydrocodone amendment to PDUFA bill

    ALEXANDRIA,Va. — Five pharmacy organizations on Thursday wrote Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients' timely relief from chronic pain while increasing drug costs.
     

  • Patients with MS show reduction in symptoms during drug trial

    CAMBRIDGE, Mass. — An experimental drug for multiple sclerosis produced a noticeable reduction in symptoms of the disease in a late-stage clinical trial, the drug's developer said Friday.

    Genzyme, a unit of French drug maker Sanofi, announced results from a phase-3 study of Aubagio (teriflunomide) in patients with relapsing forms of MS. According to the study, patients taking the drug in the 14-mg strength experienced a 36.3% reduction in annualized relapse rates and 31.5% reduction in the risk of sustained accumulation of disability over a 12-week period.

  • Teva makes the switch from NASDAQ to NYSE

    NEW YORK — Teva Pharmaceutical Industries has transferred its stock listing from NASDAQ to the New York Stock Exchange, the drug maker said Wednesday.

    The company began trading on the NYSE under the ticker symbol "TEVA." On hand Wednesday to ring the Opening Bell and celebrate the company's first day of trading on NYSE were Teva's new president and CEO Jeremy Levin, as well as board chairman Phillip Frost, CFO Eyal Desheh, Teva Americas CEO William Marth and employees from Teva's businesses around the world.

  • House passes PDUFA bill 387 to 5

    WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

    The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

  • Janssen seeks FDA approval for canagliflozin as Type 2 diabetes treatment

    RARITAN, N.J. — A Johnson & Johnson subsidiary is seeking approval for a Type 2 diabetes treatment.

    Janssen Research and Development has submitted a new drug application to the Food and Drug Administration for the approval of canagliflozin — an investigational oral, once-daily, selective sodium glucose co-transporter 2 inhibitor — for use in adult patients. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels, the company said.

  • Lower medical inflation expected in 2013, report finds

    NEW YORK — The slow economy, cost cutting and lower use of services by patients looking to save money will combine to cause healthcare spending to grow at a "historically" low rate in 2013, according to a new report released Thursday.

  • Pharmacy groups submit recommendations to FDA as agency finalizes draft guidance for biosimilars

    WASHINGTON — As the Food and Drug Administration works to finalize draft guidance related to the development of biosimilar products, pharmacy groups recently weighed in with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.

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