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  • Avandia's labeling information revised

    PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

    GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

    The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

  • Report: Generic drug makers may look to diversify portfolios

    PHILADELPHIA — An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

    According to the report, “Gaining Market Share in the Generic Drug Industry Through Acquisitions and Partnerships,” generic drug makers face competition, as well as government-mandated price cuts in Europe and such policies as lowest-price tendering. As a result, many could seek deals that would cause them to diversify their portfolios.

  • FDA grants Acurox priority review

    PALATINE, Ill. — The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

    Acura Pharmaceuticals announced Monday the acceptance of King Pharmaceuticals’ application for Acurox (oxycodone hydrochloride). King developed the drug using Acura’s Aversion technology, which is designed to limit or impede the ability to abuse the drug by dissolving or crushing the pills and then injecting them.

  • E-prescribing of generics may be limited by pending legislation

    NEW YORK — Bills introduced in the legislatures of nearly a dozen states have pharmacy benefit managers and the generic drug industry fearing that the bills could lead to limits on doctors’ abilities to prescribe generics through e-prescribing.

    The Pharmaceutical Care Management Association, the main lobby for PBMs, said the bills would prohibit doctors from seeing lower-cost drug options, including generics and preferred brands; would prevent the e-prescribing software from showing safety information; and would disallow lower-cost pharmacy options.

  • Elan, Boehringer Ingelheim enter development, manufacturing agreement

    DUBLIN — Irish biotech company Elan and German drug maker Boehringer Ingelheim will collaborate to develop and manufacture antibody-based medicines.

    The two companies said BI would perform technical development, clinical manufacturing and regulatory filing support, while Elan would lead discovery, preclinical testing, clinical development and commercialization of the drugs. Financial terms of the deal were not disclosed.

  • Lucentis improves vision among diabetes patients in trial

    SOUTH SAN FRANCISCO, Calif. — Genentech, a subsidiary of Roche, reported that its eye drug helped improve vision in patients suffering from a complication caused by diabetes.

    In its phase-3 RISE study, Genentech said diabetic macular edema patients that received monthly Lucentis (ranibizumab injection) achieved an improvement in vision at 24 months, compared with placebo.

  • Makena receives FDA approval

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.

    The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.

  • Lilly chief calls on industry, public policy to support innovation

    LONDON — Public policies to support medical innovation will help drug companies address diseases that devastate people’s lives, a drug company executive said at a summit Thursday.

    Speaking at The Economist magazine’s 2011 Pharma Summit, Eli Lilly chairman, president and CEO John Lechleiter called for a new approach to research in such illnesses as Alzheimer’s disease, diabetes and cancer. This included changing the way companies conduct research and public policies that promote an environment in which innovation can flourish.

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