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Regulatory and Washington

  • PhRMA: More than 50 drugs in development for COPD

    WASHINGTON — More than 50 drugs are under development for treating a respiratory disease that is the third-leading cause of death in the United States.

    The Pharmaceutical Research and Manufacturers of America released a list Thursday of 54 drugs in clinical development for chronic obstructive pulmonary disease, or COPD.

  • Mylan wins tentative approval for generic Lipitor

    PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

    Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

  • Statement: Walgreens a differentiating factor in Medicare Part D plans

    DEERFIELD, Ill. — Medicare Part D plans that had incorporated Walgreens into their network gained market share last year, while those without Walgreens collectively lost market share, according to a Walgreens statement issued Wednesday.

  • CBO: Government health spending to hit $1.8 trillion

    WASHINGTON — A projection issued by the Congressional Budget Office concluded that healthcare spending in the United States would reach a substantial high.

  • NACDS Foundation releases second wave of funding via Community PREP

    ALEXANDRIA, Va. — The charitable arm of the National Association of Chain Drug Stores once again has released funding that will support 15 new residencies for recent pharmacy graduates.

  • FDA approves new indication for Novartis' Gleevec

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

    The FDA approved Novartis' Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors.

    The drug was originally approved in 2001 for a type of leukemia.

  • FDA approves Lilly-Boehringer Ingelheim diabetes drug

    INDIANAPOLIS — The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

    The FDA approved Jentadueto (linagliptin and metformin) tablets, designed to be taken twice daily. The approval marks the second since the two companies announced their collaboration to develop diabetes drugs in January 2011; the first drug approved under the Lilly-BI partnership was Tradjenta (linagliptin), approved in May 2011.

  • Medi-Cal reimbursement rate cut tentatively blocked by court

    SACRAMENTO, Calif. — California state officials tentatively are blocked from moving forward with a 10% Medi-Cal reimbursement rate cut.

    The court decision, handed down by Judge Christina Snyder, was applauded by several organizations, including the California Medical Association, the California Dental Association, the National Association of Chain Drug Stores, the California Association of Medical Product Suppliers, the AIDS Healthcare Foundation and the American Medical Response.

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