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Regulatory and Washington

  • Amylin seeks FDA approval for metreleptin

    SAN DIEGO — Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.

  • FDA OKs Levemir for pregnant women

    NEW YORK — A diabetes treatment made by Novo Nordisk is safe for pregnant women, according to a recent decision by the Food and Drug Administration.

    Novo Nordisk said Monday the FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses. The agency's decision was based on results of a clinical trial involving 310 women that compared Levemir to another insulin product.

    The insulin is used to treat Type 1 and Type 2 diabetes.

  • NACDS, NCPA renew merger opposition with new court filing seeking immediate relief

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Monday afternoon announced their intent to file an additional motion requesting that the judge direct Express Scripts and Medco to keep separate their assets pending review of the lawsuit and/or schedule an expedited review of the merits of a case the two associations filed in district court last week.

  • Super PBM merger approved; NACDS, NCPA file emergency motion to block merger

    WASHINGTON — The controversial merger between Express Scripts and Medco was completed Monday morning, according to a press release issued by both Express Scripts and the Federal Trade Commission.

  • Report: Cancer death rates continue to decline

    ATLANTA — Mortality rates from all cancers combined continued to drop between 2004 and 2008 among men, women and children, according to the annual "Report to the Nation on the Status of Cancer, 1975-2008."

  • NCPA submits comments to House committee debating H.R. 1946

    ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday submitted written comments to the U.S. House Judiciary Committee Subcommittee on Intellectual Property, Competition and the Internet hearing on H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act, in support of the bill.

  • GSK advocates broadening scope of nicotine replacement therapy

    PARSIPPANY, N.J. — GlaxoSmithKline Consumer Healthcare strongly supported efforts to inform smokers of the impact tobacco use has on the body, as well as effective ways to quit, during a congressional briefing Friday that was sponsored by Reps. Frank Pallone, D-N.J., and Tim Murphy, R-Pa.

    The briefing, entitled "Understanding Smoking Addiction and How to Accelerate Quitting," addressed how to improve the nation's policies and programs to help smokers become tobacco free.

  • FDA extends approval time for COPD drug by three months

    NEW YORK — Regulators will take a few months longer to review the approval application for a new drug for treating chronic obstructive pulmonary disease, the drug's developers said Thursday.

    Forest Labs and Almirall said the Food and Drug Administration would require a three-month extension to complete its review of their application for aclidinium bromide, a maintenance drug for COPD. The FDA plans to complete its review and decide whether or not to approve the drug in July.

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