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Regulatory and Washington

  • Outgoing FMI exec awarded

    SCOTTSDALE, Ariz. — The Food Marketing Institute gave an outgoing executive one of its top awards at a supermarket industry conference, the group said Monday.

    FMI gave VP government relations Anne McGhee Curry its Glen P. Woodard, Jr. Award for her work in public affairs over the last three decades. Curry will retire from FMI at the end of this month.

  • GSK submits approval application for albiglutide

    LONDON — Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.

    GSK announced the submission to the FDA of a regulatory approval application for albiglutide. The drug is not approved in any market yet, and the company plans to also seek approval in the European Union this year.

    GSK assumed control of albiglutide with its $3.6 billion acquisition of Human Genome Sciences, announced last July.

  • CDC: Influenza rates continue to drop nationwide, though flu incidence is picking up in the West

    ATLANTA — The Centers for Disease Control and Prevention on Friday reported a slight drop in influenza-like illnesses across the country, but even so the season is still going strong. The proportion of outpatient visits for influenza-like illness for the week ended Jan. 12 was 4.6%, above the national baseline of 2.2%

  • Reports: Roche dips into Tamiflu reserve

    NEW YORK — The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

    Reuters reported that the Swiss drug maker would start selling its reserve stock of the adult formulation of the drug, whose chemical name is oseltamivir.

    The FDA has reported spot shortages of the pediatric formulation of the drug, but has said pharmacists can break open the capsules and dissolve it in liquid to create a substitute. Meanwhile, a shortage of the adult formulation has appeared in Canada.

  • SIDI Work Group releases voluntary supplier qualification guidelines

    WASHINGTON — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, on Thursday announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices. 

  • FDA approves sterile blood-plasma product

    SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

    The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

  • Report finds 'innovative and robust' global drug pipeline

    WASHINGTON — More than 5,000 medicines are under development, of which 70% are potentially the first of their class, according to a new report.

  • FDA approves Flublok, a trivalent influenza vaccine not made with eggs

    SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Protein Sciences' Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. 

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