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  • GSK, Valeant respond to CRL for ezogabine

    LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

  • GSK applauds agreement to support global preparedness against pandemic influenza

    LONDON — Companies that make vaccines, drugs and diagnostic tests for influenza will become key stakeholders in the World Health Organization’s Global Influenza Surveillance Network under an agreement reached at the Open Ended Working Group that WHO coordinated to support global preparedness for a future influenza pandemic.

  • Government agencies draft plan to curb opioid abuse

    WASHINGTON — The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

    Elements of the plan include expansion of state-based prescription drug monitoring programs, recommendation of convenient and environmentally responsible drug-disposal methods, education and reduction of doctor shopping.

  • Rituxan OKed as treatment for two inflammatory diseases

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

  • Salix granted three patents for Xifaxan

    RALEIGH, N.C. — The U.S. Patent and Trademark Office has awarded Salix Pharmaceuticals three patents related to a drug used for travelers’ diarrhea.

    Salix announced Wednesday that it had secured patents for the drug Xifaxan (rifaximin) covering its methods of treating travelers’ diarrhea, as well as two related to the drug’s chemical composition.

    The patents are set to expire between 2024 and 2029.

  • Sigma-Tau OKed to manufacture primary ingredient in Oncaspar

    GAITHERSBURG, Md. — The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.

    Sigma-Tau was approved to manufacture L-asparaginase, the primary ingredient in the drug Oncaspar (pegaspargase). Sigma-Tau began seeking approval when the previous manufacturer ceased production. The drug is used to treat acute lymphoblastic leukemia, also known as ALL.

  • Leading Edge Innovations announces strategic partnership with San-Mar Labs

    BRANCHBURG, N.J. — Leading Edge Innovations, a laboratory that develops formulas based on emerging trends in the market for the over-the-counter, skin care, sun care and cosmetic industries, and product manufacturer San-Mar Labs on Tuesday announced a strategic partnership that makes LEI’s technology platform a part of San-Mar’s advanced research and technology, known as S.M.A.R.T.

  • IMS Institute: Rx drug spend experiences slower growth

    PARSIPPANY, N.J. — U.S. spending on drugs grew 2.3% to $307.4 billion in 2010, according to a new report by the IMS Institute for Healthcare Informatics, part of industry research firm IMS Health.

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