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  • FDA advisory committee to meet in July on opioid painkiller

    SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

    Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.

  • Committee advances bill to secure pharmaceutical supply chain

    ARLINGTON, Va. — A federal drug track-and-trace bill has made it out of a congressional committee.

    The House Energy and Commerce Committee voted to approve H.R. 1919, the Safeguarding America's Pharmaceuticals Act of 2013, sponsored by Reps. Bob Latta, R-Ohio, and Jim Matheson, D-Utah.

  • FDA approves Genentech drug for lung cancer with genetic mutation

    SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

    Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

    The drug was already approved for advanced NSCLC that did not exhibit the mutation.

     

  • FDA approves new prostate cancer drug

    SILVER SPRING, Md. — A new treatment for late-stage prostate cancer has received approval from the Food and Drug Administration.

    The FDA announced Wednesday the approval of Bayer's Xofigo (radian Ra 223 dichloride) for men with symptomatic, castration-resistant prostate cancer that has spread to the bones but not other organs, also known as metastasis. The drug is designed for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

  • FDA approves J&J's Simponi for ulcerative colitis

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis, the agency said Wednesday.

  • Actavis issues regulatory filing to comply with Irish company-takeover rules

    PARSIPPANY, N.J. — Actavis is continuing to pursue a plan to buy Irish drug maker Warner Chilcott, as the U.S.-based company announced Tuesday its total number of shares and share-purchase options in order to comply with Ireland's merger-and-acquisition rules.

    Actavis listed about 133.3 million ordinary shares, 1.5 billion restricted shares and 1.26 options to purchase ordinary shares.

  • Study finds large numbers of students abuse prescription drugs to cope with stress of finals

    WASHINGTON — Finals can be a stressful time for any college or graduate student, with many hours spent studying and few spent socializing or relaxing. But many students are using prescription drugs to get through finals, according to a new study.

  • Study: CVS Caremark researchers explore demographic factors on medication adherence

    WOONSOCKET, R.I. — A study conducted by researchers at CVS Caremark and Brigham and Women's Hospital and published in the May issue of the American Heart Journal found that non-white patients had 50% greater odds of statin medication nonadherence compared with white patients, while women had 10% greater odds of statin nonadherence compared with men.

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