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  • Exenatide improves glucose control among diabetes patients in mid-stage trial

    SAN DIEGO — A once-monthly formulation of a drug made by Amylin Pharmaceuticals, Eli Lilly and Alkermes improved glucose control in patients with Type 2 diabetes, according to results of a mid-stage clinical trial presented at the American Diabetes Association’s 71st Scientific Sessions.

    The three companies said once-monthly injections of the drug exenatide improved blood-sugar control and produced modest weight loss in the 121-patient phase-2 study.

  • Xarelto OKed by FDA

    RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

    Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.

  • Par to restructure branded business

    WOODCLIFF LAKE, N.J. — As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

    The company said last week that its restructuring of Strativa Pharmaceuticals will result in a reduced workforce, prompting one-time noncash charges in the second quarter in addition to severance costs, although Par said the restructuring will generate expense savings in the $8 to $12 million range for the remainder of the year.

  • Fionnuala Walsh joins Lilly's executive committee

    INDIANAPOLIS — Eli Lilly's SVP global quality has joined the drug maker's executive committee, effective July 1.

    Fionnuala Walsh, who joined Lilly in 1988, will continue in her current role at Lilly, where she ensures the company maintains high-quality standards across its worldwide operations.

    Walsh reports to company chairman, president and CEO John Lechleiter.

  • Novartis receives FDA approval for COPD drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis for treating chronic obstructive pulmonary disease, the FDA said Friday.

    The FDA approved Arcapta Neohaler (indacaterol inhalation powder) for long-term, once-daily maintenance of bronchodilator treatment of airflow obstruction in people with COPD, including chronic bronchitis and emphysema.

    COPD, which often results from cigarette smoking, is the fourth-leading cause of death in the United States, according to the Centers for Disease Control and Prevention.

  • Shire files suit against Amneal, Sandoz over generic Vyvanse

    DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

    Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

  • Lazanda approved as breakthrough pain treatment

    BEDMINSTER, N.J. — The Food and Drug Administration has approved a drug made by Archimedes Pharma for treating breakthrough pain in cancer patients, Archimedes said last week.

    Archimedes announced the approval of Lazanda (fentanyl) nasal spray for cancer patients who have acquired a tolerance to opioid drugs. Breakthrough pain is an intense, sudden pain that is unpredictable and often debilitating and occurs despite otherwise appropriate pain therapy.

  • Pfizer stands by Chantix

    NEW YORK — Pfizer defended a drug used for smoking cessation Monday following reports of a Canadian study that found it raised the risk of heart problems.

    The 8,216-patient study of Chantix (varenicline), published in the Canadian Medical Association Journal, found that of the 4,908 patients who received Chantix, 52 had an increased risk of serious heart problems, with similar risks appearing in 27-of-the-3,308 patients who took placebo.

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