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  • FDA committee doesn't recommend regulatory approval for dapagliflozin

    WILMINGTON, Del. — A Food and Drug Administration committee of experts has advised against approving a drug for Type 2 diabetes made by AstraZeneca and Bristol-Myers Squibb, the companies said Tuesday.

    The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 against recommending approval for dapagliflozin, saying that data from a two-year clinical trial program that included about 6,000 people did not support the drug’s approval for use in patients along with changes to diet and exercise.

  • Investigational antidepressant garners positive results in late-stage clinical trial

    NEW YORK — Patients taking an investigative antidepressant undergoing late-stage clinical development showed “significant” improvement, according to study results released Monday.

    Forest Labs and Pierre Fabre Medicament announced results of a phase-3 trial of levomilnacipran in adults with major depressive disorder. Results showed a statistically significant improvement in patients treated with the drug, compared with those taking placebo.

  • Six drug makers OKed to produce flu vaccines

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new influenza vaccine formulation for the 2011-2012 flu season, the agency said Monday.

    The FDA said six manufacturers are licensed to produce vaccines. These include GlaxoSmithKline Biologicals, manufacturing Fluarix; CSL Limited, manufacturing Afluria; ID Biomedical, manufacturing FluLaval; MedImmune Vaccines, manufacturing FluMist; Novartis Vaccines and Diagnostics, manufacturing Fluvirin; and Sanofi Pasteur, manufacturing Fluzone.

  • QRxPharma seeks FDA approval for MoxDuo IR

    SYDNEY — Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

    QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.

  • Sanofi begins shipping flu vaccine for 2011-2012 season

    SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, on Monday announced that it has begun shipping its 2011-2012 Fluzone influenza virus vaccine in the United States. This shipment represents the first of approximately 70 million doses of seasonal influenza vaccine the company plans to deliver to the United States in the upcoming season.

  • Upsher-Smith commences late-stage trial for epilepsy treatment

    MAPLE GROVE, Minn. — Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

  • Minimal drug interaction found between Livalo, HIV drugs

    INDIANAPOLIS — A statin made by Eli Lilly and Kowa Pharmaceuticals America appears to work well with drugs used to treat HIV, according to a study presented at the sixth International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome.

    The study was designed to investigate potential interactions between Livalo (pitavastatin) and Abbott’s antiretroviral protease inhibitor Kaletra (lopinavir and ritonavir). The study found that each drug had only a minimal effect on the other.

  • Shire's Lialda receives FDA approval

    PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.

    Shire announced the approval of Lialda (mesalamine) delayed-release tablets for the maintenance of remission in patients with the disease.

    The drug was already approved for inducing remission in patients with ulcerative colitis, an inflammatory disease that affects the colon and causes chronic inflammation, sores and ulcers.

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