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  • FDA approves new breast cancer treatment

    SILVER SPRING, Md. The Food and Drug Administration has approved a new treatment for breast cancer, the agency said Monday.

    The FDA approved Eisai’s Halaven (eribulin mesylate) for patients with breast cancer that has spread and who have received at least two chemotherapy regimens for the disease in its late stages. More than 200,000 women will be diagnosed this year with breast cancer, and nearly 40,000 will die from it, making it the second leading cause of cancer-related death among women, according to the National Cancer Institute.

  • FDA approves ADHD drug for adolescents

    PHILADELPHIA — The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use in adolescents.

    British drug maker Shire announced Monday the approval of Vyvanse (lisdexamfetamine dimesylate) capsules for patients aged 13 to 17. The drug was already approved for children ages 6 years to 12 years and adults.

  • RA patients may benefit from weekly injection of Orencia, study finds

    NEW YORK Patients with rheumatoid arthritis derive about as much benefit from a weekly injection of a biotech drug made by Bristol-Myers Squibb for the disease as they do from receiving it via IV on a monthly basis, according to late-stage clinical trial data released Monday.

  • FDA approves Cymbalta for treating chronic musculoskeletal pain

    INDIANAPOLIS The Food and Drug Administration has approved a new usage for a drug used to treat depression and pain.

    Eli Lilly said Thursday that the FDA had approved Cymbalta (duloxetine hydrochloride) for treating chronic musculoskeletal pain. This is the fifth indication for which the agency has approved Cymbalta, after major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, Lilly said.

  • Savient announces shipping date for chronic gout treatment

    EAST BRUNSWICK, N.J. Drug maker Savient Pharmaceuticals will begin shipping its treatment for chronic gout to specialty distributors at the end of this month, Savient said.

    The company announced that it would begin shipping Krystexxa (pegloticase) on Nov. 30, and it would become available for prescription on Dec. 1.

  • Biodel receives complete response letter for Linjeta

    DANBURY, Conn. The Food and Drug Administration has turned down an application for an insulin product made by Biodel, Biodel said.

     

    The drug maker announced that it received a complete response letter from the FDA for Linjeta (human insulin [rDNA origin]) for the treatment of Type 1 and Type 2 diabetes.

     

     

  • Study finds ProbioKid reduces infections in children during winter months

    MONTREAL A study presented last month before the European Respiratory Society Annual Congress determined that the branded probiotic ProbioKid reduced infectious events in children by 25% during the winter period, as compared with a placebo. The study was conducted during the winter of 2006-2007 and involved 135 healthy, school-aged children who had suffered from at least three episodes of ear-nose-throat, bronchopulmonary or gastric disorder during the course of the previous winter.

     

  • FDA approves Latuda

    SILVER SPRING , Md. (Oct. 29) The Food and Drug Administration has approved a new drug for treating schizophrenia, the agency said Thursday.

    The FDA announced the approval of Latuda (lurasidone hydrochloride), made by Fort Lee, N.J.-based Sunovion Pharmaceuticals. The drug is approved to treat adults with the disease, a mental illness that causes hallucinations, delusions, paranoia and disordered thinking and behavior.

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