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  • FDA advisory committee recommends approval of BI's atrial fibrillation drug

    RIDGEFIELD, Conn. A Food and Drug Administration advisory committee has recommended approval of a drug for patients with atrial fibrillation.

     

    The FDA cardiovascular and renal drugs advisory committee voted unanimously to recommend approval for Boehringer Ingelheim's Pradaxa (dabigatran etexilate), for preventing strokes in atrial fibrillation patients. For the last 50 years, warfarin has been the only oral anticoagulant drug available for this purpose.

     

     

  • FDA accepts NDA for Aricept patch

    WOODCLIFF LAKE, N.J. The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said Friday.

     

    The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.

     

     

  • Sanofi-Aventis' WISE program gets recognition from HBA

    FAIRFIELD, N.J. The Healthcare Businesswomen’s Association has given the U.S. subsidiary of French drug maker Sanofi-Aventis its 2010 HBA ACE Award for building women’s leadership in the company, the HBA said Thursday.

     

  • Novo Nordisk featured in Working Mother's '100 Best Companies' list

    PRINCETON, N.J. Working Mother magazine has named drug maker Novo Nordisk one of the best companies in the country for family-friendly benefits, the company said Thursday.

     

    The U.S. subsidiary of the Danish drug maker was named a Working Mother 100 Best Company for programs designed to help families balance work-life needs, such as adoption reimbursement, health benefits, paid time off and assistance for families sending their kids to college.

     

     

  • Forest Pharmaceuticals pays $313 million in settlement deal

    SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.

  • FDA approves gout treatment from Savient

    WASHINGTON The Food and Drug Administration has approved a new treatment for gout, a painful condition that affects 3 million adults in the United States.

    The FDA announced the approval of Savient Pharmaceuticals’ Krystexxa (pegloticase), a biotech drug for people who have not responded to or tolerated conventional therapies.

  • Oramed calls oral insulin drug trial 'successful'

    JERUSALEM Oramed Pharmaceuticals has seen promising results from a clinical trial of an oral insulin for diabetes, the Israeli drug maker said.

     

    The company said its exploratory clinical trial of the oral insulin capsule ORMD-0801 was successful. The company is developing the capsule as a treatment for patients with uncontrolled Type 1 diabetes. The company also is developing the oral insulin as a treatment for Type 2 diabetes.

     

     

  • Safeway offering Fluzone High-Dose to seniors

    PLEASANTON, Calif. Safeway on Tuesday announced that all Safeway pharmacies in the United States now have a new high-dose flu vaccine called Fluzone High-Dose, which has been approved by the Food and Drug Administration for use in people 65 years of age and older.

     

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