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Specialty Pharmacy

  • FDA appoints new commissioner's chief of staff

    SILVER SPRING, Md. — The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

    In the letter, Hamburg announced the appointment of Lisa Barclay. Barclay, currently a partner at the Washington law firm Zuckerman Spaeder, will replace Molly Muldoon, who was previously chief of staff and more recently the agency's acting COO.

  • Abbott announces results of phase-3 trial of Humira

    ABBOTT PARK, Ill. — A large number of patients with a serious form of arthritis experienced improvement in their condition after taking a drug made by Abbott Labs for three months, according to results of a late-stage clinical trial announced Monday.

  • Reports: FDA finds manufacturing problems at Genentech plant

    NEW YORK — A new report from the Food and Drug Administration indicated that Roche division Genentech may not have followed proper procedures to prevent the contamination of certain drugs, according to published reports.

    Dow Jones Newswires reported that an FDA report from September regarding an inspection of a plant in South San Francisco, Calif., found problems related to gaskets and caps used to cover vials of the cancer drug Avastin (bevacizumab).

    The caps are made by a contract manufacturer, according to the reports.

  • Octapharma USA to reintroduce immune disorder drug

    HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

  • BMS to present abstracts from Orencia studies at American College of Rheumatology meeting

    NEW YORK — Drug maker Bristol-Myers Squibb will present 20 study abstracts at the American College of Rheumatology Annual Scientific Meeting in Chicago, the company said Thursday.

    Bristol said that of those, 18 contain new data from studies of Orencia (abatacept) in patients with rheumatoid arthritis or lupus nephritis.

  • FDA report: 35 new drugs approved in past year

    SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

  • FDA approves update to Takeda cancer drug label

    CAMBRIDGE, Mass. — The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

    Takeda and Millennium, the Japanese drug maker's cancer-drug subsidiary, announced Tuesday that the FDA approved a supplemental new drug application for the injectable multiple myeloma drug Velcade (bortezomib) that updates its label to include additional data from a clinical study showing that the drug extended patients' survival time.

  • ABC posts 3% revenue gain with $80.2 billion in sales

    VALLEY FORGE, Pa. — AmerisourceBergen on Tuesday recorded revenues of $20.4 billion for fourth quarter 2011 ended Sept. 30, up 3.5%. Diluted earnings per share increased 8% to 54 cents. For the year, AmerisourceBergen posted $80.2 billion in revenue, up 2.9%.

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