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Specialty Pharmacy

  • Amgen offers testimony at FDA biosimilars hearing

    THOUSAND OAKS, Calif. — Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

  • FDA advisory committee recommends PrEP approval for Truvada

    FOSTER CITY, Calif. — An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

  • FDA panel recommends approval for Pfizer RA drug

    NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.

  • BioScrip reports Q1

    ELMSFORD, N.Y. — BioScrip experienced a boost in revenue and gross profit during first quarter 2012 ended March 31.

  • Sandoz to testify at FDA biosimilars hearing

    HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

  • Reports: FDA may be close to approving drug for HIV prevention

    NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

    The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.

  • Seattle Genetics, Millennium start phase-3 trial of Adcetris

    BOTHELL, Wash. — Seattle Genetics and Takeda's cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.

    Seattle Genetics and Millennium announced the start of a phase-3 trial of Adcetris (brentuximab vedotin) in patients relapsed cutaneous T-cell lymphoma that expresses the CD30 cell membrane protein. The study will enroll more than 120 patients who will be divided into two groups, one of which will receive Adcetris and another that will receive methotrexate or bexarotene.

  • Walgreens finalizes BioScrip deal; expands specialty pharmacy footprint

    DEERFIELD, Ill. — Walgreens on Monday announced it has completed its acquisition of certain assets of BioScrip’s community specialty pharmacies and centralized specialty and mail-service pharmacy businesses. The transaction represents a total deal value of approximately $225 million.

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