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Specialty Pharmacy

  • Report: FDA’s Hamburg says creating biosimilars pathway likely to be complex

    NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

     

    While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

     

     

  • FDA grants fast-track designation for CDI vaccine

    SWIFTWATER, Pa. A vaccine for a bacterial infection that affects the gastrointestinal tract has been granted expedited approval by the Food and Drug Administration.

     

    French drug maker Sanofi-Aventis announced Tuesday that it had received fast-track designation from the FDA for its investigational Clostridium difficile vaccine. The FDA grants the designation to ease the development of new drugs and vaccines for serious or life-threatening conditions or unmet medical needs.

     

     

  • Armada Health Care expects boost in summit attendance

  • Lilly to acquire Avid

    INDIANAPOLIS and PHILADELPHIA Eli Lilly's acquisition of a leader in molecular imaging development could boost its Alzheimer's disease drug pipeline.

  • PhRMA: Alzheimer’s drug market continues to expand

    WASHINGTON Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report by the main lobby for the pharmaceutical industry.

     

    The Pharmaceutical Research and Manufacturers of America said 98 medicines for dementia, mostly Alzheimer’s, were in clinical trials or under review by the Food and Drug Administration.

     

     

  • Sanofi-Aventis: Dengue fever vaccine in clinical development

    LYON, France A vaccine for the mosquito-borne illness dengue fever is in the final stages of development, Sanofi-Aventis said Thursday.

     

    Sanofi said the first phase-3 trial of the vaccine was under way in Australia.

     

     

  • Biogen Idec, Cardiokine terminate lixivaptan agreement

    WESTON, Mass. Swiss drug maker Biogen Idec and U.S. drug maker Cardiokine have terminated an agreement to develop a treatment for abnormally low sodium levels in the blood, the two companies said Wednesday.

     

    The agreement will give Cardiokine all rights to lixivaptan, a treatment for the condition, known as hyponatremia. The collaboration began in 2007, and the drug is in late-stage clinical studies.

     

     

  • BIO, GPhA and Sandoz testify at FDA biosimilars hearing

    SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

     

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