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    Voyager Therapeutics Announces FDA Clearance of Investigational New Drug Application for Advanced Parkinson’s Disease

    Gabrielle Lakusta
    Jan. 23, 2018 09:03AM PST
    Genetics Investing

    Voyager Therapeutics (NASDAQ:VYGR) a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases today announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for VY-AADC, allowing the Company to formally initiate clinical trial sites, screen and begin dosing patients for its pivotal Phase 2-3 program …

    Voyager Therapeutics (NASDAQ:VYGR) a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases today announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for VY-AADC, allowing the Company to formally initiate clinical trial sites, screen and begin dosing patients for its pivotal Phase 2-3 program for advanced Parkinson’s disease.
    As quoted in the press release:

    “Our baculovirus manufacturing process is designed for production of AAV vectors at clinical and commercial scale, with the potential for increased yields and efficient scalability compared with mammalian-based systems,” said Bernard Ravina, M.D., M.S., chief medical officer of Voyager Therapeutics.

    Click here to read the full press release.

    investigational new drug applicationchief medical officernew drug applicationfood and drug administration
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