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BioWorld - Wednesday, July 6, 2022

BLA

Home » Topics » Regulatory » BLA
  • Amyloid plaque
    Sep. 28, 2021
    By Michael Fitzhugh

    Eisai, Biogen advance efforts to tackle early Alzheimer's with BLA filing for lecanemab

    Just months after the controversial FDA approval of Alzheimer’s disease drug Aduhelm (aducanumab), partners on that medicine, Eisai Co. Ltd. and Biogen Inc., are advancing a BLA for another possible AD therapy, lecanemab. Formerly known as BAN-2401, the Bioarctic AB-originated antibody is designed to neutralize and eliminate soluble, toxic amyloid beta for the treatment of early AD. The rolling submission, in pursuit of an accelerated approval, was primarily based on data from a phase IIb trial in people with early AD and confirmed amyloid pathology.
  • Sep. 21, 2021
    By Doris Yu

    FDA accepts Beigene’s first filing outside China; BLA seeks nod for anti-PD-1 tislelizumab

    The FDA has accepted for review Novartis AG and Beigene Ltd.’s BLA filing for the anti-PD-1 monoclonal antibody tislelizumab.
  • Sep. 16, 2021
    By Doris Yu

    FDA accepts Beigene’s first filing outside China; BLA seeks nod for anti-PD-1 tislelizumab

    The FDA has accepted for review Novartis AG and Beigene Ltd.’s BLA filing for the anti-PD-1 monoclonal antibody tislelizumab.
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