Regeneron Pharmaceuticals announced that the Biomedical Advanced Research and Development Authority has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation Covid-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection. The agreement is part of “Project NextGen,” an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines and therapeutics for Covid-19. The new contract has an estimated value of up to approximately $326M of government funding. Under the project structure, Regeneron independently invents and proposes an antibody candidate, which BARDA and Regeneron will then evaluate and agree upon for further development, manufacturing and regulatory activities. Regeneron’s most advanced next-generation antibody candidate under this agreement is expected to enter clinical trials later this year.
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