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ZymoGenetics And Merck Serono Receive FDA Special Protocol Assessment For Atacicept Pivotal Study In Lupus Nephritis
Lupus ZymoGenetics, Inc. (Nasdaq: ZGEN) announced that, together with its collaborator Merck Serono, it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) to conduct a pivotal clinical trial with the investigational new drug atacicept for the treatment of patients with lupus nephritis. This is one of two clinical studies intended to form part of the application for marketing authorization. [click link for full article]
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