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Viatris And Mapi Knocked Back On Once-Monthly US Copaxone Rival

CRL For GA Depot 40mg Means Approval Denied; Are Manufacturing Issues At Play?

Executive Summary

Viatris offered little in the way of detail as it announced a setback for its Mapi Pharma-partnered proposed once-monthly glatiramer acetate product for relapsing forms of multiple sclerosis. The firm has previously shouted from the rooftops about Mapi’s Phase III clinical study and the potential to establish a new standard of care for glatiramer acetate patients.

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