Tag Archive for: Sobi

Sobi has announced a streamlining and simplification of the contractual economics for nirsevimab through a new royalty agreement with Sanofi and the termination of the participation agreement with AstraZeneca.

The FDA approved Sanofi and Sweden-based Sobi’s efanesoctocog alfa, now marketed as Altuviiio, to treat bleeding in adults and children with hemophilia A.

The FDA last year accepted the marketing application for the therapy, which is being developed in collaboration with Swedish drugmaker Sobi, and is expected to decide on an approval status by Feb. 28.

The U.S. Food and Drug Administration (FDA) is on a mission to recover from the review lag seen through the early years of COVID-19 and has issued special designations for two treatments that could improve the lives of millions diagnosed with recurrent glioblastoma or hemophilia.