The US Food and Drug Administration (FDA) has approved Sanofi and Sobi’s Altuviiio (efanesoctocog alfa): a first-in-class, high-sustained factor VIII replacement therapy.
Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.
Pfizer currently has an unprecedented number of anticipated launches, says its CEO: with the company expecting to have up to 19 new products or indications in the market in the next 18 months.
Phase 3 data for efanesoctocog alfa has been published in the New England Journal of Medicine (NEJM): ahead of a decision on the therapy by the US Food and Drug Administration (FDA) at the end of next month.
Novo Nordisk has announced positive results from a Phase 3 study assessing the efficacy and safety of concizumab, its prophylactic treatment of hemophilia A or B with inhibitors.
Charles River Laboratories International and ASC Therapeutics have announced plans to manufacture ASC618, a second-generation gene therapy for hemophilia A.
Novo Nordisk partners with bluebird on a three-year research arrangement looking to discover gene therapy candidates for the treatment of genetic diseases, including hemophilia.
