With Alhemo (concizumab-mtci) from Novo Nordisk A/S, a third hemophilia drug in the past eight months has been approved by the U.S. FDA. The once-daily injectable prophylaxis is to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fennec, Humacyte, Innovent, Ionis, Santhera, Zealand Pharma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apollomics, GSK, Novo Nordisk, Stemcyte, TC Biopharm.
A year after Generate Biomedicines Inc. pulled off its $273 million series C financing round, the Flagship Pioneering-spawned and AI-powered protein therapeutics firm drew investment of an undisclosed amount from the Samsung Life Science Fund Dec. 18.
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