The cell and gene therapy sector is poised to deliver a wave of new therapies with the potential to cure rare and common diseases. As many as 13 new cell or gene therapies could be approved for use in the U.S., Europe, or both by the end of 2023. While manufacturing and regulatory challenges remain,…
Takeda publishes Phase 3 Livtencity data in peer-reviewed journal
Takeda Pharmaceutical (TSE:4502/NYSE:TAK) has announced that it has published data from the SOLSTICE Phase 3 trial for Livtencity (maribavir) in post-transplant recipients with cytomegalovirus (CMV) infection in the peer-reviewed journal of Clinical Infectious Diseases. The drug was statistically superior to conventional therapies at week 81. The trial met its primary endpoint. A total of 55.7%…
FDA approves novel treatment for post-transplant CMV infection
FDA has approved Takeda Pharmaceutical’s (NYSE:TAK) Livtencity (maribavir) for use in patients at least 12 years old with post-transplant cytomegalovirus (CMV) infection or disease that does not respond to available antiviral therapy. The indication covers patients weighing at least 35 kilograms. Livtencity blocks virus replication by blocking the activity of the human cytomegalovirus enzyme pUL97.…