Approvals
The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.
Merck’s Enflonsia will go up against Sanofi and AstraZeneca’s Beyfortus, which the partners plan to ship out early in the third quarter.
Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD for their blockbuster antibody Dupixent.
The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed.
AbbVie’s Emrelis is the first non-small cell lung cancer therapy approved for patients with high c-Met expression levels who have received prior lines of treatment.
With Imaavy, J&J will go toe-to-toe with fellow Big Pharma AstraZeneca, which owns Soliris and Ultomiris.
With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the air.
Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.
Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.
PRESS RELEASES