CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.

Pfizer’s lineup of novel agents under review stands at seven, while no other big pharma has more than two novel candidates; Sanofi is tops in recent approvals since 2021, with seven novel agents cleared, but has no pending NMEs.

Public Company Edition: Seven companies revealed $2.1bn worth of royalty financings in the first quarter of 2023 and the deals keep coming in Q2, with uniQure monetizing Hemgenix royalties for up to $400m. Also, Legend grossed $350m in a follow-on offering and Athenex is liquidating via bankruptcy. 

A new deal worth up to $2bn-plus with Eisai has put Bliss Biopharmaceutical's HER2-targeting antibody-drug conjugate BB-1701 in the spotlight, as the global race heats up to find a possible challenger to Enhertu.