More than half of emerging biotech companies have less than two years of cash to fund operations, according to EY’s Beyond Borders report.

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.