Administrative constraints adds Moderna’s mRNA-1345 to the recently increasing number of US FDA user fee goal date misses.

Xbrane Biopharma’s recent CRL for its proposed US biosimilar to Lucentis has not prevented the Swedish company from announcing a successor to Bausch + Lomb to partner on the biosimilar’s US marketing and commercialization.

Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.

Public Company Edition: Verona Pharma arranged up to $400m in new debt and up to $250m in revenue-related financing ahead of its COPD drug launch. Also, Organon, Sobi and Pacira priced $1bn, $275.1m and $250m note sales, respectively. Marinus, Emergent and Ginkgo cut jobs.