Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.

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. 

Biogen’s return of rights to the BTK inhibitor orelabrutinib to originator InnoCare signals an ongoing tough reality for Chinese biotechs with go-global ambitions.

Start-up hopes to bring its first candidate, an NY-ESO-1-targeting off-the-shelf product, into the clinic in Q2. Astex and Cardiff University team up on novel therapies for neurodegenerative disease.