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.

After shutting down its trial for a leukemia conditioning agent due to a patient death, Magenta’s review of strategic alternatives concludes with a combination with complement inhibitor-focused Dianthus.

Shin Nippon Biomedical Laboratories would take over migraine candidate STS101, now under FDA review. Blue Water Vaccines to pick up BPH drug from Veru.

Agreement with Alexion is JCR’s first international deal for its blood-brain barrier drug delivery technology. Sartoris buys PolyPlus from private equity investors.