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.

Pfizer’s InnoPharma unit finally overcame US FDA’s concerns about injectable acetaminophen GMPs and leachables. Meanwhile, Azurity resolved zonisamide manufacturing issues, Amphastar overcame doubts about naloxone’s nasal spray device, Incyte reused Zynyz CMC data, Cidara showed Rezzayo vials had enough powder, Pharming showed equivalence between Joenja tablets and capsules, and Orphalan avoided half-tablet stability testing of its functionally scored Cuvrior tablets.

Lilly hopes to address immunology and pain indications with biotech’s LYTAC technology. Sunovion licenses European rights to Parkinson’s therapy Kynmobi to Bial.

Plus recent deals involving AbbVie/Caribou, Sanofi/i2O, Merck & Co./Starpharma, Protalix/SarcoMed, Targovax/Papyrus, Medivir/Ubiquigent, Eton/Azurity