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.

Pear Therapeutics filed for Chapter 11 bankruptcy in April and sold its remaining assets in an auction for about $6m. The demise of one the pioneers in the prescription digital therapeutics industry highlights the challenges PDT developers face getting their products reimbursed.

With mirikizumab delayed until Lilly overcomes the FDA’s manufacturing concerns, the company has fallen behind on its goal of five approvals in 2023.

Aspect says its bioprinted tissue therapeutics include immune-resistant encapsulation, which Novo Nordisk hopes will offer a safer approach to type 1 diabetes cell therapy.