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.

ReNAgade Therapeutics came out of stealth mode with $300m to fund its proprietary technology for delivery of RNA medicines – including coding, editing and gene insertion modalities – beyond the liver.

Bristol Myers Squibb believes LPA1 receptor inhibition is the best approach to meet the urgent need for well tolerated new pulmonary fibrosis treatment options that can improve symptoms and address the underlying cause of disease.

Roche’s decision to discontinue a Phase III program in idiopathic pulmonary fibrosis was the latest of several recent late-stage clinical failures, emblematic of the difficulty in finding new approaches to treat the disease.