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.

Arrowhead has spent years in the shadows of rivals Alnylam and Ionis, but could make its mark with new ways to target cardiovascular and lung disease using RNA interference.

The Swiss firm’s lead candidate has hit the mark in the first stage of a pivotal diabetic macular edema program, edging closer to becoming the first eye drop treatment for a condition where unmet need remains despite the advent of anti-VEGFs.

Pfizer chief clinical officer William Pao, Roche pharma CEO Teresa Graham and others weighed in on what FTC’s action could mean for pharma M&A at the Financial Times Pharma Summit.