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.

Private Company Edition: Two companies raised multiple hundreds of millions of dollars each helping to keep the number of $100m-plus venture capital mega-rounds on the rise in May. Also, Ascend raised $132.5m to make gene and cell therapies, and Nido emerged with $109m for neurological diseases.

The company’s dual drug-device development pipeline is progressing well, especially its direct sodium removal therapy for congestive heart failure.

Higher-dose mazdutide showed superiority over placebo after 24 weeks of treatment in a Phase II trial in Chinese adults with obesity. The potential best-in-class efficacy profile of the Lilly-originated GLP-1 receptor agonist is expected to help it gain the upper hand in the race for the leadership of the country's obesity market, estimated at $5.5bn in 2030.