Yuhan and J INTS BIO and Betta and C4 sign deals centered on lung cancer candidates. Viatris’s Japanese affiliate gets in-country rights to InDex’s Phase III ulcerative colitis candidate.

The drug showed efficacy in hemophilia A and B with no sign of clots, an issue that historically has dogged anticoagulation agents, but it remains unclear whether that advantage will hold.

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

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.