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.

Large Korean pharma firms’ first-quarter earnings were mostly mixed on a range of diverse factors such as solid prescription sales and impacts from acquisitions, with some even looking to space for new business opportunities.

A mega deal with Eli Lilly to exclusively market, promote and distribute Emgality (galcanezumab) in China for migraine prevention offers a critical opportunity for C-Bridge backed AffaMed in an untapped, large market, CFO Vijay Karwal told Scrip in an exclusive video interview on the sidelines of EBD's Asia Bio Partnering Forum.

The Korean contract development and manufacturing industry is rapidly growing with more established firms and newcomers set to sharply expand capacities and diversify portfolios, but competition to secure relevant workforce in the country is also getting fiercer.