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.

Japanese tech major re-structures its teams for artificial intelligence-based drug development and strategies while expanding its presence in Europe. With confidence in the utility of AI for discovery, it is retaining a key focus on oncology while adding infectious diseases to its targets.

When the traditional fundraising window closes and clinical, regulatory or commercial success eludes, other routes to raise cash emerge. But these have also become more scarce recently, leaving all-stock consolidations.