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.

With excellent academic centers and a thriving start-up scene, Switzerland’s biotech scene has garnered significant interest in recent years. However, without being a priority for EU funds, the sector remains reliant on foreign cash and needs a funding push from within to boost success.

The XinThera deal gives Gilead multiple PARP1 and MK2 inhibitors. Also, Roche licenses a HER2 kinase inhibitor from Zion, Amgen partners with TScan in Crohn’s disease and Baxter sells the last of its biopharma operations – a CDMO business – for $4.5bn.