Tolebrutinib has missed its goal in the GEMINI 1 and 2 trials of reducing annualised relapse rate in multiple sclerosis patients but the Paris-headquartered firm is claiming a resounding victory for the BTK inhibitor in delaying disability progression in people with non-relapsing secondary progressive MS in the HERCULES study.

More than 75 industry executives and experts gazed into the crystal ball and shared with Scrip their predictions around transformative technologies. Perhaps unsurprisingly, AI was the dominant theme – but gene editing, cell therapies and new targeting modalities were also among the highlights.

Bristol and Regeneron sign separate cell therapy technology pacts, plus deals involving Takeda/ImmunoGen, Serina/AgeX, Cybin/Small Pharma, Taiho/Phost’in, Royalty/Ferring and Aardvark/GRI Bio.

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.