Adding to a growing pattern within the BTK inhibitor pipeline for multiple sclerosis, the US FDA has placed Merck’s evobrutinib on a partial clinical hold following two liver injury incidents, prompting questions over its ultimate approvability.

Biogen’s return of rights to the BTK inhibitor orelabrutinib to originator InnoCare signals an ongoing tough reality for Chinese biotechs with go-global ambitions.

Christopher Viehbacher told his first earnings call as CEO that a review is under way to reverse Biogen’s fortunes, but noted Leqembi will not be a meaningful contributor while treatment and reimbursement bottlenecks remain.

The short-notice reopening of the country made 2022 a tough year for the health sector in China, where divestments, cash crunches and commercial challenges abounded. Throughout the year, despite clinical trial activity continuing to blossom, multiple Chinese innovative drug developers faced setbacks in the US from regulatory rejections of oncology products. Meanwhile, others quietly scaled back their operations in China, hit by the negative impact of deep price cuts.