Entries by Thomas Gabrielczyk

Genfit SA discontinues lead programme

Lille-based Genfit SA has discontinued Phase II development of its lead drug candidate VS-01, a liposomal ammonia scavenger designed to prevent organ failure in acute chronic liver failure (ACLF). The company will reprioritise its (preclinical) pipeline, including VS-01, which will be further developed in the area of urea cycle disorder (UCD).

Roche acquires 89bio for US$3.5bn

Roche has signed a definitive merger agreement to acquire 89bio and its Phase III candidate pegozafermin, an FGF21 analogue for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH). The deal is expected to close in Q4 2025.

Trump dismantles FDA expert committees

The FDA under President Trump is heading for a radical break with decades of practice: the external advisory committees that have long served as critical checks in approval decisions are to be largely sidelined. George Tidmarsh, head of the Centre for Drug Evaluation and Research, has dismissed the panels as redundant and instead wants to rely on the publication of Complete Response Letters (CRLs). Officially, the move is framed as efficiency – in reality, it raises serious questions about the agency’s transparency.