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.
Genfit SA discontinues lead programme
Latest NewsLille-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).
Mondego Bio kicks off with Series A financing
Latest NewsLisbon’s immuno-oncology company Mondego Bio Lda has left stealth mode through a Series A financing led by Biovance Capital, supported by OrbiMed and Torrey Pines.
Whitepaper Plastic Injection Molding in Cleanrooms
Products, sliderDue to its properties, plastic is a sought-after material for medical technology components. Depending on the specification, the manufacturing of these components is subject to strict hygiene measures. The whitepaper from RKT shows what is important in plastic injection molding and the assembly of components under cleanroom conditions.
Roche acquires 89bio for US$3.5bn
Latest NewsRoche 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.
CSL backs VarmX in US$2.2bn deal
Latest NewsCSL has signed an option and collaboration agreement with VarmX valued at up to US$2.2bn. The company will pay US$117m upfront and will fund a global Phase III trial of VMX-C001.
Enhanced Genomics raises US$19m
Latest NewsBritish Enhanced Genomics Ltd has extended its Series A funding to US$19m. Investors include BGF, Parkwalk, and Meltwind.
Monte Rosa Therapeutics and Novartis agree on second billion-dollar deal
Latest NewsMonte Rosa Therapeutics Inc, founded in Basel in 2018, can look forward to an upfront payment of US$120m for its second collaboration and licensing deal with Novartis AG to develop protein degraders. A total of US$5.7bn is on the table for the new development of an anti-inflammatory candidate that is not part of Monte Rosa’s pipeline.
Trump dismantles FDA expert committees
Latest NewsThe 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.
UK pharma lobby warns of crisis in British life sciences
Latest NewsThe Association of the British Pharmaceutical Industry (ABPI) has warned that the UK could miss its target of becoming the number one in European life sciences by 2030.
A Universal Solution Emerges: Anti-Linker Antibodies Simplify CAR-T Detection and Development
Sponsored PublicationsCAR-T cell therapy has demonstrated remarkable success in treating hematologic malignancies and is now expanding into solid tumors. On June 1, 2025, The Lancet published positive results from the world’s first randomized controlled trial of CLDN18.2 specific CAR-T in gastric cancer, led by Professor Lin Shen’s team at Peking University.