Entries by Thomas Gabrielczyk

CSL backs VarmX in US$2.2bn deal

CSL 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.

Monte Rosa Therapeutics and Novartis agree on second billion-dollar deal

Monte 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

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.

NRG Therapeutics Ltd bags £50m in Series B financing

British mitochondrial dysfunction specialist NRG Therapeutics Ltd. (“NRG”) has closed an oversubscribed £50m Series B financing. Funds will be used to to achieve clinical proof of concept for NRG5051 in amyotrophic lateral sclerosis (ALS)/motor neurone disease (MND) and to generate Phase Ib data in Parkinson’s disease.

BioNTech‘s breast cancer ADC outperforms Roche’s Kadcyla

Data on the primary endpoint of BioNTech’s/Duality Biologics’ pivotal Phase III study of its HER2 antibody-drug conjugate BNT323/DB-1303 are not yet public, However, BioNTech says that progression-free survival is better than with Roche’s second-line breast cancer therapy Kadcyla.