The U.S. FDA’s complete response letter (CRL) for Biohaven Ltd.’s lead asset, troriluzole, to treat spinocerebellar ataxia has prompted a wave of downstream changes at the company. There will be a roughly 60% cutback in annual R&D spending, not including personnel, as Biohaven focuses on three other late-stage clinical programs.
Psychiatry has struggled to enter the precision medicine era. But through a mix of innovations and bootstrapping, progress is coming to the field. Scientists are working on improving diagnoses by investigating potential biomarkers and collection methods.
In 2025, the biopharma industry has undergone a wave of workforce reductions that surpasses previous years’ trends. Multiple major pharma companies have announced sizeable job cuts, driven by a convergence of shifting regulatory terrain, vaccine slowdowns and cost-structure rationalization.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Achieve, Akeso, Alvotech, Belite, Outlook, Rein, Uniqure, Viridian.
Biopharmas raising money in public or private financings, including: Aavantgarde, BMS, Boost, Courage, Cybin, Cytodyn, Kyverna, Mind Medicine, Shuttle, Savara.
Transthera Sciences Inc. is out-licensing one of its preclinical NLRP3 inhibitors to Neurocrine Biosciences Inc. under a collaboration agreement worth $881.5 million. Under deal terms, Nanjing, China-based Transthera will receive an undisclosed up-front payment and is eligible to receive research and development and sales-based milestone payments up to $881.5 million.
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