BioCentury

Current Editions

August 24, 2026
Loosening the reins: The bold risks required to overhaul first-in-human trials

Back to School 2026: China has brought new urgency to a longstanding bottleneck. Transformational reform will require rethinking the risk-control paradigm

Regulation

Australia looks beyond healthy volunteers to defend Phase I edge: Back to School 2026

Government and CRO initiatives aim to streamline trial infrastructure and extend early studies into patient cohorts as global competition intensifies

Product Development

Outside of China, other Asian biotech hubs have early ambitions, too

Back to School 2026: Korea, Taiwan, and Singapore seek earlier roles in global development, while Japan removes barriers to joining global trials

Product Development

Denmark, Spain, and the U.K. build fast lanes for FIH trials — Back to School 2026

National initiatives are pushing review times well below EU-wide targets

Product Development

Similar regulatory clocks, divergent paths to study start

Review structure, dedicated trial units, and site operations together determine how quickly clinical trials reach first patient

Product Development

U.S. aims to slash pre-IND timelines: Back to School 2026

Cutting the time needed to file an IND is low-hanging fruit

Regulation

Going beyond TrialBlazer to speed FIH trials

Back to School 2026: Proposals center on emulating Australia, integrating trials into routine care

Regulation

China’s value proposition in first-in-human trials: Back to School 2026

On the edge of the radar just a few years ago, China has moved center stage in FIH trials by continually innovating and modernizing rules

Regulation

Big ambitions, big fractures — Europe’s FIH conundrum: Back to School 2026

Can Europe overcome its fractured regulatory environment to be globally competitive?

Regulation

Product Development

Moderna, Merck Phase III win opens door to personalized neoantigen vaccines

Melanoma adjuvant success could mark a turnaround for Moderna

Discovery & Translation

Science Spotlight: A late-acting antimalarial turns infection into vaccination 

BioCentury’s translational roundup also includes research on hypertension, asthma, and brain-penetrant TEAD inhibitors

Regulation

Politics, Policy & Law

Pick of Trump loyalist Overton revives questions of FDA independence 

Johns Hopkins-trained physician was chief policy officer at Center for a Healthy America before joining White House

Deals

Aiming for larger rare disease market, BioMarin buys Alesta program

Acquisition-and-spinout deal brings hypophosphatasia program into BioMarin’s skeletal disease portfolio

Finance

Buoyed by readout, Amylyx banks $500M ahead of submission: Finance Report

Plus: Ambros lines up $150M PIPE as it heads to NASDAQ via reverse merger; and more

Biopharma Stock Performers

Use BioCentury's interactive dashboard to view top-performing biopharma stocks for the day and the week.

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