Back to School 2026: China has brought new urgency to a longstanding bottleneck. Transformational reform will require rethinking the risk-control paradigm
Regulation
Government and CRO initiatives aim to streamline trial infrastructure and extend early studies into patient cohorts as global competition intensifies
Product Development
Back to School 2026: Korea, Taiwan, and Singapore seek earlier roles in global development, while Japan removes barriers to joining global trials
Product Development
National initiatives are pushing review times well below EU-wide targets
Product Development
Review structure, dedicated trial units, and site operations together determine how quickly clinical trials reach first patient
Product Development
Cutting the time needed to file an IND is low-hanging fruit
Regulation
Back to School 2026: Proposals center on emulating Australia, integrating trials into routine care
Regulation
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
Can Europe overcome its fractured regulatory environment to be globally competitive?
Regulation
Product Development
Melanoma adjuvant success could mark a turnaround for Moderna
Discovery & Translation
BioCentury’s translational roundup also includes research on hypertension, asthma, and brain-penetrant TEAD inhibitors
Regulation
One to Millions will begin with shared ASO safety data,
Politics, Policy & Law
Johns Hopkins-trained physician was chief policy officer at Center for a Healthy America before joining White House
Deals
Acquisition-and-spinout deal brings hypophosphatasia program into BioMarin’s skeletal disease portfolio
Finance
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.
Product Development
BioCentury ISSN 1097-7201