Short turnaround times, recalibrating risk, improving recruitment are key to major overhaul of new clinical trial regulations
Regulation
Patient-centric HIV interventions, oncology deals and an I&I rebuild are on the 2026 strategic agenda for Gilead
Product Development
C-Path’s One to Millions initiative seeks to build the shared infrastructure needed to operationalize FDA’s plausible mechanism framework
Regulation
Approval is first for Denali, first in the U.S. for a brain shuttle-enabled protein therapy
Regulation
Shares had been rising since ASH data showed potential to challenge Novartis’ Scemblix — and improve treatment-free remission rates
Deals
Product Development
Phase II data suggest some sporadic ALS cases are SOD1-driven, but mixed all-comer results make patient stratification critical in Phase III
CSF p-tau-217 fell sharply, but the discontinued mAb had only a modest effect on tau PET and none on spread to new brain regions
Korean biotech is punching above its weight with first-in-class programs and Western deals
Zenkuda meets in two Phase IIIs, ending the company’s four-year struggle to show late-stage opthlamic efficacy
Emerging Company Profile
U.K. biotech’s platform identifies small molecules that can shift disease-driving gene networks toward a healthier state
Data Byte
mRNA expression data suggest little additional efficacy to be gained from higher doses of INHBE-targeted WVE-007
CHMP recommends two FDA-approved therapies for extended-stage small cell lung cancer but rebuffs expanded label for Vanda’s Hetlioz in Smith-Magenis syndrome
Discovery & Translation
Plus: New ways to improve delivery vectors, and translational innovations from cancer companies
Politics, Policy & Law
Republican senator advocates restrictions that could limit U.S. patients’ access to therapies, restrict Chinese companies’ access to U.S. market
Deals
Deal in the works to add BCMA-targeting T cell engager to Belgian biotech’s thin pipeline, as its partner commits nearly $1.7B up front to buy NewCo
Finance
Plus: Gilgamesh spinout, Cohen’s Oryon, Neion draw cash; Ysios’ company creation fund; Apogee’s upsized offering; and more
Biopharma Stock Performers
Use BioCentury's interactive dashboard to view top-performing biopharma stocks for the day and the week.
Product Development
Management Tracks
BioCentury ISSN 1097-7201