BioCentury

Current Editions

March 30, 2026
MHRA’s Tallon on the tall order of boosting the U.K. as a destination for clinical trials

Short turnaround times, recalibrating risk, improving recruitment are key to major overhaul of new clinical trial regulations 

Regulation

Gilead seeks to defend HIV, reset I&I and bolster oncology

Patient-centric HIV interventions, oncology deals and an I&I rebuild are on the 2026 strategic agenda for Gilead

Product Development

Critical Path Institute aims to bring scale to individualized medicines

C-Path’s One to Millions initiative seeks to build the shared infrastructure needed to operationalize FDA’s plausible mechanism framework

Regulation

Denali approval revives surrogate-endpoint path in neuronal MPS

Approval is first for Denali, first in the U.S. for a brain shuttle-enabled protein therapy

Regulation

With $6.7B buy, Merck sees ‘best-in-class’ blockbuster in Terns’ CML therapy

Shares had been rising since ASH data showed potential to challenge Novartis’ Scemblix — and improve treatment-free remission rates

Deals

Product Development

AL-S Pharma tests how far SOD1 biology extends into sporadic ALS

Phase II data suggest some sporadic ALS cases are SOD1-driven, but mixed all-comer results make patient stratification critical in Phase III

J&J’s posdinemab data sharpen questions around tau biomarkers in Alzheimer’s

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

Going ‘Golden’: K-Biotech may be prepping for its moment on the global stage 

Korean biotech is punching above its weight with first-in-class programs and Western deals

Kodiak’s VEGF conjugate finally finds footing in diabetic retinopathy

Zenkuda meets in two Phase IIIs, ending the company’s four-year struggle to show late-stage opthlamic efficacy

Emerging Company Profile

Scripta: Reprogramming Alzheimer’s through transcription factors

U.K. biotech’s platform identifies small molecules that can shift disease-driving gene networks toward a healthier state

Data Byte

Wave loses half its market cap on obesity data

mRNA expression data suggest little additional efficacy to be gained from higher doses of INHBE-targeted WVE-007

EMA’s CHMP backs four new medicines in March

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

Science Spotlight: AI studies link preserved thymic function to longer life

Plus: New ways to improve delivery vectors, and translational innovations from cancer companies

Politics, Policy & Law

Scott’s push to decouple China-U.S. cell therapy R&D could cost both sides

Republican senator advocates restrictions that could limit U.S. patients’ access to therapies, restrict Chinese companies’ access to U.S. market

Deals

Gilead seeks to put Galapagos’ cash to work as it buys bispecifics developer Ouro

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

Pinnacle, Immutrin move toward clinical goals with new VC rounds: Finance Report

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.

BioCentury ISSN 1097-7201