Latest in My Picks
Latest
One Pivotal Trial May Be Enough — NEJM Challenges the Two-Trial Dogma
EXCERPT: A New England Journal of Medicine perspective argues that the longstanding expectation of two adequate and well-controlled trials for FDA approval is due for reconsideration, particularly for rare diseases
My Picks
WuXi Bio’s Record 2025 Project Intake Was Heavily US-Driven
EXCERPT: WuXi Biologics recorded a record number of new projects in 2025, with US clients accounting for a disproportionate share — a notable data point given the ongoing geopolitical and
My Picks
FDA Halts RegenxBio Trial After AAV Vector Integration Event Linked to Proto-Oncogene
EXCERPT: REGENXBIO reported a clinical hold following detection of an AAV vector genome integration event associated with overexpression of PLAG1, a proto-oncogene. The finding adds to a growing body of
My Picks
Gilead to Acquire Arcellx for $7.8B, Consolidating Control of BCMA CAR-T Program
EXCERPT: Gilead is acquiring Arcellx outright for $7.8 billion, bringing the BCMA-directed CAR-T therapy anitocabtagene autoleucel fully under Gilead’s Kite unit. The deal reflects continued big pharma confidence in cell
My Picks
Charles River Sells CDMO and Discovery Businesses — A Structural Shift in the CRO Landscape
EXCERPT: Charles River is divesting its manufacturing business to GI Partners and its discovery assets to IQVIA. The move reshapes the competitive landscape for CROs and CDMOs supporting early and
My Picks
AAV Contaminants Found in Liver Biopsy After Gene Therapy Infusion — A Manufacturing Wake-Up Call
EXCERPT: A Nature Medicine study found manufacturing plasmid sequences and incomplete helper virus genomes in liver tissue from a patient who developed acute liver failure after AAV therapy. The implications
My Picks
Eli Lilly Acquires Orna Therapeutics for Up to $2.4B, Betting on Circular RNA
EXCERPT: Lilly’s acquisition of Orna Therapeutics brings circular RNA and LNP delivery technology into one of pharma’s largest genetic medicine pipelines. The deal signals serious commercial interest in circRNA as