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In part one of an interview with Cardinal Health’s Anna Catalanotto, Catalanotto outlines how early, payer-informed commercialization planning keeps cell and gene therapies accessible and financially viable.

VectorY Therapeutics advances ALS R&D with a vectorized antibody strategy that targets TDP-43 pathology to enable sustained CNS exposure and biomarker-driven evaluation.

Akeso’s bispecific antibody gains momentum on the NMPA’s designation, while Phase III data advance a new first-line option for advanced biliary tract cancer.

Lonza’s Michael De Marco emphasizes that early tox milestones strengthen investor confidence, support funding decisions, and reduce development risk for emerging biotechs.

PharmaResearch’s DOT-based nanoparticle platform enters US clinical testing, highlighting delivery innovation aimed at improving tolerability in solid tumor therapies.

NeoVac first-in-human data suggest that optimized lipid nanoparticles may improve mRNA tolerability, enabling repeat dosing and broader therapeutic use.

Integrated CDMO networks streamline complex drug development across advanced modalities like ADCs.

Study data show high-dose nusinersen can improve function and slow neurodegeneration, informing future SMA dosing strategies and lifecycle management.

The Eisai–Henlius partnership expands Japan’s access to a differentiated PD-1 antibody, highlighting cross-border oncology deals targeting high unmet need.

A new Cellares–Stanford collaboration aims to demonstrate how automated platforms could standardize gene-edited stem cell manufacturing and accelerate clinical translation.

FDA’s acceptance of Affinia Therapeutics’ IND positions the company to test lower-dose, heart-targeted AAV gene therapy for BAG3 cardiomyopathy.

The SK bioscience–Gates MRI agreement highlights how scalable mAbs could broaden infant RSV prevention beyond high-income markets.

Industry experts discuss the standout packaging trends from 2025 that will influence the industry’s future.