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The Clinical Execution Gap: Why Great Science Often Fails at the Trial Stage

FDA Clears In-Vivo Gene Editing Therapy PBGENE-DMD for Duchenne Trial

Women in STEM: Building Sustainable Cost and Access Models for Advanced Therapies (Part 1)

VectorY Doses First Patient in TDP-43–Targeting ALS Trial

Ivonescimab Breakthrough Designation Highlights Progress in BTC Treatment

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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.

AI, biomarkers, and novel oncology modalities are driving evolution in biopharma pipelines, according to Nmblr CEO Janice MacLennan.

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.

The VESPER-3 trial results show that extended-interval GLP-1 dosing may expand obesity care by balancing sustained weight loss with reduced injection burden.

Janice MacLennan, CEO of Nmblr, notes how AI is transforming biopharma R&D and market access, forcing teams to prove value beyond science and redesign work around human strengths.

AdvanCell and 48Hour Discovery align peptide discovery with a Lead-212 infrastructure to build a durable targeted alpha therapy pipeline aimed at oncology markets.

This new licensing deal with SanegeneBio signals growing confidence in RNAi technologies.





















