Manufacturing

BioNTech’s decision to close its Singapore manufacturing facility reflects mounting financial pressure, ongoing restructuring efforts, and uncertainty around the pace at which next-generation mRNA therapies will scale.

While allowing for high throughput and efficiency, the bulk fill/finish process exerts extreme stress on glass containers, resulting in cosmetic defects and breakage.

New phase 3 data from AstraZeneca suggest that adding systemic agents to embolization can significantly delay disease progression in early hepatocellular carcinoma.

Experts from Acuitas, Mana.bio, NanoVation, and ReCode share their input on targeted LNP engineering, which is accelerating pipeline expansion of nucleic acid therapies for chronic and rare diseases beyond the liver.

The approval introduces a one-time gene therapy for LAD-I that restores immune function and addresses the underlying cause of a life-threatening pediatric disease.

Phase 3 data from AstraZeneca show IL-33 inhibition reduces COPD exacerbations across broad populations, supporting a new biologic approach beyond eosinophil-driven disease.

The hub will integrate the company’s manufacturing and R&D in China to streamline CAR-T development while addressing scalability and accelerating regional access to advanced therapies.

Phase III data show retatrutide reduces HbA1c and body weight, supporting triple-agonist strategies for metabolic disease treatment.

The current Middle East conflict is disrupting Gulf air and sea hubs, forcing bio/pharma firms to reroute cold-chain drug shipments and raising risks of oncology medicine shortages.

Results from a head-to-head study highlight cytokine-targeting differences between UCB’s bimekizumab and risankizumab, strengthening evidence for dual IL-17 blockade in psoriatic arthritis therapy

The new clinical data show biomarker reductions and new motor milestones with salanersen, which supports once-yearly antisense therapy development in spinal muscular atrophy.

The launch of a new mRNA biotech spinout signals a structural shift in how next-generation RNA therapeutics are developed and commercialized.

Updated analysis from the COMPASSION-03 Phase II trial links response depth to survival, which supports PD-1/CTLA-4 bispecific checkpoint strategies in heavily pretreated cervical cancer.

Under the partnership, INOVIO and Akeso will evaluate DNA-encoded tumor antigen priming plus PD-1/CTLA-4 bispecific blockade in an adaptive Phase II trial for glioblastoma.

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CGT Catapult’s newly formed advisory board aims to address manufacturing, data, and regulatory constraints influencing scalable development and clinical deployment of ATMPs.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

FDA’s acceptance of Precision BioSciences’ IND advances ARCUS gene excision toward clinical validation, signaling progress for durable DMD therapies.

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.

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.