Development

FDA’s priority review designation of Regeneron Pharmaceuticals’ garetosmab underscores Activin A inhibition as a potential disease-modifying strategy for genetically driven ossification disorders.

Lilly’s Phase IIIb trial shows improved psoriasis disease control using an integrated immune and metabolic pathway modulation approach, supporting biologically informed combination strategies in inflammatory disorders.

Under the collaboration, Merck and Mayo Clinic will integrate multimodal clinical and genomic datasets with AI models to enhance target biology insights and translational decision-making.

FDA’s breakthrough therapy designation for Johnson & Johnson’s co-formulated bispecific antibody therapy validates dual EGFR/MET targeting in HPV-negative head and neck cancer.

Phase III data showed sustained IL-5 suppression with 48–58% exacerbation reduction and significant CRSwNP score improvements across 52 weeks.

In part two of an interview, Cardinal Health’s Anna Catalanotto discusses how collaboration, payer education, and streamlined treatment-site workflows accelerate patient access to complex cell and gene therapies.

FDA’s IND clearance advances CStone’s trispecific antibody into Phase II development, expanding multispecific immunotherapy in solid tumors.

Under an exclusive license, the joint venture aims to advance HCW11-006 into Phase I for solid tumors, validating TRBC-derived immunotherapy in a global development strategy.

Stoke has initiated a Phase I trial of STK-002, advancing antisense protein restoration as a potential strategy for genetic optic neuropathies.

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

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.

Webinar Date/Time: This event is now available on demand

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

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.

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.

Webinar Date/Time: Thu, Feb 26, 2026 4pm GMT / 5 pm CET / 8am PT