Development

Webinar Date/Time: Tue, Mar 17, 2026 11:00 AM EDT

Avance Clinical’s Ben Edwards explains how biotechs must design Phase I trials for quantitative exposure–response data to meet current FDA guidance and de‑risk Phase II dose selection.

Data from Novo Nordisk’s UBT251 Phase II trial support triple-receptor metabolic modulation as a strategy to enhance weight-loss efficacy beyond single-pathway incretin therapies.

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.

Roche’s termination of the SHIELD DMD trial highlights how recruitment and regulatory feasibility increasingly shape rare disease drug development.

In the final installment of an interview with Cardinal Health’s Anna Catalanotto, she discusses how leveraging real-world evidence and advanced value-based reimbursement models can optimize clinical adoption and long-term sustainability of CGTs.

Long-term data from a Johnson & Johnson study show that sustained IL-23 inhibition maintains histologic and endoscopic remission, supporting durability-driven UC drug development strategies.

Bristol Myers Squibb’s luspatercept-aamt data validate erythroid maturation targeting, supporting scalable development strategies for genetic anemia therapeutics.

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.