Clinical Trial Materials

Updated RestorAATion-2 data show durable M-AAT restoration and Z-AAT reduction across biweekly and monthly dosing regimens, with FDA accelerated approval pathway feedback anticipated mid-2026

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

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

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

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.

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.

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.

Pluri’s newly launched CDMO business will manufacture two novel cell therapy product candidates for Kadimastem.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

The new facility also provides a plan for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally.

GAO calls for more oversight of institutional review boards in clinical trials.

It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning.

Catalent has completed the expansion of its clinical supply facility located in Shanghai, China.

The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

The clinical trial research environment has evolved because of specific solutions designed to overcome uncertainty.

Finding specific solutions to overcome uncertainty has led to the evolution of a new clinical trial research environment.

A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.

Democrats have proposed a measure to facilitate access to less costly comparator drugs needed in clinical trials, while another bill aims to increase transparency in the costs of clinical trials.

Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.

Capacity concerns and regulatory compliance considerations will drive the decision about outsourcing the manufacture of clinical trial materials.