Under an agreement with LabCorp and Shandong XuanZhu Pharma, the wholly-owned subsidiary for drug R&D of China-based Sihuan Pharmaceutical, Covance will support the preclinical and clinical development of the pharma's pipeline, which includes new molecules across a range of therapeutic areas, including cardiovascular, metabolic, infectious disease, oncology and urology. Specifically, Covance will provide Sihuan Pharmaceutical with global drug development and regulatory expertise, particularly in efforts to achieve dual or multiple filings for regulatory approvals such as investigational new drug (IND) applications and new drug applications (NDA) in China and internationally.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.