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.
HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate
June 4th 2025Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.