Mitsubishi Tanabe Joins Certara’s Simcyp Consortium
Certara announces the addition of Mitsubishi Tanabe to its Simcyp Consortium as the group’s 34th biopharmaceutical company.
Certara announces the addition of Mitsubishi Tanabe to its Simcyp Consortium as the group’s 34th biopharmaceutical company. Mitsubishi Tanabe has also licensed its proprietary Simcyp Population-based Simulator, which enables companies to study drug activity in virtual patients.
Read the full release here
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
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.
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
