50 Years of EU Pharma Legislation
To mark the 50th anniversary of the adoption of the first European Union (EU) pharmaceutical legislation, the European Commission is organizing a one-day conference that will take place in Brussels September 28.
To mark the 50th anniversary of the adoption of the first European Union (EU) pharmaceutical legislation, the European Commission is organizing a one-day conference that will take place in Brussels September 28. The conference will review past achievements but also focus on the present and future role of EU pharmaceutical legislation in protecting the health of people in Europe and in the world, and in advancing science and innovation. A live webcast will also be available. Registration for the live event ends July 24, 2015. Read the full release here.
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.
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.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
