Sponsor Preference of CRO Experience in Orphan Drug Trials
Despite the substantial difficulties associated with orphan drug trial recruitment, this segment of the drug development market is booming. By 2020, orphan drug sales are expected to make up 19% of prescription drug sales, excluding generics. In ISR’s Orphan Drug Market Dynamics and Patient Recruitment Best Practices report, ISR provides an overview of the orphan drug development market as well as how to best drive patient recruitment in an area of drug development in which drug developers do not want to be left behind. Read more here.
Source: Industry Standard Research, February 2015
Source: Industry Standard Research, February 2015
Source: Industry Standard Research, February 2015
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.
