Celerion Expands Service Offering
Celerion announced the expansion of molecular and cellular capabilities to Good Laboratory Practice/Good Clinical Practice (GLP/GCP) standards. The expanded service offering is available in both of the company’s Lincoln and Zürich bioanalytical laboratories and includes ELISpot analysis, flow cytometry, and qPCR.
Read more about the expanded offering here.
Roche’s Susvimo Lands FDA Approval for Diabetic Retinopathy Based on Phase III Pavilion Trial Data
May 22nd 2025One-year results from the Pavilion study showed patients who received Susvimo (ranibizumab) refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale.
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.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
