UBC Acquires Gigamoto Technology Partners
The recent acquisition of Gigamoto Technology Partners (W. Conshohocken, PA) expands United BioSource Corporation's (Bethesda, MD) leadership in drug safety, the company says. The purchase is UBC's second of the year and provides the company with several risk management programs, including the largest and longest running FDA-mandated program: iPLEDGE, an interactive computer-based distribution center that monitors pregnancy in women on Accutane.
“Managing drug safety for increasingly complex drugs and biologicals requires world class scientific expertise, strong operations, and demands state of the art technology,” said Ethan Leder, Chief Executive Officer of United Biosource. “The acquisition of Gigamoto enhances and accelerates our technology platform to include more top-notch FDA approved technology solutions for complex post-approval programs."
The full press release is available 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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
