DrugDev, Citeline Partner to Integrate Data

Results 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.

In 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.

Results from the Phase III KEYNOTE-689 trial show that adding perioperative Keytruda (pembrolizumab) to standard-of-care radiotherapy improves event-free survival in patients with resectable, locally advanced head and neck squamous cell carcinoma, potentially setting a new benchmark for treatment in this setting.

The Phase I/IIa CLARICO trial of OpCT-001 marks the first clinical trial of an investigational induced pluripotent stem cell-derived therapy for primary photoreceptor diseases.

Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.