Coast Issued Warning Letter by FDA

Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.

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.

JNJ-1900 (NBTXR3), a novel, potentially first-in-class oncology therapy, demonstrated a median overall survival of 23 months from date of diagnosis as well as a favorable safety profile.

Companies share their experience in future-proofing clinical data technology.

The single-inhaler demonstrated a meaningful improvement in lung function in the Phase III KALOS and LOGOS studies.