Partnership Creates Turnkey Offering for Direct-to-Patient Clinical Trials

Data from the FIBRONEER-IPF and FIBRONEER-ILD studies, published in The New England Journal of Medicine, highlight nerandomilast’s potential as a first-in-class PDE4B inhibitor for idiopathic and progressive pulmonary fibrosis, demonstrating efficacy as monotherapy or with existing antifibrotics.

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.

The FDA’s Oncologic Drugs Advisory Committee voted against an application for Columvi (glofitamab) plus GemOx for relapsed/refractory diffuse large B-cell lymphoma due to concerns about the applicability of multiregional trial data to the US patient population.

A pragmatic approach to streamlining technology and innovating processes will help advance clinical data management.

Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.