Krka Extends Use of Calyx Regulatory Information Management System

An article published by the Journal of the American Medical Association highlights recent updates made to the CONSORT checklist and how they ensure the accuracy of trial reports.

Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access

In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.

Phase III trial data published in The New England Journal of Medicine support Nucala’s role as an add-on biologic therapy to lower exacerbation rates and delay disease progression in patients with eosinophilic chronic obstructive pulmonary disease receiving standard inhaled treatment.

Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.