Elsevier, Novartis Collaborate on Drug Development Safety Risk Tool
Global life sciences information analytics provider Elsevier announced a collaboration with Novartis to develop a safety margin risk assessment prediction tool, largely using Elsevier’s PharmaPendium data. The data, which includes searchable FDA and EMA drug approval documentation and packages (including Adverse Events Reports and FDA Advisory Committee meetings), and comparative drug safety, pharmacokinetic, efficacy, and metabolizing enzyme and transporter data, will be used to predict and better justify earlier in the process target selections for development related to human safety, interpretation of clinical significance, and early submission to monitor and mitigate safety risks throughout clinical drug development.
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Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging 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
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In 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.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval 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.
