ICON announced it has been awarded a project by the FDA to develop an industry-standard Patient Reported Outcome
ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, announced it has been awarded a project by the FDA to develop an industry-standard Patient Reported Outcome (PRO) measure that can be used in anti-bacterial drug development trials for hospital-acquired bacterial pneumonia (HABP).
HABP is the second most common hospital-acquired infection and is the primary cause of death in intensive care units.
The collaboration brings together scientists from ICON’s Commercialization and Outcomes group, FDA, the National Institute of Allergy and Infectious Diseases, the Infectious Diseases Society of America, pharmaceutical and biotechnology companies, and the academic research community to develop new approaches to evaluating the efficacy of antibiotics in future clinical trials of therapies for HABP.
Read the full release here.
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.