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Preliminary Phase IV trial results show that Moderna’s 2025–2026 Spikevax formula boosted neutralizing antibodies more than eight-fold in high-risk adults and older populations against COVID-19.

Maximizing AI’s potential in medical writing and regulatory submissions requires data standardization, objective content practices, and a streamlined document ecosystem that accelerates timelines while ensuring compliance.

Clinical trial enrollment and retention challenges, coupled with limited site resources, highlight the need for stronger site support, collaboration, and patient-centered trial models.

The Phase II trial (NCT07145229) will evaluate the safety, efficacy, and pharmacodynamics of ABP-745 compared with placebo and standard colchicine therapy in over 200 patients with acute gout flares.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, describes how double-blind double-dummy dosing, standardized assessments, and site training ensured protocol adherence and data integrity in the NIMBLE trial.

The IDeate-Lung01 trial showed a 48% confirmed response rate with Merck’s B7-H3 directed antibody-drug conjugate in previously treated extensive-stage small cell lung cancer, with durable benefit observed across second- and later-line patients, including those with brain metastases.

In this week’s Applied Clinical Trials Brief, we recap three top stories: Novo Nordisk’s stepwise approach to AI adoption, new perspectives on eClinical technology as a growth driver, and expert insights on how recent policy changes could impact research funding and future therapies.

Interim results from the ongoing Phase IV LOTUS trial showed that Daybue delivered sustained behavioral improvements and manageable gastrointestinal outcomes in Rett syndrome patients over one year.

Results from the Phase III STRIDE-13 trial (NCT06177912) showed that Merck’s Capvaxive was noninferior to PPSV23 in children and adolescents aged 2 to <18 years who are at increased risk of pneumococcal disease due to chronic medical conditions.

In this Q&A, Randa Wahid of Indero, and Lyn Mursalo, a freelance clinical research professional, share how sponsors and CROs can build collaborative partnerships, navigate global trial complexities, and apply practical strategies to deliver studies on time and with quality.

The FDA-approved therapy is now included in National Comprehensive Cancer Network clinical guidelines as a treatment option for both pediatric and adult patients with aggressive H3 K27M-mutant diffuse gliomas, offering a new standard of care for recurrent disease.

Results from the two-year AVONELLE-X extension study (NCT04777201) and the Phase IIIb/IV SALWEEN trial showed that Roche’s Vabysmo demonstrated durable vision improvements, extended dosing potential, and reliable safety treating wet age-related macular degeneration and polypoidal choroidal vasculopathy.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, outlines how the Phase III NIMBLE trial showed cemdisiran improved daily living and clinical assessments in patients with generalized myasthenia gravis.