In today’s ACT Brief, we examine what changes when AI is embedded across clinical operations, why faster trial data isn’t yet producing faster decisions, and how FDA granted accelerated approval to a therapy for a rare airway disease.
News|Podcasts|November 4, 2026
ACT Brief: Community Research Financing Gaps, Neuroscience Endpoint Data, and Teva’s Biosimilar Deal
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we examine why community research needs lasting financing and infrastructure, how electronic outcome tools can strengthen neuroscience endpoints, and how Teva is licensing two biosimilars from Samsung Bioepis.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
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new ACT FAQ examines what it would take to make community research infrastructure permanent. Community participation gaps look less like a question of patient willingness and more like a financing and infrastructure problem that no single bill has yet solved. The barriers sit in how patients are supported, how sites are burdened, and how research capacity is funded. - In a
new contributed article , Estelle Haenel, PharmD, PhD, chief medical officer at Kayentis, explains why neuroscience trials struggle to show benefit when symptoms are subjective and highly variable. She describes how electronic clinical outcome assessment tools standardize clinician-reported scales and capture outcomes in real time to reduce recall bias. She also notes that adding patient and caregiver perspectives helps capture what clinician scales can miss. Teva and Samsung Bioepis have signed a license and commercialization agreement giving Teva US rights to two approved immunology products, with closing expected by the end of 2026. The products are supported by a Phase III trial of 596 patients with rheumatoid arthritis, where response rates at week 24 were 78.1% for one product and 80.3% for the reference product, within the prespecified equivalence margin. Antidrug antibodies were detected in 0.7% of patients on the biosimilar versus 13.1% on the reference product.
That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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