In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
News|Podcasts|December 18, 2025
ACT Brief: Rethinking Site Support in 2026, GSK’s New Severe Asthma Approval, and Priority Review Momentum in Multiple Myeloma
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we look at emerging operational changes aimed at reducing site burden, review the FDA approval of GSK’s twice-yearly biologic for severe asthma, and examine a national priority voucher granted for a new multiple myeloma treatment combination.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- A new video interview
examines what operational changes may be needed in 2026 to better support investigative sites. Kevin Williams of Ledger Run discusses how sponsors are evaluating functional sourcing models, CRO utilization strategies, and system changes, while noting that sites continue to face significant switching burden from managing multiple sponsor processes and platforms. Williams also highlights a growing trend of sponsors reassessing whether capabilities are best handled in-house, through functional service providers, or via hybrid operating models. - The FDA has
approved GSK’s Exdensur (depemokimab-ulaa) as an add-on maintenance therapy for severe asthma in patients aged 12 years and older. The approval is supported by Phase III SWIFT-1 and SWIFT-2 trial data showing significant reductions in annualized asthma exacerbations with twice-yearly subcutaneous dosing, with safety profiles comparable to placebo. Exdensur is an anti–interleukin-5 monoclonal antibody and represents the first ultra-long-acting biologic evaluated in Phase III trials for severe asthma. - And the FDA has
granted a Commissioner’s National Priority Voucher to Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in combination with daratumumab for relapsed or refractory multiple myeloma. The designation follows Phase III MajesTEC-3 trial results demonstrating improved survival outcomes compared with standard-of-care regimens in patients previously treated with one to three lines of therapy. Tecvayli is an off-the-shelf bispecific antibody that targets CD3 on T cells and BCMA on myeloma cells to induce tumor cell lysis.
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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