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AI-driven discovery, EHR-based real-world evidence, and synthetic patient modeling are rapidly reshaping drug repurposing, reducing development timelines, expanding therapeutic applications, and accelerating regulatory acceptance of computational approaches.

In today’s ACT Brief, we look at what’s fueling rapid growth in CNS and autoimmune research, why former FDA leaders are warning that new vaccine policies could reshape clinical development, and how the agency’s latest leadership change may influence drug review operations.

Investigate how sponsors are responding to rapid growth in obesity drug development, including strategies for manufacturing, supply chain optimization, dosing innovations, and combination therapies to meet market and patient needs.

Twelve former FDA leaders have publicly challenged the agency’s proposed overhaul of vaccine approvals, sparked by an internal memo linking child deaths to COVID-19 vaccination, arguing the changes threaten evidence-based standards, weaken immunobridging practices, and risk eroding public trust.

In today’s ACT Brief, we look at new insights on strategy-driven clinical development, fresh survey data revealing persistent site startup delays, and major leadership turnover inside FDA’s drug division.

Explore the drivers behind increased investment in CNS and autoimmune trials, including pain, mental health, and inflammatory conditions, and see how technology, decentralized trials, and hybrid designs are shaping study operations.

ICON’s June 2025 survey of more than 100 investigators and site leaders reveals persistent bottlenecks in study startup driven by contract and budget delays, slow activation timelines, and insufficient collaboration from sponsors and CROs.

Examine the rise of personalized and biomarker-driven therapies, the logistical challenges of rare patient populations, and how historical controls and real-world evidence are supporting strategy-driven trial designs.

In today’s ACT Brief, we look at the FDA’s deployment of an agency-wide agentic AI platform, review new data showing how structured exercise programs can improve long COVID symptoms, and explore how PROs and real-world evidence are reshaping how industry measures treatment impact.

In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission readiness, review the FDA’s accelerated approval of Voyxact for IgA nephropathy, and explore new insights from the Veeva R&D and Quality Summit on modernizing clinical reference data management.

Explore the challenges sponsors and CROs face in maintaining clinical reference data, uncover the hidden costs of traditional upkeep models, and see how integrated data solutions can streamline operations across the clinical ecosystem.

The FDA has granted accelerated approval to Otsuka’s Voyxact for adults with primary IgAN at risk of disease progression, based on Phase III VISIONARY trial results showing a 51% reduction in proteinuria at nine months and a generally well-tolerated safety profile, offering the first targeted APRIL-blocking therapy for this patient population.

In this Q&A, John Kirk, principal regulatory strategist at Veristat, explains how the FDA’s Commissioner’s National Priority Voucher (CNPV) Program is accelerating operational timelines, tightening cross-functional workflows, and redefining what sponsors and CROs must deliver to secure and execute an ultra-compressed one-to-two-month review.