News

In this Q&A, John Kirk, principal regulatory specialist 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.

In today’s ACT Brief, we examine how the CRA role is transforming alongside modern clinical trial technology, review the FDA’s approval of Imfinzi plus FLOT as the first immunotherapy regimen for resectable gastric and GEJ cancers, and look at Novo Nordisk’s fast-tracked submission of its higher-dose Wegovy injectable under the Commissioner’s Priority Review Program.

The company submitted the new dosage for approval based on its Phase III trial results.

The approval of AstraZeneca’s Imfinzi in combination with perioperative FLOT chemotherapy marks the first immunotherapy regimen for resectable gastric and gastroesophageal junction cancers, delivering a 22% overall survival benefit and establishing a new standard of care.

As clinical trials become more complex and decentralized, the role of the CRA is evolving from site monitor to strategic, digitally fluent partner, requiring expertise in hybrid oversight, risk-based monitoring, and multi-system data management.

In today’s ACT Brief, we examine how AI is being integrated into administrative workflows at investigative sites, highlight the FDA’s approval of the first gene therapy for adolescents and adults with SMA, and explore strategies for pharmaceutical companies to build high-performing hospital-based clinical trial programs.

FDA approval of Itvisma, the first gene replacement therapy for adolescents, teens, and adults with SMA, is backed by Phase III data showing meaningful gains in motor function and a consistent safety profile across previously untreated and previously treated patients.

As AI adoption accelerates across clinical research, clear distinctions between AI agents, AI teammates, and integrated intelligence are essential for understanding how automation will reshape site operations, workforce roles, and end-to-end study processes.

In today’s ACT Brief, we examine how AI and functional service partners are reshaping global pharmacovigilance, look at new data on how investigative sites are investing in and integrating digital solutions, and explore how Trialbee assesses ROI across emerging multi-touch recruitment platforms.

A new global Tufts CSDD survey of 387 investigative site professionals reveals broad experience with digital and decentralized trial tools, growing site-driven technology investments, and strong support for remote data collection—while highlighting persistent burdens tied to fragmented systems, training demands, and financial strain.

How pharma–hospital partnerships can overcome operational, financial, and organizational barriers to build high-performing clinical trial programs that expand access, accelerate accrual, and strengthen research capacity across both academic and community settings.

Explore methods to evaluate recruitment performance across multiple platforms, including engagement tracking, conversion analysis, and data-driven optimization for emerging digital spaces.

New 48-week results from the Phase IIIb APEX trial show Tremfya delivers sustained radiographic protection and deeper clinical responses in active psoriatic arthritis, reinforcing its potential as an early, structural-sparing therapy.

Examine real-world examples of patient engagement through less conventional channels and see how targeted campaigns can reach high-quality participants even in low-volume or emerging platforms.

Epkinly plus rituximab and lenalidomide is the first bispecific antibody combination FDA-approved for relapsed or refractory follicular lymphoma, backed by Phase III data showing substantially improved disease control over standard therapy.

Emerging applications of AI/ML, automation, and digitization are helping sponsors cut clinical trial start-up times to as little as four weeks, reduce data errors, and enhance patient engagement—demonstrating how tech-enabled processes are reshaping trial efficiency and experience across the study lifecycle.

Understand the regulatory and policy considerations for running clinical trial recruitment campaigns on nontraditional or entertainment-focused platforms, and how ongoing collaboration with ad teams ensures compliant, effective outreach.

Phase III HERIZON-GEA-01 trial results show Ziihera combinations, with or without tislelizumab, significantly improve progression-free and overall survival in patients with HER2-positive advanced gastroesophageal adenocarcinoma, positioning these regimens as potential new first-line standards of care.

In today’s ACT Brief, we look at how Trialbee evaluates nontraditional digital platforms for patient recruitment, review new 48-week data from J&J’s APEX trial of Tremfya in psoriatic arthritis, and explore how agentic AI is poised to reshape commercial operations in life sciences.

Learn how demographic and behavioral insights inform platform-specific messaging, creative formats, and call-to-action strategies to engage patients and caregivers effectively across diverse digital channels.

New 48-week results from Johnson & Johnson’s Phase IIIb APEX trial show Tremfya delivers durable symptom improvement, slows radiographic progression, and maintains a consistent safety profile in biologic-naïve psoriatic arthritis patients—supporting J&J’s sBLA to expand the therapy’s label.

Explore which factors—audience relevance, content fit, and engagement quality—determine the best use of platforms like TikTok, Reddit, and Spotify for targeted patient recruitment campaigns.

In today’s ACT Brief, we look at how real-world data and AI are helping prevent costly study rescue, review the FDA’s approval of a first-in-class menin inhibitor for NPM1-mutated AML, and explore new insights on closing biomarker-testing gaps in oncology.

FDA has approved Komzifti (ziftomenib) as the first once-daily, oral menin inhibitor for adults with relapsed or refractory NPM1-mutated AML, supported by Phase II KOMET-001 data showing meaningful remission rates, durable responses, and a manageable safety profile in a population with limited treatment options.

Leveraging real-world data and AI-driven insights in clinical trial planning can reduce enrollment failures, improve retention, and prevent costly rescue studies by providing a more accurate view of patient populations and site feasibility.

In today’s ACT Brief, we examine declining site satisfaction and strategies to improve sponsor-site collaboration, review a new partnership enabling automated eSource-to-EDC data transfer, and highlight Gilead’s positive Phase III ARTISTRY-1 trial results in virologically suppressed adults with HIV.

The ARTISTRY-1 Phase III trial demonstrated that a single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg maintains viral suppression and simplifies therapy for people living with HIV, supporting safer, more convenient treatment options.

A new integration between Advarra and IgniteData will enable secure, automated transfer of clinical trial data from EHRs and eSource systems to sponsor EDCs.