Key Insights from the 2026 REMS Industry Consortium Annual Meeting
AI, standardization, and a shifting FDA landscape — here’s what the 2026 RIC Annual Meeting revealed about the future of REMS.
How North American Privacy Frameworks Shape Real-World Evidence: A Comparison of Canada and the United States
Canada’s consent-driven data silos and the U.S.’s regulatory patchwork aren’t just administrative hurdles — they’re determinants of bias in real-world evidence.
EU Post-Marketing Compliance: What Regulation 2025/1466 Means for Your Pharmacovigilance Program
Implementing Regulation (EU) 2025/1466 is in full effect — and it’s the biggest change to EU pharmacovigilance rules in over a decade. Here’s what your compliance team needs to act on right now.
Access USA 2026: Key Takeaways on AI, Affordability, and Patient Support
Two phrases defined this year’s Access USA conference: “calm the chaos” and “can’t eliminate the human touch.” As AI reshapes patient support programs, the question isn’t whether to adopt it, but how to deploy it without losing what patients value most.
Getting from Taboo to Treatment: Understanding stigma and perceived gender differences in mental health and psychedelics
Women’s depression is often framed as a hormonal imbalance of the body. Men’s? A failure of will. These aren’t just outdated ideas — they’re active barriers to diagnosis, treatment, and survival. As treatment-resistant depression challenges conventional medicine, psychedelic-assisted therapy is emerging not only as a clinical option, but as a way to dismantle the very stigmas that keep people from seeking help in the first place.
Oregon Psilocybin Service Centers are a Model for Patient-Centered Care
As psychedelics move toward potential FDA approval, Oregon’s psilocybin service centers offer early lessons in patient-centered care. This article examines real-world practices in preparation, dosing, facilitation, and integration—and what they may reveal about future clinical use.
Breaking Barriers in Immuno-Oncology: Mechanistic Insights into Immune Checkpoint Inhibitor Resistance and Implications for Health Economics and Outcomes Research and Value Assessment
Immune checkpoint inhibitors deliver transformative outcomes, yet real‑world durability is often limited by primary and acquired resistance. This article explores the biological foundations of ICI resistance and outlines how integrating these insights into HEOR models can improve value assessment and real‑world decision‑making.
Redefining PV Skillsets in an AI-Driven World: Training the Next Generation of Safety Scientists
As AI becomes embedded across pharmacovigilance, the skills required of safety scientists are rapidly evolving. This article examines the shifting balance between human expertise and AI-enabled tools, outlining the competencies, training pathways, and cultural changes needed to prepare tomorrow’s hybrid PV workforce.
Old Medicine, New Frameworks: the Often Overlooked Mind-Body Connection with Therapeutic Psychedelics
The history of depression treatment reflects a centuries-old tension between mind and body—and how we conceptualize the condition has always shaped how we treat it. Today, with up to 30% of patients classified as treatment-resistant, psychedelic-assisted therapies are attracting serious scientific and regulatory attention. But emerging evidence suggests that the therapeutic context surrounding these treatments—relationships, setting, and social environment—may matter as much as the compounds themselves.
