USA The US Food and Drug Administration (FDA) finds itself in the midst of unprecedented political turmoil. The Trump Administration’s Department of Government Efficiency (DOGE) removed 3,500 of the Agency’s 20,000 employees in 2025, and a relentless succession of leadership upheavals has compounded the disruption. After 17 months of regulatory and…
Europe A 2025 collection of perspectives from over 30 biopharmaceutical industry stakeholders finds that while patient centricity has made real progress — moving from an afterthought to an expectation in the US and Europe — implementation remains patchy and often superficial. As Matthew Reaney, writing in ISPOR’s Value & Outcomes Spotlight…
Global Brendan Shaw maps the global fallout from the Trump Administration’s Most Favoured Nation drug pricing agenda. From stalled launches to rattled health ministries, Shaw argues that MFN has thrown pharmaceutical pricing strategy into unprecedented chaos while uncovering a counterintuitive silver lining for access in low- and middle-income countries. In a…
Australia Medicines regulatory agencies face enormous challenges in supporting and maintaining the safety, quality and supply of therapeutic goods in their respective countries and regions. Professor Anthony (Tony) Lawler, head of Australia’s Therapeutic Goods Administration (TGA), took time out from this work to respond to questions regarding the progress that TGA is…
Global Jay Iyer, CEO of the Access to Medicine Foundation, warns that rising nationalism and “onshoring” risk dismantling decades of progress in global health. As geopolitical tensions reshape how drugs are made and priced, Iyer argues that fragmented supply chains and profit-driven R&D often leave low-income nations – and the world’s…
Europe The European Health Data Space (EHDS) is a landmark regulation designed to unify health data across the EU for both direct patient care and medical research. Writing in the April 2026 edition of DIA’s Global Forum magazine, Tom Brookland, Pascal Hofer, and Didier Pomeranc of Roche explain that while the…
Europe Rainer Westermann offers a sobering take on Europe’s declining global status as both a source and recipient of biopharmaceutical innovation. He argues that the time for a paradigm shift in how the EU values innovation is now, calling for pricing system reform, speedier regulatory and HTA procedures, manufacturing investments, and…
China Writing in the March 2026 edition of DIA’s Global Forum magazine, PharmCube’s Juan Valencia looks back on a record year for drug approvals in China, and what it means for the future of access and innovation in the world’s second largest market. With the tremendous development of China’s innovative…
Global Healthcare is finally moving from a reactive “machine” to a proactive shield. In the latest issue of ISPOR’s Value & Outcomes Spotlight, Editor-in-Chief Zeba M. Khan, PhD, examines how Real-World Evidence is providing the definitive proof that prevention is now an economic and medical necessity. For decades, the guiding…
Global Ahead of this year’s International Women’s Day on March 8th, Unjela Kaleem highlights the disproportionate impact of cancer on women, especially those in developing countries. Kaleem – drawing on 20+ years of experience in healthcare strategic communications – argues that celebrating women’s economic empowerment while ignoring the cancers that take…
Global Jerry Radich of the Fred Hutchinson Cancer Center, writing in the February 2026 edition of DIA’s Global Forum magazine, lays out a framework for taking cutting-edge cancer therapies – currently the preserve of the world’s wealthiest nations – to a broader global patient population. It’s been said that geography…
Global Andrea Johnston,* Senior Phorum Director at BioPhorum,** argues that the biopharma industry’s rapid embrace of digital twins is being undermined by a fundamental problem: agreeing what a digital twin actually is. Drawing on fresh benchmarking data from leading manufacturers, Johnston contends that this lack of shared definition is slowing regulatory…
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