Industry news round-up: updates from December 2025
Explore the latest advancements in real-world data (RWD), real-world evidence (RWE), drug pricing and reimbursement and regulation as featured on The Evidence Base during December 2025.
RWD/RWE
FDA signals broader acceptance of de-identified real-world data in regulatory reviews
Updated FDA guidance will allow certain medical device applications to rely on RWE derived from de-identified data sources, potentially expanding the role of large real-world datasets in regulatory decision-making.
FDA finalizes long-awaited guidance on using real-world evidence for medical device decisions
The FDA has finalized its guidance on the use of RWE to support regulatory decision-making for medical devices, replacing its 2017 framework and finalizing the 2023 draft guidance. The updated document provides clearer expectations around data relevance, reliability, and documentation, offering sponsors a more practical roadmap for integrating RWD into regulatory submissions.
The FDA’s latest Broad Agency Announcement details two complementary streams of RWD methodology for evidence generation and regulatory decision-making, spanning cross-cutting research and disease- and product-specific areas including oncology, women’s health, rare diseases, drugs, biologics, and devices.
The agreement connects home-based care providers with an automated registry platform, enabling patients to participate in longitudinal clinical research from home, with initial cohorts planned in cardiometabolic disease and Parkinson’s disease from 2026.
The new PPD™ CorEvitas™ Alzheimer’s Disease Registry aims to generate harmonized, regulatory-grade RWD to support long-term evaluation of treatment safety, effectiveness, and unmet needs in routine clinical practice.
BC Platforms expands global access to real-world and genomic data through GeneVault partnership
The agreement expands BC Platforms’ data partner network to include large-scale datasets from under-represented populations across Asia, the Middle East, Africa, and Latin America, supporting more globally representative evidence generation.
The partnership will use AI-curated real-world COPD data to better characterize underserved patient subgroups and inform earlier, more targeted drug development strategies.
The Heart Rhythm Society, with sponsorship from Johnson & Johnson MedTech, has announced plans to develop a national registry to collect RWD on pulsed field ablation in atrial fibrillation, aimed at supporting long-term outcomes assessment, post-market surveillance, and evidence generation.
Drug pricing and reimbursement
UK raises NICE QALY thresholds amid new UK–US drug pricing deal
The UK Government has set out the first increase to NICE’s cost-effectiveness thresholds in over two decades as part of a wider policy package, accompanied by a new UK–US pharmaceuticals agreement that provides zero-tariff access to the US market and clarifies the UK’s position under the US Most-Favored-Nation (MFN) pricing initiative.
PrecisionLife and Ovation partnered to analyze multiomic and clinical data to identify biomarkers that may help predict patient response to GLP-1 receptor agonists, with the aim of informing future value-based reimbursement approaches.
FDA and CMS launch TEMPO pilot to test real-world use of digital health devices
Through the TEMPO pilot and CMS’s ACCESS model, the US regulator will allow limited, supervised use of certain digital health devices while RWD are generated to inform future regulatory and payment decisions.
Nine more companies sign US most-favored-nation pricing deals
The Trump administration has announced agreements with nine major drugmakers, marking the largest expansion to date of MFN pricing and extending lower drug prices to state Medicaid programs and future product launches.
CMS proposes mandatory GLOBE and GUARD models to link Medicare drug prices to global benchmarks
The US Centers for Medicare & Medicaid Services (CMS) has proposed two new mandatory drug payment models, GLOBE and GUARD, which would link Medicare drug prices and rebates to international benchmarks. The proposals extend the Administration’s most-favored-nation pricing agenda across Medicare Parts B and D.
Regulation
What to expect from the EU HTA Regulation in 2026
The Member State Coordination Group on Health Technology Assessment (HTACG) has announced adoption of the 2026 Work Program outlining a major expansion of EU-level joint clinical assessments (JCAs), the first device-focused assessment, and updated governance measures as the EU Health Technology Assessment Regulation enters its second operational year.
The International Council for Harmonisation (ICH) has released the draft E22 guideline, General Considerations for Patient Preference Studies, for public consultation. The guideline sets out harmonized principles for how patient preference studies (PPS) can inform drug development, regulatory submissions, and benefit–risk assessments.
Landmark agreement on EU pharma package sets stage for new access and innovation rules
The Council of the European Union and the European Parliament have reached a provisional agreement on the long-anticipated “pharma package,” concluding months of trilogue negotiations and setting in motion the first major overhaul of EU medicines legislation in more than two decades. The deal comes at a moment of heightened scrutiny over drug pricing and increasing concern that Europe is losing ground in pharmaceutical innovation. Policymakers have sought to produce a framework that expands patient access, strengthens supply resilience and supports the competitiveness of the region’s life sciences sector.
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