Industry news round-up: updates from March 2025
Explore the latest advancements in real-world data (RWD), real-world evidence (RWE) and health technology assessment (HTA) as featured on The Evidence Base during March 2025.
New guidance from Canada’s Drug Agency (CDA-AMC) sets out recommendations for rare disease registries to enhance the quality, transparency, and governance of RWE, aiming to support better health care decision-making and aligning with international best practices.
Briya partners with leading Italian hospital to advance real-world data collection in Europe
Briya has announced a new collaboration with Casa Sollievo della Sofferenza, one of Italy’s top research hospitals, to improve access to high-quality RWD in the region.
Just weeks after adoption by the EU council, the European Health Data Space (EHDS) has officially been published, setting the stage for a unified digital health data system across the EU. In response, a coalition of 39 European health stakeholders has called for effective stakeholder engagement and capacity building during the implementation phase of the regulation.
Premier, Inc. and NEST partner to advance medical device evaluation with real-world evidence
Premier, Inc. and NEST are collaborating to enhance RWD and RWE in medical device evaluation, with the objective to streamline regulatory submissions and accelerating innovation.
ISPOR Real-World Evidence Summit 2025 to focus on Asia Pacific region
ISPOR—The Professional Society for Health Economics and Outcomes Research has announced the “ISPOR Real-World Evidence Summit 2025: Through the Lens of Asia Pacific”, set to take place in Tokyo, Japan, September 28–30, 2025.
OneMedNet teams up with Datavant to deliver AI-powered, tokenized real-world data
OneMedNet is collaborating with Datavant to expand access to tokenized RWD for use in life sciences and medical research. By integrating OneMedNet’s patient data network with Datavant’s ecosystem, the collaboration is intended to improve data connectivity, streamline discovery, and support research efforts in healthcare.
OM1 expands into Europe to enhance AI-driven real-world evidence solutions
OM1 is expanding into Europe to meet the growing demand for AI-powered RWE solutions, supporting healthcare and life sciences organizations in drug development, market access, and regulatory decision-making.
Novartis Pharmaceuticals and Folia Health are partnering on a remote study to assess the daily impact of IgA nephropathy (IgAN). Using Folia Health’s platform, the study will collect home-reported outcomes on symptoms, treatment effects, and quality of life, providing insights to support research and personalized care.
Medicare drug price negotiations enter second cycle with full industry participation
The Centers for Medicare & Medicaid Services (CMS) has confirmed that all companies producing the 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program have agreed to participate.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have officially adopted the European Medicines Agencies Network Strategy to 2028 (EMANS 2028), setting out priorities to boost the EU’s global competitiveness in medicine development and manufacturing.
Why real-world evidence matters in Medicare drug price negotiations
Newly proposed best practices checklist details how RWE can be generated and evaluated to support the CMS’ decision-making in Medicare drug price negotiations.
New US policy brief calls for reform of international drug pricing practices
As the US contributes a significant share of global pharmaceutical R&D costs, a new policy brief examines how international drug pricing practices could be adjusted to better support innovation and expand patient access.
Looking beyond drug launch prices in cost-effectiveness analyses
A new publication in The American Journal of Managed Care questions the extent to which a value-based launch price, derived from conventional cost-effectiveness analysis, accurately reflects a drug’s value over its full lifecycle.
GSK has announced a new research collaboration with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to explore whether a shingles vaccination may be linked to a reduced risk of dementia. The study will use the UK’s national health data infrastructure and is expected to contribute to understanding neurodegenerative conditions through large-scale RWE.
Should real-world evidence play a bigger role in FDA drug approvals?
A new issue brief from the Manhattan Institute explores whether broader use of real-world evidence could make drug development more efficient, less expensive, and more accessible to patients, particularly those with rare diseases.
Canada’s Drug Agency publishes first-ever methods guide for health technology assessment
Canada’s Drug Agency (CDA-AMC) has released a ‘Methods Guide for Health Technology Assessment’, offering a detailed, transparent framework for evaluating clinical evidence submitted for drug reimbursement. The guide outlines key appraisal methods and evidence expectations, supporting consistent decision-making across Canada’s health system.
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