Industry news round-up: updates from October 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 October 2025.
Trump administration announces first ‘most-favored nation’ drug pricing deal with Pfizer
On September 30, 2025, the White House announced a first-of-its-kind agreement with Pfizer to bring “most-favored nation” (MFN) pricing to US patients. The deal is presented as part of President Donald Trump’s broader effort to reduce prescription drug costs and address what the administration has termed “global freeloading” in pharmaceutical markets.
OneMedNet grows real-world data offering in healthcare AI with Medcase partnership
OneMedNet has announced a collaboration with Medcase to expand into the $1.5 billion healthcare data annotation market. The collaboration combines RWD capabilities with medical annotation services to meet rising demand for high-quality datasets in healthcare AI.
The European Medicines Agency (EMA) has released a new draft reflection paper encouraging developers and other stakeholders to plan, generate, and submit patient experience data (PED) across the medicine lifecycle, and to engage early with regulators on methods and use cases.
CMS releases final guidance for 2028 Medicare Drug Price Negotiation cycle
CMS has issued final guidance for the 2028 cycle of the Medicare Drug Price Negotiation Program, expanding the process to include Part B drugs, enhancing orphan drug protections, and introducing the first framework for renegotiation of previously selected medicines.
Data4Life and South Korea’s EvidNet collaborate to advance global federated RWE generation
Data4Life and EvidNet have announced a collaboration to advance federated, privacy-preserving RWE generation. The partnership will integrate the Data2Evidence and FeederNet platforms to support scalable, standards-based, and responsible health research across borders.
The UK’s health technology assessment body, the National Institute for Health and Care Excellence (NICE), has revised its Real-World Evidence Framework, introducing new guidance on the use of unstructured data and tools to support target trial reporting.
Stakeholders across Europe are invited to provide feedback on a new series of draft guidelines and technical specifications supporting the implementation of the European Health Data Space (EHDS). The consultation, open from September 30, 2025 to November 30, 2025, will help refine the operational and technical tools needed to put the EHDS Regulation into practice across Member States.
Event preview: Celebrating 5 Years of VAC4EU
In this event preview, we look ahead to Celebrating 5 Years of VAC4EU, taking place on November 4, 2025 in Brussels. Bringing together leaders from regulatory, public health, academic, and industry communities, the event will reflect on lessons learned in RWE generation and discuss future priorities for vaccine monitoring and pandemic preparedness.
Century Health and Balboa Nephrology have announced they are partnering to apply AI to RWD, transforming unstructured clinical information into actionable evidence to advance research, improve patient care, and accelerate drug development for chronic kidney disease and related conditions.
The European Medicines Regulatory Network (EMRN) – a regional regulatory system between the EMA, the European Commission, and the national competent authorities of EU and EEA Member States – has released its first network data strategy, setting a shared vision for how authorities across the EU will manage, govern, and use data to strengthen decisions and protect public and animal health.
HEMA opens consultation on framework for evaluating benefits in health technology assessment
HEMA group, the international collaboration between ICER, NICE, and Canada’s Drug Agency, has released its first draft report defining appropriate benefits for economic evaluation in HTA, inviting global stakeholder feedback ahead of final guidance expected in early 2026.
The US Food and Drug Administration (FDA) has issued a September 2025 draft guidance titled “Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products” that explains how sponsors should generate postapproval evidence using RWD, registries, and decentralized or remote data collection approaches outside of traditional clinical sites. The guidance was released alongside two companion drafts under the Prescription Drug User Fee Act (PDUFA VII), which is the seventh authorization for fiscal years 2023 to 2027.
Three investigational therapies for rare and serious conditions have become the first to enter the UK’s renewed Innovative Licensing and Access Pathway (ILAP), a collaborative initiative designed to accelerate development and patient access through coordinated support from regulators, the NHS, and HTA bodies.
The European Commission has adopted the final implementing regulation under the EU Health Technology Assessment Regulation (EU HTAR), setting detailed rules for joint clinical assessments (JCAs) of medical devices and in vitro diagnostic medical devices. The measure marks the completion of the regulatory framework needed to ensure consistent, evidence-based evaluation of health technologies across the EU.
HealthVerity and Claritas Rx partner to enhance real-world insights for life sciences
HealthVerity and Claritas Rx have announced a collaboration to integrate RWD with specialty pharmacy insights, supporting commercial, RWE, and health economics and outcomes research (HEOR) teams in developing a more complete understanding of patient access, adherence, and outcomes across the pharmaceutical lifecycle.
Oracle Health and Life Sciences has announced a collaboration with Baylor College of Medicine to advance research on alcohol-related liver disease (ALD), using AI and RWD to support earlier detection and improved understanding of the condition.
FDA finalizes PFDD Guidance 3 on selecting fit-for-purpose clinical outcome assessments
The FDA has released the third guidance in its Patient-Focused Drug Development (PFDD) series, outlining how to select, develop, or modify clinical outcome assessments (COAs) that are fit-for-purpose in medical product development and regulatory decision-making. The FDA noted it is posting the document “to provide advance notice to the public,” with a Federal Register notice to follow after the lapse in appropriations ends.
An analysis of electronic health records (EHRs) for 57 million people in England has revealed evolving trends in cardiovascular disease before, during, and after the COVID-19 pandemic. The findings highlight significant health inequalities and regional variations that could help target future prevention and care strategies.
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