Industry news round-up: updates from August 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 August 2025.
President Donald Trump has issued letters to 17 major pharmaceutical companies requesting commitments to provide US patients with the same prices for prescription drugs as those in other developed nations, setting a 60-day deadline and threatening further action if the industry fails to comply.
Flatiron Health appoints Nathan Hubbard as CEO following leadership transition
Flatiron Health has appointed Nathan Hubbard as CEO, succeeding Carolyn Starrett following a period of significant growth, international expansion, and advancements in real-world oncology data under her leadership.
Inka Health and OneMedNet launch AI-powered oncology initiative using external control arms
Inka Health will lead a new initiative with OneMedNet to explore how AI and regulatory-grade RWD can support the development of external control arms in oncology, offering a potential alternative to traditional clinical trials.
The Institute for Quality and Efficiency in Health Care (IQWiG) has published a preliminary rapid report outlining methodological considerations for collecting routine practice data on new drugs in Germany.
Saudi Arabia’s SFDA issues draft framework on real-world data and evidence for regulatory use
The Saudi Food and Drug Authority (SFDA) has published a draft guideline on the use of RWD and RWE in medicines marketing authorizations. The document, now open for stakeholder feedback, aims to improve regulatory decision-making in line with Saudi Vision 2030 by defining key concepts, outlining quality standards, and expanding potential applications.
Datavant and Veritas Data Research have deepened their partnership to improve the availability and integration of high-quality mortality data for life sciences research, aiming to support survival analysis, safety monitoring, and regulatory decision-making.
UK to accelerate patient access to medicines under new MHRA–NICE joint approach
Patients in England could receive new medicines up to 6 months earlier under a coordinated regulatory and HTA process announced by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) as part of the government’s 10-Year Health Plan.
OM1 expands neurology network to over 3 million patients for real-world data research
OM1 has announced the expansion to its Neurology Specialty Network, adding around 500,000 patients and bringing the total to more than 3 million. The network contains electronic health records (EHRs) and clinician notes from relevant specialists, making it one of the largest neurology-focused RWD resources currently available.
Atropos Health and Novartis roll out AI trained on real-world data to aid rare disease diagnosis
Atropos Health, in collaboration with Novartis, has developed an AI model trained on EHR data from 67 million patients to help identify individuals who may warrant further workup for the rare disease, paroxysmal nocturnal hemoglobinuria (PNH).
NIH unveils unified strategy to strengthen research priorities, real-world data, and public trust
The US National Institutes of Health (NIH) has announced a unified strategy designed to sharpen research priorities, accelerate evidence generation, and expand the use of RWD as part of efforts to rebuild public trust. Amid ongoing questions about how the agency sets priorities and manages taxpayer resources, the strategy is intended to bring greater clarity and coherence to the NIH’s mission.
NICE has issued draft guidance on Type 2 diabetes that expands early use of SGLT-2 inhibitors and GLP-1 receptor agonists, while drawing on RWD to address inequalities in access and outcomes. Described as the “biggest shake-up in Type 2 diabetes care in a decade,” the update aligns with the NHS 10-Year Health Plan.
EVERSANA and Waltz Health merge to form new pharma commercialization and drug access platform
EVERSANA and Waltz Health have merged to create a combined platform that integrates commercialization services with payer technology, with the aim of addressing patient access, affordability, and drug value in the US healthcare system.
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