Industry news round-up: updates from November 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 November 2025.
BEKhealth announced a partnership with Innovo Research and RTI Health Solutions to support the generation and use of community-sourced RWD. The initiative is intended to improve the quality, representativeness, and timeliness of RWE used in research, healthcare decision-making, and patient care.
UK’s MHRA outlines new patient-focused regulatory approach for rare disease treatments
With around 3.5 million people in the UK affected by rare diseases, the MHRA has unveiled plans to create a patient-focused framework aimed at accelerating access to innovative therapies. The proposals seek to balance rapid development with robust safety and evidence requirements.
US advances MFN pricing deals for obesity drugs with Eli Lilly and Novo Nordisk
The Trump administration has unveiled new most-favored-nation (MFN) pricing agreements with Eli Lilly and Novo Nordisk to expand access to obesity and diabetes medicines while boosting US pharmaceutical manufacturing. The arrangements, announced jointly by the White House and both companies, introduce lower prices for GLP-1 receptor agonists through the new TrumpRx purchasing platform.
CMS launches new GENEROUS model to lower Medicaid drug prices
Amid growing momentum around the US government’s most-favored-nation (MFN) pricing reforms, CMS has unveiled the five-year, voluntary GENEROUS Model for Medicaid. Launching in January 2026, the initiative will tie drug prices to international benchmarks and aims to harmonize coverage policies across participating states to improve affordability and consistency.
Natera’s oncology testing portfolio, including Signatera™, is now integrated into Flatiron Health’s OncoEMR platform, enabling electronic ordering and results delivery for more than 4500 US cancer care providers.
FDA’s plausible mechanism pathway to advance personalized therapies
The US Food and Drug Administration (FDA) has introduced the “plausible mechanism pathway,” a new regulatory path designed to support the development of personalized therapies for diseases with clearly defined biological causes, particularly where randomized trials are not feasible.
Century Health and Memory Treatment Centers have announced a partnership to convert unstructured clinical data into research-grade RWE to support the analysis of Alzheimer’s disease treatments in everyday practice.
Real-world data show tirzepatide and semaglutide offer comparable cardiovascular protection
A large real-world analysis from Mass General Brigham comparing nearly one million patients finds that tirzepatide and semaglutide deliver similar cardiovascular benefits in routine clinical practice, reinforcing trial evidence and highlighting the growing role of RWD in cardiometabolic research.
Datavant and UBC integrate capabilities to support evidence generation and patient access pathways
Datavant and United BioSource Corporation (UBC) have announced a collaboration designed to support biopharmaceutical companies in generating RWE and improving patient access. The partnership combines Datavant’s data connectivity and privacy technologies with UBC’s capabilities in observational research, specialty therapies, and patient access programs.
A new €27 million public–private partnership, led by Erasmus University Rotterdam and Pfizer, has launched to develop an internationally aligned framework for applying patient-centered endpoints in clinical research, regulatory review, and HTA.
The second round of Medicare drug price negotiations under the Inflation Reduction Act sets new reference points for fifteen widely used therapies. The update offers insight into how CMS is applying the statutory framework and how these decisions may shape future pricing, evidence generation, and innovation.
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