News from Friday, December 19, 2025
Articles
FDA Loosens Restrictions on Using Patient-Level RWD in Medical Device Submissions
(12/18, Joanne S. Eglovitch, Regulatory Focus) reports “...The move acknowledges the position of sponsors and data scientists that meaningful information can be derived from certain big data sources that do not catalog individual-level personal information. FDA reviewers will now assess the strength of submitted RWE on an application-by-application basis.” Full
Long-Term IL-17 Data and Real-World Comparisons: Preventing PsA in Psoriasis
(12/19, Andrew Dorizas and Saakshi Khattri, HCP Live) reports “...In this episode, the panelists discuss long-term IL-17 data and real-world evidence on preventing psoriatic arthritis (PsA) in patients with psoriasis. They highlight results from the five-year secukinumab study presented at ACR Convergence 2025, which showed that 97.9% of psoriasis patients treated with secukinumab did not develop PsA over the study period.” Full
Clinical Research Demands Agile CROs
(12/19, Dinkar Sindhu, PharmaPhorum) reports “...In short, agility is no longer a desirable capability; it is fundamental to scientific and commercial success...Agencies worldwide are encouraging adaptive trial designs, diversity in enrolment, and earlier incorporation of real-world evidence. Global regulatory coordination requires responsiveness to emerging guidance and varying regional timelines.” Full
Press Releases
Johnson & Johnson Backs HRS Registry to Advance Real-World Evidence in PFA
(12/19, Johnson & Johnson) “...‘We’re sponsoring this registry to enable real-world data generation at scale across the industry to shape the future of AFib ablation. By complementing our own evidence-generation registries and studies with this data platform, we aim to shape best practices, guide continued innovation and ultimately improve outcomes for more people living with AFib,’ said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, Johnson & Johnson MedTech.” Full
Thermo Fisher Scientific Launches PPD CorEvitas Alzheimer’s Disease Registry to Advance Real-World Evidence in Neurodegenerative Care
(12/18, Thermo Fisher) “...‘The launch of this registry reflects the power of collaboration between clinicians, industry partners and scientific leaders to accelerate progress in Alzheimer’s disease research,’ said Peter Wahl, Sc.D, vice president and global head of scientific affairs for PPD CorEvitas Clinical Registries, Thermo Fisher Scientific. ‘Together, we are building a regulatory-grade, real-world evidence foundation that will help shape the understanding of current and next generation of therapies.’” Full
CorMedix Therapeutics Announces Positive Data From Ongoing Real World Evidence Study of DefenCath
(12/18, CorMedix) “...[CorMedix Therapeutics] announced interim results for the Company’s ongoing real-world evidence study being conducted in conjunction with U.S. Renal Care’s (USRC) use of DefenCath in adult hemodialysis patients with central venous catheters.” Full
Journals
Comparative Effectiveness of Ertapenem Versus Other Empirical Antibiotics in Elderly Patients With Complicated Intra-Abdominal Infection: A Real-World Inverse Probability of Treatment Weighting Study
Yao Sun, Yiming Guo, Haizhen Cui, Yueyao Jiang, and Qian Yu
December 19, 2025, Frontiers in Cellular and Infection Microbiology
Comparative Effectiveness of Linvoseltamab Versus Standard-of-Care (SOC) Treatment (Tx) in Real-World Patients (PTS) in the United States (US) With Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM).
Shajo Kumar
December 18, 2025, American Society of Clinical Oncology