Clinical Research Focus. 49th Edition

NIH Ends Use of Human Fetal Tissue in Funded Research, Shifts to Next-Generation Models

In January 2026, the NIH announced a major policy change to phase out the use of human fetal tissue in NIH-supported research. The agency will prioritize validated alternative models, including organoids, iPSC-based systems, and advanced in vitro and in silico approaches, reshaping future biomedical and translational research.

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After JPM 2026: Where Healthcare Strategy Is Actually Heading

In this article, Vlad Bogin, MD, FACP, CEO of Cromos Pharma, analyzes the signals that mattered most after the conference, where capital is truly flowing, why execution quality now outweighs ambition, how AI, GLP-1 therapies, and platform-based oncology strategies are evolving, and what these changes mean for clinical development decisions in 2026.

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Clinical Research in 2026: What Changed — and Why It Matters

The uncertainty of the past year has become the new baseline, reshaping how trials are designed, funded, and executed. Rather than reacting to volatility, sponsors and CROs are making more deliberate choices about where to invest, how to manage risk, and what it truly takes for a clinical program to move forward. This article examines the forces that will define clinical research in 2026, and how they are already changing expectations around trial design, data, and execution.

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EMA and FDA Agree on Common Principles for AI in Medicines Development

In January 2026, the EMA and FDA jointly announced ten guiding principles for the use of artificial intelligence across the drug developement lifecycle. The framework aims to support safe, ethical, and aligned AI practices in research, clinical trials, manufacturing, and post-market monitoring, strengthening international regulatory collaboration.

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2025’s Top Clinical Trials: Closing a Transformative Year in Medicine

2025 was not just a year of positive trials. It was defined by effect sizes and disease-modifying signals already shaping clinical decisions. Across oncology, cardiometabolic, liver, and rare diseases, several late-stage studies stood out for resetting expectations, setting new standards of care or delivering progress where little existed before. In this article, we highlight the studies that marked genuine momentum in drug development and clinical impact.

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Moderna & MSD Report Durable 5-Year Recurrence-Free Survival With Personalized Cancer Vaccine + Keytruda

Moderna and MSD (Merck outside the U.S.) announced five-year follow-up data from the Phase 2b KEYNOTE-942 study showing that their personalized mRNA cancer vaccine (intismeran autogene) combined with Keytruda significantly improved recurrence-free survival in high-risk melanoma patients compared with Keytruda alone, thus reducing the risk of recurrence or death by about 49%.

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Akeso’s PD-1/CTLA-4 Bispecific Antibody Cadonilimab Shows Survival Benefit in Frontline Gastric Cancer

Akeso’s bispecific immune checkpoint inhibitor cadonilimab, targeting both PD-1 and CTLA-4, combined with chemotherapy demonstrated significant improvements in overall survival and progression-free survival compared with chemotherapy alone in first-line treatment of advanced, HER2-negative gastric or gastroesophageal junction adenocarcinoma, including in patients with low PD-L1 expression, which is aa key advancement in immunotherapy approaches for this patient population

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NICE Recommends Obinutuzumab Plus Mycophenolate for Severe Lupus Nephritis

The UK’s National Institute for Health and Care Excellence (NICE) has recommended the combination of obinutuzumab with mycophenolate mofetil for adults with active severe lupus nephritis, after clinical evidence showed higher rates of normal or near-normal kidney function compared with standard therapy. This guidance offers a new treatment option for thousands of patients and could prevent long-term kidney damage and the need for dialysis or transplant.

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