News on non-animal methods
FEBRUARY 23 - 27, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Japan endorses two iPSC-derived drugs for approval
Japan, through a Ministry of Health committee, is backing the first positive approval recommendations worldwide (under the Conditional Early Approval pathway) for two allogenic (from human donors) cell therapies derived from induced pluripotent stem cells (iPSCs).
The two drugs are ReHeart, developed by the Osaka University-based start-up Cuorips, intended for patients with severe heart failure, and Amchepry, developed by Sumitomo Pharma and Racthera, indicated for Parkinson’s disease. ReHeart uses sheets of cardiac muscle derived from human iPSCs applied to the surface of the heart to promote the formation of new blood vessels and the recovery of cardiac function. Amchepry uses iPCs cells differentiated into dopaminergic neuronal progenitors, injected into the patient’s brain ; showing dopamine release and improvements in motor function.
2. European Research Area Act public consultation closes with strong stakeholder engagement
The European Commission closed the public consultation on the European Research Area (ERA) Act on 23 January 2026. The consultation drew strong interest from across Europe and beyond. In total, 735 contributions and 117 position papers were submitted, with responses coming from all 27 EU Member States, 8 Associated Countries to Horizon Europe and 15 non-EU countries. Participation was particularly high among academic and research institutions (45%), followed by EU citizens (24%).
Ekaterina Zaharieva, European Commissioner for Startups, Research, and Innovation, said: “Europe cannot afford a research system that is fragmented or held back by borders. Our goal is to give researchers and innovators the freedom and the conditions they need to succeed anywhere in Europe. The strong response to this consultation shows clear support for this direction and will directly shape the next steps of this initiative.”
3. Building trust in the integration of AI into CRA: Findings from the 2024 ECETOC workshop
Artificial Intelligence (AI) is increasingly influencing chemical risk assessment (CRA), enabling faster, more comprehensive, and potentially more ethical assessments. In October 2024, ECETOC held an international workshop, with experts from academia, industry, and regulatory bodies, to reflect upon the historical challenges in integrating multidimensional omics technologies into chemical regulation and explore the current capabilities and future potential of AI in toxicology and regulatory science.
Among the key takeaways from the workshop presentations and breakout groups discussions: AI enhances but does not currently replace human judgment in risk assessment; Generative and predictive AI offer complementary functions in toxicology; Governance frameworks must evolve rapidly to keep pace with AI development, particularly for generative models; Lessons from Omics data analysis and regulatory acceptance can inform responsible AI integration and acceptance…
INTERVIEWS, NOMINATIONS & AWARDS
4. Interview: How digital pathology and AI are helping validate complex in vitro models
One of the most exciting updates to emerge at DP&AI (Digital Pathology and AI Congress): Europe 2025 was around complex in vitro models (CIVMs). In one compelling presentation, Luisa Bell, Neuropathology scientist at Roche, demonstrated how CIVMs offer an unprecedented opportunity to support enhanced preclinical to clinical translation by generating high-quality mechanistic data in human in vitro models. Alongside fellow researcher Nadine Stokar, Bell elaborates on a new digital pathology approach for preclinical toxicity testing using blood-brain barrier (BBB) organoids.
5. FNIH: NAMs Pilot Projects selection
The Foundation for the NIH (FNIH) has selected four innovative, human-based research platforms for development into pilot projects to help advance New Approach Methodologies (NAMs) through the Validation and Qualification Network, a public-private partnership that’s currently in the design phase.
The four pilot projects aim to validate and qualify the selected NAMs through existing national and international standards and processes: Developmental Neurotoxicity; Acute Oral Toxicity; Inhalation Toxicity; Preterm Birth Risk. The FNIH will now assemble project development teams — including key public and private partners from government, academia, life sciences companies, and others — to validate each platform.
TOOLS, PLATFORMS, CALLS
6. Innovate UK funding: Alternative models for drug development
The UK is accelerating a major shift away from animal testing and towards human‑relevant, technologically advanced approaches to drug development. To translate this national ambition into real world capability, Innovate UK, working in partnership with the National Centre for the 3Rs (NC3Rs), is launching a two phase competition designed to deliver the next-generation of validated non-animal PK/pharmacodynamics and cardiovascular safety assays, positioning UK innovators to compete in a rapidly expanding global market.
Phase 1, opening 2 March, will focus on developing technical and commercial feasibility: generating early evidence, refining methods and showing a credible pathway toward broader adoption. Phase 2 will support the most promising projects to move toward development and real world applicability.
7. Launch of the CoARA Collection: A community-owned library of tools for reform
As a coalition built on collective action and mutual learning, the Coalition to Advance Research Assessment (CoARA)‘s key communities, including Working Groups, National Chapters, and Cascade Funding beneficiaries, have been developing tools and resources over the past three years, since the launch of CoARA. These resources serve as the foundation for the CoARA Collection: a community-owned resource library that consolidates tools to support institutions in their reform journeys, putting CoARA Commitments into action.
First presented to members at the CoARA General Assembly in December 2025, the Collection is now open to the wider research community. It brings together the first outputs developed by CoARA Working Groups, alongside foundational third-party resources that informed the Agreement on Reforming Research Assessment (ARRA). Thetypes of documents in the CoARA Collection are actionable policy documents & evidence-based review documents.
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INDUSTRY, BIOTECH & PARTNERSHIPS
8. Roche opens new high-tech innovation center in Bavaria
Roche opens one of the world’s most modern development centers for diagnostics in Penzberg, data-driven, automated and sustainable. Roche has invested around 300 million euros in the new 23,000 square meter building since construction began in February 2022. The high-tech building is part of Roche’s long-term investment agenda in Germany.
In this center, Roche is working on highly innovative in vitro diagnostics for the fields of neurology, e.g. Alzheimer’s and multiple sclerosis, cardiovascular diseases and infectious diseases, as well as on specific test procedures for personalized medicine. “Our investment in Penzberg is a clear commitment to Germany as a business and science location,” says Thomas Schinecker, CEO of the Roche Group. “By bringing research ideas to market faster, we are specifically strengthening Europe’s competitiveness.”
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. Paralysis treatment heals lab-grown human spinal cord organoids
Damage to the spinal cord can lead to irreversible paralysis and loss of sensory function, but translation of preclinical therapies remains elusive. Northwestern University scientists have developed the most advanced organoid model for human spinal cord injury (SCI) to date.
For the first time, the scientists demonstrated that human spinal cord organoids can accurately mimic the key effects of SCI, including cell death, inflammation and glial scarring. The human spinal cord organoid models developed in this new study could accelerate the discovery of therapies to treat severe SCI and possibly damage of other central nervous system tissues owing to trauma or disease.
Read the article in Nature Biomedical Engineering
10. Patient-Derived 3D bioprinted cardiac organoid and key pathological features of Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration that significantly reduces the quality of life and lifespan of patients. Currently, cardiomyopathy represents the leading cause of death in later stages of the disease. While calcium dysregulation, fibrosis, and fat deposits are well-documented hallmarks of DMD cardiomyopathies, the exact pathogenic mechanisms remain unclear due to the lack of reliable models.
In a recent study, researchers developed 3D cardiac organoids (COs) from DMD patient-derived induced pluripotent stem cells (DMD-hiPSCs). By day 15 of cardiac differentiation, DMD-COs exhibited key disease features, and by day 14 post-bioprinting, DMD-bCOs showed increased cell death and dysregulated expression of cardiac and fibrotic markers, mimicking DMD-associated cardiomyopathy.. This study demonstrates the potential of both COs and bioprinted-COs as a tool for studying DMD cardiomyopathy and advancing drug screening and therapies.
Read the article in Advanced Healthcare Materials
11. Parkinson’s disease patient-specific striatum organoids show hallmarks of increased inflammation
In Parkinson’s disease (PD), dopaminergic neuron terminals degenerate in the striatum, leading to dopamine depletion, which in turn causes alterations in the basal ganglia circuits, essential for movement control. However, the reasons for dopaminergic neuron terminal degeneration in the striatum are still not understood.
The LRRK2 gene is highly expressed in the striatum, and the LRRK2-G2019S mutation is one of the most common mutations associated with PD. A recent study aimed to examine the phenotypic differences between healthy and patient striatum organoids carrying the LRRK2-G2019S mutation and revealed that striatum organoids recapitulate PD-relevant inflammation phenotypes autonomously, independent of dopaminergic input.
Read the article in Movement Disorders
