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iPSC Therapies Make History: Japan Authorizes World’s First Two iPSC-based Cell Therapies
The world recently witnessed the approval of the world’s first two iPSC-derived medicines, as Japan’s health ministry panel authorized their commercialization. The approved therapies are ReHeart, developed by Cuorips Inc., a regenerative medicine company spun out of research at Osaka University, and Amchepry, developed by Sumitomo Pharma Co., Ltd. in collaboration with Racthera. ReHeart is for the treatment of severe heart failure and Amchepry is for the treatment of patients with Parkinson’s disease. |
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GMP Working Cell Banks to Accelerate MSC & Exosome Therapies into the Clinic
Save critical time and valuable resources while ensuring your path to clinical implementation by utilizing a consistent supply of high-volume, well-characterized working cell banks. Available from multiple tissues and donors, RoosterBio’s Xeno-Free CliniControl™ MSCs are manufactured in compliance with current Good Manufacturing Practices, supported by US FDA Type II Master Files, and designed to help you bypass the major costs and risks of GMP cell bank manufacturing.
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REPROCELL Introduces StemEdit Platform AI-Designed Genome Editors & Hypoimmune iPSC Lines
REPROCELL has launched StemEdit, a comprehensive gene editing platform for iPSCs and newly engineered iPSC lines enabled by OpenCRISPR-1™, an AI-designed genome editing system. The platform integrates high-fidelity genome engineering with predictive off-target modelling, designed to support research, translational development and future clinical applications. StemEdit enables a seamless transition from research-grade to clinical-grade iPSC lines.
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Nucleus Biologics Launches Krakatoa® K500: A Pod-Based, On-Demand Media and Buffer Manufacturing System Transforming Scale Bioproduction
Nucleus Biologics, a leading provider of custom cell culture solutions and manufacturing technologies for advanced therapies, announced the launch of Krakatoa® K500, the first bioreactor-scale, pod-based media and buffer manufacturing system designed to deliver sterile solutions on demand and at point-of-use. The system enables the co-location of cell culture media and buffer manufacturing and bioproduction. |
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Cytonome Congratulates Sumitomo Pharma on Regulatory Approval for Regenerative Medicine Therapy for Parkinson’s disease
Cytonome-ST congratulated Sumitomo Pharma Co., Ltd. following the company’s announced receipt of regulatory approval for the world’s first iPS cell-derived regenerative medicine for the treatment of Parkinson’s disease. Over the past decade, Cytonome’s GigaSort® microfluidic cell isolation platform has been used within the program’s manufacturing workflow to support purification and enrichment steps that allow gentle, consistent cell processing at commercial scale for the first time. |
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I Peace Announces Successful Generation of Human iPS Cells from NKT Cells and Commences Their Availability
Leading GMP cell therapy CDMO I Peace, Inc., specializing in iPSCs and iPSC-derived cell therapies, has successfully generated human iPSCs from NKT cells and has begun offering them for research use. NKT cells are immune cells known to possess characteristics of both innate and adaptive immunity and to play important roles in cancer, infectious diseases, autoimmune disorders, and other conditions. The establishment of iPS cells derived from NKT cells is expected to significantly advance research in regenerative medicine and cancer therapy based on immune mechanisms.
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Green Elephant Biotech Introduces Archimedes® One, the First Dynamic Adherent Bioreactor for Cell Therapy Manufacturing
Green Elephant Biotech announced the market introduction of Archimedes® One, the first system in a new category called the Dynamic Adherent Bioreactor. The company is introducing the platform to the market ahead of its planned commercial launch later this year. Archimedes® One was developed to address a central challenge in cell therapy manufacturing: how to scale adherent cell processes without compromising biology or introducing unnecessary complexity. |
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BioLife Solutions Signs Multi-Year Supply Agreement with Qkine Limited to Expand its Product Portfolio into the Rapidly Growing Cytokines Market
BioLife Solutions (NASDAQ: BLFS), a leading developer and supplier of bioproduction tools and services for the cell and gene therapy (CGT) market, entered into a multi-year supply agreement with Qkine Limited under which BioLife will distribute certain cytokine and growth factor products manufactured by Qkine for use in CGT manufacturing. The agreement provides BioLife with exclusive worldwide distribution rights to specific Qkine products for the CGT market and non-exclusive rights to Qkine products in the CGT market. |
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Longevity Medical Institute® Opens Federally Licensed Stem Cell and Regenerative Medicine Biotechnology Laboratory in Los Cabos
Longevity Medical Institute® announced the opening of its federally licensed Stem Cell and Regenerative Medicine Biotechnology Laboratory, further expanding what is now one of the most comprehensive regenerative and advanced diagnostic medical campuses in Los Cabos. Operating under full federal COFEPRIS licensure, Mexico’s national health regulatory authority, Longevity Medical Institute® is the only facility in Los Cabos holding federal authorization for stem cell administration and regenerative medicine services, including an ISO-certified biotechnology laboratory operating on-site. |
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Gilead Sciences to Acquire Arcellx a Staggering $7.8 Billion CAR-T Cell Therapy Deal
Gilead Sciences has announced a definitive agreement to acquire Arcellx in a transaction valued at a staggering $7.8 billion, providing Gilead with full ownership of anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR-T therapy for patients with relapsed or refractory multiple myeloma. Arcellx is a clinical-stage biotech company headquartered in Rockville, Maryland, founded in 2014. |
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Eli Lilly Commits Up to $2.4B to Orna Therapeutics in Major Bet on In Vivo CAR-T
Eli Lilly has revealed plans to acquire Orna Therapeutics for up to $2.4 billion, a truly astounding price tag. The move marks a decisive step toward the next generation of cell therapy: programming immune cells directly inside the patient rather than manufacturing them outside the body. Across the past year, this transaction also fits into a larger and accelerating industry pattern: big pharmaceutical companies are actively building positions in in vivo cell engineering. |
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10 Biotherapies Books From AABB To Add To Your Reading List In 2026
There is no better time to put together your biotherapies reading list for 2026! In partnership with AABB (Association for the Advancement of Blood & Biotherapies), BioInformant shares 10 must-have technical resources and guides for biotherapies enthusiasts. |
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Longevity Medical Institute® Publishes Systematic Review of Stem Cell Safety Based on Landmark Human Clinical Trials
Physicians and scientists from Longevity Medical Institute® have published new peer-reviewed research examining the safety of allogeneic mesenchymal stem cell therapies across a broad range of human clinical indications. The study, titled “Safety of Allogeneic Mesenchymal Stromal Cell Therapy Across Human Clinical Indications: A Systematic Review of Landmark Clinical Trials and Published Safety Evidence,” reviewed more than 15 years of published human clinical research across more than 60 stem cell studies, approximately 4,000 patients, and multiple disease categories.
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TriHaz Solutions Opens New Chattanooga, Tennessee Facility to Expand Regulated Medical Waste Services Across the Southeast
TriHaz Solutions, a trusted provider of regulated medical waste management, is proud to announce the opening of a new operational facility in Chattanooga, Tennessee. This expansion strengthens TriHaz’s ability to serve healthcare facilities, laboratories, and clinical operations throughout Chattanooga and surrounding Tennessee markets with reliable and fully compliant medical waste disposal services. |
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World-First EXO 001 Exosome Platform Enables In Vivo Multi-Target CAR-T for Solid Tumors
Cancer has long ranked among the leading causes of death in Taiwan, and solid tumors account for more than 90% of cancer cases worldwide—making them the most challenging frontier for CAR-T cell therapy. China Medical University Hospital (CMUH) announced that, in collaboration with Ever Supreme Bio Technology, it has successfully developed the world’s first EXO 001 targeted exosome platform, a breakthrough technology that enables direct in vivo programming of T cells to generate multi-target nanobody-based CAR-T cells.
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MEDIPOST Surpasses 330,000 Cord Blood Units Amid $140M Funding Boost
MEDIPOST Inc., the U.S. affiliate of South Korea‑based regenerative medicine and biotechnology company MEDIPOST Co., Ltd., have successfully closed a $140 million funding round aimed at accelerating late-stage clinical development and operational growth. The funds are intended to support MEDIPOST’s anticipated Phase III clinical trial of its allogeneic, umbilical cord blood-derived MSC therapy for symptomatic cartilage defects in knee osteoarthritis, as well as expansion of its scientific, manufacturing, and infrastructure capabilities. |
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FDA Grants RMAT to iRegene’s NouvNeu001, Making It World’s First iPSC Therapy with FTD and RMAT Recognitions
iRegene Therapeutics Co., Ltd., a biotech company pioneering chemically induced allogeneic cell therapy, announced that its lead product, NouvNeu001, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease (PD).
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Top iPSC Providers Transforming Preclinical Safety for Big Pharma
The pharmaceutical industry continues to grapple with preclinical and clinical safety issues, with toxicity remaining a leading cause of drug failure. Cardiovascular toxicity, in particular, stands out, accounting for approximately 40% of all drug withdrawals due to safety concerns. To mitigate these risks, human iPSC-derived cardiomyocytes (iPSC-CMs) have emerged as a critical tool for evaluating cardiac safety. Traditionally, most studies have relied on iPSC-CMs from one or two healthy donors, limiting the representation of broader population variability in the drug response.
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Longevity Medical Institute® Physicians and Scientists Publish Peer-Reviewed Research on Stem Cell Therapies for Diabetic Foot Ulcers
Physicians and scientists from Longevity Medical Institute® have published new peer-reviewed research examining the therapeutic potential of allogeneic mesenchymal stem cell therapies for diabetic foot ulcers, one of the most serious and difficult-to-treat complications of diabetes. The publication adds to the growing body of evidence supporting stem cell-based approaches in chronic wound care and reflects Longevity Medical Institute’s broader investment in clinical research, diagnostics, and regenerative medicine infrastructure.
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Big Pharma Makes M&A Moves to Secure Positions in In Vivo Cell Engineering
In recent months, a striking trend has emerged. Major pharma companies are racing to acquire in vivo cell engineering platforms, signaling that reprogramming cells inside the body has moved from speculative science to strategic priority. Recently, the field has transformed with AstraZeneca, AbbVie, Gilead’s Kite Pharma, and Bristol Myers Squibb all making acquisitions designed to accelerate their capabilities in in vivo cell therapy. Each deal highlights the growing importance of technologies that can directly engineer immune cells without removing them from the body.
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The Cultured Meat Industry is a Nascent Industry that is Scaling Fast
The cultured meat industry is a young but revolutionary industry, with the potential to change agricultural practices and human meat consumption as we know it. Cultured meat refers to meat created using cell culture techniques within a laboratory or manufacturing facility. It is produced by growing stem cells collected from cattle, chicken, pigs, fish, lamb, and other livestock and then differentiating them into the various meat components, such as muscle (myocytes) and fat (adipose) tissue. |
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The Remarkable Rise of iPSC-derived MSC Therapeutics: iMSCs
The rise of iPSC-derived mesenchymal stem cells (iMSCs) represents a significant evolution in regenerative medicine. iMSCs are generated by reprogramming adult somatic cells, typically fibroblasts, into induced pluripotent stem cells (iPSCs), which are then differentiated into mesenchymal stem cells (MSCs). This breakthrough technology offers several advantages over traditional MSC therapies, which are often derived from limited, patient-specific sources such as bone marrow or adipose tissue. |
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Gameto Licenses Foundational Meiosis IP from Harvard to Advance Human Ovary-in-a-Dish Platform
Gameto, a clinical-stage company advancing cell engineering solutions for women’s health, has exclusively licensed additional IP from Harvard University related to the induction of meiosis in human cells. Gameto’s platform uniquely integrates genetic engineering and organoid biology to model discrete and continuous stages of ovarian development from human iPSCs. The newly licensed meiosis IP further extends the platform’s ability to interrogate key developmental transitions.
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Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases
GelMEDIX Inc., a biotechnology company developing regenerative therapies to restore vision, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, entered a global partnership to access Catalent’s GMP-iPSCs and Catalent’s cell therapy manufacturing expertise and capabilities to support the development and clinical manufacturing of GelMEDIX’s iPSC-derived cell therapies to treat ocular and retinal diseases.
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[SALE] Global Induced Pluripotent Stem Cell (iPSC) Industry Report - Market Size, Trends, and Forecasts
In addition to companies developing iPSC-derived cell therapeutics, a growing number of companies are commercializing iPSC-based products across a wide range of applications, including drug discovery, disease modeling, toxicology testing, personalized medicine, tissue engineering, 3D bioprinting, and cultivated meat production. This report reveals critical industry findings, such as rates and types of scientific publications, clinical trials, patents, funding rounds, strategic partnerships, and M&A activity, while identifying leading global iPSC players. It also provides comprehensive Market Size Data segmented by Application, Technology, Cell Type, and Geography (North America, Europe, Asia-Pacific, and Rest of World), with forecasts through 2030.
For 48 hours only, you can claim this global strategic report for 20% off. |
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[SALE] Global CAR-T Cell Therapy Market – Market Size, Forecasts, Trials, and Trends, 2026
Since 2017, 13 CAR-T cell therapies have reached commercialization. Seven therapies have been approved by the U.S. FDA, after which approvals for them were issued in other major healthcare markets. This report presents market size data for the Global CAR-T Cell Therapy Market, segmented by Product, Geography, and Indication, with forecasts through 2032. It quantifies CAR-T funding activity, including licensing deals, collaborations, financing rounds, IPOs, and M&A transactions, as well as identifies leading global competitors within this fast-growing market. Additionally, it analyzes trends in CAR-T–related publications, patents, grants, and clinical trials, and presents critical insights designed to provide a competitive edge.
This week only, you can claim this global strategic report for 20% off. |
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[SALE] Global Regenerative Medicine Industry Database, 2026 - Featuring 1,920+ Companies
Regenerative medicine (RM) companies are continuing to multiply. There are now an astonishing 1,920+ companies developing RM products to advance human health. This database is designed to help you identify all known market participants in this fast-growing field, including competitors, collaborators, or acquisition targets. RM companies include those advancing stem cell therapies, cell and gene therapies, tissue engineering and biomaterials, direct cell reprogramming, exosome therapeutics, cellular scaffolds and matrices, 3D bioprinting, and more. For a limited time, you can claim it for $150 off. |
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Interested to learn about other market segments, such as MSCs, iPSCs, CAR-T cells, exosomes, cord blood, or the cell therapy industry at large?
To view all available products, explore the BIOINFORMANT SHOP. |
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