Clinical Trials
6
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
2
33.3%
Not yet recruiting
4
66.7%
No approval data available
- FUJIFILM Cellular Dynamics opened a new 175,000-square-foot headquarters and iPSC manufacturing facility in Madison, Wisconsin, as part of a $200 million strategic investment by Fujifilm. - The facility is expected to quadruple the company's manufacturing capacity for iPSC-based research products and expand capabilities for next-generation cell therapy development. - The expansion addresses growing demand from pharmaceutical companies for new approach methods (NAMs) in drug discovery as regulatory guidance shifts away from animal testing. - The facility integrates state-of-the-art capabilities including cell culture manufacturing laboratories, process development laboratories, and a center of excellence for gene editing.
- FUJIFILM Toyama Chemical received manufacturing and marketing approval in Japan for SAVYSCUS® Injection, the first regenerative medical product approved for meniscal injury under the Pharmaceutical and Medical Device Act. - The therapy uses autologous synovial mesenchymal stem cells to treat meniscal injuries that would otherwise require meniscectomy, offering a meniscus-preserving treatment option. - Phase III trial results showed statistically significant improvement in Lysholm knee scores from 38.1 to 91.6 at 52 weeks, with 35.7% of patients achieving complete healing in the avascular central meniscus region. - The approval addresses an unmet medical need, as approximately 50,000 meniscal surgeries are performed annually in Japan, with half involving meniscectomy that increases long-term osteoarthritis risk.
- Fujifilm Corporation has developed an innovative screening methodology for cyclic peptides that exhibit high affinity toward membrane proteins, particularly targeting challenging multi-pass transmembrane proteins. - The new technology overcomes previous limitations by designing peptide libraries with mRNA tags resistant to degradation in cell culture media, enabling direct screening on living cells. - Fujifilm successfully demonstrated the platform's effectiveness by identifying peptides that specifically bind to G protein-coupled receptors (GPCRs), a class of multi-pass transmembrane proteins. - The breakthrough is expected to significantly expand drug discovery possibilities for membrane protein targets that have been challenging for conventional peptide discovery methods.
- VALANX Biotech raised €3 million from new investors including Foundation Fournier-Majoie and FUJIFILM Corporation to advance its lead ADC program VLX-ADC-001 targeting LIV-1 for metastatic triple-negative breast cancer. - The company's proprietary GoldenSite™ platform enables precise and reproducible conjugation at defined sites on antibodies, potentially improving therapeutic outcomes and safety profiles compared to conventional ADC approaches. - Candidate selection for VLX-ADC-001 is planned for June 2026, with funding also supporting GMP readiness and partnership activities for the conjugation platform technology. - The investment highlights growing European interest in ADC development, with the field attracting significant financing as companies address key challenges including toxicity control and conjugation optimization.
- Fujifilm Corporation announced the completion of one of Japan's largest bio CDMO facilities at its Toyama Second Factory, marking the company's first antibody drug manufacturing plant in Japan. - The new facility features 2 x 5,000-liter mammalian cell culture bioreactors, which are among the world's largest single-use bioreactors, along with 2 x 2,000-liter bioreactors for biopharmaceutical production. - The plant will become operational in 2027 and will serve as Fujifilm's bio CDMO hub in Asia, offering end-to-end manufacturing services for antibody drugs and antibody-drug conjugates. - The facility has been selected by Japan's Ministry of Economy, Trade, and Industry for dual-use capability, allowing it to manufacture biopharmaceuticals during normal times and switch to vaccine production during pandemics.
- Emulate and FUJIFILM Cellular Dynamics have launched the Brain-Chip R1, a first-in-class isogenic model of the human neurovascular unit designed to study blood-brain barrier drug transport and neuroinflammation. - The platform integrates five human iPSC-derived cell types into a dynamic microenvironment, addressing the critical challenge that more than 99% of potential CNS therapies fail due to inadequate preclinical models. - The Brain-Chip R1 offers ready-to-use cells and streamlined workflows that enable researchers to generate more robust, reproducible data for CNS drug candidates with enhanced human relevance.
- Fujifilm and HORIBA have co-developed the industry's first continuous electroporation technology that enhances gene delivery efficiency by approximately 100 times compared to conventional chemical transfection methods. - The novel gene delivery system addresses manufacturing challenges in the rapidly growing gene therapy market, which is projected to expand at a 30% compound annual growth rate through 2030. - HORIBA plans to commercialize the finalized device globally by 2026 or later, targeting North American and European markets where gene therapy demand is particularly high. - The continuous electroporation technology uses precisely controlled electrical pulses to create pores in cell membranes, enabling direct gene delivery and offering flexible throughput from small to large-scale production.
- Fujifilm has successfully validated peptide-oligonucleotide conjugates that selectively target cancer cells, utilizing cyclic peptides from their proprietary library containing trillions of variants. - The company developed a cyclic peptide that binds strongly to integrins overexpressed on cancer cell surfaces with a low dissociation constant of 1.6 nM, enabling higher cellular uptake compared to non-conjugated oligonucleotides. - This breakthrough addresses delivery challenges in oligonucleotide-based therapies and will be presented at TIDES USA 2025 in San Diego, highlighting Fujifilm's expansion of global drug discovery services for peptide therapeutics.
