Clinical Trials
4
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2014
Active, not recruiting
1
25.0%
Completed
2
50.0%
Recruiting
1
25.0%
No approval data available
- FUJIFILM Biosciences and NextCell Pharma AB have launched a new commercial mesenchymal stromal cell research platform combining PRIME-XV MSC Expansion XSFM medium with NextCell-Cord RUO umbilical cord-derived cells. - The platform addresses key MSC research challenges including cell heterogeneity, immunocompatibility issues, and inefficient manufacturing processes through standardized, high-quality solutions. - NextCell-Cord RUO is available globally as a standalone product or bundled with FUJIFILM's media and reagents, supporting researchers in immunology, regenerative medicine, and cell therapy development. - This collaboration represents NextCell Pharma AB's first commercial product launch and strengthens FUJIFILM Biosciences' commitment to advancing life science solutions for academic, biotech, and pharmaceutical partners.
- Diamyd Medical's investigational antigen-specific immunotherapy for type 1 diabetes has been assigned the global non-proprietary name "retogatein" by the WHO's International Nonproprietary Names Programme and the United States Adopted Names Council. - Retogatein is designed to preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 genotype, which constitutes approximately 40% of patients with type 1 diabetes in Europe and the US. - The therapy is currently being evaluated in the pivotal Phase 3 DIAGNODE-3 trial and has received Orphan Drug and Fast Track designations from the FDA. - The INN/USAN designation provides a standardized global identifier for the active substance, recombinant human GAD65, facilitating consistent identification in scientific, clinical, and regulatory settings worldwide.
- Diamyd Medical has received patent grants from the Eurasian Patent Office and Hong Kong for insulin-based antigen treatment targeting individuals with type 1 diabetes carrying the HLA DR4-DQ8 genetic marker. - The company now holds comprehensive patent protection for precision medicine treatments covering up to 90% of type 1 diabetes patients through two genetic markers: HLA DR3-DQ2 and DR4-DQ8. - Patent protection extends until 2038 across key global markets including Europe, Eurasia, Hong Kong, and South Korea, strengthening the company's intellectual property portfolio. - The HLA DR3-DQ2 targeted therapy Diamyd® is currently in Phase 3 trials with FDA Fast Track Designation for both symptomatic and pre-symptomatic type 1 diabetes treatment.
- NextCell Pharma AB received a US patent for its MSC Prediction Algorithm, which predicts the efficacy of mesenchymal stromal cell therapy in individual patients with autoimmune diseases. - The patent covers innovative methodology for determining personalized treatment options based on in vitro laboratory assessments, particularly for conditions like type 1 diabetes. - This intellectual property strengthens NextCell's portfolio as it advances toward commercializing ProTrans, its flagship MSC-based drug product for autoimmune disorders. - The company's expanding patent portfolio includes granted protection in multiple jurisdictions for its allogeneic MSC composition and pending applications for CNS disorders and COVID-19 treatments.
- Diamyd Medical has raised approximately SEK 267 million ($25.5 million) through rights issues and a directed issue, receiving an additional SEK 1.6 million beyond previously announced figures. - The company's Phase III DIAGNODE-3 trial for Type 1 Diabetes has received Fast Track Designation from the FDA, allowing for an accelerated readout in March 2026. - Diamyd® is an antigen-specific immunotherapy targeting individuals with the HLA DR3-DQ2 genotype, which represents approximately 40% of Type 1 Diabetes patients in Europe and the US.
