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71
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监管机构数
成立时间
1971
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1
1.4%
招募中
67
94.4%
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1
1.4%
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2.8%
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- eXmoor Pharma and KU Leuven have established a strategic partnership to support a new cell and gene therapy hub, focusing on accelerating AAV gene therapies from bench to first-in-human trials. - The collaboration will develop a proprietary AAV producer cell line, build a scalable platform process, and provide comprehensive CMC support, combining KU Leuven's academic innovation with eXmoor's manufacturing expertise. - This alliance aims to address critical bottlenecks in gene therapy development by streamlining translation pathways and ensuring cost-effective, scalable vector production for promising therapeutic candidates.
- Two major clinical trials demonstrate that hybrid closed-loop insulin delivery systems significantly improve time in range and reduce hypoglycemia in pregnant women with type 1 diabetes compared to standard care. - The CRISTAL trial found the MiniMed 780G system reduced time below range by nearly half and improved overnight glycemic control, while also showing potential cost-effectiveness through reduced hospitalizations. - A separate multicenter trial using Control-IQ Technology showed even more dramatic results, with 12.6 percentage points greater time in range and 11.2 mg/dL lower mean glucose levels. - Both studies suggest hybrid closed-loop therapy provides critical safety benefits during pregnancy, with reduced severe hypoglycemia hospitalizations and improved treatment satisfaction for mothers.
- KU Leuven and UZ Leuven are investing €14 million to establish an Advanced Therapy Medicinal Products (ATMP) facility on the Gasthuisberg campus, scheduled to be operational by late 2025. - The facility aims to develop personalized cell and gene therapies at significantly lower costs than pharmaceutical companies, with projects focusing on rare pediatric diseases, CAR-T cell therapy for leukemia, and a glioblastoma cancer vaccine. - By keeping expertise and production in-house within the public domain, the facility expects to bring treatments to clinical trials for approximately €5 million, compared to the €25-50 million typically required by pharmaceutical companies.