A novel regenerative medicine for a severe cardiovascular disease indication initially granted a conditional approval in Japan almost a decade ago has hit a roadblock due to challenges meeting the terms of this regulatory approach.
Japan Cell Therapy Hopes Hit By HeartSheet Full Approval Hurdles
Despite initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges in gaining full approval in Japan, potentially providing learnings for other developers of regenerative medicines.
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The latest in a long line of restructuring measures will see Sumitomo Pharma making a stepped sale of its pharma operations in Asia to major Japanese trading house Marubeni.
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Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.
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Move to acquire profitable Tokyo-based venture part of Japanese major's strategy of building a broader ecosystem for dementia detection and care.
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With two major deals since just the beginning of the year in Japan, private equity groups appear to be ramping up their presence in the country's biopharma sector, amid ongoing activity across the wider APAC region.
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RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
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Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.
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Heads of Novartis Biomedical, World Economic Forum and Indian majors like Sun Pharma’s SPARC, among others, discuss generative AI in drug discovery along with pointers for India to leapfrog the R&D process