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BioJapan 2023: Japan invests in bio clusters to foster global innovation

Oct. 12, 2023
By Tamra Sami
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Japan’s economy has remained stagnant for the last few decades, and Prime Minister Fumio Kishida has heralded the biotech industry as a strategic industry to attract global partners, which was also one of the expectations for the BioJapan 2023 conference held Oct. 10-12 in Yokohama, drawing attendees from more than 37 countries and was the first live biotech industry event that welcomed foreigners since the COVID-19 pandemic.
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Neurology/Psychiatric

Novel 15-PGDH inhibitor improves muscle force in models of SMA and muscle atrophy

Oct. 11, 2023
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It has been previously demonstrated that therapeutic inhibition of the prostaglandin E2 (PGE2)-degrading enzyme, 15-prostaglandin dehydrogenase (15-PGDH), was able to improve muscle strength in aged mice. Researchers from Epirium Bio Inc. have now reported the discovery and preclinical characterization an orally bioavailable small molecule inhibitor of 15-PGDH – MF-300 – being developed for the treatment of neuromuscular dysfunction.
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Laptop displaying FDA logo
2023 Med Tech Conference

PCCP concept at risk of being subsumed in debate over artificial intelligence

Oct. 10, 2023
By Mark McCarty
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The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
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2023 Med Tech Conference

Advamed’s Whitaker more bullish on VALID Act in light of FDA draft rule for LDTs

Oct. 10, 2023
By Mark McCarty
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The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.


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