The Ministry of Health, Labor and Welfare (MHLW) on December 16 granted orphan drug designation for five APIs including Takeda Pharmaceutical’s maralixibat chloride.Maralixibat was designated for two rare liver disease indications - Alagille syndrome and progressive familial intrahepatic cholestasis.The four…
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REGULATORY
- Japan Panel to Review Kyowa Kirin’s Libmeldy for Approval on Nov. 9
November 4, 2026
- PMDA Sets Out AI Principles for Regulatory Activities, Stresses Human Oversight
November 4, 2026
- Public-Private Pharma Talks Expand to Domestic R&D, Manufacturing Investment
November 2, 2026
- Japan’s Healthcare Spending Hits Record 48.8 Trillion Yen in FY2024
November 2, 2026
- PMDA Renews Warning on Off-Label GLP-1 Use amid Adverse Event Reports
November 2, 2026
Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…





