The Ministry of Health, Labor and Welfare (MHLW) on March 24 granted sakigake designation to two APIs - Chugai Pharmaceutical’s satralizumab and Lundbeck Japan’s Lu AF82422.Satralizumab snagged the status for two proposed indications, autoimmune encephalitis and myelin oligodendrocyte glycoprotein antibody-associated…
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REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





