The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
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Study Group Recommends “Reference Groups,” Dose-Escalation Studies to Promote Development of Ultra-Orphan Drugs
A study group backed by the Ministry of Health, Labor and Welfare has issued guidance for promoting the development of “ultra-orphan drugs” for diseases that affect no more than around 1,000 people in Japan. Among other things, the study group,…
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PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
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