The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
REGULATORY
LDP Lawmakers Want Specific Definitions for Emergency Approval Prerequisites
Lawmakers of the ruling Liberal Democratic Party (LDP) are calling for more specific definitions for the concept of “emergencies” and “no alternative products,” which are terms used to describe prerequisites that would trigger the proposed emergency approval scheme in Japan.…
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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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