The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
REGULATORY
Japan’s Amended Next-Gen Medical Infrastructure Law Takes Effect
The Diet-enacted amendment of the so-called next-generation medical infrastructure law was enforced on April 1, creating a new category of data called “pseudonymized medical information” with a view to its use in regulatory submissions. The amendment of the law, formally…
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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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