The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
REGULATORY
Regulators Will Be Involved in Safety Data Transition for LLP Withdrawals: MHLW Official
Regulatory authorities will be involved in efforts to ensure the smooth transition of safety information and other data when original drug makers decide to pull their long-listed products (LLPs) off the market under a newly proposed LLP rule, a health…
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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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