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Latest From Eisai Co., Ltd.

No Korea-Originated New Drugs Approved Domestically In 2023

Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.

South Korea Approvals

Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development

Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.

Reimbursement Rare Diseases

Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings

Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.

Japan Pricing Debate

Medicare Spending Forecast For Leqembi Reflects CMS Angst About Alzheimer’s Drug Costs

The agency’s projection that Medicare will spend $3.5bn on Leqembi in 2025 is nearly three times the level of sales that marketer Eisai is expecting for the drug in North and South America combined in its fiscal year 2026.

Reimbursement Medicare
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    • EA Pharma Co., Ltd.
    • Eisai China Inc
    • Eisai Laboratorios
    • Eisai Mexico
    • Eisai Participacoes Ltda. (Brazil Subsidiary)
    • H3 Biomedicine
    • HI-Eisai Pharmaceutical Inc.
    • Jingyi Weixiang (Shanghai) Health Industry Development Limited
    • Liaoning TianYi Biological Pharmaceutical Co., Ltd.
    • KAN Research Institute, Inc.
    • MGI Pharma, Inc.
    • Morphotek, Inc.
    • Zycos Inc.
    • Eisai Vietnam Co., Ltd.
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