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REGULATORY
- MHLW Reports 1st Mpox Death in Japan, Man in 30s
December 14, 2023
- Panel Discusses Potential Waiver of Japanese Trials for Ultra-Orphan Medicines
December 14, 2023
- 120 APIs/Specs to Get Higher-than-Peer Prices with Generic Company Indicators: MHLW Simulation
December 14, 2023
- Shionogi’s Novel Antibiotic Fetroja Gets Fast-Track Listing for Dec. 20
December 14, 2023
- Koshiro Slapped with 40-Day Biz Suspension over GMP Violations
December 14, 2023
- MHLW Evaluation Panel Won’t Discuss Rx-to-OTC Switches for Injectable Drugs
December 13, 2023
- Sales of Patented Drugs to Be Excluded from “Innovation Box” Tax Relief Scheme
December 13, 2023
- Leqembi OK’ed for Listing on Dec. 20; Peak Sales Put at 98.6 Billion Yen
December 13, 2023
- Panel Snubs Outline of Guidelines for Supply Info Reporting, Production Requests Due to Lack of Explanations
December 12, 2023
- Japan Reform Minister Calls for Roadmap to Eliminate “Switch Lags” in 3 Years
December 12, 2023
- Ultragenyx’s Evinacumab, Alexion’s Danicopan in Line for Japan Approval
December 11, 2023
- Japan Panel OKs Basic Plan for Elective Care Scheme for LLPs; 900 APIs Targeted
December 11, 2023
- Will R&D Tax Credit Be Scaled Back with “Innovation Box” Rollout? Political Settlement Likely
December 8, 2023
- Sawai’s Revlimid Generic, BMS’ AG Now Available; Trerief AG Launch Set for Feb. 20
December 8, 2023
- Japan Diet Enacts Bill to Lift Ban on Cannabis-Derived Drugs
December 8, 2023
- First Generics for 5 APIs to Join NHI Price List; No Entries for Januvia, Zytiga
December 7, 2023
- JPWA Calls for Permanent Mechanism to Shore Up Drug Prices
December 7, 2023
- Pharma Industry Backs MHLW Proposal to Scrap PMP Indicators: Chuikyo Hearing
December 7, 2023
- CEFP Discusses Social Security Reform Timeline, No Surprises for Pharma Measures
December 6, 2023
- Authorized Generics Cannot be Regulated Now but Must Be Watched Closely: MHLW Panel Members
December 5, 2023
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