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REGULATORY
- 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
- 500 Billion Yen-Plus Annual Savings Expected from Generic Switches: Reiwa Rincho
December 5, 2023
- Japan Eyes Stronger OTC Sales Restrictions Due to Drug Abuse
December 4, 2023
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For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…