Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
REGULATORY
Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
Japan’s Ministry of Health, Labor and Welfare (MHLW) granted regulatory approvals for a long list of new medicines and label expansions on December 22. The roster includes Janssen Pharmaceutical’s (J&J) Rybrofaz (amivantamab + vorhyaluronidase alfa), a subcutaneous formulation of Rybrevant…
To read the full story
Related Article
- Imulrio Finally Set for NHI Listing after 296-Day Wait; Zero Rule Strikes Again
October 8, 2026
- Japan to List 1st Biosimilars for Xolair, Ranmark, Simponi on May 20
May 19, 2026
- Japan OKs Listing of Exdensur, Aquipta, Tukysa, and More; New Price Rules Applied to Two
April 9, 2026
- Santen Sets May Launch Date for Upneeq as Non-Reimbursed Drug
April 2, 2026
- Blenrep, Minjuvi, Zynyz, and More New Drugs Hit Japan Market
March 19, 2026
- Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
- GSK’s Exdensur, Lilly’s Inluriyo Missing from March Listing Roster
March 12, 2026
- MHLW Panel Green-Lights Approval for Kissei’s Uterine Fibroid Drug, 3 More NMEs
December 4, 2025
- Japan Panel Clears KalVista’s HAE Drug, GSK’s Asthma Agent, and More for Approval
November 28, 2025
- Shionogi/Sage’s Zurzuvae Clears MHLW Panel, Label Wording on Combo Use under Review
October 31, 2025
- Data Error Delayed Japan Review of Subcutaneous Rybrevant; Approval Still Expected This Year
October 30, 2025
REGULATORY
- PMDA Halts Medical Device Application Platform after Unauthorized Access
October 30, 2026
- Drug Makers Can Refuse Diabetes Drug Supply over Improper Prescribing: JFTC
October 30, 2026
- Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
October 29, 2026
- FY2027 Revision: HCPs Press for Action on Drug Shortages, Negative Margins
October 29, 2026
- Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
October 29, 2026
The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…