Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- 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
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
- LDP Study Group’s Honebuto Proposal Urges “Freeze” on On-Patent Drug Price Cuts
May 20, 2026
- PMDA Flags Iron Products, ST Combination Drug in Risk Review
May 20, 2026
- MHLW Orders Detailed Report on Tavneos Efficacy Concerns
May 20, 2026
- Japan Approves Jascayd, mNEXSPIKE, Zepbound OSA Use, Others
May 19, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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…