The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
CSL Behring’s hereditary angioedema (HAE) treatment garadacimab and a label expansion for Chugai Pharmaceutical’s PD-L1 inhibitor Tecentriq (atezolizumab) cleared the review of a key health ministry panel on January 30. They are expected to be approved in late February under…
To read the full story
Related Article
- Japan Approves CSL’s HAE Med Andembry, Tecentriq Sarcoma Use, and More
February 21, 2025
- CSL’s HAE Drug, Tecentriq Up for Panel Review on Jan. 30; 1st Cases of Expedited Approval
January 17, 2025
- Humira Filed for nr-axSpA in Japan Based on Public Knowledge: AbbVie
September 2, 2024
- Japan to Increase Reimbursement Rounds to 7 Times a Year from 2025
May 16, 2024
- Sanofi Files Sarclisa as 1st-Line Quad Therapy for MM in Japan
May 15, 2024
- Tecentriq Filed for Alveolar Soft Part Sarcoma in Japan: Chugai
March 15, 2024
- Genmab Files Epkinly for Follicular Lymphoma Grade 1-3A in Japan
March 12, 2024
REGULATORY
- Japan to Cut Drug Prices by 0.86% in FY2026; Central Govt Savings Seen at 105 Billion Yen
December 25, 2025
- Japan Ministers Agree to Scrap “Spillover” Rule, Plan Wider CEA Price Cuts
December 25, 2025
- Japan Weighs Scrapping “Spillover” Rule in Shift from Draft Reform Outline
December 24, 2025
- Heparinoid, Allergy Drugs among OTC-Like Meds Up for Special Charge Rule
December 24, 2025
- Japan Hands Out Orphan Designation to 11 Drugs
December 24, 2025
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…