The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
Mitsuaki Kamata, director general of the Pharmaceutical Safety and Environmental Health Bureau, urged Novartis Pharma to seriously reflect on its flaws in the review process for sakigake-designated Zolgensma (onasemnogene abeparvovec) whose approval was delayed. The company’s products should be made…
To read the full story
Related Article
- Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
December 4, 2020
- Japan Rolls Out Full-Fledged Sakigake System, Designations 2 Times a Year with Tougher Revocation Rules
September 1, 2020
- Will Zolgensma Delay Spur Revision of Sakigake Designation System?
June 11, 2020
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
REGULATORY
- Japan to Cut Drug Prices by 0.86% in FY2026; Central Govt Savings Seen at 105 Billion Yen
December 25, 2025
- Japan Growth Strategy Council to Set Up Drug Discovery Working Group
December 25, 2025
- Japan Ministers Agree to Scrap “Spillover” Rule, Plan Wider CEA Price Cuts
December 25, 2025
- Takeda Plans January Rollout of Overseas Plasma-Derived Ig amid Suspension
December 25, 2025
- Japan Panel OKs Label Warning Update for Labor Inducers to Mention Epidural Births
December 25, 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…