The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
REGULATORY
MHLW Weighs Another Business Improvement Order to Novartis
The Ministry of Health, Labor and Welfare (MHLW) is considering issuing another business improvement order to Novartis Pharma over delays in side effect reporting - this time caused by a system glitch - sources familiar with the matter told Jiho.…
To read the full story
Related Article
- Novartis Japan Told to Improve Business over Delayed Reporting of Nearly 5,500 ADRs
November 16, 2015
- Business Improvement Order Issued to Novartis Japan
November 13, 2015
- Novartis Fails to Report Nearly 5,500 Side Effect Cases, Biz Improvement Order Likely This Month
November 10, 2015
- Novartis Slapped with 15 Day Biz Suspension over Flawed ADR Reporting
February 27, 2015
- Improvement Order Issued to Novartis over Delayed ADR Reporting
August 1, 2014
REGULATORY
- 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
- Japan Eyes Priority Review for MCMs, Bill Submission Planned for 2027
October 28, 2026
- Panel Member Urges Review of Tavneos Blue Letter Timing
October 28, 2026
PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
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…