Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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REGULATORY
- Health Ministry Shares Views on PI Studies for Japanese Patients
October 29, 2014
- Risk of Fulminant Hepatitis Added to Lyrica Package Insert: MHLW
October 29, 2014
- PAFSC Second Committee Backs Approval of Janssen’s Combination Tablet for HIV
October 28, 2014
- Off-Label Use of Avigan Allowed for Ebola Treatment: Health Ministry Panel
October 28, 2014
- Janssen Ordered to Issue Blue Letter on Sovriad after Three Deaths
October 28, 2014
- MHLW Official Says Price Settlement Rate Apparently Topped 90% at End of Sept., but Annual Revisions Unrealistic for “Exhausted” Wholesalers
October 28, 2014
- Cultured Epidermal Autograft JACE Recommended for Orphan Designation
October 27, 2014
- Health Ministry Panel Agrees to Regulate Clinical Research by Law
October 24, 2014
- MHLW Orders Revision of Package Insert for Xtandi
October 24, 2014
- MHLW Orders Revision of Package Inserts for Acetaminophen
October 24, 2014
- Trade Groups Seek Insurance Coverage for Conditionally Approved Regenerative Medicine Products
October 24, 2014
- Chuikyo OKs New Review Organs for Regenerative Medicines and Medical Devices under Senshin-Iryo System
October 24, 2014
- Chuikyo Begins Discussions on Patient-Initiated Mixed-Care System
October 24, 2014
- Online Document Filings for Healthcare Product Import/Export Possible from November
October 23, 2014
- Shiozaki Sounds Positive about Fact-Finding Study for Yearly NHI Price Cuts
October 23, 2014
- NIBIO, PMDA Join Hands in Advisory Services to Bring Academic Seeds to Market
October 22, 2014
- Editor’s Pick: Five Healthcare News Headlines for October 6 - October 17
October 21, 2014
- Takeda Takes Over Development of Glatiramer Acetate from Teva: Official
October 21, 2014
- Health Ministry Eyes Future Genomic Data Registration at National Medical Centers
October 21, 2014
- Applications Based on the Revised PAL to Be Accepted from Nov. 25
October 17, 2014
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Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
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…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…