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…
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REGULATORY
- MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
November 21, 2023
- Provide “One-Stop Services” to Facilitate Multiregional Clinical Trials: Expert
November 21, 2023
- 1st G-Lasta Biosimilar Gets Japan Listing, Stelara Follow-On Not on Roster
November 21, 2023
- LDP Study Group Submits Proposal for FY2024 Reform, Urges Boosted Drug Price Premiums at Launch
November 21, 2023
- MOF Panel Renews Call for Full Execution of Annual Price Cuts, Urges LLP Copay Review: Budget Proposal
November 21, 2023
- Pilot Sales of Emergency Contraceptives without Prescription to Start on Nov. 28
November 20, 2023
- Japan to Adopt Generic Company Indices for Drug Pricing on Pilot Basis from FY2024
November 20, 2023
- Pharma Fiercely Opposes Proposed CEA Cut into Drug Base Price: Chuikyo Hearing
November 20, 2023
- Japan Agrees to Buy 1.4 Million Doses of Daiichi Sankyo’s COVID Vaccine
November 17, 2023
- LDP Raises Stable Drug Supply as Major Topic of FY2024 Budget Formulation
November 17, 2023
- Meiji’s mRNA Vaccine, Daiichi’s XBB.1.5 Jab Up for Nov. 27 PAFSC Session
November 17, 2023
- Chuikyo Agrees to Adopt Normal Rules to Price, Re-Price Leqembi
November 16, 2023
- Listing OK’ed for Phesgo, Leqvio, Epkinly, and More; 30 Billion-Plus Yen Peak Sales for 3 Meds
November 16, 2023
- Vyvgart to Get 7.8% Price Cut, Tiny Reductions for Dysval, Retevmo: CEA
November 16, 2023
- Imfinzi Faces Price Slash of 25%, Polivy 15% in February: Quarterly Re-Pricing
November 16, 2023
- Wegovy Lands Reimbursement Listing in Japan 8 Months after Approval
November 16, 2023
- MHLW Plans Joint Surprise Onsite Inspections by PMDA and Prefectural Govts
November 16, 2023
- MHLW Panel Pins Hope on PMDA’s Overseas Offices to Foster Global Appeal of Japan Market
November 16, 2023
- LDP Pharma Study Group Calls for Expanding Sakigake Premium, Creating New Premium
November 15, 2023
- Industry Can’t Endure Further Price Cuts for Creating Savings: LDP Health Affairs Chief
November 14, 2023
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Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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…
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…