Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- Japan to Simplify Screening for Third-Party Use of Highly Anonymous NDB Data
March 11, 2024
- Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
March 11, 2024
- Japanese Health Minister Cautions Public on Multiple Measles Outbreaks
March 11, 2024
- PMDA Looks to Rev Up Pediatric and Orphan Drug Initiatives in Next 5-Year Plan: Chief
March 11, 2024
- MHLW Urges Distribution at Fair Price for Unprofitable Products
March 8, 2024
- New Govt Forum to Compile Interim Report to Create Innovation Ecosystem
March 8, 2024
- COVID Vaccine Labels to Be Updated with Booster Use as Main Regimen
March 8, 2024
- Japan Cabinet OKs Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
March 7, 2024
- New Govt Forum for Fighting Drug Loss Should Devise Strategies for Honebuto: LDP Members
March 6, 2024
- Xocova Approval Meaningful, but Careful Use Should Continue: Minister
March 6, 2024
- Opdivo Faces 15% Slash in Spillover, Re-Pricing to Hit 23 Drugs in FY2024 Revision
March 5, 2024
- Drug Prices Cut by 4.67% in FY2024 Revision, 314 APIs to Keep Full Prices with PMP
March 5, 2024
- Shionogi’s COVID Pill Xocova Lands Standard Approval in Japan
March 5, 2024
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 2024
- MHLW to Ask All Generic Makers in Japan to Execute Self-Inspections
March 4, 2024
- Japan’s Revised Drug Distribution Guidelines Take Effect
March 4, 2024
- PMDA Reviewing Safety Risks for 4 CAR-T Therapies and More
March 4, 2024
- Generic Mergers, Product Consolidations Unlikely to Pose Antitrust Issue: FTC Official
March 1, 2024
- Chugai’s PNH Med, Takeda’s cTTP Therapy Now in Line for Japan Approval
March 1, 2024
- Hospitals, Pharmacies Must Also Join Effort in Improving Drug Distribution: Expert Panel Member
February 29, 2024
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The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…