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
- MHLW Panel OKs Bayer’s Xtandi Rival, AbbVie’s JAK Inhibitor; 2 More Keytruda Usages Now in Line for Approval
November 26, 2019
- MHLW Panel Members Call for Need to “at Least Discuss” Whether to Resume Actively Recommending HPV Vaccines
November 26, 2019
- Plaintiffs of HPV Vaccine Suits Prod JMA to Hear Stories of Victims
November 26, 2019
- MHLW Floats 2 Rules to Address Unreasonable Price Rises for Listed Generics
November 26, 2019
- Xolair’s Pollen Allergy Nod Delayed as Novartis Says It Needs More Time to Prepare for Launch
November 25, 2019
- Chuikyo Members Remain Divided over Timing of Comparator PMP Removal
November 25, 2019
- MHLW Wants to Subject Innovative Add’l Use to PMP, but No Price Raise
November 25, 2019
- MHLW Wants to Ease Unfairness Concerns by Adding New Innovation Gauge to PMP Company Criteria
November 25, 2019
- Industry Urges Careful Approach to Creating Special Rule for Indication Change Re-Pricing: Chuikyo
November 25, 2019
- Japan Approves Add’l Indications for Taltz, Lucentis and More
November 25, 2019
- No Change to Essential Drug Rule in 2020 Reform: MHLW
November 25, 2019
- MHLW Proposes Earlier Price Cuts for Off-Patent Drugs with 80%-Plus Gx Rates, but Chuikyo Questions 2-Year Grace Period
November 25, 2019
- MHLW Proposes Continued Discussions for Cell & Gene Therapy Pricing
November 25, 2019
- PIC/S Reports State of Discussions on Data Integrity Guidance in Japan Meeting: MHLW
November 25, 2019
- US, European Pharma Groups Push LDP to Expedite Vaccine Policies
November 22, 2019
- Upper House Panel Discusses PMD Law Amendment Bill, Another Session Set for Nov. 26
November 22, 2019
- MHLW Proposes 3-Stage Plan to Develop Systems to Promote Genomic Medicine for Intractable Diseases
November 22, 2019
- Chuikyo Discussing Admission Fee for Schizophrenia Patients on Drug Clozapine, Eyeing Transition to Home
November 21, 2019
- MHLW to Propose “Special Rule” for Indication Change Re-Pricing
November 21, 2019
- Japan Grants Orphan Status to Tepotinib and More
November 20, 2019
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Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…