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
- Alnylam’s RNAi Drug Now in Line for Japan Approval in June
May 29, 2019
- Japan’s 2nd Enbrel Biosimilar, Pfizer’s Herceptin Follow-On Get Listing
May 28, 2019
- Quizartinib Added to List of MHLW Panel Review on May 30
May 24, 2019
- LDP’s Life Science Study Group Eyes Enhancement of Databases, AMED Functions
May 23, 2019
- MHLW Approves Entyvio’s Crohn’s Disease Indication and More
May 23, 2019
- JPMA Prods Revamp of PMP, Launch Premiums, Comparator Selection Criteria towards 2020 Reform
May 22, 2019
- Minister Says Kymriah Pricing Appropriate Even with Low Cost Disclosure Ratio
May 22, 2019
- MHLW Planning to Launch Report System on Inappropriate Detailing Activity as Early as Summer
May 21, 2019
- Govt, Industry Share Views on Challenges in Data Use, Drug Pricing
May 21, 2019
- 74 Suspected Violations Found in Sales Reps’ Advertising Activities: MHLW
May 21, 2019
- Eli Lilly Ordered to Issue Blue Letter on Verzenio
May 20, 2019
- Kymriah’s Impact on Health Insurance Finances Limited for Now: Health Minister
May 20, 2019
- LDP Lawmaker Group Discusses Measures for APIs to Ensure Stable Generic Drug Supplies
May 17, 2019
- Chugai’s Entrectinib Up for Review for NTRK Tumors on May 30; Label Expansions for Lynparza, Cyramza Also on Agenda
May 17, 2019
- MHLW Compiles Optimal Promotion Guidelines for Kymriah
May 16, 2019
- Coefficients for Cost-Based Pricing Formula Updated: Chuikyo
May 16, 2019
- As Kymriah Fetches Highest List Price, Policymakers Talk over Difficulty in Cell Therapy Pricing
May 16, 2019
- Alnylam’s siRNA Drug Patisiran Up for MHLW Panel Review on May 28
May 16, 2019
- Japan OKs Listing of Trelegy, Erleada, and More; GSK’s COPD Hopeful to Face Cost-Effectiveness Analysis
May 15, 2019
- Opdivo to Face CEA-Based Price Tweaks on Aug. 1
May 15, 2019
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…