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 Clears Biktarvy, Trelegy, Dupixent Asthma Use; Actemra OK’ed for CAR-T Side Effect
February 25, 2019
- Takecab, Clozaril under PMDA Risk Review
February 25, 2019
- MHLW Panel OKs Pfizer’s Vyndaqel for Sakigake-Designated Use
February 22, 2019
- Vyvanse Clears MHLW Panel after a Hold; Approval Expected in March
February 22, 2019
- Japan Approves Label Expansions for Humira, Other Drugs
February 22, 2019
- MHLW Panel OKs AnGes’ Gene Therapy Collategene for Conditional Approval
February 21, 2019
- Kymriah in Line for Japan Approval Next Month as It Gets Key Panel Nod
February 21, 2019
- Japan to Roll Out Cost-Effectiveness Assessment Scheme in April
February 21, 2019
- MHLW Makes No Change to Drug Prices, but Corrects Pricing Coefficient after Wage Scandal, Sloppy Errors Also Found
February 21, 2019
- MHLW Acknowledges Need to Ponder Rules for “Regenerative Medicines”: Official
February 21, 2019
- Doctor Rep Calls for Discussion to Ensure Proper Use of Osteoporosis Treatment Evenity: Chuikyo
February 21, 2019
- Japan OKs Listing of Evenity, Tarlige, Epclusa, and More on Feb. 26
February 20, 2019
- Stemirac Fetches 15 Million Yen Price Tag, Peak Sales Put at 3.7 Billion Yen
February 20, 2019
- HSC Panel Discusses Data Standardization to Promote Use of Real World Data
February 19, 2019
- Japan Approves Symbicort Generics, Asthma Drug Stalwart Could Face Competition in June
February 15, 2019
- Chuikyo Issues Recommendation on October Tax Hike Medical Fee Revision; No Timeline for New Drug Price Announcement
February 14, 2019
- Label Revisions Ordered for PD-1 Inhibitors, Ibrance, Maviret, and More
February 13, 2019
- Kymriah Pre-Treatment Regimens Up for Review on Feb. 22
February 12, 2019
- MHLW Panel to Review Gilead’s Biktarvy, GSK’s Trelegy and More on Feb. 22
February 12, 2019
- MHLW Council Recognizes High Unmet Medical Needs for Busulfan, Octreotide
February 12, 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…