Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
HOME > REGULATORY
REGULATORY
- METI Seeks 5.1 Billion Yen in FY2020 to Develop Technology Platforms for Cell and Gene Therapies
September 2, 2019
- Astellas’ “Post-Nesp” Renal Anemia Drug Now in Line for September Approval, 1st Forteo Biosimilar Too
August 30, 2019
- MHLW Panel Puts a Hold on Possible World’s 1st OK for Ono’s Cancer Cachexia Drug
August 30, 2019
- Ultomiris Caught by CEA Rule despite Intractable Disease Indication: Chuikyo
August 29, 2019
- Tagrisso Gets 15% Re-Pricing, but Other EGFR Drugs Spared: Chuikyo
August 29, 2019
- MHLW Seeks Record 32.6 Trillion Yen Budget for FY2020
August 28, 2019
- Rozlytrek, Onpattro and Many More to Join NHI Price List on Sept. 4
August 28, 2019
- Gene Therapy Collategene Gets 600,000 Yen Price Tag, Peak Sales Put at 1.2 Billion Yen
August 28, 2019
- Public Knowledge-Based Filing OK’ed for Busulfex Use in Lymphoma HSCT
August 27, 2019
- Evenity under PMDA Risk Review
August 27, 2019
- Tagrisso to Face 15% Price Cut in November Because It Sold Too Well
August 27, 2019
- Japan Eyes 1st Revision in 15 Years for Cancer Drug Development Guidelines to Deal with Rare Subtypes, Tumor-Agnostic Indications
August 27, 2019
- AbbVie’s Venetoclax Now in Line for September OK; Tecentriq’s Breast Cancer Use, 2nd Biosimilars and More
August 26, 2019
- MHLW to Seek Budgets to Forge “Drugs for Specific Use” System for FY2020
August 23, 2019
- Japan to Set Up Dedicated Team to Expedite Review of Sakigake-Designated Cell/Gene Therapies
August 23, 2019
- Tecentriq Wins Japan Nod for SCLC as 1st Checkpoint Drug for This Use
August 23, 2019
- MHLW Orders Label Revision for Xeljanz to Add “Venous Thromboembolism” to ADR List
August 23, 2019
- MHLW Grants Orphan Status to Nippon Shinyaku’s DMD Med Viltolarsen
August 22, 2019
- No PMP for Tecentriq, but Prices Rise for All 5 Checkpoint Drugs in Tax Hike Re-Pricing
August 21, 2019
- MHLW Calls for Proper Price Negotiation after October Price Revision
August 21, 2019
ページ
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…