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
- Xolair Faces 37.3% Price Slash, Keytruda 20.9% in April: MHLW
March 5, 2020
- MHLW Orders Package Insert Revisions to Eliminate Vaccination Interval Restriction
March 5, 2020
- Sandostatin Now Eligible for Health Coverage for Congenital Hyperinsulinemia
March 4, 2020
- Japan Mulling Legal Preparations to Declare State of Emergency over Coronavirus
March 4, 2020
- Japan Panel Says No to Nonprescription Switch for Domperidone, Menatetrenone; Decision Now Up for Public Comments
March 3, 2020
- MHLW to Announce New NHI Prices on March 5
March 3, 2020
- Senior Vice Health Minister, Parliamentary Secretary Test Negative for Coronavirus
March 3, 2020
- MHLW Panel Clears Latuda, 1st Japan-Originated Oligonucleotide; Approval Expected in March
March 2, 2020
- Daiichi Sankyo’s Enhertu Clears MHLW Panel, Conditional Nod Expected in March
February 27, 2020
- Rust in Needles in Sanofi’s ActHIB “Occurred Accidentally,” Supplies to Resume: MHLW
February 27, 2020
- Zolgensma Now in Line for Japan Approval in March, All Eyes Now Riveted on Price
February 27, 2020
- MHLW Orders Label Revisions for 9 Hep C Drugs
February 26, 2020
- Japan Plans to Reimburse Coronavirus Tests: Health Minister
February 26, 2020
- Japan Adopts Basic Plan against Novel Coronavirus
February 26, 2020
- Japan Approves Label Expansions for Rozlytrek, Alecensa and More
February 25, 2020
- MHLW Has to Decide Which Bureau Will Lead Formulary Push: Pharmacy Officer
February 21, 2020
- AMED to Fund Development of Coronavirus Diagnostics, Treatments, and Vaccines by NIID, Univ. of Tokyo
February 21, 2020
- Japan Panel to Review J-TEC’s Cell Product, Zolgensma on Feb. 26; Orphan Status for Luxturna Also Up for Discussion
February 20, 2020
- MHLW Looking to Build an “Integrated Pre- to Post-Marketing Assessment System”: Safety Division Chief
February 20, 2020
- MHLW Panel Backs Approval of Sakigake-Designated BNCT Radiation Therapy System
February 20, 2020
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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…