Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Gilead Files Truvada for HIV Prevention in Japan
Gilead Sciences said on February 28 that it has filed a public knowledge-based application for Truvada (emtricitabine + tenofovir disoproxil fumarate) for an additional indication of pre-exposure prophylaxis (PrEP) against HIV-1 infection. In Japan, the drug was approved in March…
To read the full story
Related Article
- Gilead Shelves Sunlenca’s PrEP Program in Japan as Coverage Issue Weighs
April 17, 2025
- Japan Approves Label Expansions for Alecensa, Nucala and More
August 29, 2024
- Takeda’s Fruzaqla in Line for Approval, Broader Labels for Truvada, Keytruda, Prevenar 20 Too
August 5, 2024
- Truvada Clears Preliminary Review for PrEP Use, but Coverage Not Granted
February 6, 2024
- Will Truvada Win Health Coverage as Japan’s First Drug for HIV Prevention?
February 5, 2024
- Council OKs Public-Knowledge Application for Truvada Use as PrEP for HIV
December 1, 2023
- HIV Groups Pin Hopes on MHLW’s Development Requests for Preventive Therapy
September 4, 2023
- Gilead to Take Over MA for HIV Franchise from JT on Dec. 1
September 3, 2019
BUSINESS
- Half of Drug Makers Reluctantly Support G1 Rule Overhaul: Jiho Survey
March 12, 2026
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
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…