Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
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
- 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
- Japan Biotechs to Be Hit Hard by TSE Growth Market Reform, 26 Firms Fail to Reach Proposed Threshold
April 11, 2025
- Kaken Bags Japan Commercial Rights to KalVista’s HAE Drug
April 10, 2025
- KM Biologic President to Be Promoted to Meiji Group’s Pharma Chief
April 9, 2025
- Daiichi Sankyo’s Datroway Approved in Europe for Breast Cancer
April 9, 2025
- JCR to Fuel Licensing of J-Brain Cargo, Invest in Global R&D: President
April 9, 2025
Your company’s employer brand is your reputation as an employer and is crucial in attracting top talent. Some reputations are just not good; they may or not be deserved. That is just the perception in the market. Years ago there…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…