Foreign investors are stepping up acquisitions of Japanese drug makers. Under the Foreign Exchange and Foreign Trade Act (FEFTA), such…
REGULATORY
Off-Label Use of Avigan Allowed for Ebola Treatment: Health Ministry Panel
A health ministry panel has effectively endorsed the off-label use of the influenza drug Avigan (favipiravir) in Japan to treat patients infected with the deadly Ebola virus. The panel of experts on infectious disease treatment agreed on October 24 that…
To read the full story
REGULATORY
- Japan OKs Biosimilars of Eylea, Actemra, Simponi, Ranmark in Likely First Debut
September 22, 2025
- MHLW Panel Endorses Rx-to-OTC Switch of Tadalafil in Japan
September 22, 2025
- Japan Approves Pluvicto, Izervay, and Lots More; Subcutaneous Rybrevant Not on Roster
September 22, 2025
- Amitiza, Shingrix under PMDA Safety Review
September 22, 2025
- Japan Extends Re-Examination Period for Nurtec, Dormicum
September 22, 2025
MSD’s new pulmonary arterial hypertension (PAH) therapy Airwin (sotatercept) hit the Japanese market in mid-August. It’s the kind of launch…
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…