The Japanese government on March 7 announced new NHI prices for the FY2025 drug price revision, effective April 1. With…
REGULATORY
BMS’ ROS1 Inhibitor, Janssen’s Bispecific Up for Review on Aug. 30
Bristol Myers Squibb’s ROS1 inhibitor repotrectinib and Janssen Pharmaceutical’s bispecific antibody amivantamab will come up for discussion by a key health ministry panel on August 30 over whether they should be granted regulatory approval in Japan. The Pharmaceutical Affairs Council’s…
To read the full story
Related Article
- Novavax COVID Vaccine to Be Adapted to JN.1 Strain: Takeda
June 10, 2024
- Keytruda/Padcev Filed in Japan for 1st Line Bladder Cancer Treatment: MSD, Astellas
February 1, 2024
- Janssen Files Bispecific Antibody Amivantamab for NSCLC in Japan
November 20, 2023
- AbbVie Japan Files Rinvoq 30 mg Regimen for Age 12-Plus Atopic Dermatitis Patients
November 16, 2023
- UCB Seeks Hidradenitis Suppurativa Nod for Bimzelx in Japan
November 13, 2023
- BMS Files Repotrectinib in Japan for ROS1-Positive NSCLC
October 26, 2023
REGULATORY
- Nitrosamine Detected in Sumitomo’s Arotinolol, but No Recall Planned
March 28, 2025
- Choseido’s Kawauchi Plant Suspended for 1 Month on GMP Violation
March 28, 2025
- Japan Approves J&J’s Lazcluze, Genmab’s Tivdak, and More
March 28, 2025
- Japan Won’t Ban Red No. 3 for Now but Asks Industry for Self-Inspections
March 27, 2025
- It’s Time to Review Conditional Approval System for Regenerative Medicines: MHLW Official
March 27, 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…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
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…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…