The global race to develop so-called “double G” and “triple G” agonists is heating up to boost the efficacy of…
REGULATORY
Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
A key Japanese health ministry panel on March 4 gave the thumbs-up to the approval of Astellas Pharma’s zolbetuximab, a first-in-class anti- Claudin 18.2 (CLDN18.2) monoclonal antibody, two months after the US FDA declined its application over manufacturing issues. Zolbetuximab…
To read the full story
Related Article
- FDA Accepts Re-Filing of Astellas’ Gastric Cancer Med for Review
June 3, 2024
- Xocova, Astellas’s Gastric Cancer Med Up for PAFSC Review on March 4; Pfizer’s Bispecific, RSV Jab Also on Agenda
February 20, 2024
- FDA Rejects Astellas’ Gastric Cancer Med over Manufacturing Issues
January 10, 2024
- AstraZeneca Seeks Label Expansion for Synagis in Japan
July 4, 2023
- Pfizer Japan Files BCMA Bispecific Elranatamab for MM
June 30, 2023
- Astellas Files Zolbetuximab for CLDN18.2-Positive Gastric Cancer in Japan
June 12, 2023
- Pfizer Japan Files RSV Vaccine for 60 Years of Age and Older
May 29, 2023
- Keytruda-Chemo Combo Filed for 1st Line Gastric Cancer in Japan: MSD
May 15, 2023
- Pfizer Japan Files 20-Valent Pneumococcal Vaccine for Pediatric Use
March 31, 2023
- Pfizer Files Tick-Borne Encephalitis Vaccine in Japan
March 29, 2023
- AstraZeneca Files Anti-RSV Antibody Nirsevimab in Japan
March 1, 2023
REGULATORY
- Chuikyo to Discuss Potential Pricing Steps to Deal with Higher Costs of Japan-Made APIs
March 13, 2025
- MHLW to Extend NIP Period for MR Vaccines by 2 Years amid Shortage
March 13, 2025
- Chuikyo Rep Calls for Proper Use of Zepbound, Frets Expansion of Obesity Market
March 13, 2025
- Imdelltra, Balversa, 2 More New Drugs Skip March Listing
March 13, 2025
- Zepbound, Qalsody, and More New Drugs Set for Japan Listing on March 19
March 13, 2025
1. Build a Strong Employer BrandFirst up, let’s talk about your employer brand. Think of it as your company’s personality and reputation. In Japan’s competitive pharmaceutical and medical device industry, it’s crucial to stand out. You need to showcase your…
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…