Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
REGULATORY
Xocova, Astellas’s Gastric Cancer Med Up for PAFSC Review on March 4; Pfizer’s Bispecific, RSV Jab Also on Agenda
A key Japanese health ministry panel will discuss regulatory approval for a throng of new medicines on March 4, including whether to grant full traditional clearance for Shionogi’s oral COVID-19 drug Xocova (ensitrelvir). Xocova is one of the eight new…
To read the full story
Related Article
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 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
- Japan Approves Zepbound, Qalsody, and Lots More Drugs
December 27, 2024
- Quality Assurance and Lag/Loss Fight to Form Pillars of PMD Act Amendment
December 27, 2024
- LDP Members Urge Ministers to End “Mechanical” Off-Year Price Cuts
December 27, 2024
- Japan to Set Up Fund to Spur Generic Shakeup; CEA, Market Expansion Re-Pricing on Agenda
December 26, 2024
- Gist of FY2025 Drug Price Revision
December 26, 2024
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…
Takeda Pharmaceutical’s overseas sales ratio has reached 90.9%, exceeding 90% for the first time though only in the first half…
In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
A Japanese health ministry panel on November 28 agreed on a plan to legally require pharma companies to set up…
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving 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…