Japan’s FY2024 pharmaceutical sales revealed a sharp divergence among immune checkpoint inhibitors as MSD’s Keytruda (pembrolizumab) surged toward the 200-billion-yen…
BUSINESS
Pfizer Pushes Back Champix Re-Supply Plan on Regulatory Delay
Pfizer Japan is postponing its re-supply of the smoking cessation aid Champix (varenicline), previously scheduled for the first half of 2025, due to stalling regulatory reviews. The suspension has been in place for already four years, and the issue looks…
To read the full story
Related Article
- 50% of Quit-Smoking Clinics Closed or Suspended, Will Champix Re-Supply Bring Them Back Online?
October 30, 2024
- Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply
September 2, 2024
- Nitrosamine Impurity Detected in Sitagliptin, Shipments in Japan to Continue with FDA-Set Limit: MSD/Ono
September 2, 2022
- Pfizer Continues to Halt Champix Shipments on Prolonged Fix of Manufacturing Process
August 24, 2022
- Pfizer Japan Recalling Some Champix Products after Detecting Carcinogen
July 29, 2021
BUSINESS
- Espha President Signals Move Toward Novel Drug Development amid Group Shift
July 11, 2025
- Izervay US Sales Reach 15.9 Billion Yen in April-June: Astellas
July 11, 2025
- Taiho’s DMD Drug TAS-205 Falls Short in PIII Trial
July 9, 2025
- JCR Licenses Gene Therapy Platform to Alexion
July 9, 2025
- Japan’s CAR-T Market Set to Double by 2030, Hitting 39 Billion Yen: Fuji Keizai
July 9, 2025
I recently attended a fantastic conference hosted by Prospection Japan, and one speaker, Dr. Joe Ledsam, really blew me away with his insights. He shared some truly fascinating developments about how AI is set to revolutionize healthcare, from how doctors…
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…