Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply
Pfizer has filed for a partial modification of the current regulatory approval for the smoking cessation aid Champix (varenicline) in Japan to change its manufacturing method with the aim of lifting the ongoing suspension of its shipments. The company submitted…
To read the full story
Related Article
- Pfizer Resumes Supply of Smoking Cessation Pill Champix after 4 Years
October 31, 2025
- Pfizer Pushes Back Champix Re-Supply Plan on Regulatory Delay
June 12, 2025
- 50% of Quit-Smoking Clinics Closed or Suspended, Will Champix Re-Supply Bring Them Back Online?
October 30, 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
- Viatris Recalls Sevoflurane Anesthetic over Manufacturing Deviation
August 3, 2026
- Belite Bio Japan Launches Stargardt Disease Awareness Initiative
August 3, 2026
- Otsuka Eyes 3.5 Trillion Yen Sales by 2035 on New Growth Drivers
August 3, 2026
- Daiichi Sankyo Cuts FY2027 Net Profit Outlook on Higher Tax Burden
August 3, 2026
- Kissei Slashes Tavneos Sales Forecast after Safety, Data Concerns
August 3, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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 all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…