Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Nitrosamine Impurity Detected in Sitagliptin, Shipments in Japan to Continue with FDA-Set Limit: MSD/Ono
MSD said on September 1 that a nitrosamine impurity, Nitroso-STG-19 (NTTP), has been detected in its diabetes drugs Januvia (sitagliptin) and Sujanu (sitagliptin + ipragliflozin). A similar announcement was made by Ono Pharmaceutical the same day for Glactiv (sitagliptin). Both…
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
- Japan Study Finds No Evidence of Increased Cancer Risk for Sitagliptin
September 3, 2024
- Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply
September 2, 2024
- Manufacturing Change OK’ed for Januvia, Glactiv to Address Nitrosamine Impurities
February 13, 2024
- Sitagliptin Increases Cancer Risk in 1 in 115,000 People with Current Global Impurity Limit: Makers
September 22, 2023
- Pfizer Assesses Cancer Risk from Amoxan as “Acceptable” at “1 in 200,000 People”
October 26, 2022
- Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks
September 1, 2022
- Pfizer Continues to Halt Champix Shipments on Prolonged Fix of Manufacturing Process
August 24, 2022
BUSINESS
- Takeda to Nominate CEO-Elect Kim to Board at June AGM
March 27, 2026
- Sephience Seen as Potential First-Line PKU Therapy: Professor
March 27, 2026
- Meiji Pharma, KM Biologics Begin PIII for 6-in-1 Vaccine
March 27, 2026
- J-TEC Files Dried Allogeneic Cultured Epidermis in Japan
March 27, 2026
- Pfizer Seeks Methotrexate Label Expansion for GVHD Prevention
March 27, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…
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…