Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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
- Eylea Bio-AG to Carry DME Indication Missing from Fuji’s Biosimilar Label
December 5, 2025
- Forxiga Generics Launch in Japan at 33.6% of Originator Price: Sawai, T’s Pharma
December 5, 2025
- Vimpat Copies Hit Shelves at 35% of Originator Price as 10 Firms Flock to Market
December 5, 2025
- Keytruda Extends Japan Sales Lead to 26 Straight Months in November: Encise
December 5, 2025
- Meiji Pharma Takes Stake in Lyric Bio to Back Next-Gen IVIg Manufacturing
December 5, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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…