Nitrosamine Impurity Detected in Sitagliptin, Shipments in Japan to Continue with FDA-Set Limit: MSD/Ono
To read the full story
Related Article
- 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
- Asahi Kasei Offshoot to Develop Cancer Vaccine Using Proprietary DDS Base
October 11, 2024
- Ono Snags Worldwide Rights to LigaChem’s ADC Assets
October 11, 2024
- Incubation JV of Takeda, Astellas, SMBC Boots Up in Japan
October 11, 2024
- Opdivo Approved for 1st Line Bladder Cancer Use in Taiwan: Ono
October 11, 2024
- Meiji Rebuts Nursing Group’s Claim on Concerns over Kostaive
October 10, 2024
It’s easy to spot motivated and engaged employees. They are more productive, they go the extra mile, and they display a sense of ownership in their work.But how do you replicate this culture throughout your organization? How do you encourage…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…