The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
BUSINESS
FDA Nixes Takeda’s Subcutaneous Entyvio Formulation
The US FDA has issued a complete response letter for a subcutaneous (SC) formulation of Takeda Pharmaceutical’s inflammatory bowel disease treatment Entyvio (vedolizumab), rejecting its approval as a maintenance therapy for moderate to severe active ulcerative colitis (UC). The Japanese…
To read the full story
Related Article
- Subcutaneous Entyvio Wins US FDA Nod for Crohn’s Disease: Takeda
April 22, 2024
- Entyvio Subcutaneous Form Approved in US: Takeda
September 29, 2023
- FDA Accepts for Review Takeda’s Entyvio SC Form for Crohn’s
September 15, 2023
- FDA Accepts BLA Re-Submission for Takeda’s Entyvio SC
May 1, 2023
- US Launch of Takeda’s Entyvio SC to Be Pushed Back to 2022
September 4, 2020
- Takeda’s Entyvio SC Form Approved in Europe
May 11, 2020
- Takeda’s Entyvio SC Form Hits Main Goal in PIII Crohn’s Disease Study
February 18, 2020
- Takeda Seeks Japan Approval for Entyvio SC Form
August 9, 2019
- Entyvio’s SC Form Accepted by US FDA for Review: Takeda
May 13, 2019
- Entyvio SC Form Now under EMA Review: Takeda
April 2, 2019
- Subcutaneous Vedolizumab Hits Primary Endpoint in PIII: Takeda
July 20, 2018
BUSINESS
- Sanofi Bets on Immunotherapy to Delay Onset of Type 1 Diabetes
December 19, 2025
- Japan’s 1st Eylea Biosimilar to Reach Market on January 7
December 19, 2025
- Padcev-Keytruda Pair Makes Mark in Cisplatin-Eligible MIBC: Astellas
December 19, 2025
- Daiichi Sets February Launch for Japan’s 1st OTC Morning-After Pill
December 19, 2025
- Takeda’s TYK2 Inhibitor Scores PIII Win in Psoriasis Trials, Tops Otezla on Key Metrics
December 19, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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…
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…