Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Entyvio’s SC Form Accepted by US FDA for Review: Takeda
Takeda Pharmaceutical said on May 10 that the US FDA has accepted a biologics license application for a subcutaneous (SC) formulation of its inflammatory bowel disease treatment Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis (UC).…
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
- FDA Nixes Takeda’s Subcutaneous Entyvio Formulation
December 24, 2019
- Takeda Seeks Japan Approval for Entyvio SC Form
August 9, 2019
BUSINESS
- Pharma Earnings Season Kicks Off; Off-Year Impact, Overseas Trends in Focus
April 24, 2026
- Gilead Files Trodelvy-Keytruda Combo for 1L TNBC in Japan
April 24, 2026
- Co-Promotions Dominate in Oncology, Diabetes Alliances: Fuji Keizai
April 24, 2026
- Medii, Pediatric Neurology Society Build System to Support Elevidys Use
April 24, 2026
- Oncolys’ OBP-301 Wins US Fast Track Designation
April 24, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…