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
- 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…