Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Subcutaneous Entyvio Wins US FDA Nod for Crohn’s Disease: Takeda
Takeda Pharmaceutical has snared US FDA approval for a label expansion of its Entyvio (vedolizumab) subcutaneous formulation for the maintenance treatment of Crohn’s disease, the company said. The FDA blessing was granted for Entyvio Pen, a single-dose prefilled pen version…
To read the full story
Related Article
- 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
- FDA Nixes Takeda’s Subcutaneous Entyvio Formulation
December 24, 2019
- Entyvio’s SC Form Accepted by US FDA for Review: Takeda
May 13, 2019
BUSINESS
- MSD Files Oral PCSK9 Inhibitor Enlicitide in Japan
September 15, 2026
- Takeda’s Zasocitinib Gets FDA Priority Review in Plaque Psoriasis
September 15, 2026
- CMIC Names CFO Yoshida as New President
September 15, 2026
- Eisai Teams with Osaka Prefecture on Dementia, MCI Awareness
September 15, 2026
- Enhertu PFS Hits 14.3 Months in PIII for 1st-Line NSCLC
September 15, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…