Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Astellas’ Pompe Gene Therapy Trial Hit with FDA Clinical Hold
Astellas Pharma said on June 27 that the US FDA has placed a clinical hold on a PI/II trial for AT845, its investigational gene therapy for Pompe disease, after one study participant experienced a serious adverse event of peripheral sensory…
To read the full story
Related Article
- Astellas Presents Update on PI/II Study of AT845 for Late-Onset Pompe Disease
February 27, 2023
- US FDA Lifts Clinical Hold of Astellas’ Pompe Gene Therapy
January 23, 2023
- Astellas to Test Selecta’s IgG Protease with Pompe Gene Therapy
January 11, 2023
BUSINESS
- Sanofi Debuts Sarclisa SC, Cutting Dosing Time
August 28, 2026
- Daiichi Starts Global PIII of Datroway in Adjuvant Urothelial Cancer
August 28, 2026
- FDA Accepts Kowa’s Glaucoma Drug K-911 for Review
August 28, 2026
- Hokuriku Downpours Cripple Some Drug Deliveries; Wholesalers Report No Damage
August 28, 2026
- Shionogi, Susmed End Sales Partnership for Insomnia App
August 27, 2026
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…