The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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 Files Dupixent for CSU in Children Aged 2-11 in Japan
December 26, 2025
- Enhertu Wins 5th China Indication in HER2-Low/Ultralow Breast Cancer
December 26, 2025
- SymBio Bags Rights to Develop Antiviral Brincidofovir for Alzheimer’s
December 26, 2025
- Dayvigo Wins Triple Crown in November HP Promotion List: Intage
December 26, 2025
- Pharma Hails End to “Spillover” Rule, Vows to Keep Fighting Off-Year Cuts
December 25, 2025
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…