Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Gilead Japan to Seek Early Remdesivir Filing If Initial Data Prove Positive: Development Chief
Gilead Sciences is poised to seek an early submission in Japan for its investigational antiviral remdesivir for the treatment of COVID-19 if it can confirm the drug’s safety and efficacy in initial trial data covering 1,000 people, Masa Omote, head…
To read the full story
Related Article
- PMDA Updates Veklury Label to Allow Its Use in Moderate COVID-19
January 8, 2021
- Check Latest Info and Make Careful Decision on Veklury Use: PMDA Review Report
May 19, 2020
- Chuikyo OKs Special Mixed Care Scheme for Veklury
May 11, 2020
- Japan Approves Remdesivir as First Drug for COVID-19
May 8, 2020
- Gilead Japan Expected to Offer Remdesivir for Free for Now
May 7, 2020
- Gilead Files Remdesivir for COVID-19 in Japan
May 4, 2020
- Japan Likely to Take FDA’s Anticipated EUA as Cue for “Special” Remdesivir OK
May 1, 2020
- Japan to Quickly Utilize “Special Approval” Scheme for Remdesivir after It’s OK’ed Overseas: Minister
April 30, 2020
- Japan Might Approve Gilead’s Remdesivir for COVID-19 in May
April 28, 2020
- Gilead Launches PIII Remdesivir Trials for COVID-19 in Japan
April 15, 2020
- Gilead-Sponsored Remdesivir Trial Expected to Start This Month: Minister
April 3, 2020
- Japan to Join NIH-Sponsored COVID-19 Trial for Gilead’s Remdesivir
March 24, 2020
- Gilead Launches PIII Studies for Remdesivir for COVID-19, Japan Included
February 28, 2020
BUSINESS
- Half of Drug Makers Reluctantly Support G1 Rule Overhaul: Jiho Survey
March 12, 2026
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…