Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Eisai Resubmits Ultra-High Dose Mecobalamin in Japan for ALS
Eisai said on January 26 that it has re-filed its ultra-high dose formulation of mecobalamin in Japan for the indication of amyotrophic lateral sclerosis (ALS). The company had pulled an application for the product in 2016 due to additional trial…
To read the full story
Related Article
- Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
August 28, 2024
- High-Dose Mecobalamin Now in Line to Become Japan’s 1st ALS Med in 9-Plus Years
August 28, 2024
- Eisai’s ALS Therapy, Amgen’s TED Drug Up for Review on Aug. 26
August 19, 2024
- Eisai Sets to File Ultra-High Dose Mecobalamin for ALS in Japan
May 11, 2022
- Eisai Withdraws Japan NDA for Ultra-High Dose Mecobalamin for ALS
March 24, 2016
- Eisai Files Ultra-High Dose Mecobalamin for ALS in Japan
May 29, 2015
BUSINESS
- Sanofi Eyes Double-Digit Annual Growth for Japan Vaccine Business: Exec
May 20, 2026
- Takeda Hit with Massive Damages Verdict in US Amitiza Antitrust Case
May 20, 2026
- Top Generic Makers Grow Sales on Higher Output, Shipment Recovery
May 20, 2026
- Tapinarof Cream Logs Positive Data in Infant Atopic Dermatitis: Shionogi
May 20, 2026
- Bayer Files FXIa Inhibitor Asundexian in Japan
May 20, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…