Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
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
- Regeneron Files MM Drug Linvoseltamab in Japan
November 6, 2026
- Fuji Pharma Recalls Eylea Biosimilar Lots over Faulty Finger Grips
November 6, 2026
- Medipal Sets Dec. 15 Shareholder Meeting, Opposes Chairman’s Ouster
November 6, 2026
- Nitrosamine Impurities Reported for Generic Telmisartan; No Recalls Planned
November 6, 2026
- Bracco Japan to Acquire Iopamiron from Bayer in July 2027
November 6, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…