The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
BUSINESS
Eisai Withdraws Japan NDA for Ultra-High Dose Mecobalamin for ALS
Eisai said on March 22 that it has withdrawn its new drug application (NDA) in Japan for an ultra-high dose preparation of mecobalamin for the treatment of amyotrophic lateral sclerosis (ALS).The Japanese major had submitted the NDA in May last…
To read the full story
Related Article
- High-Dose Mecobalamin Now in Line to Become Japan’s 1st ALS Med in 9-Plus Years
August 28, 2024
- Eisai Resubmits Ultra-High Dose Mecobalamin in Japan for ALS
January 29, 2024
- Eisai Sets to File Ultra-High Dose Mecobalamin for ALS in Japan
May 11, 2022
- Eisai Files Ultra-High Dose Mecobalamin for ALS in Japan
May 29, 2015
BUSINESS
- Daiichi Begins Global PIII of Enhertu in Adjuvant Endometrial Cancer Use
December 23, 2025
- Enhertu Wins US Breakthrough Tag in Post-Neoadjuvant HER2 Breast Cancer
December 23, 2025
- Teikoku to Market Medipost’s Knee OA Cell Therapy in Japan
December 22, 2025
- Clinigen Japan Adds 4 Products, Including Takeda’s Buccolam
December 22, 2025
- Meiji Backs US Incubator MBC BioLabs to Boost Open Innovation
December 22, 2025
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…