Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Accepts NDA for Insomnia Med Lemborexant, Target Date Set for Dec. 27
Eisai and its US partner Imbrium Therapeutics said on March 12 that the US FDA has accepted a new drug application for their insomnia treatment lemborexant, with the target action date under the Prescription Drug User Fee Act (PDUFA) set…
To read the full story
Related Article
- Eisai’s Insomnia Med Dayvigo Now Available in US
June 3, 2020
- Eisai’s Insomnia Drug Grabs US Approval, Japan Nod Expected Soon
December 24, 2019
- Eisai Seeks Japan Approval for Insomnia Med Lemborexant
March 8, 2019
- Insomnia Treatment Lemborexant Filed for US Approval: Eisai, Purdue Pharma
January 16, 2019
- Eisai’s Insomnia Treatment Lemborexant Smashes Primary Target in Long-Term PIII Study
October 18, 2018
BUSINESS
- Lunsumio Combo Hits PIII Goal in Follicular Lymphoma: Roche
September 18, 2026
- Padcev-Keytruda Gets CHMP Nod for Expanded MIBC Use
September 18, 2026
- SanBio Eyes October Start for Akuugo Treatment
September 18, 2026
- Toho Unit to Launch Pharma-Wholesaler Payment Service
September 18, 2026
- Astellas Names Marino General Counsel, Compliance Chief
September 18, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…