Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
US FDA Accepts Rexulti sNDA for Alzheimer’s Agitation: Otsuka/Lundbeck
Otsuka Pharmaceutical and Lundbeck said on January 10 that the US FDA has accepted a supplementary new drug application (sNDA) for the atypical antipsychotic Rexulti (brexpiprazole) for use in the treatment of agitation associated with Alzheimer’s dementia. The application has…
To read the full story
Related Article
- Rexulti Makes Mark in Japan PIII Study for Alzheimer’s Agitation: Otsuka
June 28, 2023
- Rexulti Snags US Approval for Alzheimer’s Agitation: Otsuka/Lundbeck
May 12, 2023
- Rexulti Backed by FDA Advisors for Alzheimer’s Agitation: Otsuka/Lundbeck
April 18, 2023
- Brexpiprazole Cuts Alzheimer’s Agitation in PIII Study: Otsuka/Lundbeck
June 28, 2022
- Otsuka, Lundbeck to Carry On Multinational PIII of Brexpiprazole for Agitation in Alzheimer’s
April 14, 2021
BUSINESS
- Leqembi FY2025 Global Sales Reach 88 Billion Yen: Eisai
May 1, 2026
- Rohto Files CMV Corneal Endotheliitis Drug in Japan
May 1, 2026
- Mochida Files in Japan for PAH Drug Tyvaso DPI
May 1, 2026
- Tanabe Clinches EU Approval for Parkinson’s Drug Onerji
May 1, 2026
- 3D “Deeply Disappointed” by Toho Plan to Seek Defense Trigger Approval
May 1, 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…