Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Rexulti Snags US Approval for Alzheimer’s Agitation: Otsuka/Lundbeck
Otsuka Pharmaceutical and Lundbeck said on May 11 that they have won US approval for a label expansion for their atypical antipsychotic Rexulti (brexpiprazole), making it the country’s first drug indicated for agitation associated with Alzheimer’s dementia (AAD). The label…
To read the full story
Related Article
- Rexulti Makes Mark in Japan PIII Study for Alzheimer’s Agitation: Otsuka
June 28, 2023
- Rexulti Backed by FDA Advisors for Alzheimer’s Agitation: Otsuka/Lundbeck
April 18, 2023
- US FDA Accepts Rexulti sNDA for Alzheimer’s Agitation: Otsuka/Lundbeck
January 11, 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
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…