Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Tolvaptan Re-Submitted to US FDA for ADPKD: Otsuka
Otsuka Pharmaceutical said on November 5 that its vasopressin V2 receptor antagonist tolvaptan was re-submitted to the US FDA for the treatment of autosomal dominant polycystic kidney disease (ADPKD) four years after the regulator rejected the drug, requesting additional data.…
To read the full story
Related Article
- Otsuka’s Jynarque Earns FDA Nod for ADPKD at Second Attempt
April 26, 2018
- US FDA Requests Additional Data for Tolvaptan for Treatment of ADPKD: Otsuka
September 2, 2013
- US FDA Advisory Committee Votes Against Approval of Tolvaptan for Treatment of ADPKD
August 8, 2013
- FDA Accepts Otsuka Tolvaptan NDA for Priority Review
April 17, 2013
BUSINESS
- DMD Gene Therapy Elevidys Hits Japan Market at Record Price
February 20, 2026
- Bayer Eyes Kerendia as Standard Therapy for CKM Syndrome
February 20, 2026
- Enhertu Accepted for EU Review in Post-Neoadjuvant HER2 Breast Cancer
February 20, 2026
- SymBio Receives Grant for Antiviral Brincidofovir
February 20, 2026
- Over 40% of Breast Surgeons Largely Unaware of Clinical Trials: Survey
February 20, 2026
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…