Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Mitsubishi Re-Files NeuroDerm’s Parkinson’s Drug in US
Mitsubishi Tanabe Pharma said on May 29 that the US FDA has accepted for review ND0612, a Parkinson’s therapy being developed by its Israeli subsidiary NeuroDerm. This comes one year after the rejection of the drug’s initial application in the…
To read the full story
Related Article
- FDA Again Rejects Mitsubishi Tanabe’s Parkinson’s Drug
October 24, 2025
- Mitsubishi Tanabe’s Parkinson’s Drug Accepted for EMA Review
February 25, 2025
- Mitsubishi to Take Another Stab at Parkinson’s Drug Submission in US
November 5, 2024
- US FDA Snubs Mitsubishi Tanabe’s Parkinson’s Drug
June 12, 2024
- NeuroDerm’s Parkinson’s Med Hits Main Goal in PIII
January 11, 2023
BUSINESS
- Nippon Kayaku Aims to Lift New Drug Sales Ratio to 30%, Bolsters Oncology Push
February 25, 2026
- Keio Spinoff Taps Nikon as CDMO, Targets 2027 Start for KP8011 Trial
February 25, 2026
- Astellas, Vir Strike Strategic Deal to Advance PSMA-Targeting TCE
February 25, 2026
- Nippon Shinyaku to Take Over UCB’s Fintepla in Japan from April
February 25, 2026
- Opdivo-Yervoy Expands Label for Colorectal Cancer in South Korea
February 25, 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…