Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Rakuten Medical’s Photoimmunotherapy Filed in Japan, Subject to Conditional Early OK
Rakuten Medical’s ASP-1929, an antibody drug conjugate (ADC) that works on its unique “photoimmunotherapy” platform, is now under Japanese regulatory review for the treatment of recurrent head and neck cancer under the conditional, early approval pathway. The San Mateo, California-based…
To read the full story
Related Article
- Rakuten Medical Ratcheting Up Overseas Expansion Drive for Akalux: Japan Chief
April 25, 2024
- Rakuten Medical Gears Up for Global Pitch on Photoimmunotherapy: Chairman
August 4, 2023
- Rakuten Medical Eyes Label Expansion for Photoimmunotherapy, Asia as Key Market
August 26, 2021
- Rakuten Medical’s Photoimmunotherapy Now Available in Japan
February 9, 2021
- After Photoimmunotherapy Nod, Rakuten’s Mikitani Says Company Is Finally at Start Line
September 30, 2020
- Mikitani Resolved to Grow Rakuten Medical into Global Biotech
July 2, 2019
- Rakuten Medical Could File Photoimmunotherapy for Head and Neck Cancer in 2022; COO Says More Indications Eyed
June 12, 2019
- Rakuten Medical’s Photoimmunotherapy Demonstrates Favorable Tolerability in PIIa
June 4, 2019
- Sakigake Status Granted to Takeda’s Narcolepsy Med, Ninlaro, Daiichi Sankyo’s Valemetostat and More
April 9, 2019
BUSINESS
- Takeda’s Zasocitinib Beats Sotyktu in PIII Psoriasis Trial
June 15, 2026
- Rakuten Medical CEO-Elect Reaffirms 2028 US Filing Plan for Akalux
June 15, 2026
- Heartseed Starts Japan PI/II of Catheter-Delivered iPSC Cardiomyocyte Therapy
June 15, 2026
- Lilly Breaks Ground on New Building at Kobe Plant
June 15, 2026
- Shionogi Invests in Reproductive Medicine Startup Dioseve
June 15, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…