Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Snubs MEDRx/DWTI’s Lidocaine Patch Yet Again
The US FDA has yet again turned down a regulatory application for MRX-5LBT (Lydolyte), a lidocaine patch being developed by MEDRx and D. Western Therapeutics Institute for the treatment of post-herpetic neuralgia. MEDRx said on July 12 that it received…
To read the full story
Related Article
- MEDRx/DWTI Clinch US FDA Approval for Lidocaine Patch
September 26, 2025
- MEDRx/DWTI Make 4th Attempt to Seek US Nod for Lidocaine Patch
March 26, 2025
- FDA Gives Thumbs-Down for MEDRx/DWTI’s Lidocaine Patch
October 3, 2023
BUSINESS
- Kyorin Starts Pivotal Study of Chronic Cough DTx in Japan
June 12, 2026
- Lotte Biopharma CVC Invests in Swiss ADC Startup
June 12, 2026
- Ono Seeks Velexbru Nod for CNS Involvement of Malignant Lymphoma
June 12, 2026
- Ono Files Opdivo for Anaplastic Thyroid Cancer
June 12, 2026
- Lilly Warns Against Off-Label Use of Mounjaro
June 11, 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…