Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Gives Thumbs-Down for MEDRx/DWTI’s Lidocaine Patch
MEDRx said on September 29 that the US FDA has turned down its regulatory application for MRX-5LBT (Lydolyte), a new type of lidocaine patch for the treatment of post-herpetic neuralgia being jointly developed with the D. Western Therapeutics Institute (DWTI).The…
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 Snubs MEDRx/DWTI’s Lidocaine Patch Yet Again
July 16, 2024
BUSINESS
- Sanofi Japan Chief Iwaya to Step Down at June End, Leave EFPIA Role
April 16, 2026
- Suntory to Acquire Daiichi Sankyo’s OTC Business for 246.5 Billion Yen
April 16, 2026
- MSD Debuts HIV Drug Idvynso in Japan in World-First Launch
April 16, 2026
- GSK’s Long-Acting Asthma Drug Exdensur Now Available in Japan
April 16, 2026
- Asahi Kasei Confident of Hitting 2027 Profit Goal, Tarpeyo as Pharma Growth Driver
April 16, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…