Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Lenvima/Keytruda Gets FDA’s Breakthrough Status for HCC
The US FDA has granted Breakthrough Therapy designation for a combination therapy pairing Eisai’s multi-kinase inhibitor Lenvima (lenvatinib) and US partner Merck’s PD-1 inhibitor Keytruda (pembrolizumab) for the treatment of hepatocellular carcinoma (HCC), the two companies said on July 23.…
To read the full story
Related Article
- Lenvima/Keytruda Gets Full US Approval for Endometrial Carcinoma
July 27, 2021
- US FDA Gives 1st Nod for Lenvima/Keytruda Combo as 2nd-Line Therapy for Endometrial Carcinoma
September 19, 2019
- Lenvima-Keytruda Combo Bags FDA’s Breakthrough Status for Endometrial Carcinoma
August 1, 2018
- Lenvima-Keytruda Combo Earns FDA’s Breakthrough Designation for RCC
January 10, 2018
BUSINESS
- Sumitomo to Launch Post-Marketing Study for iPSC Therapy by Year-End
March 9, 2026
- Drug Pricing Reform Draws Sharp Industry Backlash in Jiho Poll
March 9, 2026
- Nitrosamine Detected in Nichi-Iko’s Tryptanol, No Need to Halt Prescriptions
March 9, 2026
- Pfizer, ASKA to Co-Promote RSV Vaccine Abrysvo in Japan
March 9, 2026
- Towa Broadens Label for Tacrolimus in Cell Transplantation
March 9, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
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…