Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Extends Action Date for Lenvima’s HCC Indication by 3 Months
The US FDA has pushed back its action date for a supplemental new drug application (sNDA) for the cancer drug Lenvima (lenvatinib) for an additional indication of hepatocellular carcinoma (HCC), Eisai and its global partner US Merck said on May…
To read the full story
Related Article
- Lenvima Approved for 1st Line HCC Use in Europe: Eisai/Merck
August 24, 2018
- FDA Approves Lenvima for 1st-Line Treatment of Liver Cancer
August 17, 2018
- FDA Accepts sNDA for Lenvima’s HCC Indication
September 27, 2017
- Lenvatinib Filed for HCC in US and EU after Japan Submission
July 26, 2017
BUSINESS
- MSD Launches RSV Antibody Enflonsia in Japan without NHI Listing
August 24, 2026
- Sumitomo Pharma Eyes Global Position as Adjuvant Supplier
August 24, 2026
- Oncolys’ Oncolytic Virus Telomelysin Hits Japan Market
August 24, 2026
- Sobi’s Still’s Disease Drug Kineret Now Available in Japan
August 24, 2026
- MSD Files Welireg-Keytruda Combo in Japan for Adjuvant RCC
August 24, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…