Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Label Expansion for Opdivo, Olumiant, Dupixent Up for PAFSC Review on Feb. 5
A key health ministry advisory panel will discuss on February 5 whether to recommend label extensions for a list of medicines including Ono Pharmaceutical’s anti-PD-1 antibody Opdivo (nivolumab) and Eli Lilly’s JAK inhibitor Olumiant (baricitinib). The Pharmaceutical Affairs and Food…
To read the full story
Related Article
- Opdivo, Olumiant, Dupixent Now in Line for Label Expansions
February 6, 2024
- Nippon Shinyaku Files Jazz’s High-Risk AML Drug in Japan
June 22, 2023
- Opdivo Filed for Malignant Epithelial Tumors in Japan
June 16, 2023
- Sanofi Seeks Dupixent Label Expansion into CSU in Japan
April 3, 2023
REGULATORY
- Officer Replacement Orders a “Last Resort” under PMD Act: MHLW Official
September 18, 2026
- Japan Panel Sees No Scientific Objection to Capvaxive NIP Addition
September 18, 2026
- Tavneos Blue Letter Action “Too Slow,” MHLW Panel Member Says
September 18, 2026
- Takaichi Tasks Ueno with Charting Growth Strategy for Drug Innovation
September 18, 2026
- Japan HIV, AIDS Cases Rise in H1 after 2025 Lows
September 18, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…