Japan’s general trading houses are steadily becoming a force to be reckoned with in the pharmaceutical industry — and not…
REGULATORY
Shionogi/Sage’s Zurzuvae Clears MHLW Panel, Label Wording on Combo Use under Review
A Japanese health ministry panel on October 30 recommended approval for Shionogi’s zuranolone, an antidepressant licensed from Sage Therapeutics, while some label language remains under review. Zuranolone, marketed as Zurzuvae overseas, gained the blessing from the Pharmaceutical Affairs Council’s First…
To read the full story
Related Article
- Shionogi/Sage’s Depression Drug Up for MHLW Panel Review on Oct. 30
October 17, 2025
- Mitsubishi Seeks Uplizna Nod for IgG4-Related Disease in Japan
March 24, 2025
- Shionogi Files Sage’s Depression Drug in Japan
September 30, 2024
REGULATORY
- Nipro-Samsung Alliance Nears First Approval in Japan with Stelara Biosimilar
November 14, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Industry Opposes Deeper CEA Price Cuts for “Cost-Increase” Products
November 13, 2025
- Pharma, Wholesalers Urge Drug Pricing Overhaul to Address Inflation: LDP Hearing
November 13, 2025
A public-private council report outlining industry views on Japan’s drug pricing systems drew little discussion at a meeting of the…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…
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…