Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
BUSINESS
Shionogi Files Japan, US NDAs for Naldemedine for Opioid-Induced Constipation
Shionogi said on March 30 that it has simultaneously filed new drug applications (NDAs) in Japan and the US for naldemedine (development code: S-297995) for the treatment of opioid-induced constipation (OIC). In Japan the agent is expected to be indicated…
To read the full story
Related Article
- Naldemedine Now Available in US: Shionogi
October 16, 2017
- Shionogi Gets FDA Nod for Naldemedine
March 27, 2017
- Shionogi Hooks Up with Purdue on Naldemedine Commercialization in US
December 20, 2016
- PDUFA Date for Naldemedine Set for March 23, 2017
June 7, 2016
- Shionogi’s Naldemedine Yields Positive PIII Results for Opioid-Induced Constipation
February 23, 2016
- Naldemedine Demonstrates Favorable Results in 3 PIII Efficacy Studies for Opioid-Induced Constipation: Shionogi
August 5, 2015
- Naldemedine Meets Primary, Secondary Endpoints in Japanese PIII Study for the Treatment of OIC in Cancer Patients: Shionogi
June 26, 2015
BUSINESS
- Japan’s 1st Xolair Biosimilar Finally Set for December Launch after Delays
October 23, 2026
- PHP Security Flaws Trigger Website Shutdowns Across Japan Pharma Sector
October 23, 2026
- Enhertu Snares China Approval for HER2 Positive Solid Tumors
October 23, 2026
- Nxera Seeks South Korean Approval for DMD Drug Vamorolone
October 23, 2026
- Vital KSK Warns of Possible Email Address Leak via External Mail Provider
October 23, 2026
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…