The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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
- AI-Driven Target Discovery Gains Ground among Japanese Pharma: FRONTEO CEO
December 17, 2025
- Enhertu Combo Wins US FDA Nod in 1st-Line HER2 Breast Cancer
December 17, 2025
- Pfizer Releases Nurtec Migraine Drug in Japan
December 17, 2025
- Towa Lifts Atomoxetine Shipment Curbs Across All Strengths
December 17, 2025
- Daiichi Sankyo Targets Cancer Cure with IO-ADC Combo Strategy
December 17, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…