PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
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
- JB Banks on Sustained Aid to Double Plasma Processing Capacity
October 27, 2026
- Keytruda Tops Japan Drug Sales in April-September: Encise
October 27, 2026
- Japan Pharma Earnings Season Opens as Drug Price Cuts, Patent Cliffs Test Growth
October 27, 2026
- Takeda Opens New Kyoto Garden Area to Preserve Plants Used in Cultural Heritage
October 27, 2026
- Otsuka Ramps Up CVC Investments, Already Backs 2 Biotechs
October 27, 2026
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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…
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…