Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
BUSINESS
FDA Accepts NDA Resubmission for Sunovion’s COPD Med
The US FDA has accepted the resubmission of a new drug application for Sunovion Pharmaceuticals’ chronic obstructive pulmonary disease (COPD) treatment SUN-101/eFlow (glycopyrrolate), with a target action date under the Prescription Drug User Fee Act (PDUFA) set for December 15.…
To read the full story
Related Article
- Nebulized COPD Med Lonhala Magnair Now Available in US: Sunovion
April 5, 2018
- FDA Clears Sunovion’s Nebulized COPD Drug
December 7, 2017
- Sunovion’s COPD Med Slapped with FDA Complete Response Letter
May 30, 2017
- PDUFA Date for COPD Drug Set for May 29, 2017: Sunovion
October 17, 2016
- Sunovion Submits US NDA for COPD Drug
August 2, 2016
BUSINESS
- Astellas on Track to Hit 30% Margin Goal Early after Strong H1 Scorecards
November 5, 2026
- Nxera Inks US$1.47 Billion Deal with AbbVie for IBD Drug
November 5, 2026
- Kissei Might Revise Midterm Targets as Tavneos Faces Approval Revocation
November 5, 2026
- Boehringer, Lung Cancer Society Launch 5-Year Hernexeos Real-World Study
November 5, 2026
- ASKA Snags Japan Rights to Minghui’s TED Therapy
November 5, 2026
Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Japan’s pharmaceutical industry asked the ruling Liberal Democratic Party (LDP) on October 29 to boost the country’s drug supply security…
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…