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
Swiss Licensee ObsEva Withdraws NDA for Kissei’s Linzagolix in US
Kissei Pharmaceutical said on August 22 that ObsEva, a Swiss-based biopharma and licensee of its GnRH receptor antagonist linzagolix, has withdrawn a new drug application (NDA) for the therapy filed in the US for the treatment of uterine fibroids. In…
To read the full story
Related Article
- Linzagolix Gets Label Expansion into Endometriosis in Europe: Kissei
December 24, 2024
- Kissei Won’t Change 2025 Targets Despite Linzagolix Setback, Decide US Plan by March
December 20, 2022
- Kissei’s Global Plan for Fibroid Med Hits Snag as ObsEva Seeks Restructuring
July 28, 2022
- Kissei-Originated Fibroid Drug Approved in Europe
June 20, 2022
- EU Panel Confirms Nod for Kissei-Originated Fibroid Drug
April 26, 2022
- Kissei to License Endometriosis Treatment to Swiss Bioventure ObsEva
November 24, 2015
BUSINESS
- JB Banks on Sustained Aid to Double Plasma Processing Capacity
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
- Medipal Shareholder Silchester Seeks Court Nod for Extraordinary Meeting
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…