In the race to develop next-generation antibody therapies for solid tumors, antibody drug conjugates (ADCs) are surging, while T-cell engagers…
BUSINESS
EU Panel Confirms Nod for Kissei-Originated Fibroid Drug
Kissei Pharmaceutical said on April 25 that a key European panel confirmed its previously adopted approval recommendation for linzagolix, an oral GnRH receptor antagonist originated by the company, for the treatment of uterine fibroids. The drug was filed with the…
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
- Swiss Licensee ObsEva Withdraws NDA for Kissei’s Linzagolix in US
August 23, 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
- Kissei to License Endometriosis Treatment to Swiss Bioventure ObsEva
November 24, 2015
BUSINESS
- FRONTEO’s AI Engine Uncovers Novel Pancreatic Cancer Targets as Company Eyes Out-Licensing
July 24, 2025
- Eisai Launches Beova in Thailand with Rights Obtained from Kyorin
July 24, 2025
- Towa Launches Task Force to Tackle Nitrosamine Impurities, Share Solutions with Peers
July 24, 2025
- Alloy Japan Teams with KSAC to Back University Startups’ Global Push
July 23, 2025
- FDA Panel Rejects Rexulti’s PTSD Bid: Otsuka/Lundbeck
July 23, 2025
I recently attended a fantastic conference hosted by Prospection Japan, and one speaker, Dr. Joe Ledsam, really blew me away with his insights. He shared some truly fascinating developments about how AI is set to revolutionize healthcare, from how doctors…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…