Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
BUSINESS
KM Biologics’ COVID-19 Jab Enters Japan PII/III Study
KM Biologics, a Meiji group company, has commenced a Japanese PII/III clinical study for its investigational inactivated COVID-19 vaccine KD-414, the company and partner Meiji Seika Pharma said on October 22. The study is a multicenter, uncontrolled, open-label clinical trial,…
To read the full story
Related Article
- KM Biologics to File COVID Jab in Japan Spring 2023: Official
November 29, 2022
- KM Biologics’ COVID-19 Vaccine Approval Likely to Delay into FY2023
November 11, 2022
- KD-414 Presumed to Have Superior Efficacy over Vaxzevria: KM Bio President
July 7, 2022
- 1st Dose of COVID-19 Jab Given in Adult and Pediatric Trials: KM Biologics/Meiji
May 10, 2022
- KM Biologics to Soon Begin Pediatric PII/III for COVID Jab, 1st Japan Trial to Include Kids below Age 5
April 21, 2022
- KM Biologics to File COVID-19 Vaccine as Early as September, Chancing Emergency Approval
April 21, 2022
- Conditional OK Might Be an Option for KM Biologics Jab: Komeito Lawmaker
February 9, 2022
- KM Biologics Eyes COVID-19 Booster Filing as Early as Spring, Trial Start Slated by Year-End
October 26, 2021
- KM Biologics Moves Up COVID-19 Vaccine Target, Aims for Rollout in FY2022
September 22, 2021
- KM Biologics Kicks Off Japan PI/II for COVID-19 Vaccine
March 23, 2021
BUSINESS
- Japan’s 1st Xolair Biosimilar Finally Set for December Launch after Delays
October 23, 2026
- PHP Security Flaws Trigger Website Shutdowns Across Japan Pharma Sector
October 23, 2026
- Enhertu Snares China Approval for HER2 Positive Solid Tumors
October 23, 2026
- Nxera Seeks South Korean Approval for DMD Drug Vamorolone
October 23, 2026
- Vital KSK Warns of Possible Email Address Leak via External Mail Provider
October 23, 2026
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…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…