Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
BUSINESS
KM Biologics’ COVID-19 Vaccine Approval Likely to Delay into FY2023
KM Biologics’ inactivated COVID-19 vaccine KD-414, which the company expected would obtain Japanese approval in FY2022, is now not likely to be approved until sometime in FY2023, with the use of the emergency approval pathway seen difficult. Meiji Holdings, the…
To read the full story
Related Article
- KM Biologics to File COVID Jab in Japan Spring 2023: Official
November 29, 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’ COVID-19 Jab Enters Japan PII/III Study
October 25, 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
- Novo Nordisk Launches Higher-Capacity Awiqli Pen in Japan
December 4, 2025
- Daiichi Sankyo Wins US Appeal in Seagen ADC Patent Dispute
December 4, 2025
- Vimpat Generics Win Added Use, Clearing Path for Full-Label Launch
December 4, 2025
- Alfresa, CMIC Ink Pact to Build Vaccination Support Platform
December 3, 2025
- Lundbeck Japan Plans to Double Workforce by 2028 as It Eyes 3 Drug Approvals
December 2, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan’s drug pricing panel on November 19 discussed a wide range of potential pricing changes related to patent-protected medicines, including…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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…