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…
REGULATORY
Shionogi’s COVID Pill Up for PAFSC Review for 1st Emergency Approval
Shionogi’s COVID-19 pill ensitrelvir will be discussed by a key health ministry committee on June 22 for its potential emergency approval. The panel’s nod, if given, is expected to open the way for the drug to become the first product…
To read the full story
Related Article
- Japan Govt to Purchase Another 1 Million Courses of Xocova
December 14, 2022
- Japan Should Hone Emergency Approval Scheme Based on Xocova Example
November 28, 2022
- Shionogi Chief Defends Xocova Data, Eager to Prove Benefits in Clinical Settings
November 25, 2022
- Japan Grants 1st Emergency Approval to Shionogi COVID Pill Xocova
November 24, 2022
- Citizen’s Group Renews Opposition to Emergency Approval of Shionogi COVID-19 Pill
November 22, 2022
- Japan Again Takes Pass on Emergency Approval for Shionogi’s COVID Pill as Panels Nix Presumed Efficacy
July 21, 2022
- Japan Shelves Decision on Shionogi’s COVID Pill with Experts at Odds, Another Session Likely Next Month
June 23, 2022
- Citizen’s Group Opposes Emergency Approval for Shionogi’s COVID Pill
June 21, 2022
- Shionogi’s COVID-19 Pill Improves Respiratory and Feverish Symptoms
April 26, 2022
- Shionogi COVID Pill Doesn’t Meet “Presumed Efficacy” Criteria: HSC Subcommittee Chair
April 13, 2022
- Japan Inks Supply Deal for Shionogi’s COVID Pill for 1 Million People
March 25, 2022
- Japan to Expedite Review for Shionogi’s COVID-19 Pill: PM
March 1, 2022
- Shionogi Files COVID-19 Pill in Japan, Seeks Conditional Approval
February 25, 2022
- Lawmakers Mixed on Use of Conditional Approval for Shionogi’s COVID-19 Pill
February 16, 2022
REGULATORY
- Vimpat Draws 10 Generic Entrants in December Listing; Forxiga Has Two, but Nipro AG Absent
December 4, 2025
- MHLW Floats Deducting Private-Practice Use for Re-Pricing, but Off-Cycle Cuts Possible; GLP-1 Eyed?
December 4, 2025
- Bayer’s Eylea Bio-AG Finally Reaches NHI Listing amid Reform Talks
December 4, 2025
- MHLW Panel Green-Lights Approval for Kissei’s Uterine Fibroid Drug, 3 More NMEs
December 4, 2025
- MHLW Proposes Pricing New AGs and Bio-AGs on Par with Originators
December 4, 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…