Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Shionogi’s COVID Pill Hits Main Goal in PIII, Discussion on Regulatory Path to Follow
Shionogi’s oral COVID-19 treatment ensitrelvir achieved the primary endpoint in the PIII part of a PII/III trial, according to preliminary results released by the company on September 28. The Osaka drug maker says it will consult with regulatory authorities to…
To read the full story
Related Article
- Shionogi’s Xocova Cuts Risks of Long COVID by 45%: Exploratory Data
February 24, 2023
- 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
- Shionogi’s COVID Pill Up for 3rd Round of Discussion for Emergency Approval on Nov. 22
November 15, 2022
- Shionogi to Test COVID Pill as Prophylaxis for Household Contacts from December
October 13, 2022
- Shionogi Eyes PIII Topline Readout for COVID Pill in Aug-Sept., Sticks to H1 Approval Plan
August 2, 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
BUSINESS
- Astellas Confirms Applying to US MFN Medicaid Pricing Model
July 7, 2026
- Otsuka’s Astex Inks Breast Cancer R&D Pact with Genentech
July 7, 2026
- Ribomic, Fujifilm to Join Forces on LNP CDMO Services
July 7, 2026
- Toray Unveils Next-Generation Opioid Painkiller Candidate
July 7, 2026
- Keytruda’s No. 1 Streak Reaches 33 Months: Encise
July 7, 2026
Japan is opening a new chapter in sleep medicine. The recent decision to allow medical institutions to advertise “sleep disorders”…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…