Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan Grants 1st Emergency Approval to Shionogi COVID Pill Xocova
Japan approved Shionogi’s oral COVID-19 treatment Xocova (ensitrelvir) on November 22, making it the first medicine to win the green light under the country’s new emergency approval pathway crafted in May. The approval came immediately after the drug gained the…
To read the full story
Related Article
- Xocova Set for Renewed Price-Setting after Full Approval, Big Cut Unlikely
March 14, 2024
- Xocova Approval Meaningful, but Careful Use Should Continue: Minister
March 6, 2024
- Shionogi’s COVID Pill Xocova Lands Standard Approval in Japan
March 5, 2024
- 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
- Japan to Begin Xocova Supply on Nov. 28 ahead of Schedule
November 28, 2022
- Shionogi Chief Defends Xocova Data, Eager to Prove Benefits in Clinical Settings
November 25, 2022
- Citizen’s Group Renews Opposition to Emergency Approval of Shionogi COVID-19 Pill
November 22, 2022
- Shionogi’s COVID Pill Up for 3rd Round of Discussion for Emergency Approval on Nov. 22
November 15, 2022
- Shionogi’s COVID Pill Hits Main Goal in PIII, Discussion on Regulatory Path to Follow
September 29, 2022
- Shionogi Eyes PIII Topline Readout for COVID Pill in Aug-Sept., Sticks to H1 Approval Plan
August 2, 2022
- Govt Should Examine Challenges with Emergency Approval Scheme Exposed by Shionogi Pill Review
July 25, 2022
- Japan to Boost Measures to Ensure COVID Drug Access, Govt Says after Shionogi Antiviral Delay
July 22, 2022
- Komeito Lawmakers Call for Assessing Shionogi’s Pill for Circulating Strains
July 22, 2022
- Shionogi to Steadily Promote PIII Trial for COVID Pill after Approval Setback
July 22, 2022
- Shionogi’s COVID-19 Pill Up for Expert Redeliberation on July 20
July 14, 2022
- Japan Shelves Decision on Shionogi’s COVID Pill with Experts at Odds, Another Session Likely Next Month
June 23, 2022
- Health Minister Defends Govt Purchase Pact for Shionogi’s COVID Pill
June 21, 2022
- Citizen’s Group Opposes Emergency Approval for Shionogi’s COVID Pill
June 21, 2022
- Shionogi’s COVID Pill Up for PAFSC Review for 1st Emergency Approval
June 16, 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
- Japan, US Launch Talks on Pharma GMP MRA to Ease Inspection Burden
July 3, 2026
- MHLW Gives Kissei until July 21 to Report on Tavneos
July 3, 2026
- Centrist Reform Alliance Warns US MFN Policy Poses “Real Crisis” for Drug Access
July 3, 2026
- Ishin Urges Govt to Make Healthcare, Drug Innovation Core Growth Strategy
July 3, 2026
- MHLW Seeks Sponsors for 6 High-Need Unapproved, Off-Label Drugs
July 2, 2026
The number of newly listed generic drugs in Japan has fallen sharply over the past decade, reflecting structural changes in…
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…