COMMENTARY

Japan Should Hone Emergency Approval Scheme Based on Xocova Example

By Izuru Ando November 28, 2022

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While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…

To read the full story

Japan Govt to Purchase Another 1 Million Courses of Xocova
December 14, 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
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
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

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