Shionogi COVID Pill Doesn’t Meet “Presumed Efficacy” Criteria: HSC Subcommittee Chair
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
- 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
- Shionogi’s COVID Pill Up for PAFSC Review for 1st Emergency Approval
June 16, 2022
- Japan’s Emergency Approval System Comes into Force, Nod Based on Presumed Efficacy
May 23, 2022
- Japan Clears Bill to Create Emergency Approval System, Enforcement Slated by Month-End
May 13, 2022
- Products Filed for Conditional OK Can Be Switched to Emergency Approval: MHLW Official
April 27, 2022
- Upper House Starts Deliberations on PMD Law Amendment Bill
April 25, 2022
- Japan’s Lower House OKs PMD Law Amendment Bill
April 20, 2022
- Emergency Approval Plan Clears Lower House Panel; Opposition Bills Rejected, but Some Ideas Make It into Resolution
April 18, 2022
- Extension of Emergency Approval Period Would Be Allowed Only Once: MHLW Official
April 7, 2022
- Japan PM Touts Proposed Emergency Approval Scheme as Bill Enters Diet Deliberations
April 1, 2022
- PMD Law Amendment Bill to Enter Diet Debate March 31, CDP’s Counter-Legislation Too
March 30, 2022
- Opposition Party Mulls Counter-Legislation against PMD Law Amendment Bill
March 24, 2022
- Japan Cabinet OKs Draft Bill to Amend PMD Law
March 2, 2022
- Bill to Amend PMD Law Set for Cabinet Approval as Early as March 1
February 24, 2022
- LDP Health Committee OKs Bill to Amend PMD Law
February 18, 2022
- LDP Health Committee to Review PMD Law Amendment Bill Mid-February
February 10, 2022
REGULATORY
- FY2025 Budget Request Would Add 7 PMDA Reviewers for Startup Consultations
September 13, 2024
- Japan Approves Meiji’s JN.1-Directed COVID-19 Vaccine
September 13, 2024
- MHLW Lays Out Updated Discussion Timeline for PMD Act Amendment
September 13, 2024
- Trodelvy Nears Japan Approval as It Sails through Panel Review
September 13, 2024
- Kamikawa Runs for LDP Presidency, Resolved to Empower Healthcare Realm
September 12, 2024
In the Western world, LinkedIn is a staple for many recruitment professionals. It has proven to be a powerful tool for networking, talent sourcing and job postings. But in Japan, people don’t use LinkedIn very much.Here’s why LinkedIn isn’t popular…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…