Is policy intervention necessary for Japanese drug makers reliant on off-patent brand-name medicines? Many members of the health ministry’s key…
REGULATORY
Japan Again Takes Pass on Emergency Approval for Shionogi’s COVID Pill as Panels Nix Presumed Efficacy
Panels of Japanese experts on July 20 agreed to put off a decision on whether to grant emergency approval for Shionogi’s oral COVID-19 treatment ensitrelvir, concluding that the drug does not demonstrate “presumed efficacy” with its current data alone. Some…
To read the full story
Related Article
- 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
- MHLW Health Policy Bureau to Bolster Staff for Pharma Industry Promotion: Director-General
January 31, 2023
- MHLW Set to Import Intranasal, High-Dose Seasonal Flu Vaccines
January 30, 2023
- Semaglutide in Line for March Approval as Obesity Drug, Precedex Too
January 30, 2023
- Panel OKs Japan’s First Abortion Pill, but Upper Organ to Review It Again after Public Comments
January 30, 2023
- It’s Official: Japan to Downgrade COVID-19 Severity Status on May 8
January 30, 2023
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
The advance of cell therapy is one of the most exciting innovations in medical treatment in recent years. These drugs offer potential curative treatments for severe or previously fatal diseases. In this article, I will explain features and challenges in…
The Liberal Democratic Party (LDP) will wrap up its discussions on the FY2023 tax reform plan within a few days. Some provisions of the R&D tax credit system, which allow drug makers to deduct a portion of R&D expenses from…
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…