Is policy intervention necessary for Japanese drug makers reliant on off-patent brand-name medicines? Many members of the health ministry’s key…
COMMENTARY
Japan Should Hone Emergency Approval Scheme Based on Xocova Example
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
Related Article
- 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
COMMENTARY
- LDP Expects to Finalize Tax Reform Plan This Week; Will It Expand R&D Credit System?
December 13, 2022
- Pharma Industry Stays Pat on “No” to Off-Year Plan, Why Not Going for Trade-Off?
November 22, 2022
- Pharma Industry Faces Hurdles in Getting Medical Circle to Accept Softer Drug Price Cut Plan
September 28, 2022
- Delving into Potential Implications of Envisaged Price Revision Overhaul
September 12, 2022
- Generic Industry Has High Hopes on New Expert Panel; Will Its Recommendations Ease Impact of Annual Re-Pricing?
September 9, 2022
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…