Japan plans to revise its guidelines on the drone delivery of medicines later this month, which would mark the first revision since they were established two years ago. Service providers are closely watching how they will be revised, with calls…
REGULATORY
Shionogi’s COVID Pill Up for PAFSC Review for 1st Emergency Approval
Shionogi’s COVID-19 pill ensitrelvir will be discussed by a key health ministry committee on June 22 for its potential emergency approval. The panel’s nod, if given, is expected to open the way for the drug to become the first product…
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
- Citizen’s Group Renews Opposition to Emergency Approval of Shionogi COVID-19 Pill
November 22, 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
- Citizen’s Group Opposes Emergency Approval for Shionogi’s COVID Pill
June 21, 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
- Suprapartisan Lawmakers’ League Discussing Bill to Establish Dementia Law
March 31, 2023
- LDP League Asks Health Minster for Proper Insurance Coverage for Patches
March 31, 2023
- AMED’s “CANNDs” Set for Full Rollout in FY2023, but Panel Members Want Wider Range of Data to Fuel Drug Discovery
March 31, 2023
- Audit Questions Rationale for Order of 882 Million COVID Vaccine Doses
March 30, 2023
- Japan to Allow Drone Deliveries of Drugs When Appropriate, Including Powerful Meds
March 29, 2023
The healthcare supply chain in Japan, as in all major markets, consists of biopharmaceutical manufacturers selling to wholesalers who in turn sell to hospitals, clinics, and pharmacies, where the drugs are finally dispensed to patients. Each party ideally contributes value…
The health ministry’s key expert panel on February 15 agreed on the need to consolidate the Japanese generic sector to…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…