Shionogi’s COVID Pill Hits Main Goal in PIII, Discussion on Regulatory Path to Follow
To read the full story
Related Article
- Shionogi’s Xocova Cuts Risks of Long COVID by 45%: Exploratory Data
February 24, 2023
- 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
- Shionogi’s COVID Pill Up for 3rd Round of Discussion for Emergency Approval on Nov. 22
November 15, 2022
- Shionogi to Test COVID Pill as Prophylaxis for Household Contacts from December
October 13, 2022
- Shionogi Eyes PIII Topline Readout for COVID Pill in Aug-Sept., Sticks to H1 Approval Plan
August 2, 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
BUSINESS
- Genmab Japan to Expand into Solid Tumors, Boost Focus on Gyn/Onc: Chief
November 22, 2024
- Tepezza, Trodelvy, and More Drugs Now Available in Japan; Kisunla Due Out on Nov. 26
November 21, 2024
- MM Drug Talquetamab Filed in Japan: J&J
November 21, 2024
- Terumo Puts Brake on Supply of Anapeine Generics
November 21, 2024
- Otsuka Plans US Filing of IgA Nephropathy Drug in H1 2025
November 20, 2024
For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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…