Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
BUSINESS
Shionogi Eyes PIII Topline Readout for COVID Pill in Aug-Sept., Sticks to H1 Approval Plan
Even after its COVID-19 pill stumbled on Japan’s newly created emergency approval pathway, Shionogi says it will not give up on its plan to obtain the regulatory nod by the end of September, noting that the company is prepping to…
To read the full story
Related Article
- Shionogi’s H1 Sales Dip on One-Off Factor, HIV Franchise Grows
October 29, 2024
- Shionogi Renews Record Earnings in FY2023, Driven by Xocova and Xofluza
May 14, 2024
- Shionogi Notches Record Earnings in April-September, Xocova Drives Growth
November 1, 2023
- Shionogi Logs Record Earnings Q1 on Xocova, ADHD License Transfer
August 1, 2023
- Xocova’s Uptake in Japan in Line with Expectations: Shionogi CEO
May 11, 2023
- Shionogi Hits Record High Earnings on Xocova Boon in FY2022
May 11, 2023
- Shionogi Logs Record Profits as Xocova Nets 100 Billion Yen from Govt Purchase: April-December
January 31, 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’s H1 Operating Profit Sinks 33.8% on COVID-Linked R&D Expenses
November 1, 2022
- Shionogi’s COVID Pill Hits Main Goal in PIII, Discussion on Regulatory Path to Follow
September 29, 2022
- Shionogi’s Q1 Sales Up 4.2% on HIV Franchise, FX
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
- Keytruda, Arexvy, Imfinzi, Lynparza Broaden Labels in Japan
November 25, 2024
- Otsuka Bags Worldwide Rights to Ionis’ ALS Drug
November 25, 2024
- Takeda’s Fruzaqla Now Available in Japan, AbbVie’s Skyrizi Adds New Version
November 25, 2024
- Genmab Japan to Expand into Solid Tumors, Boost Focus on Gyn/Onc: Chief
November 22, 2024
- COVID as a Lesson, Pfizer Exec Urges Govt to Draft Emergency Safety Management Guidelines
November 22, 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…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
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…