Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Shots: The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…

ByRidhi RastogiSeptember 3, 2025

NEWS

BioVersys Partners with Shionogi to Jointly Develop Non-Tuberculous Mycobacteria (NTM) Clinical Candidate

Shots: BioVersys & Shionogi have entered into a global research & exclusive license option agreement to co-develop novel ansamycin compounds from BioVersys’ BV500 program into clinical candidates for treating NTM infections Shionogi will gain access to BioVersys’ ansamycin chemistry platform & BV500 program, with an exclusive option to license selected molecules for clinical development &…

ByRidhi RastogiJuly 2, 2025

VIEWPOINTS

Nathan McCutcheon shares highlights of Qpex Biopharma’s acquisition by Shionogi

Shots: Nathan McCutcheon, President, and Chief Executive Officer of Shionogi, shares the highlights of the recent acquisition of Qpex Biopharma by Shionogi Nathan believes that Qpex’s specialized expertise and extensive experience in chemistry and molecular design are sure to strengthen and be useful for the combined antibiotic pipeline The acquisition provides Shionogi exclusive development, manufacturing,…

BySaurabh ChaubeyOctober 16, 2023

VIEWPOINTS

Simon Portsmouth Shares Insights from P-III Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Shots: Simon spoke about the enrollment of the first participant in Japan in the P-III (SCORPIO-PEP) study to evaluate the safety and efficacy of Ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection He mentioned how this study will supplement data from the pivotal SCORPIO-SR trial's P-III segment which showed ensitrelvir's effectiveness in treating mild-to-moderate COVID-19…

BySenior EditorSeptember 18, 2023

VIEWPOINTS

Simon Portsmouth, VP, Head of Clinical Development, Shionogi Shares Insights from the New Data on an Antibiotic to Treat Bacterial Infections

Shots: Simon spoke about the new data on FETROJA (cefiderocol), an antibiotic for the treatment of serious Gram-negative (highly resistant) bacterial infections He also talked about Shionogi’s agreement with GARDP & CHAI for the manufacturing and commercialization of cefiderocol in different countries The interview summarizes how Shionogi is advancing by developing medicines to treat serious…

BySenior EditorNovember 7, 2022

INSIGHTS+

Insights+: COVID-19 Healthcare News Monthly Updates – April 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019 PharmaShots is keeping a track of all of the important updates in the Lifesciences sector, where…

BySenior EditorJanuary 5, 2020

INSIGHTS+

Insights+: The US FDA New Drug Approvals in November 2019

The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year's record of approvals. However, there is a significant…

BySenior EditorDecember 13, 2019

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

BioVersys Partners with Shionogi to Jointly Develop Non-Tuberculous Mycobacteria (NTM) Clinical Candidate

Nathan McCutcheon shares highlights of Qpex Biopharma’s acquisition by Shionogi

Simon Portsmouth Shares Insights from P-III Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Simon Portsmouth, VP, Head of Clinical Development, Shionogi Shares Insights from the New Data on an Antibiotic to Treat Bacterial Infections

Insights+: COVID-19 Healthcare News Monthly Updates – April 2020

Insights+: The US FDA New Drug Approvals in November 2019

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