A separate global Phase 3 study of S-217622 is underway aiming to recruit participants globally to support regulatory filings this year
The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic
Pre-exposure prevention trial reduced risk of symptomatic Covid-19, with no severe disease or Covid-19-related deaths in the Evusheld group
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC
Veeda Clinical Research will submit data in an application for Emergency Use Authorisation
Among patients with infectious virus at baseline, no patients who received Lagevrio had infectious virus at days 3, 5 or 10
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months
Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status
There are currently no approved systemic treatments for prurigo nodularis; regulatory filings for prurigo nodularis planned in the first half of 2022
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