Phase III
It was a busy week for clinical trial updates. Here’s a look.
AstraZeneca reported that its Phase III KESTREL trial of Imfinzi (durvalumab) failed to meet the primary endpoint of improving overall survival (OS) compared to the EXTREME treatment regimen, which was chemotherapy plus cetuximab, a standard of care.
Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.
Johnson & Johnson’s Janssen Biotech submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its single-dose COVID-19 vaccine.
Roche is closing out its fourth-quarter with some house cleaning. The Swiss pharma giant announced in its earnings report that it was terminating studies of several mid- and late-stage assets, including two late-stage breast cancer programs.
A few companies shared some big Phase III results this week. Here’s a look.
Amgen released its fourth-quarter and full-year 2020 results today and although there was good news financially, there was also news of five cancer programs that have either been halted or abandoned.
Although designed for two doses, primary analysis of AstraZeneca and the University of Oxford’s Phase III data for its COVID-19 vaccine found it to have 76% efficacy after the first dose.
Prothena said it anticipates beginning the Phase III study of birtamimab, previously known as NEOD001, in mid-2021.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 2, 2021.
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