U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail

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Additional Analyses of AstraZeneca's (AZN) ENHERTU Reinforce Groundbreaking Efficacy in Patients with HER2 Positive Metastatic Breast Cancer

December 9, 2021 9:46 AM EST

New results from the DESTINY-Breast03 phase 3 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated higher progression-free survival (PFS) and objective response rate (ORR) in prespecified patient subgroups compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. ENHERTU is a HER2 directed... More

AstraZeneca (AZN) Evusheld Authorized for Emergency Use in the US or Pre-Exposure Prophylaxis (Prevention) of COVID-19

December 8, 2021 4:05 PM EST

AstraZeneca's (NASDAQ: AZN) Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.

The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination,... More