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Symbiotica and Quidel Score FDA Authorizations for COVID-19 Tests

XTalks

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

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Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

The Pharma Data

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. High immune response after a single dose in patients with prior infection shows strong booster potential. Global Phase 3 study expected to start in the coming weeks. About the Phase 2 study.

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Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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3 Newest COVID-19 Tests Authorized by the FDA

XTalks

Adding to the testing repertoire is the first T cell-based test that can detect previous infection, akin to antibody tests. Adaptive Biotechnologies’ T-Detect COVID Test is a next-generation sequencing (NGS) test that can indicate recent or prior infection with SARS-CoV-2 through detection of a T cell immune response to the virus.

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AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

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INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

The Pharma Data

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg and 2.0 The 1.0

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