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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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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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Tampa General Hospital is First in Florida To Offer Monoclonal Antibody Treatments to COVID-19 Patients

The Pharma Data

Eli Lilly and Company’s antibody therapeutic will be distributed as part of the federal government’s Operation Warp Speed. . 18, 2020 /PRNewswire/ — Tampa General Hospital provided the first monoclonal antibody treatment to a COVID-19 positive patient today. TAMPA, Fla., Have diabetes.

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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. The persistence of antibodies after both natural COVID-19 infection and vaccination continues to be an area of intense study. 1. First T-Cell Test from Adaptive Biotechnologies.

Protein 98
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Novartis builds radio-oncology pipeline with iTheranostics deal

pharmaphorum

The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is found much more abundantly in solid tumours. “We believe this technology has the potential to transform many patients’ lives,” she added. Kesimpta approval in Europe.

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AZD1222 US Phase III primary analysis confirms safety and efficacy

The Pharma Data

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. The Phase III D8110C00001 trial is part of this funding agreement. JPEO-CBRND. Source link:[link].

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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. In the placebo arm, there were three cases of severe COVID-19, which included two deaths. W911QY-21-9-0001.

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