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CureVac blames variants for COVID-19 vaccine fail in pivotal trial
firstwordpharma
June 17, 2021
CureVac's stock was cut in half on Wednesday after the company reported that its vaccine candidate CVnCoV was only 47% effective at preventing COVID-19 disease of any severity in a second interim analysis, falling short of pre-specified statistical.
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Boan Biotech to Start Phase II Clinical Trial in U.S. for Neutralizing Antibody Against SARS-CoV-2
firstwordpharma
June 17, 2021
Luye Pharma Group today announced that its subsidiary Boan Biotech has submitted the investigational new drug (IND) application for a self-developed drug LY-CovMab to the U.S. Food and Drug Administration.
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STORM CHASER Trial Fails to Meet Primary Endpoint in Post-Exposure Prevention of Symptomatic COVID-19
americanpharmaceuticalreview
June 17, 2021
AstraZeneca announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus.
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University of Arkansas, NOWDiagnostics Partner for COVID-19 Antibody Test and Prevalence Study
prnewswire
June 17, 2021
The University of Arkansas and NOWDiagnostics, Inc., a Springdale-based leader in innovative diagnostics testing, announced today an active partnership to study the prevalence of SARS-CoV-2 virus antibodies among University of Arkansas (U of A) students,
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Third Dose of COVID Vaccine Boosts Protection in Transplant Recipients
drugs
June 16, 2021
Researchers say an extra dose of two-dose COVID-19 vaccines may improve immune system protection for organ transplant patients, a group that's so far responded poorly to two-dose vaccines.
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SARS-CoV-2 Antibodies Identified Before Cases Recognized in U.S.
drugs
June 16, 2021
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies were identified in individuals before the first cases of infection were recognized, according to a study published online June 15 in Clinical Infectious Diseases.
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Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test - FDA MedWatch
americanpharmaceuticalreview
June 16, 2021
The U.S. FDA issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use.
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COVID Rapid Test Confirms Presence of Antibodies
prnewswire
June 16, 2021
A U.S. clinical trial of a COVID-19 rapid test approved by an institutional review board found the Specificity of confirmed negative Covid-19 patients by RT-PCR was 100% (95% CI, 88.4%-100.0%).
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Nineteen Percent of Asymptomatic COVID-19 Patients Develop Long-Haul COVID
prnewswire
June 16, 2021
Nineteen percent of COVID-19 patients without symptoms went on to exhibit at least one of the post-COVID conditions known as long-haul COVID 30 days or more after their initial COVID-19 diagnosis.
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BioVaxys Receives Positive FDA Response For Pre-IND Review For CoviDTH Clinical Development
prnewswire
June 15, 2021
BioVaxys Technology Corp. is pleased to announce today that FDA has reviewed its Pre-IND request for a Type B review of its CoviDTH program and has determined that a Written Response is sufficient to address the Company's questions regarding