Coronavirus disease (COVID-19) is an infectious disease caused by the coronavirus SARS-CoV-2. Here we have collected APR news related to the COVID-19 pandemic, vaccination efforts and emerging treatments.
Thursday, October 28, 2021
Aetion announced the expanding its relationship with the FDA to use real-world evidence (RWE) to study COVID-19 interventions and advance regulatory science and innovation. FDA and Aetion will use ...
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Tuesday, October 26, 2021
Merck and Ridgeback Biotherapeutics announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of...
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Tuesday, October 26, 2021
BioNTech announced plans to construct a state-of-the-art manufacturing site for mRNA-based vaccines in the African Union in mid-2022. This is the next step in BioNTech’s efforts to implement ...
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The Medicines Patent Pool (MPP) and Merck announced the signing of a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral ...
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Looking back, I think we had about two to three weeks in May – June where things related to the pandemic were looking up. Cases, hospitalizations, and deaths were all trending down. If you were ...
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Wednesday, October 20, 2021
Health Canada received a submission from Pfizer-BioNTech seeking an authorization for the use of its Comirnaty COVID-19 vaccine in children 5 to 11 years of age. As with all COVID-19 vaccines, the ...
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Wednesday, October 20, 2021
The FDA is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback's request for an emergency use authorization (EUA) for molnupiravir, an ...
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Wednesday, October 20, 2021
Johnson & Johnson announced the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster dose of the...
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Thursday, October 14, 2021
Regeneron Pharmaceuticals announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized...
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Wednesday, October 13, 2021
Merck announced the submission of an Emergency Use Authorization (EUA) application to the FDA for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-...
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Wednesday, October 13, 2021
Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction ...
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Vaxart announced?that it has begun recruiting subjects for its Phase II COVID-19 oral tablet vaccine clinical trial. Vaxart expects to begin dosing the first of 96 U.S. subjects, split evenly between ...
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Thursday, October 07, 2021
Merck announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the ...
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Thursday, October 07, 2021
The US FDA announced two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.
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Thursday, October 07, 2021
Labcorp announced that it received Emergency Use Authorization (EUA) from the U.S. FDA for a combined home collection kit that detects COVID-19 and influenza A/B simultaneously in individuals as young...
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