The Pharma Data
JUNE 24, 2021
Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an Emergency Use Authorization (e.g., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. in the U.S.) or a variation to Conditional Marketing Authorizations (e.g., BioNTech COVID-19 Vaccine. The Pfizer?BioNTech
The Pharma Data
SEPTEMBER 9, 2020
During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies.
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The Pharma Data
DECEMBER 29, 2020
The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.
The Pharma Data
OCTOBER 28, 2020
Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Yancopoulos , M.D., combined dose groups; 6.5%
The Pharma Data
DECEMBER 17, 2020
These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Have chronic kidney disease. Have diabetes.
The Pharma Data
NOVEMBER 20, 2020
The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Definition of High-Risk Patients.
The Pharma Data
FEBRUARY 8, 2021
Business net income is a non-GAAP financial measure (definition in Appendix 9). 1 See Appendix 9 for definitions of financial indicators. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Full-year 2020, BOI increased 4.4%
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