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COVID-19 Vaccine Developers Adjust Phase 3 Trial Protocols to Allow Authorized Vaccines | 2020-12-17

The Pharma Data

Regardless of their decisions or which treatment they receive, all participants will be monitored for two years. Currently, healthcare personnel and long-term care facility residents participating in their trial are the only ones who can opt to receive the vaccine.

Vaccine 52
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Therma Bright Acquires 100% Control of its COVID-19 Rapid Saliva Antigen Test and Announces Proposed Name Change for the Test

The Pharma Data

The test can help identify infected individuals in 15 minutes and is designed for at-home or point-of-need settings such as long-term care facilities, schools, or sporting events. To identify if patients require further testing or treatment in a clinical setting. About Therma Bright Inc.

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Analysis Chemical Thank You EPA issues guidance for disinfectant product claims used on soft surface textiles in non-residential settings

Agency IQ

A pesticide is any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, or any nitrogen stabilizer. All pesticides sold or distributed in the U.S.

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Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

The Pharma Data

Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Sites of care will then confirm their need and AmerisourceBergen will distribute bamlanivimab overnight.

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Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19

The Pharma Data

Lilly submitted a request for an EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA in early October. Discussions with global regulators are ongoing. government will accept the vials of bamlanivimab if it is granted an Emergency Use Authorization (EUA) by the U.S.

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EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP scientific opinion under Article 5.3

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Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

In this new Phase 3 cohort, there were four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together. Lilly’s chief scientific officer and president of Lilly Research Laboratories.