Long-Term Care Facilities Regulations Treatment Vaccine 
The Pharma Data
DECEMBER 17, 2020
COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.
The Pharma Data
NOVEMBER 9, 2020
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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The Pharma Data
OCTOBER 28, 2020
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.
The Pharma Data
MARCH 5, 2021
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
The Pharma Data
MARCH 11, 2021
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.
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