The Pharma Data

SEPTEMBER 18, 2020

The Marburg facility is expected to start the production of mRNA formulation for a Covid-19 vaccine in the first half of 2021, pending regulatory authorization or approval.

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The Pharma Data

APRIL 14, 2021

Food and Drug Administration. A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing.

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The Pharma Data

OCTOBER 28, 2020

Food and Drug Administration (FDA). A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. INDIANAPOLIS, Oct. This press release reflects Lilly’s current beliefs.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration advisory panel recommended on Thursday that the agency authorize the emergency use of Pfizer’s coronavirus vaccine, clearing the way for a national campaign to inoculate enough Americans to stop the spread of COVID-19. THURSDAY, Dec. 10, 2020 — A U.S.

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The Pharma Data

DECEMBER 2, 2020

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. Earlier this month, Pfizer asked the U.S.

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The Pharma Data

JUNE 25, 2021

Financial considerations On 16 March 2021, AstraZeneca announced an extended agreement with the US Government to supply up to 500,000 additional doses of AZD7442 for $205m, contingent on AZD7442 receiving Food and Drug Administration Emergency Use Authorisation in post-exposure prophylaxis.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). INDIANAPOLIS, Nov.

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The Pharma Data

APRIL 16, 2021

Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone. A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing.

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The Pharma Data

JANUARY 24, 2021

The drug appears to inhibit IL-6, IL-1beta, TNF-alpha and other pro-inflammatory cytokines and chemokines. Researchers out of Brazil published a small study in the BMJ British Medical Journal that did not find the addition of Roche ’s Actemra to standard of care to help the most severe cases.

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The Pharma Data

MARCH 5, 2021

A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501 ) is ongoing.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in high-risk patients, and it has also been granted authorizations in several additional countries. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization.

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The Pharma Data

MAY 4, 2021

Serious Side Effects : Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib. There are limited clinical data available for baricitinib use in coronavirus 2019 (COVID-19).

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The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing.

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The Pharma Data

JANUARY 8, 2021

.” The CDC has decided that health care workers and people working or living in long-term care facilities will be the first folks to get the COVID-19 vaccine. Food and Drug Administration earlier this week reiterated that both doses are required to provide full immunity against COVID-19.

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