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

The Pharma Data

It’s going to change everyone’s behavior otherwise,” suggested Hayley Gans, a pediatrics and infectious diseases expert at Stanford University Medical Center. This would mean volunteers who already received a vaccine would be given a placebo and vice versa, allowing companies to evaluate their product’s safety and long-term efficacy.

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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

Discussions with global regulators are ongoing. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. patients who recovered from COVID-19. . www.lilly.com?and?www.lilly.com/news.?P-LLY.

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Britain Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

Having beat the United States to emergency approval of a coronavirus vaccine may pressure American regulators, who are already taking heat for not moving faster to get doses to people, The New York Times reported. Not only that, the vaccine was 100 percent effective at preventing severe disease from the coronavirus, Moderna officials said.

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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

“The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, M.D., www.lilly.com?and?www.lilly.com/news.?P-LLY.

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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

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

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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

” Lilly continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world. 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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Study Suggests Link Between Sleep Supplement and COVID-19

The Pharma Data

A study published in the journal Cell Discovery back in March initially suggested that melatonin – and repurposing existing medicines in general – may be the key to regulating COVID-19 within the body. Its role as a moderator may lead to it one day protecting the body from going haywire when exposed to disease.