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.

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The Pharma Data

OCTOBER 28, 2020

Discussions with global regulators are ongoing. 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.

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The Pharma Data

DECEMBER 2, 2020

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. The global race to develop a vaccine has been stunningly fast. Hospitalizations reach record high.

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The Pharma Data

NOVEMBER 9, 2020

We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.” Lilly is in discussions with global regulators to make bamlanivimab available around the world. Across all treatment arms, the trial will enroll over 800 participants.

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The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. ” To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial. The CHMP scientific opinion under Article 5.3 Lilly Antibody Therapies Around the World. About BLAZE-1.

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The Pharma Data

MARCH 11, 2021

In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. ” Lilly continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world. .

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The Pharma Data

DECEMBER 21, 2020

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. A study published as recently as November took a closer look at the theory.

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