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FDA Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

Health care workers and nursing home residents and staff should get the initial shots, according to guidelines issued recently by a U.S. The nursing home industry applauded the approval. The association represents 14,000 nursing homes and assisted living facilities. The emergency approval comes not a moment too soon.

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4 Life Science Trends To Pay Attention To in 2021

XTalks

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D.

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

Data from the Phase 1/2/3 clinical trial supported an Emergency Use Authorization for casirivimab and imdevimab administered together, granted by the U.S. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

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Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Casirivimab and imdevimab have not been approved by FDA and remain investigational. Data from these trials will be used to support a future BLA submission.

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Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Casirivimab and imdevimab have not been approved by FDA and remain investigational. Data from these trials will be used to support a future BLA submission.