Update from Operation Warp Speed on Monoclonal Antibodies and Convalescent Plasma

This week’s update from Operation Warp Speed included updates on the distribution of Regeneron’s monoclonal antibody cocktail and a call for Americans to donate Convalescent Plasma. THERAPEUTICS DEVELOPMENT: Regeneron announced its monoclonal antibody cocktail – casirivimab and imdevimab administered together – received Emergency Use Authorization by the FDA. Operation Warp Speed began distribution of the new […]

AstraZeneca and Oxford Release Promising Data on Efficacy, Dosing and Cost for their Coronavirus Vaccine

Two different dosing regimens demonstrated efficacy with one showing a better profile No hospitalizations or severe cases of COVID-19 in participants treated with AZD1222 AstraZeneca announced today that an early analysis of its late-stage clinical trials of its AZD1222 coronavirus vaccine in Britain and Brazil showed positive high-level results across efficacy, safety and dosing. The clinical […]

Regeneron’s REGEN-COV2 Receives Emergency Use Authorization

First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2 Authorized for recently diagnosed, mild to moderate COVID-19 in high-risk patients Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation program Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the […]

Early Data from Phase 3 Trial Show Moderna’s Coronavirus Vaccine Is 94.5% Effective

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified […]

FDA Approves Eli Lilly’s Monoclonal Antibody Cocktail

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms […]

Pfizer and BioNTech Vaccine Trial Results Show 90%+ Efficacy Against SARS-COV2

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety […]

US Government Purchases 300,000 Doses of Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555)

Patients will have no out-of-pocket costs for the medication; potential for purchase of an additional 650,000 vials Eli Lilly and Company (NYSE: LLY) announced today an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. The U.S. government will accept the vials […]

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