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

The Pharma Data

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Schleifer , M.D.,

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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

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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

The Pharma Data

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Data from these trials will be used to support a future BLA submission.

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‘Warp Speed’ Officials Say U.S. COVID Vaccine Distribution Too Slow

The Pharma Data

million doses of the approved Pfizer and Moderna COVID-19 vaccines had been distributed across the United States by Monday morning, just 2.1 That’s far too slow a pace, said one official charged with spearheading the vaccination of Americans. million vaccination tally — compiled by the U.S. . THURSDAY, Dec.

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COVID Daily Death Toll Sets New U.S. Record, Soars Past 4,400

The Pharma Data

Health Secretary Alex Azar said Tuesday that the federal government would now release all available vaccine doses and told states to vaccinate every American aged 65 and older. “Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied.”

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. Our best expert admissibility/Rule 702 (and best trial court) decision of 2023 was issued earlier this month, shortly after the Rule 702 amendments went into effect. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

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Two New Appellate COVID-Related Developments

Drug & Device Law

Suffice it to say that it covers the administration of COVID vaccines – the heart of this nation’s response to the COVID-19 pandemic. The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent.

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