FDA Law Blog: Biosimilars

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). In January 2021, MHCC agreed to pay $7,750,000 and comply with a comprehensive three-year MOA. By Larry K.

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The Pharma Data

DECEMBER 1, 2020

1, 2020 — Health care workers and people in nursing homes should be at the front of the line for upcoming COVID-19 vaccines, a U.S. In 2021, five to 10 million doses of vaccine are anticipated to ship each week. In 2021, five to 10 million doses of vaccine are anticipated to ship each week. TUESDAY, Dec.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Department of Health and Human Services under OT number: HHSO100201700020C. If REGN-COV2 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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Hospitals Trials Clinical Trials Production 52

The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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The Pharma Data

JANUARY 12, 2021

12, 2021 /PRNewswire/ — . Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 None of the SAEs were considered to be related to study drug. TARRYTOWN, N.Y. , New agreement covers 1.25 supply to over 1.5

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The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. None of the SAEs were considered to be related to study drug. high dose, 0.9%

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Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). In the first quarter of 2021, we expect to increase available global supply as we continue our collaboration with Roche.”. Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021.

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Therapies FDA Clinical Trials Hospitals 52