FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Once the device is required to bear a UDI, any NHRIC and NDC codes will no longer be permitted on the device label or device packaging.

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The Pharma Data

DECEMBER 17, 2020

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. Once both companies are at full manufacturing capacity in 2021, there are expected to be at least 2 million treatment doses available annually.

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The Pharma Data

DECEMBER 5, 2020

We are also expanding our odronextamab program with multiple pivotal trials in 2021.” We are currently enrolling patients in a potentially registrational Phase 2 portion of this REGN5458 trial.

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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 TARRYTOWN, N.Y. , New agreement covers 1.25 supply to over 1.5 million doses. million doses. million doses.

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The Pharma Data

DECEMBER 29, 2020

The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. 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. Under an agreement with the U.S.

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The Pharma Data

OCTOBER 28, 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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The Pharma Data

NOVEMBER 5, 2020

In 2021, we look forward to important potential launches including for our PD-1 inhibitor Libtayo in non-small cell lung cancer and advanced basal cell carcinoma. Regulatory submissions in the United States and European Union (EU) are planned by the first quarter of 2021. Oncology Program. Evinacumab , an antibody to ANGPTL3.

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Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. active pharmaceutical ingredient, fill/finish, packaging/labeling). Read AgencyIQ’s analysis of the non-paper.] points of disruption).

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The Pharma Data

NOVEMBER 20, 2020

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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The Pharma Data

NOVEMBER 21, 2020

In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche.” Regeneron continues to increase in-house production of REGEN-COV2, and the company has partnered with Roche to increase the global supply of REGEN-COV2 beginning in 2021.

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Agency IQ

JUNE 16, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. Circuit vacated the final rule in 2021.

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Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. Circuit vacated the final rule in 2021. What ever happened to that thing?

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Codon

FEBRUARY 13, 2024

Phage therapies are sold at a pharmacy in Georgia. 2 As you might imagine, getting packages marked ‘viruses’ through customs is a problem in many countries, requiring special permissions or fees. To learn more about how bacteria and other microbes develop resistance, check out the CDC’s information sheet on AMR.

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The Pharma Data

JANUARY 20, 2021

20, 2021 — The tragic milestone was reached before a COVID-19 memorial service began in the nation’s capital Tuesday evening: More than 400,000 Americans have now died from the new coronavirus. trillion pandemic “rescue” package that includes $20 billion for the vaccine effort. © 2021 HealthDay.

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The Pharma Data

JANUARY 19, 2021

19, 2021 — On the eve of his inauguration, President-elect Joe Biden will preside over a ceremony on Tuesday evening that will honor those who have died during the coronavirus pandemic. trillion pandemic “rescue” package that includes $20 billion for the vaccine effort. © 2021 HealthDay. Posted: January 2021.

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Drug & Device Law

DECEMBER 29, 2023

Plaintiff’s claim against the pharmacy and its employee who administered the vaccine were a hodgepodge of invasion of privacy, “parental right of control,” battery, and informed consent claims, brought under the questionable auspices of the state’s (Kansas) consumer protection statute. Overcoming plaintiff’s intentional vagueness, M.T.

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Drug & Device Law

JANUARY 4, 2024

To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since. Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d The FDA, however, did not and does not share that belief.

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Drug & Device Law

MAY 15, 2023

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. includ[es] retail pharmacies. 2021); Texas Health Huguley, Inc. 2021); Frey v. 10, 2021); DeMarco v.

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