The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. “The investigational cocktail is now available to indicated high-risk U.S. Source link.

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Agency IQ

JANUARY 26, 2024

Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”

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The Pharma Data

DECEMBER 29, 2020

Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19.

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The Pharma Data

JANUARY 12, 2021

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. NASDAQ: REGN ) today announced that the U.S.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. The FDA accepted for priority review, with a target action date of February 28, 2021 , the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab) as monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ?50%

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Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. Phage therapies are sold at a pharmacy in Georgia. 4 But the same barriers still exist today.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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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. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. TARRYTOWN, N.Y., Food and Drug Administration (FDA).

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The Pharma Data

NOVEMBER 21, 2020

Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. 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.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S. “We are incredibly proud that the FDA has approved Inmazeb, which is also known as REGN-EB3. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. Forest Pharmaceuticals, Inc.

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