The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration (“FDA”) with respect to a potential Emergency Use Authorization (“EUA”) for REGN-COV2, and possible regulatory approval of REGN-COV2; whether the FDA will grant an EUA for REGN-COV2 and, if an EUA is granted, the scope and terms of such EUA and how long such EUA would remain in effect for REGN-COV2; (..)

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The Pharma Data

DECEMBER 5, 2020

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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Agency IQ

JANUARY 26, 2024

This report yielded some clarification from both industry and the government at the time: According to PhRMA, U.S. This report also refers to an article in the Wall Street Journal indicating that, between 1993 and 1998, the government spent $3.9 PhRMA is unaware of expiration dating for drug products beyond 60 months.”

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The Pharma Data

DECEMBER 29, 2020

government, Regeneron is producing approximately 300,000 doses (2,400 mg) for outpatient use under the EUA. government regarding additional doses. . Under an agreement with the U.S. The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. In the U.S.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

OCTOBER 28, 2020

Food and Drug Administration will grant an Emergency Use Authorization (“EUA”) for REGN-COV2 and, if an EUA is granted, how long it would remain in effect for REGN-COV2; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates (such as REGN-COV2) and new indications (..)

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Virus Trials Clinical Trials Production 40

The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (the “FDA”) for casirivimab and imdevimab will remain in effect and whether the EUA is revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons; the likelihood, timing, and scope of possible regulatory approval and commercial (..)

Hospitals 52

Hospitals Production Clinical Trials Virus 52

Agency IQ

JULY 12, 2024

In May 2023, a non-paper drafted by the Belgian government, obtained by POLITICO Pro EU, called attention to the continuing issue of medicine supply shortages. In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. points of disruption).

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The Pharma Data

NOVEMBER 5, 2020

government. government. (e) Corporate and Business Development Update. In July 2020 , the Company announced an agreement whereby the Company was awarded a $450 million contract to manufacture and supply REGN-COV2 to the U.S. The Company commenced delivery of REGN-COV2 drug product under the agreement during the third quarter of 2020.

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Production FDA FDA Approval Trials 52

The Pharma Data

NOVEMBER 20, 2020

Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need. As part of Operation Warp Speed, in July the U.S.

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Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

NOVEMBER 21, 2020

government allocation program. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. government and Regeneron signed an agreement for this initial supply of REGEN-COV2.

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. 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.

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. That means at 12:01 on November 18, the government will shut down unless Congress is able to pass either a full budget (unlikely) or a continuing resolution (more likely). the drug and device) of the combination product.

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FDA Science Regulations Production 40

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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Regulations FDA Science Production 40

The Pharma Data

OCTOBER 14, 2020

. “Decades of investment in our VelociSuite® rapid response technologies, the dedication of world-class scientists, and the courageous contributions of healthcare providers and patients, together with remarkable cooperation between leading international health organizations and governments, have led to this important moment.

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FDA Approval FDA Production Vaccine 52

Agency IQ

AUGUST 25, 2023

The questions contained in the letter are organized into six high-level topics : (1) current market dynamics; (2) (regulatory) pathway; (3) federal-state interaction; (4) safety; (5) quality; and (6) form, packaging, accessibility, and labeling. Alternatively, Congress could simply grant a specific preclusion for CBD.

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Regulations FDA Science Production 40

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether. Polansky v. UnitedHealthcare, Inc. ,

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Testimonials FDA Drugs Vaccine 105