The Pharma Data

OCTOBER 28, 2020

Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended June 30, 2020. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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The Pharma Data

NOVEMBER 5, 2020

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. Total revenues increased by 32% to $2.294 billion in the third quarter of 2020, compared to $1.744 billion in the third quarter of 2019. TARRYTOWN, N.Y. , Third quarter 2020 EYLEA ® U.S. Total revenues (4). $.

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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

JANUARY 26, 2024

More recently – in 2019 – researchers from Germany published a sweeping review of the available literature on drug stability beyond the labeled expiration date. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date. Every facility (i.e.,

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. billion during 2019-2023 (Technavio 2019).

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

JANUARY 12, 2021

Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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The Pharma Data

NOVEMBER 20, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020.

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The Pharma Data

NOVEMBER 21, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020.

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The Pharma Data

DECEMBER 29, 2020

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. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

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The Pharma Data

JANUARY 5, 2021

Besides giving telemedicine a boost, the pandemic has also fostered the rise of innovative medical services, everything from getting prescriptions by mail to drive-through virus testing and pharmacy-based vaccinations. Researchers compared data from February to June in 2019 and February to June 2020. Pharmacies also fill gaps.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Stacking” refers to aggregating discounts provided by a manufacturer to different customers on the same unit of drug – for example a discount to a pharmacy and a rebate to a third-party payor – when determining best price. Allergan Sales , which affirmed a lower court decision in a Federal False Claims case involving best price stacking.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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Agency IQ

SEPTEMBER 29, 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. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

OCTOBER 14, 2020

In 2019, as reported in the New England Journal of Medicine, the PALM Trial was stopped early following a pre-specified interim analysis that showed superiority of Inmazeb to ZMapp and remdesivir with respect to mortality. 2019; 381(24):2293-2303. 1Mulangu, S, Dodd, LE, Davey, RT, et al. New England Journal of Medicine.

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FDA Law Blog: Biosimilars

MAY 13, 2025

FDA recognized that there are pharmacy websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines, but there are many that fail to adhere to safeguards followed by pharmacies licensed in the U.S. See Proposed Rule, Importation of Prescription Drugs , 84 Fed. 70,796, 70,800 (Dec.

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Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. In 2019 (during the Trump Administration), the FDA approved generic mifepristone, subject to the same REMs. Sorsaia , 2023 WL 3211847, at *2.

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Drug & Device Law

JUNE 2, 2022

Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate. This is not a matter of us injecting our personal and political views into areas we do not belong. 3d 27 (Okla.

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