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

OCTOBER 28, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes. Investor Relations Mark Hudson Tel: +1 (914) 847-3482 mark.hudson@regeneron.com . .

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y., NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S.

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The Pharma Data

DECEMBER 29, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. View original content: [link].

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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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The Pharma Data

NOVEMBER 21, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. 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. Contacts: Media Relations Alexandra Bowie Tel: +1 (914) 847-3407 alexandra.bowie@regeneron.com.

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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

NOVEMBER 27, 2023

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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The Pharma Data

MAY 13, 2021

Before I show you what this breakthrough pain solution is, I want to let you in on the “dirty little secret” of the pharmaceutical industry. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm. Please don’t blame yourself.

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DrugBank

NOVEMBER 7, 2023

DrugBank’s customer base, which includes 13 of the top 20 pharmaceutical companies and users in more than 24 countries, have also gained access to ASHP’s evidence-based information. DrugBank is honoured to partner with the world’s leading biomedical researchers as they pursue their goal of better medical outcomes.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. REGENERON PHARMACEUTICALS, INC. FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). In millions). 5,901.0. $. 6,471.1.

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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.

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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. The Commission’s communication was accompanied by a Q&A document defining key terms and ideas, including how the effort was related to ongoing efforts to overhaul the pharmaceuticals legislation.

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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 Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. It’s always a good idea to compare prices at different pharmacies. What Are Generic Drugs? FAQs Q: Are generic drugs always cheaper than brand-name medications? A: In most cases, yes.

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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. The letter gave respondents until August 18, 2023 to respond to the request.

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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 ). That meant both the pharmacist and the pharmacy where the vaccine was administered “covered persons” under the act. Forest Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc. 4th 851 (6th Cir.

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Drug & Device Law

OCTOBER 25, 2023

Weigh any packaged meat at a grocery store, and there’s a decent chance the weight will be wrong. But every once in a while, a court will see through the consumer fraud case as itself being phony, and will throw the case out as if it was a package of spoiled meat. Wilson applied Nexus Pharmaceuticals, Inc. LEXIS 185688 (N.D.

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