Agency IQ

JANUARY 4, 2024

Pharmacopeia (USP) defines impurities as “any component of the drug substance that is not the chemical entity that is defined as the drug substance” or, “any component of a drug product that is not the drug substance or an excipient in the drug product.” Read AgencyIQ’s analysis of the ICH guideline here ].

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The Pharma Data

OCTOBER 30, 2020

Regeneron Pharmaceuticals, Inc. Food and Drug Administration , which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes. TARRYTOWN, N.Y. , Finally, the IDMC recommends continuation of the outpatient trial without modification.

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. About Sedor Pharmaceuticals, LLC.

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The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. TARRYTOWN, N.Y. ,

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The Pharma Data

JANUARY 12, 2021

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. Regeneron Pharmaceuticals, Inc. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. 6 months of follow-up, 83% have ongoing responses for up to 13 months at the time of analysis. Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients.

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The Pharma Data

DECEMBER 29, 2020

Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. Casirivimab and imdevimab injection is not FDA approved for any use. None of the SAEs were considered to be related to study drug. high dose, 0.9%

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. What is drug compounding?

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The Pharma Data

OCTOBER 28, 2020

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. Regeneron Pharmaceuticals, Inc. Regeneron has shared these results with the U.S.

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The Pharma Data

NOVEMBER 5, 2020

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). Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus.

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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FDA Law Blog: Biosimilars

OCTOBER 29, 2023

With this guidance, the Departments decided to reference the 2019 HRSA Guideline rather than the FDA Birth Control Guide for the range of identified categories of contraception (FAQ Part 54, Q2), stating that plans and issuers must cover without cost sharing at least one form of contraception in each category.

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The Pharma Data

MAY 13, 2021

I’ll also show you why their top scientists are now saying that this breakthrough treatment could replace traditional medical approaches for a wide range of painful conditions… What this means is that you can now say goodbye to your daily aches and pains without harmful drugs or having to resort to painful surgery. he continued.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

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Agency IQ

SEPTEMBER 29, 2023

Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans.

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Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

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The Pharma Data

NOVEMBER 21, 2020

Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

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Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. First, drug prices in the U.S. He points to “a mere 1.5%

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , This litigation does not allege that anybody ever actually suffered from bladder cancer (or any other injury) from the drug.

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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 ). This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. 332 (2023) ( here ); Sanofi Aventis U.S. 4th 696 (3d.

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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.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.”

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Drug & Device Law

MAY 26, 2023

In that case, the Fourth Circuit knocked out a Maryland law designed to prevent price gouging on drugs because of its extraterritorial reach. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

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Drug & Device Law

OCTOBER 10, 2023

Plaintiff has listed its patches on the FDA’s National Drug Code (“NDC”) database. Doing so comes with obligations to comply with FDA’s labeling requirements for such OTC drugs, which Plaintiff alleges they do. That’s the FDA’s job, not the court’s. Similarly, the court in Nexus Pharmaceuticals, Inc.

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