The Pharma Data

JANUARY 16, 2021

” He pledged to ramp up vaccination availability in pharmacies, build mobile clinics to get vaccines to underserved rural and urban communities and encourage states to expand vaccine eligibility to people 65 and older, The New York Times reported. ” The vaccine distribution plan comes one day after Biden proposed a $1.9

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The Pharma Data

JANUARY 13, 2021

These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), (..)

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Agency IQ

AUGUST 4, 2023

a wholesaler or pharmacy) would be able to see a valid chain of custody for a product. They may seek “exceptions… to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label.” The system is intended to increase transparency and safety.

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The Pharma Data

NOVEMBER 5, 2020

Food and Drug Administration (“FDA”) will grant an Emergency Use Authorization (“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; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates (such (..)

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Agency IQ

JANUARY 26, 2024

In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened. For example, the stability of the oral anticoagulant Pradaxa (dabigatran; Boehringer Ingelheim) is compromised once the original packaging is opened due to concerns related to moisture.

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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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FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Once the device is required to bear a UDI, any NHRIC and NDC codes will no longer be permitted on the device label or device packaging.

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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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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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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 (..)

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The Pharma Data

JANUARY 12, 2021

Food and Drug Administration (the “FDA”) for the casirivimab and imdevimab antibody cocktail 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 (..)

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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

DECEMBER 29, 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 (..)

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The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

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The Pharma Data

NOVEMBER 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

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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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 rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

OCTOBER 27, 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 20, 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 launch (..)

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Therapies FDA Clinical Trials Hospitals 52

Codon

FEBRUARY 13, 2024

Phage therapies are sold at a pharmacy in Georgia. 2 As you might imagine, getting packages marked ‘viruses’ through customs is a problem in many countries, requiring special permissions or fees. To learn more about how bacteria and other microbes develop resistance, check out the CDC’s information sheet on AMR.

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The Pharma Data

NOVEMBER 21, 2020

Food and Drug Administration (the “FDA”) for REGEN-COV2 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 launch (..)

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The Pharma Data

JANUARY 20, 2021

He pledged to ramp up vaccination availability in pharmacies, build mobile clinics to get vaccines to underserved rural and urban communities and encourage states to expand vaccine eligibility to people 65 and older, The New York Times reported. trillion pandemic “rescue” package that includes $20 billion for the vaccine effort.

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The Pharma Data

JANUARY 19, 2021

” He pledged to ramp up vaccination availability in pharmacies, build mobile clinics to get vaccines to underserved rural and urban communities and encourage states to expand vaccine eligibility to people 65 and older, the Times reported. trillion pandemic “rescue” package that includes $20 billion for the vaccine effort.

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The Pharma Data

OCTOBER 14, 2020

Department of Health and Human Services (HHS), discussed in this press release (the “BARDA Supply Agreement”) and the impact of the BARDA Supply Agreement on Regeneron’s financial condition and results of operations; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product (..)

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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.

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Drug & Device Law

DECEMBER 29, 2023

Plaintiff’s claim against the pharmacy and its employee who administered the vaccine were a hodgepodge of invasion of privacy, “parental right of control,” battery, and informed consent claims, brought under the questionable auspices of the state’s (Kansas) consumer protection statute. Overcoming plaintiff’s intentional vagueness, M.T.

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Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d For “covered persons” and “covered countermeasures” the Act provides extensive preemption: (8) Preemption of State law During the effective period of a declaration. . ., 247d-6d(b)(8). “To 4th 902, 905 (11th Cir.

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Drug & Device Law

MARCH 8, 2023

The cream product’s packaging was a different size and shape, and its text bullet points and bubbles were different from the patches. Consumers coming into pharmacies without a prescription would not be able to buy any product that is stronger. The label was not misleading. Rather, the label was fully accurate.

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Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. 247d-6d(b). 2023 WL 3135662, at *3-5 (detailed PREP Act discussion). pharmacist. . .

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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. Central Admixture Pharmacy Services, Inc. , LEXIS 185688 (N.D.

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