Agency IQ

AUGUST 4, 2023

Ahead of a November deadline, FDA finalizes guidance on waivers, exemptions or exceptions from supply chain security requirements In a busy week for Drug Supply Chain Security Act (DSCSA) policy updates, the FDA finalized new guidance on waivers, exceptions or exemptions (WEE) from requirements under the DSCSA.

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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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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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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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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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The Pharma Data

OCTOBER 30, 2020

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. Finally, the IDMC recommends continuation of the outpatient trial without modification. Regeneron is also informing the U.S.

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DrugBank

NOVEMBER 7, 2023

ASHP’s full suite of drug information has been integrated into and made available through DrugBank, bringing together both company’s offerings to provide streamlined access to a broader range of high quality products. For more information, visit ashp.org and ASHP’s consumer website, SafeMedication.com.

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The Pharma Data

DECEMBER 5, 2020

About the Phase 1/2 Dose-escalation Trial REGN5458 monotherapy is being investigated in an open-label, Phase 1/2 dose-escalation trial in patients with R/R multiple myeloma who are at least triple refractory to existing therapeutic options, including proteasome inhibitors, immunomodulatory drugs and CD38 antibody treatments.

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The Pharma Data

OCTOBER 28, 2020

“The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. . Regeneron has shared these results with the U.S.

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The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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The Pharma Data

JANUARY 12, 2021

The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations. None of the SAEs were considered to be related to study drug.

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). None of the SAEs were considered to be related to study drug. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

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The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. None of the SAEs were considered to be related to study drug. Infusion reactions were more common with the high dose of the antibody cocktail (2.7% high dose, 0.9% low dose, 1.4%

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Agency IQ

JULY 12, 2024

In response to even more acute drug shortages during the Covid-19 pandemic, the European Commission issued proposals to set up a “European Health Union” meant to address drug shortages in several ways. The non-paper also suggested three potential actions to address drug shortages. Read AgencyIQ’s analysis of the non-paper.]

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The Pharma Data

NOVEMBER 21, 2020

Food and Drug Administration (FDA). None of the SAEs were considered to be related to study drug. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

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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 5, 2020

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). The Company commenced delivery of REGN-COV2 drug product under the agreement during the third quarter of 2020. REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus.

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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. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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The Pharma Data

OCTOBER 14, 2020

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. DRUG INTERACTIONS. TARRYTOWN, N.Y., WARNINGS AND PRECAUTIONS.

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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. It is, in the words of Chapo Extrax, ‘the newest drug cartel in town.’”

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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). 247d-6d(b)(8). 4th 902, 905 (11th Cir.

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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

MARCH 8, 2023

March 2, 2023), visited their friendly neighborhood drug store and bought a lawsuit. The court’s opinion was like a bag of stuff you might bring back from a drug store – some goodies and some stuff that might make you embarrassed. The plaintiffs in Acosta-Aguayo v. Walgreen Co. LEXIS 34836 (N.D. No prescriptions were required.

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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. United States Department of Health and Human Services , 58 F.4th 4th 696 (3d.

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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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