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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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. If you have any questions before purchasing a license to the report, please email me ( afein@drugchannels.net ). d/b/a Drug Channels Institute.

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Policy Prescription

MAY 28, 2021

For the past decade, I’ve written extensively about my view that pharma-funded organizations and initiatives are responsible for misleading Americans about the safety of buying more affordable prescription drugs over the Internet for import from Canada and other countries. Here’s one example and you can be the judge.

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Policy Prescription

DECEMBER 22, 2021

Mark Rubio (R-FL) and Amy Klobuchar (D-MN) , called the “Domain Reform for Unlawful Drug Sellers Act’’ or, for short, the ‘‘DRUGS Act,’’ could effectively end online access to safe and affordable imported medicines for Americans. But the FDA already has a program for tackling online opioid drug dealers.

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Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Starting with the drug. Pharmacokinetics: How the body handles drugs.

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Drug Channels

OCTOBER 13, 2020

I am pleased to announce our new 2020–21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Click here to download a free report overview (including the Table of Contents and a List of Exhibits) New Drug Channels Institute Study Examines Impact of COVID-19 on U.S.

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Policy Prescription

MARCH 11, 2022

A recent opinion from an appeals court in Manitoba, Canada sheds new and more favorable light about the CanadaDrugs-related wholesale drug importation case that was first covered a decade ago in the Wall Street Journal. for sales of mostly misbranded (but not counterfeit drugs) and two batches of counterfeit drugs. supply chain.

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Drug Channels

OCTOBER 19, 2020

Drug Channels readers will save $300 off the standard rate when they use code GJE973 and register prior to October 30th.*. Drug Channels readers will save $300 off the standard rate when they use code GJE973 and register prior to October 30th.*. Visit www.informaconnect.com/trade-channel for further details and to register.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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The Pharma Data

MARCH 26, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. Food and Drug Administration (“FDA”) approval.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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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 5, 2020

Forward-Looking Statements and Use of Digital Media This statement includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking (..)

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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 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. None of the SAEs were considered to be related to study drug. TARRYTOWN, N.Y. , Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

OCTOBER 28, 2020

Regeneron Pharmaceuticals, Inc. “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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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

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. None of the SAEs were considered to be related to study drug. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19.

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The Pharma Data

JANUARY 12, 2021

Regeneron Pharmaceuticals, Inc. 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. Authorized Emergency Use.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. 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. Oncology Program.

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The Pharma Data

NOVEMBER 8, 2020

PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sedor Pharmaceuticals, LLC.

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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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The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). Food and Drug Administration (FDA) in support of an efficacy supplement to the Tyvaso new drug application (sNDA), which we expect to result in revised labeling reflecting the outcome of the INCREASE study.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

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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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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

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). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.

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

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. None of the SAEs were considered to be related to study drug. TARRYTOWN, N.Y.,

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The Pharma Data

NOVEMBER 21, 2020

Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. None of the SAEs were considered to be related to study drug. government allocation program.

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Agency IQ

FEBRUARY 15, 2024

Priority A List. 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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Policy Prescription

APRIL 1, 2022

Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patients. Fake DSCSA Pedigrees.

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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. 5 x ULN).

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