FDA Law Blog

JUNE 3, 2021

North Dakota’s new law, HB 1032 , sets forth reporting requirements applicable to drug manufacturers, pharmacy benefit managers (PBMs), and health insurers.

Development 52

Development Drugs Manufacturing Pharmacy 52

Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation?

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

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”), (..)

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. The drug performed “extraordinarily well” in a variety of cohorts, said Nimish Patel, PharmD, professor of clinical pharmacy at University of California San Diego.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

Druggist

NOVEMBER 17, 2020

When prescribed, PPIs, including esomeprazole and omeprazole, have a wider licensed used. General sale medicines (GSL): available on sale in retail outlets and pharmacies, without a prescription. pylori), management of ‘ reflux ‘ symptoms. . Esomeprazole vs Omeprazole legal classification . £11.99. −£1.99.

Drugs 87

Drugs Production Branding Medicine 87

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 (..)

Trials 52

Trials Production Clinical Trials Clinical Trials 52

Druggist

NOVEMBER 17, 2020

When prescribed, PPIs, including esomeprazole and omeprazole, have a wider licensed used. General sale medicines (GSL): available on sale in retail outlets and pharmacies, without a prescription. pylori), management of ‘ reflux ‘ symptoms. . Esomeprazole vs Omeprazole legal classification . £11.99. −£1.99.

Drugs 52

Drugs Production Branding Medicine 52

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; (..)

Production 52

Production Antibody Manufacturing Trials 52

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 (..)

Antibody 40

Antibody Production Trials Medicine 40

Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. FMD requires that every single prescription drug dispensed in the EU must be verified for authenticity via a mandatory 2D barcode on the packaging. Canada believes it is too small to facilitate U.S. wholesale importation of lower-cost drugs.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

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 (..)

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

Antibody 52

Antibody Trials Production Clinical Trials 52

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 (..)

Antibody 52

Antibody Medicine Production Trials 52

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., For more information, please visit www.PAXLOVID.com.

Drugs 69

Drugs Licensing Licensing Containment 69

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 (..)

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

Pharma Marketing Network

JUNE 10, 2020

Most recently, telemedicine and specialty pharmacy connected together to create a product that a consumer can get directly. Where you can get ED medication, hair loss, medication, that sort of thing, all packaged together. You go online, you talk to a doctor via telemedicine, and a specialty pharmacy then delivers it for you.

Marketing 52

Marketing Clinical Trials Clinical Trials Nurses 52

The Pharma Data

NOVEMBER 5, 2020

The FDA accepted for priority review, with a target action date of February 28, 2021 , the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab) as monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ?50% Oncology Program. 50% PD-L1 expression.

Sales 52

Sales Production Manufacturing Antibody 52

Pharma Marketing Network

JUNE 10, 2020

Most recently, telemedicine and specialty pharmacy connected together to create a product that a consumer can get directly. Where you can get ED medication, hair loss, medication, that sort of thing, all packaged together. You go online, you talk to a doctor via telemedicine, and a specialty pharmacy then delivers it for you.

Marketing 40

Marketing Clinical Trials Clinical Trials Nurses 40

The Pharma Data

NOVEMBER 20, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 21, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

Pharmacy Checkers

OCTOBER 11, 2019

Those FDA-approved drugs also are labeled and packaged in accordance with U.S. I’m not certain of this, but I believe that the concept of how this will lower drug prices goes like this: The drug companies have contracts with pharmacy benefit managers (PBMs). Most prescription drugs sold in the U.S. are made outside the U.S.,

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

JANUARY 23, 2020

Amazon Pharmacy recently registered trademarks in Australia, Canada, and the United Kingdom but has not announced its stated plans for these registrations. For those of you who did not know that there is an Amazon Pharmacy, now you do. Amazon acquired online pharmacy PillPack in 2018 as part of its push into pharmaceutical sales.

Pharmacy 55

Pharmacy Drugs Licensing Licensing 55

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 (..)

FDA Approval 52

FDA Approval Antibody Production Trials 52

Pharmacy Checkers

MARCH 11, 2020

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41