Licensing, Manufacturing, Packaging and Pharmacy

Digital health player UpHealth swells with three-way merger

pharmaphorum

NOVEMBER 24, 2020

The three-way deal combines UpHealth – which provides patient care management, telemedicine and digital pharmacy services and gives its name to the new group – with CloudBreak, which provides a video consultation platform for doctors and patients.

Behavioural Health

Behavioural Health Pharmacy Packaging Packaging

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. costs only $90 for a three-month supply at the lowest-cost PharmacyChecker-accredited international online pharmacy: a savings of 71%. pharmacies. and arguably just as safe. That was not my concern.

FDA Approval

FDA Approval Branding Pharmacy Manufacturing

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pharmacy Checkers

OCTOBER 11, 2019

Sometimes a drug company will manufacture a product in only one plant, which is then shipped to many countries. FDA-approved” drugs must be made in manufacturing plants that are registered with the FDA. Those FDA-approved drugs also are labeled and packaged in accordance with U.S. Most prescription drugs sold in the U.S.

FDA Approval

FDA Approval Drugs Manufacturing Pharmacy

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

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

Pharmacy Drugs FDA Approval Licensing

Developments in State Prescription Drug Price Transparency Laws

FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. The North Dakota law includes three reporting requirements for drug manufacturers.

Development

Development Drugs Manufacturing Pharmacy

FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

XTalks

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. If approved, FluMist will be available through an online pharmacy request system.

Vaccination

Vaccination Vaccine Sales Pharmacy

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Eban walked us through the corruption and negligence among pharmaceutical manufacturers but also at the FDA, which has led to far more instances of substandard drugs than most people know. Canada believes it is too small to facilitate U.S.

Drugs

Drugs Manufacturing Medicine Compliance

RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

NOVEMBER 5, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. and Roche will develop, manufacture and distribute it outside the U.S. .

Trials

Trials Production Clinical Trials Clinical Trials

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

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

Drugs Licensing Licensing Containment

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

OCTOBER 30, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. and Roche will develop, manufacture and distribute it outside the U.S.

Production

Production Antibody Manufacturing Trials

MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

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

Clinical Trials Clinical Trials Development Trials

European Commission vs Big Pharma, or profit vs access?

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

Clinical Trials Clinical Trials Production Medicine

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

JANUARY 12, 2021

The development and manufacturing of the antibody cocktail has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of HHS, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

Antibody

Antibody Production Manufacturing Clinical Trials

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. and Roche will develop, manufacture and distribute it outside the U.S.

Antibody

Antibody Trials Production Clinical Trials

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

The development and manufacturing of the antibody cocktail has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Antibody

Antibody Medicine Production Trials

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

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. The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. In the U.S.

Antibody

Antibody Trials Production Clinical Trials

Regeneron Reports Third Quarter 2020 Financial and Operating Results

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. government.

Sales

Sales Production Manufacturing Antibody

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

Antibody

Antibody Production Trials Medicine

Ep. 003 – Ritesh Patel Podcast Transcript

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

Marketing Clinical Trials Clinical Trials Nurses

Ep. 003 – Ritesh Patel Podcast Transcript

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

Marketing Clinical Trials Clinical Trials Nurses

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

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 development and manufacturing of the antibody cocktail has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C.

Antibody

Antibody Production Clinical Trials Clinical Trials

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

Utilizing production and manufacturing platforms developed over decades, Regeneron rapidly scaled up REGEN-COV2, beginning in the early days of the pandemic with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

Antibody

Antibody Production Clinical Trials Clinical Trials

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

OCTOBER 14, 2020

As we apply the same sophisticated technologies and manufacturing capabilities against COVID-19, we hope this will be one of many demonstrations of how the power of science can be successfully deployed against dangerous infectious diseases.”

FDA Approval

FDA Approval Antibody Production Trials

Clinical Research Informer

Digital health player UpHealth swells with three-way merger

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Trending Sources

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Developments in State Prescription Drug Price Transparency Laws

FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

European Commission vs Big Pharma, or profit vs access?

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Ep. 003 – Ritesh Patel Podcast Transcript

Ep. 003 – Ritesh Patel Podcast Transcript

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

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