Licensing, Packaging, Pharmacy and Sales - Clinical Research Informer

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. The largest by far was the $18.5

Behavioural Health

Behavioural Health Pharmacy Packaging Packaging

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. Sales of FluMist have been yo-yoing for the past several years for AstraZeneca.

Vaccination

Vaccination Vaccine Sales Pharmacy

What is the best over the counter migraine medication?

Druggist

JANUARY 9, 2021

With approximate 190,000 migraine attacks experienced by people in the UK (NICE, 2012), pharmacies are among the first points of call to find over the counter migraine medication. This post will focus on the acute management of migraines with drugs, which can be purchased over the pharmacy counter. £4.49. −£0.67.

Containment

Containment Pharmacy Production Drugs

Lansoprazole vs Omeprazole: differences and similarities

Druggist

OCTOBER 8, 2020

Treatment Zollinger–Ellison syndrome Treatment of Gastro-oesophageal reflux disease (GORD) Verdict : both lansoprazole and omeprazole have the same licensed use as listed above. Both omeprazole 10g and 20mg tablets are available as pharmacy-only medications, for example, Boots Acid Reflux 10 mg and 20mg Gastro-Resistant Tablets.

Pharmacy

Pharmacy Drugs Production Medicine

Can you take co-codamol with naproxen and diazepam?

Druggist

JANUARY 28, 2021

As a part of the discussion, I will review a licensed use of each drug and reasoning for combination treatment. Co-codamol – licensed use. The lower strength of co-codamol is widely available as a pharmacy-only medication. Another example of NSAIDs, which is commonly available over the counter from pharmacies is ibuprofen.

Licensing

Licensing Licensing Drugs Pharmacy

Developments in State Prescription Drug Price Transparency Laws

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

Development Drugs Manufacturing Pharmacy

Esomeprazole vs Omeprazole – Which one is BETTER?

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 . Omeprazole 20mg.

Drugs

Drugs Production Branding Medicine

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

net sales increased 11% to $1.32 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 “This is evidenced by Dupixent achieving in excess of $1 billion in global net sales this quarter.” TARRYTOWN, N.Y. , billion versus third quarter 2019 (4). Total revenues (4). $.

Sales

Sales Production Manufacturing Antibody

Esomeprazole vs Omeprazole – Which one is BETTER?

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 . Omeprazole 20mg.

Drugs

Drugs Production Branding Medicine

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

No dynamic analysis is provided to support the review’s two-year across-the-board RDP reduction, despite the projected impact (28% reduction in non-contested sales of RDP-protected products, and a 15% decline in gross profits).” Effects analyses are missing for several more of the review’s proposals, Meulenbelt and Koutsoupia confirm.

Clinical Trials

Clinical Trials Clinical Trials Production Medicine

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

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

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 (..)

Trials

Trials Production Clinical Trials Clinical Trials

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

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 (..)

Production

Production Antibody Manufacturing Trials

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

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

Antibody Production Trials Medicine

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

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

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

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

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. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

Antibody

Antibody Trials Production Clinical Trials

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

The Pharma Data

JANUARY 12, 2021

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

Antibody Production Manufacturing Clinical Trials

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 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

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

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

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

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 (..)

FDA Approval

FDA Approval Antibody Production Trials

Amazon Pharmacy is going international. Will that lower drug prices?

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

Pharmacy Drugs Licensing Licensing

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

Clinical Research Informer

Digital health player UpHealth swells with three-way merger

FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

Trending Sources

What is the best over the counter migraine medication?

Lansoprazole vs Omeprazole: differences and similarities

Can you take co-codamol with naproxen and diazepam?

Developments in State Prescription Drug Price Transparency Laws

Esomeprazole vs Omeprazole – Which one is BETTER?

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Esomeprazole vs Omeprazole – Which one is BETTER?

European Commission vs Big Pharma, or profit vs access?

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

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

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

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

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

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)

Amazon Pharmacy is going international. Will that lower drug prices?

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

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