Licensing, Marketing, Packaging and Pharmacy

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

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

FDA committee recommends AstraZeneca and Sanofi’s RSV prophylactic nirsevimab

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

FDA Approval Antibody Allergies Packaging

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

Pharmacy Checkers

JANUARY 10, 2020

costs only $90 for a three-month supply at the lowest-cost PharmacyChecker-accredited international online pharmacy: a savings of 71%. We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research.

FDA Approval

FDA Approval Branding Pharmacy Manufacturing

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. FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

Vaccination

Vaccination Vaccine Sales Pharmacy

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

Pharmacy Checkers

OCTOBER 11, 2019

Drug companies make their products in many countries and ship those same drugs around the world to different markets. In other cases, two or even three plants will make the same drug for different markets. Those FDA-approved drugs also are labeled and packaged in accordance with U.S. Some of this is guesswork.

FDA Approval

FDA Approval Drugs Manufacturing 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. Price incl.

Containment

Containment Pharmacy Production Drugs

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

Clinical Trials

Clinical Trials Clinical Trials Production Medicine

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. The European Union (EU) has similar challenges to us when it comes to drug safety, including inspections of the plants that make pharmaceuticals for the European market. Canada believes it is too small to facilitate U.S. What about other countries?

Drugs

Drugs Manufacturing Medicine Compliance

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. Information submitted in response to the new law will be published on a public website that is to be developed by the North Dakota insurance commissioner.

Development

Development Drugs Manufacturing Pharmacy

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

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

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. In pharmaceuticals, it is possible to bring isomers to the market as sperate drugs and market them accordingly. £11.99.

Drugs

Drugs Production Branding Medicine

Ep. 003 – Ritesh Patel Podcast Transcript

Pharma Marketing Network

JUNE 10, 2020

RJ Lewis (EHS): Hello, this is RJ Lewis from Pharma Marketing Network. And he’s also a Pharma Marketing Network Editorial Advisory Board member. Ritesh Patel (OGILVY): So, you know, it’s been really interesting as the growth of investment goes into this market, and I really focus really on digital health.

Marketing

Marketing Clinical Trials Clinical Trials Nurses

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

Ep. 003 – Ritesh Patel Podcast Transcript

Pharma Marketing Network

JUNE 10, 2020

RJ Lewis (EHS): Hello, this is RJ Lewis from Pharma Marketing Network. And he’s also a Pharma Marketing Network Editorial Advisory Board member. Ritesh Patel (OGILVY): So, you know, it’s been really interesting as the growth of investment goes into this market, and I really focus really on digital health.

Marketing

Marketing Clinical Trials Clinical Trials Nurses

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. In pharmaceuticals, it is possible to bring isomers to the market as sperate drugs and market them accordingly. £11.99.

Drugs

Drugs Production Branding Medicine

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 Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. R&D: Up-front payments related to license and collaboration agreements. (85). Non-GAAP net income per share – diluted (1). $. In millions).

Sales

Sales Production Manufacturing Antibody

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

Clinical Research Informer

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

Digital health player UpHealth swells with three-way merger

Trending Sources

FDA committee recommends AstraZeneca and Sanofi’s RSV prophylactic nirsevimab

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

FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

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

What is the best over the counter migraine medication?

European Commission vs Big Pharma, or profit vs access?

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

Developments in State Prescription Drug Price Transparency Laws

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

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

Esomeprazole vs Omeprazole – Which one is BETTER?

Ep. 003 – Ritesh Patel Podcast Transcript

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

Ep. 003 – Ritesh Patel Podcast Transcript

Esomeprazole vs Omeprazole – Which one is BETTER?

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 Reports Third Quarter 2020 Financial and Operating Results

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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