Licensing, Pharmacy and Protein - Clinical Research Informer

Best OINTMENT or CREAM for insect bites

Druggist

FEBRUARY 17, 2021

In this post, I will review the best ointment or cream for insect bites available over the counter and from pharmacies. Products available for insect bites in supermarkets or pharmacies come almost entirely in the form of creams. For many customers, ointment or cream for insect bites is the first line of rescue in stings management.

Pharmacy

Pharmacy Containment Production Sales

Apixaban vs warfarin: rise of newer anticoagulant

Druggist

APRIL 29, 2021

Apixaban vs warfarin: differences in licensed use. Warfarin is licensed for treatment/prevention of the following conditions: Prevention of clot formation in patients with rheumatic heart disease and atrial fibrillation (AF). Although not precisely the same, warfarin and apixaban have similar licensed use.

Drugs

Drugs Licensing Licensing Production

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. What is a Biosimilar? Biosimilars are the “generic” drugs of the biopharma world. What is an Interchangeable Biological Product?

Production

Production Insulin Branding Generic Drugs

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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COVID-19 nasal vaccine candidate effective at preventing disease transmission

The Pharma Data

SEPTEMBER 30, 2021

” To solve those problems, Varadarajan collaborated with Xinli Liu, professor of pharmaceutics at the UH College of Pharmacy, and an expert in nanoparticle delivery. the corporate has an exclusive license agreement with UH with reference to the property covering intranasal vaccines and STING agonist technologies.

Vaccine

Vaccine Vaccination Immune Response Licensing

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

Pfizer

DECEMBER 20, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Microsomal triglyceride transfer protein inhibitor: lomitapide.

Drugs

Drugs Licensing Licensing Containment

Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends

XTalks

JUNE 12, 2023

In addition to dialysis treatments, Fresenius Medical Care offers a range of healthcare services including value and risk-based care programs, pharmacy services and services related to vascular, cardiovascular and endovascular specialties, as well as ambulatory surgery centers.

FDA Approval

FDA Approval Production Sales In-Vitro

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

NOVEMBER 20, 2020

Zokinvy blocks the accumulation of defective, farnesylated proteins which form tight associations with the nuclear envelope, leading to cellular instability and the process of premature aging in children and young adults with Progeria and processing-deficient Progeroid Laminopathies. LIMITATIONS OF USE.

FDA Approval

FDA Approval Genetics 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

The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

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

BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. (NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. and the world, respectively, in 2020.

Antibody

Antibody Production Trials Medicine

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 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

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 two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Antibody

Antibody Medicine Production 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

The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

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

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Antibody

Antibody Production Manufacturing 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

Clinical Research Informer

Best OINTMENT or CREAM for insect bites

Apixaban vs warfarin: rise of newer anticoagulant

Webinars

Trending Sources

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

Webinars

COVID-19 nasal vaccine candidate effective at preventing disease transmission

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

Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

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

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

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

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

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

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

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