Definition, Immune Response, Licensing and Therapies

FIRST AUTHORIZATION IN EUROPEAN UNION FOR COVID-19 VACCINE IN ADOLESCENTS

The Pharma Data

JUNE 24, 2021

Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an Emergency Use Authorization (e.g., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. in the U.S.) or a variation to Conditional Marketing Authorizations (e.g., BioNTech COVID-19 Vaccine. The Pfizer?BioNTech

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Vaccine Clinical Trials Trials FDA

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

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. futility analysis). . In the U.S.

Hospitals

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Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. and Germany as well as animal immunogenicity studies.

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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 follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. who require oxygen therapy due to COVID-19, OR.

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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

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Yancopoulos , M.D., combined dose groups; 6.5%

Virus

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Where's the Synthetic Blood?

Codon

JULY 14, 2024

While blood doesn’t fit neatly into the various definitions of an organ , it still comprises a discrete system with specific functions. From Early Transfusion to Component Therapy The earliest documented attempts at blood transfusions involved the transfer of blood from animals to humans in the 17 th century. Always free.

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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

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

Therapies

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Models of Life

Codon

SEPTEMBER 29, 2024

” The definition was nebulous, but there were agreed-upon themes. Given the fuzziness of the definition, it was unclear which of the released projects deserved the name. It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life.

Engineering

Engineering Virus DNA Therapies

Tezepelumab granted Priority Review by U.S. FDA

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018. About Severe Asthma.

FDA

FDA Trials Therapies Treatment

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

The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA).

FDA

FDA Clinical Trials Hospitals Government

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

Business net income is a non-GAAP financial measure (definition in Appendix 9). 1 See Appendix 9 for definitions of financial indicators. At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. Full-year 2020, BOI increased 4.4% to €9,762 million. At CER, BOI increased 9.7%.

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Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

FEBRUARY 4, 2021

Business net income is a non-GAAP financial measure (definition in Appendix 9). 1 See Appendix 9 for definitions of financial indicators. At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. Full-year 2020, BOI increased 4.4% to €9,762 million. At CER, BOI increased 9.7%.

Vaccine

Vaccine Production FDA Pharmaceuticals

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7) (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7).

Vaccine

Vaccine Production FDA FDA Approval

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.

Trials

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Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. It’s a commitment that extends beyond introducing novel therapies.

Trials

Trials Production Clinical Trials Government

Drug Discovery Digest

FIRST AUTHORIZATION IN EUROPEAN UNION FOR COVID-19 VACCINE IN ADOLESCENTS

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

Trending Sources

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

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

Where's the Synthetic Blood?

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

Models of Life

Tezepelumab granted Priority Review by U.S. FDA

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

Sanofi delivered close to double-digit Q4 2020

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

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