Definition, FDA Approval and Immune Response

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

Vaccine

Vaccine Immune Response Virus Clinical Trials

Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

APRIL 14, 2023

Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. M Celeste Simon, PhD, FAACR – GHA Clowes Award for Outstanding Basic Cancer Research Simon, a Fellow of the AACR Academy, is the Arthur H Rubenstein, MBBCh, Professor in Cell and Developmental Biology in the Perelman School of Medicine at the University of Pennsylvania.

Clinical Trials

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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 analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Casirivimab and imdevimab injection is not FDA approved for any use. did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk.

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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. Have chronic kidney disease. Have diabetes.

Hospitals

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Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. supplemental oxygen, mechanical ventilation). These topics were covered in the body of the guidance and were addressed in two new appendices.

FDA

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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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FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

The Pharma Data

OCTOBER 14, 2020

Additionally, immunogenicity, duration of immune response and occurrence of symptomatic COVID-19 will be measured. ImmunityBio and NantKwest Joint Collaboration Agreement Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio, Inc. and its affiliate NantKwest, Inc.

Vaccine

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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. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. 5 There is a caveat in the linked studies, however.

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World RNA Day: What impact RNA it had on drug discovery?

Drug Discovery World

AUGUST 1, 2023

As per a definition provided by AstraZeneca: “Once inside, ASOs bind with high specificity to target mRNA or pre-mRNA, inducing its degradation – effectively silencing it – to prevent its translation into a detrimental protein product.

RNA

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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

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Definition of High-Risk Patients.

Therapies

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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

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

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Definition of High-Risk Patients. Have diabetes.

FDA

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Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

JULY 23, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Treatment

Treatment Trials Therapies Disease

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

The Pharma Data

MARCH 11, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Treatment

Treatment Trials Therapies FDA Approval

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

The Pharma Data

JANUARY 29, 2021

In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. COV2-S (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine

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Drug Discovery Digest

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

Who are the AACR Scientific Achievement Award winners?

Trending Sources

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

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

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

FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

Where's the Synthetic Blood?

World RNA Day: What impact RNA it had on drug discovery?

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

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

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

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

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