XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units.

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Vaccination Vaccine Antibody Protein 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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Antibody Vaccination Vaccine Trials 52

The Pharma Data

NOVEMBER 30, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. and Australia. Source: Novavax, Inc. .

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Clinical Development Vaccination Vaccine Development 52

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 goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

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Vaccination Vaccine Immune Response Protein 52

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

AUGUST 17, 2020

Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. Treatment vaccines : these boost the immune system responses to target cells. Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses.

Protein 98

Protein Engineer Immune Response In-Vivo 98

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

Antibody 52

Antibody Immune Response Production Engineer 52

Drug Discovery World

MAY 29, 2024

He says: “If you compare that with what’s happening within the monoclonal antibody space, for instance, everybody’s got standardised processes with standardised equipment. The packed capsids are the ones you really want, as they contain the genetic information that’s going to be transferred to the host”, he says.

Gene Therapy 109

Gene Therapy Gene Genetics DNA 109

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. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 11, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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. government allocation program. Regeneron Pharmaceuticals, Inc.

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Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 10, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The information contained in this release is as of December 10, 2020. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

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Vaccination Vaccine Trials Medicine 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. INTERCHANGEABILITY. Pfizer Disclosure Notice.

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Vaccination Vaccine Protein Immune Response 111

Drug Discovery World

MAY 11, 2023

In these cases, injection of the viral vector vaccines induced the production of antibodies recognising platelet factor 4 (PF4) found on patients’ platelets 1. Another dangerous consequence can occur when the therapeutic or vaccine introduces proteins that can activate an uncontrolled immune response. coli, and Pichia cells.

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Production Gene Protein Vaccination 52

The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell. Forward-Looking Statements.

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Manufacturing Production Development Clinical Trials 52

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 The information contained in this release is as of July 19, 2022. INTERCHANGEABILITY.

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Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. This indication is approved under accelerated approval based on tumor response rate and durability of response.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

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Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

AUGUST 17, 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.

Immune Response 52

Immune Response Trials Medicine FDA Approval 52

The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

Immune Response 52

Immune Response Medicine Protein Gene 52

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.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

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Vaccination Vaccine Trials Containment 52

The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

Sales 52

Sales Vaccination Vaccine Medicine 52

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.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

AUGUST 11, 2020

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.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

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.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

Pfizer

NOVEMBER 2, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. . INDICATION.

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Vaccination Vaccine Clinical Trials Clinical Trials 85

XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98

pharmaphorum

OCTOBER 31, 2022

s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). It is the first FDA-approved treatment for Zaire ebolavirus. These mice contain the “full repertoire” of human heavy chain immunoglobulin genes and kappa light chain genes, each linked to the endogenous mouse constant regions.

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Production FDA Approval Antibody Gene 52