Immune Response and Regulation - Clinical Research Informer

Pfizer says coronavirus vaccine is safe and spurs immune response in children

Bio Pharma Dive

SEPTEMBER 20, 2021

But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators. The results position Pfizer and BioNTech to seek clearance in children as young as five years old.

Immune Response

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Polyphenols may be missing component in regulating inflammatory immune responses

Medical Xpress

FEBRUARY 21, 2023

PCB2DG, a polyphenol with anti-inflammatory properties, works by targeting and directly interacting with the major glutamine transporter protein, alanine serine cysteine transporter 2 (ASCT2), to inhibit the uptake of glutamine, an important amino acid found in the blood.

Immune Response

Immune Response Regulation Protein

Researchers explain how lipids can control immune response

Medical Xpress

NOVEMBER 24, 2022

But they are also involved in regulating the genes expressed within—and the signaling between—cells. Lipids influence how our cells behave and function, which affects many processes in the body including the immune system.

Immune Response

Immune Response Gene Expression Research Regulation

Study identifies noncoding RNA involved in immune response and sepsis

Scienmag

FEBRUARY 1, 2021

A long noncoding RNA regulates the expression of inflammatory genes and has a surprising effect on vulnerability to septic shock in mice Credit: Apple Vollmers When the body’s immune response to an infection gets out of control, the result can be sepsis, a life-threatening condition in which an overwhelming inflammatory response can lead rapidly (..)

Immune Response

Immune Response RNA Regulation Gene

J&J, without details, makes case for a coronavirus booster shot

Bio Pharma Dive

AUGUST 25, 2021

A second shot given six months after the first appears to provide a bigger immune response, the company said, a finding J&J aims to take to regulators in the U.S. and elsewhere.

Immune Response

Immune Response Regulation

Regulating immunological memory may help immune system fight disease, study finds

Medical Xpress

JANUARY 20, 2023

Scientists have long sought to better understand the human body's immune responses that occur during various diseases, including cancer and inflammatory diseases.

Immune Response

Immune Response Regulation Scientist

Early data shows Russia’s Sputnik V COVID-19 vaccine produces immune response

pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. Preclinical and clinical studies have made it possible to provisionally approve the vaccine under the current Russian coronavirus regulations.

Immune Response

Immune Response Vaccination Vaccine Trials

Chinese regulator approves personalised cancer vaccine trial

Drug Discovery World

MARCH 30, 2023

Anupama Mishra, Pharma Analyst at GlobalData, commented: “Vaccine-based immune responses have already been explored for the development of preventive vaccines for infectious diseases, but in oncology, the stimulation of a tumour-specific immune response is a novel concept.

Regulation

Regulation Vaccination Vaccine Trials

Drug made from pig intestine helps escape the “trap” of clot-causing immune response

Scienmag

DECEMBER 9, 2021

When the body attempts to fight off an infection, immune cells called neutrophils may shoot out spider web-like networks of toxic proteins to help contain the invaders. Utilizing […].

Immune Response

Immune Response Containment Protein Regulation

Immune surprise: Recently evolved alarm molecule drives inflammation

Medical Xpress

DECEMBER 16, 2022

Scientists from Trinity College Dublin have made an important breakthrough in understanding how inflammation is regulated. They have just discovered that a key immune alarm protein previously believed to calm down the immune response actually does the opposite.

Immune Response

Immune Response Protein Regulation Scientist

B or not to B: Insights in the regulation of anti-viral immunity

Drug Discovery Today

APRIL 5, 2022

Researchers delve into the inner workings of the antibody immune response, finding key differences in the metabolism of two closely related immune cell subsets.

Immune Response

Immune Response Regulation Antibody Research

Zydus gets FDA approval for antibiotic drug azithromycin

Pharmaceutical Technology

APRIL 11, 2023

The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response. It carries out operations in the regulated markets of the US and Europe, as well as in Latin America and South Africa.

FDA Approval

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HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India

Pharmaceutical Technology

JUNE 30, 2022

HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. This technology can stimulate an immune response with a dose up to 20 times lower than current vaccines, which enhances safety, lowers costs, and increases production speed. .

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

COVID-19 vaccine development: Setback for Sanofi and GSK candidate, University of Queensland and CSL abandon trial

BioPharma Reporter

DECEMBER 11, 2020

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

Immune Response

Immune Response Vaccination Vaccine Trials

Parasitic worms offer ‘the missing link’ on the dual nature of a key immune regulator

Scienmag

NOVEMBER 13, 2020

Whether the signaling molecule IL-33 wakes up or turns down the immune response depends on what cell type releases it, School of Veterinary Medicine researchers found. ” “The mantra of my […].

Immune Response

Immune Response Regulation Medicine Research

Bimervax Covid-19 vaccine authorised in UK

Drug Discovery World

AUGUST 3, 2023

It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination. Bimervax combines a part of the SARS-CoV-2 virus spike protein with an adjuvant.

Vaccination

Vaccination Vaccine Immune Response Medicine

Existing drug could aid spinal injury recovery

Drug Discovery World

JULY 12, 2023

However, drugs that reduce inflammation by suppressing the whole immune response also inhibit the immune cells which promote repair. The University of Edinburgh-led study tested multiple drugs in zebrafish larvae for their ability to prevent excessive inflammation during an immune response.

Immune Response

Immune Response Drugs Scientist Regulation

Comparing immune-humanized platforms: Which one is best for my application?

Drug Discovery World

JUNE 8, 2023

Humanization of highly immunodeficient NSG mice with hematopoietic stem cells or peripheral blood mononuclear cells provides a powerful platform for very precise modeling of human immune responses.

Immune Response

Immune Response Regulation Development Drugs

Investigating the role of Brd4 in diet-induced obesity

Scienmag

MAY 4, 2021

Credit: Lin-Feng Chen A new study, published in JCI Insight, looks at how Brd4, a regulator of the innate immune response, influences diet-induced obesity. The researchers believe that Brd4 could be used as a target for obesity and insulin resistance. Approximately one-third of the adults and one in five children in the U.S.

Immune Response

Immune Response Insulin Regulation Research

First patient dosed with AgenTus’ cell therapy designed to clear COVID-19 virus while reducing inflammation

BioPharma Reporter

NOVEMBER 9, 2020

Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary, AgenTus Therapeutics.

Immune Response

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Encouraging data from Johnson & Johnson on Ebola vaccine

BioPharma Reporter

SEPTEMBER 14, 2021

Johnson & Johnson says data published in The Lancet on its Ebola vaccine regimen shows it has a robust and durable immune response in adults and children.

Vaccination

Vaccination Vaccine Immune Response Regulation

Encouraging data from AZ/Oxford coronavirus shot

pharmaphorum

NOVEMBER 19, 2020

The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found. Although both vaccines are not yet approved by regulators, the results are encouraging as older people seem to be most at risk from the virus.

Immune Response

Immune Response Vaccination Vaccine Regulation

STAT+: Pharmalittle: Merck KGaA probed by French court for misleading info; former Genentech scientists given prison terms over trade-secret theft

STAT News

OCTOBER 19, 2022

1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months , Reuters notes. Omicron-tailored Omicron-tailored shots by Pfizer and Moderna are already authorized by regulators in several countries. 5 subvariants of Omicron.

Immune Response

Immune Response Scientist Vaccination Vaccine

Altimmune ditches nasal COVID vaccine on weak trial data

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

Vaccination

Vaccination Vaccine Trials Immune Response

J&J single-shot COVID-19 vaccine shows early promise

pharmaphorum

JANUARY 15, 2021

Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years. J&J expects to file with the FDA first, followed by other regulators.

Vaccination

Vaccination Vaccine Immune Response Antibody

Novavax in talks with FDA over quick approval for COVID-19 shot

pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

Vaccination

Vaccination Vaccine Regulation Immune Response

Which immune-humanized platform is right for my application?

Drug Discovery World

JULY 5, 2023

Humanization of highly immunodeficient NSG mice with hematopoietic stem cells or peripheral blood mononuclear cells provides a powerful platform for very precise modeling of human immune responses. Join DDW for this exclusive free event, Comparing immune-humanized platforms: Which one is best for my application?

Immune Response

Immune Response Genetics Regulation Development

Webinar: How to choose the right immune-humanized platform

Drug Discovery World

JUNE 28, 2023

Humanization of highly immunodeficient NSG mice with hematopoietic stem cells or peripheral blood mononuclear cells provides a powerful platform for very precise modeling of human immune responses. Join DDW for this exclusive free event, Comparing immune-humanized platforms: Which one is best for my application?

Immune Response

Immune Response Genetics Regulation Development

Exclusive event: How to compare immune-humanized platforms

Drug Discovery World

JUNE 21, 2023

Humanization of highly immunodeficient NSG mice with hematopoietic stem cells or peripheral blood mononuclear cells provides a powerful platform for very precise modeling of human immune responses. Join DDW for this exclusive free event, Comparing immune-humanized platforms: Which one is best for my application?

Immune Response

Immune Response Genetics Regulation Development

How to determine which immune-humanized platform is best for your application

Drug Discovery World

JUNE 14, 2023

Humanization of highly immunodeficient NSG mice with hematopoietic stem cells or peripheral blood mononuclear cells provides a powerful platform for very precise modeling of human immune responses. Join DDW for this exclusive free event, Comparing immune-humanized platforms: Which one is best for my application?

Immune Response

Immune Response Genetics Regulation Development

Which immune-humanized platform is best for my application?

Drug Discovery World

JUNE 8, 2023

Humanization of highly immunodeficient NSG mice with hematopoietic stem cells or peripheral blood mononuclear cells provides a powerful platform for very precise modeling of human immune responses. Join DDW for this exclusive free event, Comparing immune-humanized platforms: Which one is best for my application?

Immune Response

Immune Response Genetics Regulation Development

Researchers uncover molecular pathways underlying depression

Drug Discovery World

OCTOBER 4, 2023

By analysing gene interactions in mice subjected to behavioural tests, the researchers from Korea University Anam Hospital, Konkuk University, and Sahmyook University identified 141 genes primarily linked to immune responses correlating with depressive behaviours.

Research

Research Gene DNA Gene Expression

Rapid COVID immune status test launched in UK, Ireland

pharmaphorum

JULY 26, 2021

. “Being able to distinguish the IgM from the IgG class of antibody response will also provide potentially useful information about the stage of a person’s immune response, and its likely persistence over time,” he added.

Antibody

Antibody Immune Response Vaccination Vaccine

Concerns emerge after AZ’s lucky vaccine trial ‘mistake’

pharmaphorum

NOVEMBER 26, 2020

As pointed out by Canada’s CBC , the change was okayed by regulators but nevertheless the stronger effect could still be a statistical quirk. Younger people would tend to produce a stronger immune response than older people, which could account for the differing results.

Vaccination

Vaccination Vaccine Trials Immune Response

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. CBER regulates products under a variety of regulatory authorities: INDs for CBER-regulated products. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

Development

Development Production Immune Response Licensing

Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

pharmaphorum

DECEMBER 11, 2020

Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune response in older adults. While antibody levels were comparable to those seen in recovering COVID-19 patients in adults aged 18-49, the response was lower in older adults.

Immune Response

Immune Response Trials Vaccination Vaccine

South African variant may cut response from Pfizer/BioNTech shot, study finds

pharmaphorum

FEBRUARY 18, 2021

Mutations may alter neutralisation by affecting spike function rather than antigen response and its also unclear from this study how the T-cell response is affected. The body’s immune response to the coronavirus is not limited to antibodies with CD8+ T-cells also playing roll combating infections.

Immune Response

Immune Response Genetic Engineering Vaccination Vaccine

Gritstone bio trumpets first data for ‘multivariant’ COVID jab

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “With new variants – like Omicron and B.1.640.2

Protein

Protein Vaccination Vaccine Immune Response

FDA guidance allows fast updates of COVID-19 vaccines

pharmaphorum

FEBRUARY 24, 2021

As the virus is constantly evolving, there is need a to quickly develop and approve updated vaccines to neutralise new versions of the virus that may be able to evade the immune response from older vaccines. Manufacturers are also encouraged to study the response in previously vaccinated and unvaccinated people.

Vaccination

Vaccination Vaccine Immune Response Regulation

Mutations leading to omicron variant did not enable virus to fully escape immune system

The Pharma Data

MARCH 13, 2022

People who gained immunity – either through vaccination or exposure – against the original strain of SARS-CoV-2, the virus that causes COVID-19, also are likely to have some protection against the pathogen’s omicron variant. The samples were stored after the researchers measured the T cell response. population.

Immune Response

Immune Response Protein Medicine Genetics

Valneva accelerates Lyme disease vaccine R&D project with Pfizer

pharmaphorum

DECEMBER 4, 2020

Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people aged 5-65 years of age. VLA15 has demonstrated a promising immune response and safety data in pre-clinical and clinical studies so far.

Vaccination

Vaccination Vaccine Bacterium Protein

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO

pharmaphorum

DECEMBER 22, 2020

Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot was independently backed by the UK’s regulator. But scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variants.”.

Vaccination

Vaccination Vaccine Protein Immune Response

China approves Sinovac’s coronavirus vaccine

pharmaphorum

FEBRUARY 8, 2021

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. It works by using inactivated viral particles to expose the immune system, which mounts an immune response that fights off the active virus in the event of an infection.

Vaccination

Vaccination Vaccine Immune Response Regulation

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen. 1 sub-lineage on 19 July.

Manufacturing

Manufacturing Vaccination Vaccine Packaging

Pfizer says coronavirus vaccine is safe and spurs immune response in children

Polyphenols may be missing component in regulating inflammatory immune responses

Trending Sources

Researchers explain how lipids can control immune response

Study identifies noncoding RNA involved in immune response and sepsis

J&J, without details, makes case for a coronavirus booster shot

Regulating immunological memory may help immune system fight disease, study finds

Early data shows Russia’s Sputnik V COVID-19 vaccine produces immune response

Chinese regulator approves personalised cancer vaccine trial

Drug made from pig intestine helps escape the “trap” of clot-causing immune response

Immune surprise: Recently evolved alarm molecule drives inflammation

B or not to B: Insights in the regulation of anti-viral immunity

Zydus gets FDA approval for antibiotic drug azithromycin

HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India

COVID-19 vaccine development: Setback for Sanofi and GSK candidate, University of Queensland and CSL abandon trial

Parasitic worms offer ‘the missing link’ on the dual nature of a key immune regulator

Bimervax Covid-19 vaccine authorised in UK

Existing drug could aid spinal injury recovery

Comparing immune-humanized platforms: Which one is best for my application?

Investigating the role of Brd4 in diet-induced obesity

First patient dosed with AgenTus’ cell therapy designed to clear COVID-19 virus while reducing inflammation

Encouraging data from Johnson & Johnson on Ebola vaccine

Encouraging data from AZ/Oxford coronavirus shot

STAT+: Pharmalittle: Merck KGaA probed by French court for misleading info; former Genentech scientists given prison terms over trade-secret theft

Altimmune ditches nasal COVID vaccine on weak trial data

J&J single-shot COVID-19 vaccine shows early promise

Novavax in talks with FDA over quick approval for COVID-19 shot

Which immune-humanized platform is right for my application?

Webinar: How to choose the right immune-humanized platform

Exclusive event: How to compare immune-humanized platforms

How to determine which immune-humanized platform is best for your application

Which immune-humanized platform is best for my application?

Researchers uncover molecular pathways underlying depression

Rapid COVID immune status test launched in UK, Ireland

Concerns emerge after AZ’s lucky vaccine trial ‘mistake’

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

South African variant may cut response from Pfizer/BioNTech shot, study finds

Gritstone bio trumpets first data for ‘multivariant’ COVID jab

FDA guidance allows fast updates of COVID-19 vaccines

Mutations leading to omicron variant did not enable virus to fully escape immune system

Valneva accelerates Lyme disease vaccine R&D project with Pfizer

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO

China approves Sinovac’s coronavirus vaccine

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

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