Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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The Pharma Data

JANUARY 31, 2021

Nasdaq: VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that it is entering a collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS).

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XTalks

NOVEMBER 6, 2020

Symvivo’s bacTRL Gene Therapy Platform is designed and optimized to address limitations associated with typical vaccines, including the inability to accommodate large or multiple genes, lack of specificity to targeted tissue and poor control over immune response, says the company.

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Pharmaceutical Technology

AUGUST 24, 2022

A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples. Quantifiable results: Researchers can obtain relative percentages and learn the absolute count and number of receptors in a cell.

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pharmaphorum

APRIL 26, 2022

PubMed cites 1,822 pieces of research relating to the microbiome in 2011, which grew to 25,153 published in 2021. As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system.

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The Pharma Data

DECEMBER 11, 2020

The University of Oxford has regularly appeared in our updates since July 2020, as its team of researchers leads an ongoing clinical trial for the Covid-19 vaccine. More recently, the university has released news of its collaboration with Thermo Fisher Scientific as it looks to discover an immune Covid-19 response pre- and post-vaccination.

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Worldwide Clinical Trials

JUNE 15, 2022

We’ve also seen a decrease in available research nurses, as they have had to be reassigned to COVID patients. There have been a few cases lately where patients receiving gene therapy had a severe adverse effect because of their immune response to the mechanism of the AAV viral vector, based on their own genomic markers.

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XTalks

NOVEMBER 23, 2020

Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials. The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

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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. Pfizer Disclosure Notice.

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The Pharma Data

SEPTEMBER 25, 2020

The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults. Immune Response Data.

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XTalks

JULY 21, 2022

Simply put, probiotic sodas are carbonated drinks that contain one or more probiotic ingredient(s). Some research shows that, when consumed, probiotics can help maintain a balanced gut microbiome, which supports gastrointestinal health and function. Its sodas also contain organic fruit juice, real herbs and spices and no stevia. .

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The Pharma Data

AUGUST 15, 2021

Even as several safe and effective COVID-19 vaccines are being administered to people worldwide, scientists are still hard at work developing different vaccine strategies that could provide even stronger or longer-lasting immunity against SARS-CoV-2 and its variants.

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The Pharma Data

SEPTEMBER 3, 2020

The data, published today in Nature Medicine , demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

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The Pharma Data

JUNE 26, 2021

We’ve all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines ”, said Jean-François Toussaint, Global Head of Research and Development, Sanofi Pasteur. “ The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

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The Pharma Data

NOVEMBER 9, 2020

President of Research and Development, Novavax. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. About Pneumococcal Disease.

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The Pharma Data

DECEMBER 13, 2020

SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response. Synlogic’s President and Chief Executive Officer.

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Pfizer

FEBRUARY 16, 2023

GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. 5,6 The program was granted Fast Track designation by the U.S.

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The Pharma Data

NOVEMBER 9, 2020

Combining ICIs with radiation therapy is emerging as a valuable strategy to “prime” an immune response and thereby increase the response rate, however the efficacy of radiation therapy is limited by toxicities related to the exposure of healthy tissues. NBTXR3 is injected one time, directly into solid tumors.

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The Pharma Data

OCTOBER 25, 2020

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Headquartered in Cambridge, Mass., To learn more, visit www.modernatx.com.

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The Pharma Data

NOVEMBER 30, 2020

Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. to determine efficacy and safety of NVX-CoV2373. Novavax was awarded $1.6

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The Pharma Data

NOVEMBER 9, 2020

The trial, conducted in collaboration with the Swiss Group for Clinical Cancer Research (SAKK), will assess the safety, tolerability and anti-tumor activity of IP-001 administered intratumorally following tumor ablation. LOUIS and BERN, Switzerland, Nov. 10, 2020 (GLOBE NEWSWIRE) — Immunophotonics, Inc. Immunophotonics, Inc.

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pharmaphorum

OCTOBER 31, 2022

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. The “normal and robust” immune response exhibited has become what is considered to be the “gold standard” for developing human antibody therapeutics.

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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. Forward-Looking Statements.

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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.

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The Pharma Data

NOVEMBER 17, 2020

. This new study will complement Mymetics’ other preclinical Covid-19 studies that are ongoing at Baylor College of Medicine in Texas USA and the Helmholtz Center of Infection Research in Germany. ” About Mymetics. . ” About Mymetics. For further information, please visit www.mymetics.com.

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The Pharma Data

DECEMBER 28, 2020

Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition. Any forward-looking statements contained in this release speak only as of its date. .

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The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

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The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses.

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The Pharma Data

SEPTEMBER 9, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, The information contained in this release is as of September 9, 2020. Jansen, Ph.D.,

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The Pharma Data

NOVEMBER 14, 2020

The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated. ENSEMBLE 2 is being conducted in collaboration with the UK National Institute for Health Research (NIHR). PHASE 3 ENSEMBLE 2 STUDY.

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The Pharma Data

APRIL 22, 2023

The current COVID-19 vaccines are designed to trigger an antibody response to the SARS-CoV-2 spike protein, which is vulnerable to mutations that could make the vaccine less effective over time. In their study, the researchers challenged mice with a lethal dose of SARS-CoV-2 and found that 87.5%

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The Pharma Data

NOVEMBER 23, 2020

It contains the genetic materials of the spike protein. After vaccination, the cells produce the spike protein, stimulating the immune system to attack the SARS-CoV-2 virus. Interim results from its Phase I/IIa trial demonstrated a single dose of the vaccine induced a robust immune response and was generally well-tolerated.

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Pfizer

JULY 8, 2022

The information contained in this release is as of July 8, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.com. . Recent Announcements.

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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). 07.13.2022.

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The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We The information contained in this release is as of August 20, 2020.

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The Pharma Data

JUNE 25, 2021

President of Research and Development, Novavax. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Glenn, M.D., PREVENT-19 is being conducted with support from the U.S.

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