Pharmaceutical Technology

OCTOBER 28, 2022

What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20. The company says that these four serotypes represent roughly 10–15% of bacteria causing pneumococcal disease in adults. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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XTalks

JUNE 21, 2024

These numbers do not reflect the efficacies of the vaccines, which have not been compared head-to-head in any trial yet. Capvaxive received accelerated approval, which means Merck will have to verify its clinical benefit in a confirmatory trial. The vaccine has done well in a Phase II trial against the Pfizer vaccine.

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FDA Approval Vaccination Vaccine Life Science 108

XTalks

JANUARY 20, 2021

While diseases like celiac are associated with inappropriate activation of the immune system triggered by food antigens, this is not the case in IBS. In a normal, healthy intestine, foods do not trigger immune responses and so in a patient with IBS, something else must activate the response. Mouse and Human Studies.

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The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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Immune Response Vaccination Vaccine FDA Approval 52

pharmaphorum

JULY 14, 2021

Last year, Pfizer made almost $6 billion from its Prevnar 13 vaccine, which covers 13 common serotypes of Streptococcus pneumoniae – a bacteria which causes non-invasive illnesses like pneumonia, sinusitis and middle ear infections, as well as invasive diseases like meningitis. That is equivalent to 14% of Pfizer’s total revenues.

Immune Response 52

Immune Response Vaccination Vaccine Protein 52

pharmaphorum

APRIL 26, 2022

In the trial, Seres announced that the product candidate had met its primary endpoint, showing a statistically significant 30.2% As naturally occurring non-engineered strains of human commensal bacteria originally isolated from healthy human donors, they are expected to have very clean safety profiles,” they said.

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The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. SYNB1891 is being evaluated in a Phase 1 clinical trial. CAMBRIDGE, Mass. , 14, 2020 /PRNewswire/ — Synlogic, Inc.

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Immune Response Engineer Medicine Clinical Trials 40

XTalks

AUGUST 18, 2021

Of important note is the aberrant immune response that occurs in patients with COVID-19, including the intensive release of cytokines (cytokine storm), which can make a patient infected with SARS-CoV2 more susceptible to contracting a bacterial respiratory infection.

Development 105

Development Bacteria Drugs Vaccination 105

XTalks

NOVEMBER 28, 2022

It may be caused by the immune system being triggered by a virus or bacteria that results in an atypical immune response, or genetics play a role in disease development as it is more common in people whose immediate family members have Crohn’s disease. EC Approval of Skyrizi Supported by Global Phase III Trials.

Trials 52

Trials Immune Response Bacteria Development 52

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. among adults 65 years of age or older.

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XTalks

DECEMBER 17, 2021

And in healthcare and health research, trends towards increased digitization continued, including remote monitoring in clinical trials, use of wearable technologies and AI-based approaches to data collection, management and analysis. The results are promising and Moderna is set to go ahead with its planned Phase II trial for the vaccine.

Life Science 98

Life Science Vaccination Vaccine Trials 98

The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. Small Molecule Inhibitors. The maximum achievable ACR CRISS score is 1.0.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. Global President of Pfizer Vaccines. “We IMPORTANT SAFETY INFORMATION.

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Vaccination Vaccine FDA Approval Containment 52

pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

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Bacteria Vaccination Vaccine Immune Response 52

Pharmaceutical Technology

MARCH 24, 2023

TB is caused by the bacillus Mycobacterium tuberculosis and is transmitted when infected individuals expel bacteria into the air (e.g., Helen McShane, PhD, a professor of vaccinology at the University of Oxford, says, “Twenty-three years ago, there were no new TB vaccines being tested in clinical trials. by coughing).

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Vaccination Vaccine Clinical Trials Trials 162

XTalks

MARCH 24, 2025

Fabhalta works by inhibiting factor B, a key enzyme in the alternative complement pathway, thus calming the damaging immune response. Due to a risk of serious infections from encapsulated bacteria, its use is limited to a Risk Evaluation and Mitigation Strategy requiring specific vaccinations.

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Bioavailability Immune Response Protein Bacteria 71