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

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.

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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.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

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

Camargo

JULY 27, 2021

Viruses and bacteria can be first modified to prevent them from causing infectious diseases and then implemented into human tissues as therapeutic gene vectors. Similarly, DNA molecules can be genetically modified and introduced into human cells, or individual patient cells can be genetically modified and reintroduced to the body.

Gene Therapy 238

Gene Therapy Gene Gene Editing Genetics 238

Pharmaceutical Technology

MAY 25, 2023

The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK. for serogroup W to 20.5

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Vaccination Vaccine Immune Response Bacteria 195

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 Clinical Trials 162

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.

FDA Approval 108

FDA Approval Vaccination Vaccine Life Science 108

Bio Pharma Dive

JULY 27, 2023

The pharma said its latest shot, which covers 21 strains of bacteria, cleared two Phase 3 trials and in some cases spurred a stronger immune response than Pfizer’s Prevnar 20.

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Immune Response Bacteria Vaccine Vaccination 245

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

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.

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Immune Response Vaccination Vaccine Protein 52

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

XTalks

NOVEMBER 12, 2024

Pneumonia is a lung infection that can be caused by viruses, bacteria or fungi and can result in millions of hospitalizations and deaths annually. For example, recent clinical trials and regulatory approvals for RSV vaccines are notable milestones that indicate advancements in preventing viral pneumonia in both children and elderly adults.

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Bacteria Life Science Vaccination Vaccine 110

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

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

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

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