XTalks

NOVEMBER 3, 2021

The authorization was based on trial data that showed the vaccine was safe, well-tolerated and induced robust immune responses among children in this age group; side effects were generally mild to moderate. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science Drug Delivery Systems Vaccination Vaccine 52

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

APRIL 7, 2021

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

Antibody 102

Antibody Immune Response Radiology Marketing 102

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. Antibody levels against the A strains were higher than the B subtypes.

Vaccination 98

Vaccination Vaccine Immune Response Antibody 98

The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

XTalks

AUGUST 16, 2021

Immune systems can be weakened in individuals with HIV/AIDS; cancer and transplant patients taking certain immunosuppressive drugs; and those with genetic diseases affecting the immune system like congenital agammaglobulinemia and congenital IgA deficiency. Related: CDC Backs J&J COVID-19 Shot Amid GBS and Delta Variant Concerns.

Vaccination 104

Vaccination Vaccine Antibody Immune Response 104

pharmaphorum

JULY 20, 2021

According to some studies, beta may be the most likely to evade immune responses stimulated by the currently available shots as well as some antibody drugs for SARS-CoV-2, and is also thought to be more transmissible. 1.351) variant first identified in South Africa.

Vaccination 98

Vaccination Vaccine Protein Immune Response 98

XTalks

NOVEMBER 22, 2022

Stage 2 is characterized by the presence of diabetes-related antibodies and abnormal levels of blood sugar. Related: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic. There are three stages of type 1 diabetes with stage 3 being the step at which a clinical diagnosis is made.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

pharmaphorum

OCTOBER 31, 2022

s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). Indeed, Regeneron believes that the success with Ebola could potentially have ushered in “a new era in which monoclonal antibodies could be used to fight viral diseases and global pandemics.”. Amgen, Inc.

Production 52

Production FDA Approval Antibody Gene 52

XTalks

DECEMBER 12, 2023

Plasma medicine is a critical and specialized field within healthcare, centering on the use of human plasma for the development and administration of life-saving treatments. Human plasma, the clear, liquid portion of blood, is composed of water, electrolytes, nutrients and crucial proteins such as antibodies, clotting factors and albumin.

Medicine 111

Medicine Recombinant Antibody Protein Antibody 111

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.

Immune Response 52

Immune Response Research Allergies Protein 52

XTalks

JUNE 15, 2022

protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. Compared to adults, immune responses were approximately two- to three-fold higher in adolescents.

Vaccination 59

Vaccination Vaccine Immune Response Protein 59

XTalks

JULY 2, 2021

Conspiracy theories citing similarities between a placental protein called syncytin-1 and the spike protein of the coronavirus started doing the rounds last year, claiming that vaccines based on this spike protein could cause the immune system to attack the placenta and lead to pregnancy issues.

Vaccination 105

Vaccination Vaccine Protein Immune Response 105

XTalks

SEPTEMBER 23, 2021

The results showed that the vaccine was safe, well-tolerated and produced robust neutralizing antibody responses in children five to 11 years old. Results showed that the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 Pfizer Inc. Results for children under the age of five are expected later this year.

Vaccination 98

Vaccination Vaccine Trials Antibody 98

XTalks

NOVEMBER 10, 2020

Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate. We also observed that the antibody levels were higher after vaccination than those observed in convalescent sera from people who recovered from the disease,” said Landry.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

Gene Therapy 52

Gene Therapy Gene Immune Response In-Vivo 52

The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ — Cytiva , a global life sciences leader, is supporting Clover Biopharmaceuticals , a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. SHANGHAI , Nov. About Cytiva.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

XTalks

MAY 24, 2024

.” XTALKS WEBINAR: AI-based Antibody Therapeutics Developability Assessment and Its Engineering Live and On-Demand: Friday, June 21, 2024, at 10am EDT (4pm CEST/EU-Central) Register for this webinar today to learn how AI can be used to improve developability screening of antibody therapeutics and optimization of antibody candidates.

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

pharmaphorum

NOVEMBER 29, 2022

From a better understanding of the tumor microenvironment to exciting advances in treatment like activated cell therapies and bispecific antibodies, one could wonder where the next therapeutic revolution in immuno-oncology (IO) will come from. T cells are known to mediate anti-tumor immune responses. NT-I7 (efineptakin alfa).

Clinical Trials 105

Clinical Trials Clinical Trials Trials Engineer 105

XTalks

AUGUST 5, 2022

monoclonal antibody that inhibits interleukin (IL) IL-12 and IL-23 cytokines, which are involved in inflammatory and immune responses. The featured speakers will discuss how to facilitate trial participation in rare disease. Stelara Clinical Trial Results. Stelara is a human IgG1?

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

XTalks

JUNE 9, 2022

Evkeeza — generically known as evinacumab — is a monoclonal antibody. Yancopoulos said, “ VelocImmune provides perhaps the most powerful and efficient way of generating fully human monoclonal antibodies that are ready for clinical testing. These antibodies bind strongly to their target and provide a robust immune response.

Trials 52

Trials Antibody Genetics Gene 52

The Pharma Data

JANUARY 19, 2021

The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). Other products include CLNB-049, a bispecific antibody against FLT3 and CD3 and CLN-619, a monoclonal antibody that simulates NK and T-cell responses. With this kind of a start, 2021 may be scorching.

In-Vitro 52

In-Vitro Production Trials Manufacturing 52

The Pharma Data

DECEMBER 23, 2020

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg and 2.0 The 1.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

XTalks

APRIL 2, 2021

In a pivotal Phase III trial involving adolescents 12 to 15 years of age, Pfizer/BioNTech’s COVID-19 vaccine trial results show that its vaccine, BNT162b2, has a demonstrated efficacy of 100 percent and elicits strong antibody responses. 1.351 variant, which may have the potential to evade the immune response.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

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. These epitopes elicit an immune response from a broad selection of T cells, ensuring a sustained coverage of future variants.

Vaccination 40

Vaccination Vaccine Protein Antibody 40

XTalks

NOVEMBER 10, 2020

These first trial results show that the vaccine yields immune activity and causes a strong immune response,” said BioNTech’s co-founder and Chief Executive Officer Ugur Sahin. The early stage trial is evaluating the safety profile and immunogenicity of the vaccine.

Vaccination 75

Vaccination Vaccine Trials Clinical Trials 75

XTalks

MARCH 8, 2024

Denosumab is a RANKL (receptor activator of nuclear factor kappa beta ligand) monoclonal antibody that blocks the ability of RANKL to bind to its receptor RANK. According to Amgen’s last earnings report , Prolia sales increased 12 percent last year to more than $4 billion, and Xgeva’s jumped five percent from last year to $2.1

Drugs 59

Drugs FDA Approval Production Immune Response 59

XTalks

SEPTEMBER 17, 2020

However, due to serious risks – including the drug’s potential to stimulate the production of anti-metreleptin antibodies and an increased risk of lymphoma – it is only available through a Risk Evaluation and Mitigation Strategy mandated by the FDA. Primary Hyperoxaluria Type 1 (PH1). Prevalence: 1 to 3 in 1 million.

Trials 98

Trials Gene Hormones Clinical Trials 98

XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. Researchers estimate that the incidence of CIDP in the US ranges from 0.8

FDA Approval 40

FDA Approval Immune Response Trials Drug Delivery 40

XTalks

AUGUST 8, 2022

Medicxi is a prominent international life sciences investment firm that invested in over 60 portfolio companies such as Versanis Bio, Rivus Pharmaceuticals, Capella Bioscience and more. One of Medicxi’s portfolio companies called MiroBio is set to be acquired by Gilead Sciences for approximately $405 million in cash.

Immune Response 98

Immune Response Antibody Life Science Engineer 98

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8 mg/kg dose with an ORR of 73.6

FDA Approval 97

FDA Approval Antibody Immune Response Drugs 97

The Pharma Data

JANUARY 3, 2021

Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected. About Tiziana Life Sciences. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. . NEW YORK and LONDON, Jan.

Life Science 40

Life Science Clinical Trials Clinical Trials Antibody 40

pharmaphorum

SEPTEMBER 22, 2022

When exposed to a virus, one’s immune system develops antibodies in response to foreign antigens, with or without a vaccine. However, a vaccine trains the immune system to recognise that familiar virus and kill it more rapidly. One arm of the immune system triggers antibodies, and the other triggers T-cells.

Vaccination 97

Vaccination Vaccine Antibody Clinical Trials 97

XTalks

MAY 7, 2021

It was made using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’s patented saponin-based Matrix-M as an adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Protein 97

Protein Vaccination Vaccine Trials 97

pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

Antibody 137

Antibody Immune Response Vaccination Vaccine 137

XTalks

JUNE 5, 2023

Abrysvo functions as a vaccine by triggering an immune response specifically aimed at RSV preF, which provides protection against RSV-induced LRTD. AstraZeneca revealed promising Phase III results for its single dose long-acting antibody, nirsevimab , against RSV. The vaccine demonstrated 83.7 percent and hospitalizations by 62.1

Vaccination 98

Vaccination Vaccine FDA Approval Protein 98