XTalks

NOVEMBER 23, 2020

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. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

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XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. There are around 300 million people worldwide living with a rare disease.

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Gene Therapy Gene Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. So, this really validates what we already knew and now we have prospective results supporting that [from this trial].”.

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pharmaphorum

AUGUST 16, 2020

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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Vaccination Vaccine Immune Response Trials 111

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

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Immune Response Dermatology Clinical Trials Clinical Trials 105

The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children.

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Immune Response Vaccination Vaccine Clinical Trials 52

XTalks

MAY 30, 2023

This year has already seen some promising developments, including breakthroughs in understanding the disease’s genetic and environmental triggers and innovative techniques to manage MS symptoms. More than 200 genetic variants have been identified that are more common in people with MS.

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Genetics Research Immune Response Drugs 98

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technology could potentially modify the amount of a key regulatory protein in the body or treat genetic diseases. The company then utilizes the de-identified records to improve the design of clinical trials and quality of life measurements. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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Vaccination Vaccine Gene Therapy RNA 98

pharmaphorum

NOVEMBER 30, 2020

Ultimately, titer levels are related to safety, as dosing a patient who has a higher titer level (however that may be defined) is more likely to trigger an immune response to the treatment, an extreme example being the infamous case of Jesse Gelsinger. “As

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Gene Therapy Gene Antibody Clinical Trials 105

The Pharma Data

SEPTEMBER 14, 2020

AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). The move follows a green light by the UK's MHRA. Source link.

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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. About Novavax. Novavax, Inc.?(Nasdaq:

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Protein Vaccination Vaccine Immune Response 52

XTalks

JUNE 15, 2022

Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. Clinical Trial Results. Results from the PREVENT-19 pediatric expansion trial showed that the vaccine was also effective in adolescents aged 12 to 17 years. NVX-CoV2373 also includes an adjuvant called Matrix-M.

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Vaccination Vaccine Immune Response Protein 59

The Pharma Data

JANUARY 3, 2021

reports that Scentech-Medical received approval from the Shamir Medical Center ( Asaf Harofe ) Review Board ( Helsinki committee) for a new clinical trial. As part of the trial, the company is verifying the biomarkers that were mapped after its early clinical trials conducted at the Meir Medical Center, in Kfar Saba.

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XTalks

FEBRUARY 19, 2024

The study compared the immune responses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. During pregnancy, CMV infection is responsible for causing severe birth defects and brain damage in newborns.

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Vaccination Vaccine Trials Clinical Trials 59

Cloudbyz

MARCH 5, 2024

They are often used to mimic or enhance natural biological processes, such as immune responses. Immunogenicity : Small Molecules: Generally have a lower risk of inducing an immune response in the body. Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics.

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Development Drugs Immune Response Manufacturing 97

The Pharma Data

NOVEMBER 9, 2020

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally.”. and Australia.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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. Adjuvants are used to help stimulate stronger vaccine immune responses. Based on the encouraging Phase I data, Medicago says it plans to proceed with its Phase II/III trials.

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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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Clinical Development Vaccination Vaccine Development 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. .

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Gene Therapy Gene Immune Response In-Vivo 52

The Pharma Data

JANUARY 17, 2021

By exploring multiple therapies across oncology and cardiovascular, genetic, neurological and autoimmune diseases, we are well positioned to bring life-changing treatments to multiple patient populations with critical unmet needs.”. A total of $15.4 References 1. About Ixaka.

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Gene Therapy Gene In-Vivo Genetics 40

Cloudbyz

JULY 31, 2024

These technologies provide insights into genetic, proteomic, and metabolomic profiles, enabling the discovery of biomarkers associated with diseases like cancer, cardiovascular diseases, and neurological disorders. For instance, in oncology, patients with specific genetic mutations (e.g.,

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

The Pharma Data

JULY 6, 2021

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. ” Arnon Rosenthal, Ph.D.,

Genetics 52

Genetics Gene Antibody Development 52

Olympian Clinical Research

NOVEMBER 30, 2023

It occurs when melanocytes, the cells responsible for skin pigmentation, are destroyed or stop functioning. The exact cause of vitiligo is still under investigation, with factors like genetics , autoimmune responses, and environmental triggers all playing potential roles.

Clinical Research 52

Clinical Research Clinical Trials Clinical Trials Immune Response 52

XTalks

SEPTEMBER 17, 2020

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. Trials for both Juxtapid and Repatha made use of this endpoint to gain regulatory approval.

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Trials Gene Hormones Clinical Trials 98

pharmaphorum

FEBRUARY 22, 2021

Bluebird Bio’s decision to hit pause on the launch of Zynteglo for beta thalassaemia after two cases of cancer were seen in a clinical trial could see fears over the safety of viral vectors used to deliver gene therapies resurface. . million in Europe.

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Gene Therapy Gene Gene Sequencing Gene Expression 52

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

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Vaccination Vaccine Trials Immune Response 40

XTalks

JUNE 10, 2024

The cause of psoriasis has yet to be fully understood, but scientists estimate its origins in genetic and environmental factors and immune dysregulation (where the body is unable to control its immune response). It is characterized by raised round or oval plaques lined with dry-looking silvery-white scales.

Immune Response 52

Immune Response Dermatology Clinical Trials Clinical Trials 52

Roots Analysis

MARCH 3, 2022

The complement-targeted therapeutics inhibit complement activation, thereby reducing tissue inflammation and dampening the adaptive immune response to foreign and tissue antigens. Broad Clinical Trial Landscape. Next Generation Complement Therapeutics – Current Market Landscape. Next Generation Complement Therapeutics.

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Drug Delivery Systems Marketing Immune Response Dermatology 52

pharmaphorum

NOVEMBER 2, 2021

In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours. The BiTE platform is an innovative technology designed to engage the immune system against numerous stages and types of cancers. Engagement of immune cells to the tumour cell.

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Antibody Immune Response Production Engineer 52

Delveinsight

DECEMBER 22, 2020

Ultragenyx (RARE) and Mereo collaborated to develop and commercialize setrusumab , a monoclonal antibody for a rare genetic disorder osteogenesis imperfecta (OI). aTyr Pharma Completes Enrollment in Phase 1b/2a Pulmonary Sarcoidosis Clinical Trial Testing ATYR1923.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

The Pharma Data

JUNE 25, 2021

“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. Glenn, M.D.,

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XTalks

JUNE 9, 2022

What happens when the liver is unable to process bad cholesterol due to genetic factors? It is one of the common genetic causes of premature coronary heart disease. This particular platform creates fully human monoclonal antibodies from immunized mouse models — labeled VelocImmune mice — with a genetically humanized immune system.

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Trials Antibody Genetics Gene 52

The Pharma Data

NOVEMBER 27, 2020

The Iceni Diagnostics approach uses glycan recognition, which is unaffected by seasonal variation in the genetic code and can be offered as a handheld home or field-based test. This new approach could potentially result in a more universal detection technique, crucial in early diagnostics of virus outbreaks.”.

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The Pharma Data

OCTOBER 27, 2020

AavantiBio’s strategic partnership with University of Florida’s Powell Gene Therapy Center provide their foundational research in rare genetic disorders. The company’s lead program is aimed at Friedrich’s Ataxia, a rare inherited genetic disease that causes cardiac and central nervous system dysfunction. Orbus Therapeutics .

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Gene Gene Therapy Medicine Development 52

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

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Antibody Trials Production Clinical Trials 40

The Pharma Data

OCTOBER 27, 2020

Mirati Therapeutics is a San Diego -based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer.

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Sales Immune Response Clinical Development Development 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

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Antibody Medicine Production Trials 52