pharmaphorum

JANUARY 21, 2022

Research led by UCLH, UCL and the Francis Crick Institute found that the booster dose successfully stimulates antibody levels that neutralise Omicron. Overall, antibody levels were nearly 2.5 Details of the study were published in The Lancet this week. times higher against Omicron after three doses compared to after two.”.

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Antibody Vaccination Vaccine Genotype 115

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

XTalks

FEBRUARY 12, 2025

XTALKS WEBINAR: Overcoming Challenges in Clinical Trial Completion Live and On-Demand: Wednesday, March 19, 2025, at 10:30am EDT (3:30pm CET/EU-Central) Register for this free webinar to transform challenges into opportunities and optimize the crucial final stages of clinical trials.

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Clinical Trials Clinical Trials Trials FDA Approval 66

XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Clinical Trials Clinical Trials Trials FDA Approval 98

Cloudbyz

AUGUST 2, 2024

The field of oncology has seen significant progress in recent years, with the development of novel therapies and advancements in clinical research. Targeted Therapies and Immunotherapies One of the most notable trends in cancer drug research is the development of targeted therapies and immunotherapies.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

JUNE 11, 2024

These statistics underscore the urgent need for innovative treatments and inclusive clinical trials that can address the diverse needs of the lupus population. The complexity of lupus, combined with its significant impact on individuals and communities, makes it a critical area of focus for rheumatology research.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Director, Therapeutic Strategy Lead, Neuroscience & Lucie Undus, MD PhD, Exec.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

XTalks

APRIL 1, 2025

Related: Niktimvo (Axatilimab) Approved as First-in-Class Therapy for Chronic GVHD More on Itolizumabs Clinical Data Itolizumab is a humanized anti-CD6 monoclonal antibody that targets the CD6-ALCAM pathway involved in T cell activation and trafficking. The risk limits the number and type of patients who receive HSCT.

Immune Response 94

Immune Response Trials Licensing Licensing 94

XTalks

DECEMBER 10, 2024

Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5 This aligns with previous studies, reinforcing its potential as a well-tolerated treatment option. percent platelet response in a study published in The New England Journal of Medicine.

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Trials Protein Clinical Development Drugs 104

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. One year post-vaccination, antibody levels remained strong, with geometric mean titers well above the required protective threshold. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

XTalks

MARCH 20, 2024

When it comes to leadership in clinical trials today, what qualities are necessary to navigate the evolving landscape of clinical research effectively? Xtalks recently had the opportunity to discuss Enciso’s journey in the clinical research industry and her decision to join Regeneron.

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

Rethinking Clinical Trials

JANUARY 17, 2024

UPMC did not allow patients to receive experimental COVID-19 therapies outside of the context of a clinical trial and used the REMAP-CAP platform, a global pragmatic adaptive trial platform, in all clinic sites. The first monoclonal antibody (mABs) treatment for treatment of COVID-19 was approved in November 2020.

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Clinical Trials Clinical Trials Antibody Trials 140

XTalks

JULY 25, 2022

Later lines of treatment can include monoclonal antibodies, tyrosine kinase inhibitors and antibody-drug conjugates (ADCs). XTALKS WEBINAR: Discussing the Concerns within Clinical Research in Oncology and In-Home Healthcare. ADCs consist of an antibody attached to a cytotoxin that is delivered to targeted cells.

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

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.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN.

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Trials Clinical Trials Clinical Trials Antibody 101

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

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Trials Clinical Trials Clinical Trials Antibody 97

XTalks

DECEMBER 31, 2024

Imlifidase is an enzyme that works by cleaving immunoglobulin G (IgG) antibodies, thereby halting the immune-mediated damage that characterizes GBS. The first-in-class IgG cleaving enzyme has shown promise in other applications, including kidney transplantation and antibody-mediated rejection.

Life Science 52

Life Science Antibody Clinical Trials Clinical Trials 52

XTalks

DECEMBER 13, 2024

Blenrep is an antibody-drug conjugate (ADC) created by linking a B-cell maturation antigen (BCMA)-targeting monoclonal antibody to a potent cytotoxic agent, auristatin F, using a stable, non-cleavable linker technology. A day before GSKs announcement, Johnson & Johnson also released two promising clinical trial results.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. percent in the 68-week STEP-1 clinical trial.

Trials 104

Trials Drugs Clinical Trials Clinical Trials 104

Velocity Clinical Research

AUGUST 8, 2024

It’s been just over a year since the monoclonal antibody Lecanemab received traditional approval from the FDA as a treatment for Alzheimer’s disease. The importance of clinical trials That hope is a motivator for many clinical trial participants. If you took a pill today, that was backed by research.”

Clinical Trials 105

Clinical Trials Clinical Trials Genetics Clinical Research 105

Delveinsight

NOVEMBER 26, 2020

Urovant’s vibegron fails Irritable bowel syndrome phase 2 trial. A phase 2a clinical trial of vibegron of Urovant in Irritable bowel syndrome (IBS) patients has flunked primary endpoint. Genmab discards antibody-drug conjugate after the early-phase fiasco. Clancy, M.D.,

Antibody 79

Antibody Trials Drugs Engineer 79

Pharmaceutical Technology

JANUARY 10, 2023

“Currently, teplizumab can delay the progression to T1D for people whose immune system has begun attacking their insulin-producing cells, but who don’t yet need insulin to survive,” says Josie Clarkson, Research Communications Lead at JDRF UK. With up to 2.3 Achieving health equity to ensure all at risk have access to the study is a priority.

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Insulin FDA Approval Research Development 246

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. The company partners with small and large biopharma and medical device and diagnostic companies to optimize early clinical development through excellence in study design and execution.

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. percent in the 68-week STEP-1 clinical trial.

Trials 96

Trials Drugs Clinical Trials Clinical Trials 96

Advarra

MARCH 10, 2023

Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Doctors 98

XTalks

AUGUST 2, 2024

These trials reveal nemolizumab’s potential to significantly improve key aspects of atopic dermatitis, including skin lesions, itch and sleep disturbance, in both adolescent and adult patients with moderate-to-severe cases. Nemolizumab is a monoclonal antibody that targets IL-31, a cytokine responsible for many atopic dermatitis symptoms.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

The Pharma Data

NOVEMBER 16, 2020

The partnership brings NIH together with other HHS agencies and government partners and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. El Sahly, M.D.,

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Roche meanwhile is continuing to trial its drug in combination with remdesivir.

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Drugs Antibody Contract Manufacturing Immune Response 97

XTalks

FEBRUARY 13, 2023

Radiopharmaceutical therapy (RPT) uses isotopes that are conjugated to tumor-targeting agents (such as peptides, antibodies and novel small molecules). Radionuclide-ligand conjugates, including radionuclides that are conjugated to antibodies or peptides, have been studied extensively. How does Radiation Cause Cell Death?

Clinical Trials 52

Clinical Trials Clinical Trials Trials DNA 52

The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS).

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial.

Protein 126

Protein Vaccine Vaccination Immune Response 126

pharmaphorum

APRIL 7, 2021

billion DKK ($672 million) from AbbVie after the companies struck an R&D deal to research epcoritamab, a bispecific antibody targeting CD3 and CD20 that the biotech developed in-house. Genmab has four technology platforms to draw from, with the most established being bispecific antibodies which target two receptors at once.

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Antibody Life Science Development Drugs 91

The Pharma Data

NOVEMBER 1, 2020

This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. The clinical data from this trial is expected to available by the end of this year. Forward-Looking Statements.

Clinical Trials 40

Clinical Trials Clinical Trials Antibody Life Science 40

XTalks

JULY 26, 2024

Merck recently announced encouraging topline results from its Phase IIb/III trial ( MALRI ) of clesrovimab (MK-1654), an investigational monoclonal antibody aimed at preventing respiratory syncytial virus (RSV) in infants. However, advancements in monoclonal antibody technology have opened new avenues for RSV prevention and treatment.

Antibody 59

Antibody Vaccine Vaccination Trials 59

XTalks

JULY 14, 2022

Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Early data also showed that methotrexate could prevent the formation of anti-drug antibodies. XTALKS WEBINAR: Beyond the EHR: Clinical Trials in the Age of Abundant Data.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

Pharmaceutical Technology

JANUARY 30, 2023

Numerous drug approval applications to the FDA failed in 2022, including oncology monoclonal antibodies (mAbs) such as Eli Lilly and Co’s (Indianapolis, IN, US) sintilimab, Y-mAbs Therapeutics Inc’s (New York, NY, US) omburtamab, and Coherus BioSciences’ (Redwood City, CA, US) toripalimab.

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Drugs Manufacturing Contract Manufacturing FDA Approval 130