pharmaphorum

JANUARY 27, 2021

AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinical trial specialist Care Access Research. The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June 2020.

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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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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.

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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.

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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.

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Clinical Research Research Clinical Trials Clinical Trials 52

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.

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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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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%

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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.

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Immune Response Trials Licensing Licensing 94

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.

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Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.

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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.

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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.

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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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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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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.

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Life Science Antibody Clinical Trials Clinical Trials 52

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.

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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.”

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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.,

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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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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.

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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.

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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.

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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.,

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Clinical Trials Clinical Trials Vaccine Vaccination 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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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).

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Clinical Trials Clinical Trials Trials Medicine 52

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.

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The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Phase1b/2 clinical study to be conducted in the United States and several European countries. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. Shailubhai, K.,

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Find Me Cure

OCTOBER 13, 2019

This Breast Cancer Awareness Month we’d like to talk about emerging areas in metastatic breast cancer treatment since clinical research has come so far in recent years. There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. Rosenberg, M.D.

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XTalks

JULY 3, 2024

Previously approved for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive, Vyvgart Hytrulo is now available for CIDP patients as weekly 30-to-90 second subcutaneous injections. Ninety-nine percent of trial participants elected to participate in the ADHERE open-label extension.

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Clinical Trials Clinical Trials FDA Approval Antibody 52

pharmaphorum

AUGUST 5, 2020

Metabolic diseases is already a focus area for Merck & Co – it markets several diabetes drugs including Januvia (sitagliptin) and last year exercised an option to develop NGM313, an antibody developed by NGM that could be used in NASH and type 2 diabetes.

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Roots Analysis

MARCH 16, 2022

Broad Clinical Trial Landscape. Till date, over 180 clinical studies which primarily include completed, ongoing and planned trials evaluating various clinical research activity related to exosomes and involving nearly 2,392 patients enrolled across different centers / hospitals, have been initiated worldwide.

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XTalks

MAY 17, 2024

XTALKS CLINICAL EDGE: Issue 2 — Calliditas interview Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. Can they do it?

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Crucial Data Soutions

OCTOBER 17, 2022

Clinical registries are a critical part of the research continuum. The ability to collect information about specific populations of patients and store them in a centralized database is extremely useful for all phases of clinical research, and particularly so for post-approval monitoring.

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Clinical Trials Clinical Trials Trials Research 52

XTalks

JUNE 4, 2024

XTALKS CLINICAL EDGE: Issue 2 — Cell Therapies for Autoimmune Diseases – Kyverna Therapeutics Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

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Clinical Trials Clinical Trials Trials Antibody 52

XTalks

OCTOBER 7, 2024

In addition, recent clinical research and new therapeutic approvals bring promising advances in managing rheumatic and musculoskeletal diseases (RMDs). Ongoing research provides insights into disease mechanisms, treatment efficacy and patient outcomes, enabling healthcare providers to guide patients more effectively.

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