STAT News

AUGUST 3, 2022

An experimental antibody treatment prevented malaria in the majority of participants in a small but important new study , providing a measure of hope in the effort to lower the burden of the disease worldwide. Read the rest…

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Pharmaceutical Technology

OCTOBER 18, 2022

Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. MGD024 is an investigational bispecific antibody that attaches to CD123 and CD3. The post Gilead partners with MacroGenics for bispecific antibody development appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

AUGUST 24, 2022

The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies.

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Pharmaceutical Technology

JANUARY 13, 2023

Being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca , Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). Enhertu’s safety profile was consistent with the previous clinical trials.

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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FDA Approval HR Clinical Trials Clinical Trials 264

STAT News

NOVEMBER 13, 2022

Roche reported negative results Monday from a pair of clinical trials investigating an antibody treatment for people with early-stage Alzheimer’s disease — another setback for the Swiss pharma giant’s decades-long effort to develop medicines against the memory-destroying disease.

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Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

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Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1) versus the 50µg mRNA-1273 booster dose. 1 variant as well as the original 2020 strain.”.

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Medical Xpress

APRIL 19, 2023

A treatment combining two antibodies against the coronavirus SARS-CoV-2 strongly protected high-risk people with early COVID-19 symptoms from hospitalization and death in an international Phase 2/3 clinical trial conducted in the first half of 2021 and co-led by researchers at Weill Cornell Medicine and NewYork-Presbyterian.

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Pharmaceutical Technology

OCTOBER 31, 2022

Actemra is claimed to be the first humanised interleukin-6 receptor-antagonist monoclonal antibody which received approval from Health Canada for intravenous and subcutaneous administration in rheumatoid arthritis. Actemra remains a part of national and international guidelines for therapy.

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Pharmaceutical Technology

JUNE 29, 2022

The treatment has maintained orphan medicinal product designation for this indication. The latest approval is based on findings from the global, single-arm Phase II ZUMA-5 clinical trial in 122 relapsed or refractory FL patients.

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Scienmag

APRIL 21, 2021

Credit: NIAID A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19.

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Scienmag

APRIL 13, 2021

Credit: NIAID A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun.

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Antibody Trials Clinical Trials Clinical Trials 93

Worldwide Clinical Trials

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Check out this webinar on navigating the landscape of oncology clinical trials. Interested in hearing more insights from Matt?

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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.

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Pharmaceutical Technology

MAY 19, 2023

In a January presentation, the company shared that approvals in additional indications would allow Rinvoq and Skyrizi, a monoclonal antibody, to gain peak share in the different markets, including inflammatory bowel disease. In patients with severe symptoms, a dosage of 30mg can be considered.

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FDA Approval Dermatology Sales Clinical Trials 264

pharmaphorum

MARCH 24, 2022

There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin. The examples remain few and far between, however, as in recent decades the pharma industry has turned its attention to synthetic molecules and biologics like antibodies.

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pharmaphorum

SEPTEMBER 16, 2020

Regeneron’s COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial, one of the largest of its kind in the world that is testing several potential coronavirus therapies at the same time. REGN-COV2 is a combination of two monoclonal antibodies, designed to block infections of SARS-CoV-2, the virus that causes COVID-19.

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Scienmag

JUNE 27, 2022

A major clinical trial, led by experts at the University of Nottingham working in partnership with several Universities and NHS hospitals, has found that by interrupting the treatment of vulnerable people on long-term immune supressing medicines for two weeks after a COVID-19 booster vaccination, their antibody response to the jab is doubled.

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Medical Xpress

DECEMBER 22, 2022

A weekly dose of dupilumab, a monoclonal antibody, led to a reduction of symptoms and tissue improvement in young adults and adolescents with eosinophilic esophagitis (EoE), according to a new study published in the New England Journal of Medicine.

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XTalks

AUGUST 22, 2022

Blueprint Medicines announced top-line results from their clinical trial of Ayvakit (avapritinib) in patients with non-advanced systemic mastocytosis (SM) that showed clinically meaningful and highly significant improvements. What Were the Results from the PIONEER Clinical Trial?

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Medicine Clinical Trials Clinical Trials Trials 98

pharmaphorum

OCTOBER 12, 2022

Genomic medicine is a rapidly growing space in which researchers use the information in a person’s genes to identify and administer medical treatment.”. The evolving field of genomic medicine. There are two components to genomic medicine, known as the payload and the vector. Forging an AI-enabled path toward precision medicine.

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Pharmaceutical Technology

APRIL 28, 2023

Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials. This funding will enable us to accelerate the development of our lead antibody programme targeting inflammatory fibrin in neurodegenerative and retinal diseases. “We

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Pharmaceutical Technology

FEBRUARY 19, 2023

Camrelizumab is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is formulated as solution for intravenous route.

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Pharmaceutical Technology

OCTOBER 17, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended granting conditional marketing authorization (CMA) for Boehringer Ingelheim’s spesolimab as a therapy option in adults with generalised pustular psoriasis (GPP) flares. Following 12 weeks, 84.4% had clear/almost clear skin.

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Pharmaceutical Technology

AUGUST 5, 2022

It is ultra-rare,” says Jesús Rodriguez Requena, PhD, associate professor in the Department of Medicine at the University of Santiago de Compostela. According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials.

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JAMA Internal Medicine

DECEMBER 19, 2021

This randomized clinical trial evaluated the effectiveness of a third dose of mRNA-based vs a vector-based vaccine in 201 kidney transplant recipients with no SARS-CoV-2 antibodies after 2 prior doses of an mRNA vaccine.

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Scienmag

APRIL 13, 2022

Louis is being advanced toward Phase I human clinical trials to treat COVID-19. A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St.

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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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Antibody Clinical Trials Clinical Trials Medicine 52

JAMA Internal Medicine

OCTOBER 19, 2020

In this issue of JAMA Internal Medicine, 3 important articles explore the use of tocilizumab in coronavirus disease 2019 (COVID-19) pneumonia. Tocilizumab is a humanized monoclonal antibody that binds human interleukin 6 (IL-6) receptors.

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Clinical Trials Clinical Trials Antibody Trials 101

The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Clinical Trials Clinical Trials Medicine Trials 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Being jointly developed and commercialised by the two companies, it is a specifically engineered HER2-directed antibody-drug conjugate (ADC). The regulatory approval is based on the data obtained from the open-label, head-to-head, randomised, international Phase III DESTINY-Breast03 clinical trial.

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XTalks

DECEMBER 4, 2024

The company’s lead candidate, ENV105, is an antibody targeting CD105, which is implicated in cancer cell resistance to various treatments. Dr. Yu has also led numerous clinical trials. Kairos is developing therapeutics that reverse cancer drug resistance in cancers such as prostate and lung cancer.

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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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Scienmag

AUGUST 10, 2020

– The COVID-19 Prevention Network (CoVPN) today announced two Phase 3 trials to determine whether monoclonal antibodies (mAbs) can prevent SARS-CoV-2, the virus that causes COVID-19. Credit: CoVPN DURHAM, N.C.

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pharmaphorum

DECEMBER 2, 2021

The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. The antibody was found to reduce the risk of hospitalisation and death by 79% in this patient group in a clinical trial.

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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