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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XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. There were a range of therapies under discussion, from targeted therapies to advanced antibody-drug conjugates (ADCs) and cell and gene therapies,” he says.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

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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Clinical Trials Clinical Trials Trials Antibody 98

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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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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Gene Therapy Clinical Trials Clinical Trials Genetics 278

Pharmaceutical Technology

FEBRUARY 3, 2023

Being jointly developed by AstraZeneca and Amgen, Tezspire is a first-in-class human monoclonal antibody and inhibits TSLP, an important epithelial cytokine that plays a vital role in multiple inflammatory cascades. Asthma control improvement and safety profile were consistent with previous clinical trials.

FDA Approval 147

FDA Approval Antibody Clinical Trials Clinical Trials 147

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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Antibody Clinical Trials Clinical Trials Trials 81

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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Antibody Clinical Trials Clinical Trials In-Vitro 162

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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Medicine Genome Genomics Engineer 105

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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Antibody Trials Manufacturing Protein 98

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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Pharmaceutical Technology

JANUARY 16, 2023

AstraZeneca has announced that its Tezspire (tezepelumab) received approv al from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU for self-administration in severe asthma patients aged 12 years and above.

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Clinical Trials Clinical Trials Trials Medicine 147

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

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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Antibody Allergies Clinical Trials Clinical Trials 66

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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Development Immune Response Clinical Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 4, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

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Marketing Clinical Trials Clinical Trials Trials 130

XTalks

DECEMBER 10, 2024

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

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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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Medicine Drugs Production Development 100

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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Antibody Clinical Trials Clinical Trials Medicine 130

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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Antibody Vaccine Vaccination Clinical Trials 68

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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Antibody Protein Clinical Trials Clinical Trials 88

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

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

Pharmaceutical Technology

SEPTEMBER 2, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.

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Vaccine Vaccination Trials Clinical Trials 147

XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

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Drug Delivery Systems Dermatology Drug Delivery Antibody 111

Pharmaceutical Technology

MAY 11, 2023

Approved as the first and only long-acting C5 complement inhibitor, Ultomiris is indicated to treat adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) NMOSD in the European Union (EU). The EC’s approval follows a positive opinion from the committee for medicinal products for human use.

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Trials Clinical Trials Clinical Trials Medicine 130

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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Drugs Life Science 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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Clinical Trials Clinical Trials Vaccine Vaccination 76

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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Antibody Research Trials Clinical Trials 84

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

Pharmaceutical Technology

OCTOBER 26, 2022

The treatment is indicated for such patients who had received four or more previous lines of therapy, including an immunomodulatory drug, proteasome inhibitor and anti-CD38 monoclonal antibody. Based on the response rate from a trial, the regulatory agency approved the indication under an accelerated approval process.

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Antibody FDA Approval Clinical Trials Clinical Trials 130

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

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Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52