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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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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Drug Discovery World

MARCH 8, 2024

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). IBI3002 has high-efficient dual-blocking function on both IL-4Rα and TSLP.

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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

JUNE 20, 2023

It was developed in collaboration with the Institute for Protein Design (IPD) at the University of Washington School of Medicine, with funding support from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

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Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . An accelerated development programme by AstraZeneca means a new Covid-19 product could be available in the second half of 2023, subject to trial readouts and regulatory reviews. .

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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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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Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). Additionally, in the trial, the antibody cocktail was found to be well-tolerated.

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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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Drug Discovery World

AUGUST 29, 2023

Fast Track designation from the Food and Drug Administration (FDA) will accelerate the path to US submission for Alentis Therapeutics’ investigational monoclonal antibody. We continue to advance our pipeline of antibodies against Claudin-1, an extraordinary target with therapeutic potential across indications in oncology and organ fibrosis.”

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Drug Discovery World

JULY 18, 2023

The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s marketing authorisation application (MAA) for zolbetuximab, an investigational Claudin 18.2 targeted monoclonal antibody. The MAA is based on results from the Phase III SPOTLIGHT and GLOW clinical trials. positive. “The

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Pharmaceutical Technology

FEBRUARY 6, 2023

It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy. These anti-pCTS-L monoclonal antibodies may help in providing effective treatments for human sepsis as well as other infectious diseases, such as Covid-19.

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Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study.

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Drug Discovery World

APRIL 17, 2023

Patients with relapsed or refractory multiple myeloma who were treated with the two highest doses of REGN5459, a bispecific antibody targeting BCMA and CD3, experienced a 90.5% This is according to results of a Phase I/II clinical trial presented at the AACR Annual Meeting 2023 in Florida. overall response rate.

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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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Scienmag

OCTOBER 30, 2020

Therapy may hold promise for fighting pandemic Credit: Photo by Cedars-Sinai COVID-19 (coronavirus) patients who were administered a novel antibody had fewer symptoms and were less likely to require hospitalization or emergency medical care than those who did not receive the antibody, according to a new study published in the The New England Journal (..)

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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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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. FoundationOne ® Liquid CDx (Foundation Medicine; end-to-end commercial provider).

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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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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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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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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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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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Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

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Drug Discovery World

APRIL 14, 2023

Dr Schon is applying his broad expertise from lead discovery to manufacture in order to progress differentiated, safe and developable bi-specific therapeutic ADC candidates to clinical development. He says it is no secret that the costs of antibody drug development are steadily increasing to ‘eye-watering heights’ per approved drug 1.

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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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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

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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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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Drug Discovery World

JULY 13, 2022

Novo Nordisk has announced positive interim results for its Mim8 antibody which is being as a treatment for haemophilia A. . The study is assessing the safety and clinical use of Mim8 in patients with haemophilia A. Zero bleeds were reported in the eight participants treated with the therapy once monthly. . Official comments .

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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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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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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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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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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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