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. Dr. Bahassi: There are several factors to consider when designing a trial that involves ctDNA detection.

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Clinical Trials Clinical Trials Trials FDA Approval 98

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

XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

Protein 97

Protein Vaccination Vaccine Trials 97

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 Vaccination Vaccine 76

Drug Discovery World

MARCH 8, 2024

The top stories: Antibody therapy shows anti-tumour activity in advanced cancer In an early phase clinical trial, a combination of antibody-based medications targeting the immune system generated promising safety data and anti-tumour activity in individuals with advanced cancer.

Antibody 52

Antibody Drugs Clinical Trials Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 14, 2022

The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Scienmag

APRIL 13, 2022

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

Antibody 88

Antibody Protein Clinical Trials Clinical Trials 88

pharmaphorum

MARCH 12, 2021

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. A total of 415 healthy adults 18 years of age and older are expected to be enrolled in the trial across 13 investigational sites.

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Clinical Trials Clinical Trials Trials Vaccination 52

Pharmaceutical Technology

JANUARY 19, 2023

This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients. Avidity Biosciences’ AOC 1020 is intended to reduce the DUX4 mRNA and DUX4 protein expression in muscles in these patients.

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Gene Expression Gene Protein RNA 246

Worldwide Clinical Trials

SEPTEMBER 29, 2022

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse. anti-human IgG).

Reagent 130

Reagent Clinical Trials Clinical Trials Antibody 130

Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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Vaccination Vaccine Protein Clinical Trials 264

pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. In Alzheimer’s, the protein runs amok, forming tangles that have been linked to cell damage and neuronal death.

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Antibody Protein Licensing Licensing 98

Roots Analysis

AUGUST 9, 2023

Novel antibody therapies are chimeric proteins having antibodies attached lethal effector molecules. Multiple novel antibody formats have been engineered to enhance therapeutic efficacy. Around 50% of the articles focused on novel antibody therapies were published post-2020.

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Antibody Marketing Development Engineer 52

pharmaphorum

SEPTEMBER 17, 2020

Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease. The double-blind placebo-controlled antibody study involved patients with symptoms outside hospitals, who were treated with four different dose strengths.

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Antibody RNA Trials Clinical Trials 122

Drug Discovery World

SEPTEMBER 25, 2023

Enrolment in a Phase I trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, US. It is an adaptation of an earlier universal flu vaccine candidate, FluMos-v1, which began first-in-human testing in 2021 and is still undergoing trials.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Drug Discovery World

NOVEMBER 14, 2023

DDW’s Megan Thomas looks at how different diseases will benefit from the success of therapeutic antibodies. Cancer Monoclonal antibodies (mAbs) are a type of targeted drug therapy, and as such are often used to treat cancer. The global arthritis monoclonal antibodies market grew from $49.44 billion in 2022 to $53.81

Antibody 59

Antibody Development FDA Approval Trials 59

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

JULY 25, 2022

The BLA, which grants permission to distribute a biological therapy across states in the US, was accepted based on data from the company’s Phase III trial. Epidermal growth factor receptor 2 (HER2)-positive breast cancer is one such type in which there is an overexpression of the HER2 protein.

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

Drug Discovery World

MARCH 29, 2023

A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). The primary objective of the trial is to evaluate the safety of intravenous ExoFlo.

Drug Trials 52

Drug Trials Trials Drugs Clinical Trials 52

pharmaphorum

MAY 19, 2022

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US.

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Vaccination Vaccine Trials Immune Response 145

Pharmaceutical Technology

JULY 29, 2022

The company submitted the BLA based on positive data from various studies of the investigational therapy, including the Phase II/III QUILT 3.032 clinical trial underway. The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients.

Trials 264

Trials Clinical Trials Clinical Trials Licensing 264

pharmaphorum

OCTOBER 8, 2020

Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial. The big US pharma is asking for an emergency approval of the monotherapy version of its antibody therapy codenamed LY-CoV555.

Antibody 98

Antibody Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

APRIL 4, 2023

Ultomiris is intended to treat NMOSD adult patients who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). Ultomiris works by inhibiting the C5 protein in the terminal complement cascade, which is part of the body’s immune system.

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Marketing Clinical Trials Clinical Trials Trials 130

Drug Discovery World

DECEMBER 6, 2022

While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy shows new promise, according to data from a first-in-human clinical trial. . The Phase I trial (IAVI G001) tested the first stage in a multi-stage HIV vaccine regimen the researchers are developing.

Vaccination 52

Vaccination Vaccine Trials Antibody 52

Pharmaceutical Technology

JUNE 15, 2023

ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells. This approval has been granted for ALE.C04 both as a monotherapy and in combination with pembrolizumab in a first-in-human clinical study in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

FDA Approval 130

FDA Approval Antibody Clinical Trials Clinical Trials 130

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

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). It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

World of DTC Marketing

APRIL 11, 2021

Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus.

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Vaccination Vaccine Clinical Trials Clinical Trials 303

Pharmaceutical Technology

OCTOBER 20, 2022

The regulatory agency based its decision on findings from the Phase III Prevent-19 clinical trial, as well as from the COV-BOOST trial, sponsored by the UK. In the Phase III trial, the vaccine booster was given to healthy adult subjects nearly eight or 11 months following the primary regimen.

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Vaccination Vaccine Antibody Trials 130

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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Antibody Immune Response Trials Clinical Trials 75

Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. Adcentrx Therapeutics is focused on developing protein conjugate therapeutics to treat cancer and other life-threatening diseases.

Clinical Development 147

Clinical Development Development Clinical Trials Clinical Trials 147

Pharmaceutical Technology

JUNE 15, 2023

Crovalimab is an anti-C5 recycling antibody. C5 is an important component of the complement system [a system of plasma proteins] and the drug is expected to control its activity. Given via subcutaneous administration, the therapy will reduce the treatment burden for patients and their caregivers.

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Clinical Trials Clinical Trials Trials Protein 130

XTalks

JULY 17, 2023

targeted monoclonal antibody is being evaluated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2-positive. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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Clinical Trials Clinical Trials Trials Antibody 95

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

OCTOBER 27, 2021

A study conducted by a consortium of Brazilian researchers has demonstrated that a hyperimmune serum consisting of purified antibody fragments produced in horses may be an efficient approach to combat COVID-19. Tests conducted in hamsters improved the animal clinical conditions. 1 (Gamma) and P.2 2 variants.

Antibody 52

Antibody Protein Scientist Clinical Trials 52

XTalks

FEBRUARY 20, 2024

IgA nephropathy is an autoimmune condition characterized by the deposition of clusters of antibodies in the kidneys, resulting in inflammation and kidney impairment. These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . Other data such as final clinical trial results will be assessed in due course. EMA_News starts evaluating the monoclonal antibody sotrovimab.

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Antibody Protein Trials Clinical Trials 52