AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 1, 2023

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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RNA DNA In-Vitro Drugs 169

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). In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target.

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Antibody Trials In-Vitro Clinical Trials 52

Pharmaceutical Technology

SEPTEMBER 19, 2022

The EMA CHMP positive opinion is based on findings from the double-blind, randomised, placebo-controlled, multicentre Phase III TACKLE clinical trial of IM dose of Evusheld. Additionally, in the trial, the antibody cocktail was found to be well-tolerated. 5 variant, the company noted. 5 variant, the company noted.

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In-Vitro Antibody Vaccination Vaccine 279

Pharmaceutical Technology

MAY 4, 2023

The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results. This cohort showed a safety profile identical to that found in older children and adults.

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In-Vitro Genetic Disease Medicine Genetics 246

XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Dr. Dhiman is a scientific expert in molecular infectious disease and women’s health and is actively engaged in multiple clinical trials with a special interest in rapid molecular diagnostics for sepsis.

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Manufacturing Clinical Trials Clinical Trials In-Vitro 108

Drug Discovery World

MARCH 24, 2023

A new study has found that highly purified gelatin biomaterials could enhance the reliability and reproducibility of 3AD in vitro models, creating new possibilities for replacing preclinical animal trials. This can improve the validity of 3D in vitro models and help to reduce animal testing.”

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In-Vitro Trials Drugs Research 52

Drug Discovery World

MARCH 8, 2023

The post Company launches ADC Phase I trial in solid tumours appeared first on Drug Discovery World (DDW). Trop2 is not expressed or has low expression levels in normal human tissues while overexpressed in a variety of solid tumours, especially epithelial tumours.

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Trials In-Vivo In-Vitro Antibody 52

Pharmaceutical Technology

OCTOBER 5, 2022

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial.

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In-Vitro In-Vivo Sales Clinical Trials 279

pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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Clinical Trials Clinical Trials Trials Vaccination 105

Pharmaceutical Technology

APRIL 12, 2023

FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples. Foundation Medicine has announced it will supply a tissue-based test as a companion diagnostic for Bristol Myers Squibb’s (BMS) recently acquired ROS1/TRK inhibitor repotrectinib.

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Genome Genomics In-Vitro Gene 130

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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Clinical Trials Clinical Trials Trials Production 52

Pharmaceutical Technology

MAY 31, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. ZNA-1041 is under clinical development by F. Buy the report here.

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In-Vitro Clinical Trials Clinical Trials Drugs 130

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. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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Clinical Trials Clinical Trials Trials FDA Approval 98

BioTech 365

OCTOBER 7, 2020

– Antiviral Activity Confirmed by Early Stage Studies Conducted through the National Institute of Allergy and Infectious Diseases Preclinical Services Program and Texas Biomedical Research Institute – Patient Enrollment for Phase 2 Trial Ongoing DALLAS, Texas, Oct. 07, 2020 (GLOBE … Continue reading →

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In-Vitro Allergies Trials Research 40

Pharmaceutical Technology

MAY 24, 2023

is expected to enter Phase II/III registration trial as the first-line treatment for advanced Merkel cell carcinoma (MCC) early next year. to investigational new drug-enabling trials, expected in 2024, to treat aggressive diffuse large B-cell lymphomas (DLBCLs). Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0,

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Gene Therapy In-Vivo In-Vitro Immune Response 130

Drug Discovery World

JANUARY 31, 2024

Breye Therapeutics, a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, has started a Phase Ib/IIa clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular oedema (DMO).

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Clinical Trials Clinical Trials In-Vivo In-Vitro 52

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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Vaccination Vaccine Trials Clinical Trials 59

Bioengineer

JANUARY 16, 2024

Analysis of circulating tumor (ct) DNA at the time of treatment discontinuation or progression showed that 49% of patients in the AURA3 trial lacked the T790M mutation. The presence of the T790M mutation during first or second-generation EGFR-TKI treatments is observed in 50-60% of patients. months vs. 15.2 months, p = 0.01).

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Genome Genomics Protein In-Vitro 119

Drug Discovery World

AUGUST 22, 2023

The company has already completed three trials in patients, including a positive open label trial in metastatic breast cancer using a prototype capsule formulation. In addition, total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range, where efficacy is seen in vitro.

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Gene Expression In-Vitro Gene Trials 52

Drug Discovery World

APRIL 8, 2024

The American Association of Cancer Research (AACR) Annual Meeting launched on Sunday 7 April in San Diego with an Opening Plenary Session showcasing cutting-edge technological advances opening new frontiers in cancer science.

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In-Vivo In-Vitro Antibody Protein 52

The Pharma Data

MAY 3, 2021

DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. Posted 03 May 2021 | By Michael Mezher . 2020 was a challenging year.

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In-Vitro Clinical Trials Clinical Trials In-Vivo 52

Drug Discovery World

APRIL 25, 2023

University of California researchers have dosed the second participant in their clinical trial to identify a potential cure for HIV utilising CAR-T cell therapy. The trial is the first-in-human clinical study investigating the duo CAR-T cell therapy for the treatment of HIV. In 2021 there were an estimated 1.5

Research 52

Research In-Vitro Clinical Trials Clinical Trials 52

BioTech 365

OCTOBER 12, 2020

Presentations to showcase in vitro activity of ibrexafungerp against fluconazole-susceptible and -resistant Candida spp. and clinical data from VANISH-303 PHASE 3 trial evaluating ibrexafungerp as a treatment for vaginal yeast infections JERSEY CITY, N.J., 12, 2020 (GLOBE NEWSWIRE) — … Continue reading →

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Drug Discovery World

OCTOBER 25, 2023

Data generated by our laboratory across in vitro and in vivo models and from human clinical samples support this important finding. Previous attempts to interrupt TGF-β pathway signaling in cancer have been thwarted by activation of alternative resistance pathways by the tumour.

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Research In-Vivo In-Vitro Clinical Development 52

The Pharma Data

NOVEMBER 12, 2021

COMET-TAIL Phase III data demonstrated that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations The trial enrolled participants during the Delta variant wave of the pandemic in the US. In the IM administration (500 mg) arm of the trial, there was a2.7

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Trials In-Vitro Antibody Clinical Development 40

Drug Discovery World

JUNE 30, 2023

Select mature stem cell lines can then be used in small-scale in vitro assays, and proven biochemical and phenotypic screens supporting target validation and deconvolution studies. amends how studies can be performed with alternative animal models to access toxicity before a compound moves into clinical trials.

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Development Drugs In-Vitro Gene Therapy 52

Advarra

SEPTEMBER 23, 2022

The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” . Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. .

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Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

JUNE 5, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Pralsetinib is under clinical development by F. Buy the report here.

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In-Vitro Drugs Clinical Trials Clinical Trials 100

Roots Analysis

AUGUST 18, 2023

Due to this biological mismatch, several toxic drugs are subjected to costly clinical trials, while potentially useful drugs do not get commercialized. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

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Production In-Vitro Branding Drugs 52

XTalks

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. SurVeil’s FDA approval was based on 24 months of data from the pivotal, head-to-head TRANSCEND clinical trial that compared it against Medtronic’s IN.PACT. The balloon is designed for the treatment of patients with peripheral artery disease.

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FDA Approval Drugs Sales In-Vitro 96

Drug Discovery World

MARCH 26, 2024

We were excited to unveil data showing that two distinct chemical series exhibit METTL1 inhibition in vitro at low nanomolar concentrations with minimal interference with other RNA and protein methyltransferases. Results of that Phase I trial are expected to be presented later this year. MT: What’s next for STORM’s research?

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RNA In-Vivo In-Vitro DNA 62

Drug Discovery World

AUGUST 31, 2023

HBC Immunology (a subsidiary of Hofseth BioCare) has secured seed capital financing of approximately $900,000 from external investors to commence preclinical animal trials with its patented peptides, FT-002 and FT-005. Other potential cancer indications with ongoing in vitro work include breast and ovarian cancer.

Gene Expression 52

Gene Expression Gene In-Vitro Research 52

The Pharma Data

AUGUST 24, 2020

In the first stage in the partnership, the companies will use KidneyIntelX, an artificial intelligence-enabled in vitro diagnostic platform, to look at further improving outcomes for patients with chronic kidney disease (CKD) and its complications, in coordination with the Mount Sinai Health System.

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In-Vitro Medicine Development Trials 52

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 5 clinical trials, which are ongoing. Pharma Mar offers in vitro diagnostic products used for detection of virus and bacteria in respiratory infections and human papilloma virus genotypes, among others. Buy the model here. It also develops RNAi candidates for the treatment of retina diseases.

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Hormones In-Vitro Genotype Bacteria 100

XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

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Clinical Trials Clinical Trials In-Vitro Protein 52

Drug Discovery World

FEBRUARY 6, 2024

In vitro and in silico models are becoming increasingly sophisticated in predicting drug safety profiles and preventing costly and time-consuming clinical trials. In vitro and in silico models are becoming increasingly sophisticated in predicting drug safety profiles and preventing costly and time-consuming clinical trials.

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Genome Genomics Genetics In-Vitro 57

Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. This article will focus on one such area of great unmet need and promise: women’s health. This is likely in part because their byproduct, lactic acid, is known to inhibit pathogenic bacteria 25.

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Clinical Trials Clinical Trials Regulation Bacteria 62