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.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccination 105

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.

In-Vitro 279

In-Vitro Antibody Vaccination Vaccine 279

XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Dr. Dhiman has 24 years of clinical research experience in the immunogenetics of vaccines and infectious disease diagnostics. She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota.

Manufacturing 108

Manufacturing Clinical Trials Clinical Trials In-Vitro 108

XTalks

APRIL 14, 2022

Conventional in vitro and in vivo studies are used in the drug development pipeline. Take this quiz to test your knowledge about in silico trials! Register for this free, upcoming webinar to learn more about the benefits of implementing in silico clinical trials with mechanistic models for drug development.

Trials 98

Trials In-Vivo In-Vitro Clinical Trials 98

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

Pharmaceutical Technology

MAY 31, 2023

ZNA-1041 is under clinical development by F. 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. Buy the report here.

In-Vitro 130

In-Vitro Clinical Trials Clinical Trials Drugs 130

Advarra

SEPTEMBER 23, 2022

The FDA requires the data for these assessments to generally come from animal studies and clinical investigations 1 of the investigational product(s) 2. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 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.

In-Vitro 279

In-Vitro In-Vivo Sales Clinical Trials 279

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).

Clinical Trials 52

Clinical Trials Clinical Trials In-Vivo In-Vitro 52

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.

Antibody 52

Antibody Trials In-Vitro Clinical Trials 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.

In-Vitro 52

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

Drug Discovery World

APRIL 8, 2024

Jakob Nikolas Kather, Professor of clinical artificial intelligence at Technical University Dresden in Germany, then discussed how AI applications can be used to derive prognostic and predictive information from routine pathology slides.

In-Vivo 52

In-Vivo In-Vitro Antibody Protein 52

Pharmaceutical Technology

JUNE 5, 2023

Pralsetinib is under clinical development by F. 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. Buy the report here.

In-Vitro 100

In-Vitro Drugs Clinical Trials Clinical Trials 100

The Pharma Data

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days quicker compared to placebo. days; 95% C.I, days; 95% C.I,

Clinical Trials 40

Clinical Trials Clinical Trials Trials In-Vivo 40

Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). When an investigational device does not carry this potential for serious risk, the clinical investigation is NSR.

Research 52

Research Clinical Trials Clinical Trials Trials 52

XTalks

APRIL 18, 2024

Conversely, a negative result suggests a low probability of amyloid pathology, guiding healthcare providers in clinical decision-making and potentially ruling out Alzheimer’s disease in symptomatic patients. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

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

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 5 clinical trials, which are ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Buy the model here. It also develops RNAi candidates for the treatment of retina diseases. over FY2021.

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Hormones In-Vitro Genotype Bacteria 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.

Production 52

Production In-Vitro Branding Drugs 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.

Genome 59

Genome Genomics Genetics In-Vitro 59

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

Clinical Trials 98

Clinical Trials Clinical Trials Trials In-Vitro 98

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.

FDA Approval 96

FDA Approval Drugs Sales In-Vitro 96

Drug Discovery World

JUNE 30, 2023

Through the use of human induced pluripotent stem cells (iPSCs) derived cells, we can improve translation and reduce risk of clinical failure. 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.

Development 52

Development Drugs In-Vitro Gene Therapy 52

Drug Discovery World

APRIL 5, 2023

A collaborative network The CBC operates as a collaborative network of 19 Institutes with longstanding drug discovery know-how from target identification through to proof-of-concept clinical trials. The post Only non-US company joins cancer drug discovery consortium appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs In-Vivo In-Vitro Engineer 52

pharmaphorum

FEBRUARY 13, 2022

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

Drug Discovery World

MAY 9, 2023

Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval. This abysmal success rate significantly trails the overall approval rate for compounds entering human trials (about 10% of which reach commercialisation). Cancer is far more complex than the sum of its parts.

Development 52

Development Drugs In-Vivo Clinical Trials 52

XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Antibody 98

XTalks

JANUARY 9, 2023

Its mechanism of action differs from currently approved antivirals and has thus far shown no cross-resistance in vitro to other drug classes. Sunlenca received New Drug Application (NDA) approval based on the results of the CAPELLA trial, in which it demonstrated high rates of sustained virological suppression. Gilead Sciences, Inc.

FDA Approval 98

FDA Approval Drugs In-Vitro Clinical Trials 98

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).

Genome 119

Genome Genomics Protein In-Vitro 119

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 64

Drug Discovery World

DECEMBER 13, 2022

Dr Mariko Taniguchi-Ikeda, Associate Professor in the Department of Clinical Genetics at Fujita Health University Hospital, said: “I have seen patients with FCMD for more than 20 years. Japanese researchers propose using RNA interference for correcting a mistake in the genetic code of patients with Fukuyama muscular dystrophy. .

RNA 52

RNA Genetics Gene In-Vitro 52

XTalks

FEBRUARY 1, 2023

The researchers found that factors in the blood can potentially predict the risk of developing the disease years before a clinical diagnosis is made. Among individuals diagnosed with MCI, ten to 15 percent of them progress to Alzheimer’s disease as observed in clinical studies and five to ten percent in population studies.

Research 98

Research In-Vitro Protein Development 98

pharmaphorum

FEBRUARY 19, 2021

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. We have proven the technology and candidate programs in vitro and in vivo in both small animal models and primate models.

Gene Editing 105

Gene Editing In-Vivo DNA In-Vitro 105

Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. In addition, they discovered that cladribine, a clinical drug, activates DGKB and inhibits DGAT1. GBM is a WHO grade IV brain tumour with dismal prognosis.

FDA Approval 52

FDA Approval Drugs In-Vivo In-Vitro 52

Drug Discovery World

JULY 3, 2023

From June 20-22, 2023, Cambridge Healthtech Institute hosted the seventh annual Immuno-Oncology Summit Europe in London.

Antibody 52

Antibody In-Vitro Engineer In-Vivo 52

Drug Discovery World

AUGUST 22, 2023

In many cases, it is also challenging to apply traditional bioequivalence methods or to ensure clarity about the comparison model (in-vitro/in-vivo) needed to gain health authority approval. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

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Production Bioequivalency In-Vivo In-Vitro 52