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.

Research 52

Research In-Vivo In-Vitro Clinical Development 52

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. In vivo, METTL1 inhibitors induce tumour growth inhibition in both immune-deficient and immune-competent mouse strains.

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RNA In-Vivo In-Vitro DNA 64

Drug Discovery World

MAY 9, 2023

The recent passage of the FDA Modernization Act, which removed the requirement for animal testing when suitable alternatives are available, has highlighted the inadequacy of animal models most often used for in vivo research. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

Development 52

Development Drugs In-Vivo Clinical Trials 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

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

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.

Development 52

Development Drugs In-Vitro Gene Therapy 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.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

pharmaphorum

AUGUST 10, 2020

Originally intended as a treatment for Ebola virus, Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against several emerging viruses. The filing is supported by data from two randomised, open-label, multi-centre phase 3 clinical studies of Veklury conducted by Gilead.

Drugs 85

Drugs In-Vivo Contract Manufacturing In-Vitro 85

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

pharmaphorum

FEBRUARY 19, 2021

Excision wants to take its lead therapy candidate, EBT-101, into a phase 1/2 clinical trial in patients with chronic HIV infection with the proceeds from this latest financing round. 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

This action sensitised GBM cells to radiotherapy both in vitro and in vivo (in mouse models). “Our research has revealed cladribine as a radiosensitiser for GBM treatment by drug repurposing, which can offer multiple advantages,” says Prof Youn. “As 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

OCTOBER 20, 2022

This technology has resulted in the launch of a proprietary pipeline of several drug discovery projects, which now range from in vitro to in vivo phases, especially in oncology and immuno-oncology. .

Drugs 52

Drugs In-Vivo In-Vitro Engineer 52

Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods? Not yet, according to Ewart.

Research 72

Research Gene Therapy In-Vivo In-Vitro 72

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 compared to placebo [5.7

Clinical Trials 40

Clinical Trials Clinical Trials Trials In-Vivo 40

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

The Pharma Data

MARCH 25, 2022

2-4 Evusheld was generally well-tolerated in the trial.(2-4). 2-4 Evusheld was generally well-tolerated in the trial.(2-4). There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1,

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 1-3 Evusheld was generally well-tolerated in the trial.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. This blog post will discuss how PK modeling can contribute to sample size estimation, a key aspect of a clinical trial protocol. Approaches to Pharmacokinetic Analysis.

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Production Bioavailability In-Vivo Bioequivalency 133

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). FDORA § 3209(a)(1).

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Clinical Trials Clinical Trials In-Vivo In-Vitro 64

The Pharma Data

JUNE 17, 2022

“The broadly neutralizing antibodies we described were more efficient in vitro than many anti–SARS-CoV-2 monoclonals previously approved by the FDA for treatment or prevention. A modified version of the Cv2.1169 antibody was also effective at treating SARS-CoV-2 infection in mice and hamsters.

Antibody 52

Antibody In-Vivo In-Vitro Immune Response 52

pharmaphorum

JANUARY 25, 2022

As the area of bringing a digital therapeutic to market means passing the same level of regulatory scrutiny as a traditional, pharmaceutical therapy, this means “prescription digital therapeutics must undergo extensive clinical trials to demonstrate their safety and effectiveness before they ever reach patients,” said McCann.

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Drug Discovery World

JULY 22, 2022

For example, in randomised clinical trials of patients with non-small cell lung cancer (NSCLC), pembrolizumab has been shown to be effective in slowing down disease progression and improving survival rates 1. However, adverse effects such as cytokine release syndrome (CRS) and neurotoxicity still occur. Jespersen et al.

In-Vivo 52

In-Vivo Engineer In-Vitro Antibody 52

The Pharma Data

DECEMBER 9, 2020

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

Drug Discovery World

NOVEMBER 16, 2022

Think of a cell culture, where scientists can observe the growth of a cell in the body in an in-vitro setting, and gain an understanding of how they react to different drug compounds. Therefore, while researchers can understand just how a drug molecule impacts a cell, they can’t be sure that it will perform the same when used in-vivo. .

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Drugs In-Vivo In-Vitro Scientist 97

Delveinsight

JANUARY 12, 2021

million after Birinapant successfully becomes a part of the Phase I trials. The companies believe that their candidate in its original IgG format has shown potent neutralization activity in in vitro assays and in an in vivo animal model. The duo will jointly develop the therapy, conducting clinical trials globally.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

Pharmaceutical Technology

MAY 16, 2023

The approval also includes clearance for a Phase I clinical trial protocol of NXP900. NXP900 plus Osimertinib in vitro showed a possible ability to reverse acquired resistance to these drugs in non-small cell lung cancers. Nuvectis has licensed the exclusive global rights to NXP900 from the University of Edinburgh in Scotland, UK.

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Drug Discovery World

FEBRUARY 22, 2024

With no in-house laboratory space, the company works closely with multiple international contract research organisations (CROs), including Axxam, which carry out all of the Libra R&D, from compound screening assays, to in vivo pharmacokinetic/pharmacodynamic and ADME work, as well as in vitro and in vivo pre-clinical safety assessments.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vivo 52

The Pharma Data

OCTOBER 22, 2020

reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. In a recent webinar, Dr. Olsson described the benefits of flow cytometric receptor occupancy assays in clinical trials. What is Flow Cytometry?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Antibody 98

The Pharma Data

OCTOBER 21, 2020

Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinical trial for advanced solid tumors in 2021. Research s howed KB-0742 i nhibited a ndrogen r eceptor -d ependent a ctivity and r educed t umor g rowth in c astration -r esistant p rostate c ancer. SAN MATEO, Calif., and CAMBRIDGE, Mass.,

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In-Vivo In-Vitro Bioavailability Clinical Trials 40

Pharmaceutical Technology

SEPTEMBER 10, 2008

IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo. Natalie Coomber: Can you provide a quick background on the history of Biotest and the main work it is currently undertaking?

In-Vitro 130

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Pharmaceutical Technology

FEBRUARY 1, 2023

Ellipses Pharma stated that the dual FLT3 inhibition and Aurora kinase demonstrated to overcome the acquired resistance to selectively inhibit FLT3 in vitro and in vivo. The FDA IND clearance allows the company to expand its ongoing first-in-human Phase I/II clinical trial of EP0042.

FDA Approval 130

FDA Approval In-Vivo In-Vitro Trials 130

The Pharma Data

JANUARY 11, 2021

Our antibody clones in their original IgG format have shown potent neutralization activity in in vitro assays and, in the case of our lead clone, in an in vivo animal model. Upon binding, the antibodies block the spike protein from interacting with ACE2 and thereby prevent virus-induced cell-killing, also known as cytopathic effect.

Antibody 52

Antibody Licensing Licensing Development 52

Pharmaceutical Technology

MAY 10, 2023

The research teams will examine the use of CytoMed’s allogeneic gdTc on multiple AML and breast cancer subtypes in vitro and in vivo. Under the two-year deal, both parties expect to develop new treatment methods for patients’ unmet AML and breast cancer needs at a reasonable price.

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Gene Therapy In-Vivo In-Vitro Gene 147

Drug Discovery World

JULY 22, 2022

But while psychedelic drug research has witnessed a relative roller-coaster ride of effort since the mid-20th century, more recent interest in the use of psychedelics for treating mental health and psychiatric disorders has spurred a raft of clinical trials 1.

Drugs 98

Drugs In-Vitro In-Vivo Clinical Trials 98

Drug Discovery World

FEBRUARY 15, 2023

Over 250 clinical trials are currently in progress, and novel immuno-oncological treatments are already proving to be successful. Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. This continues to be the standard of care.

Research 52

Research In-Vitro In-Vivo Development 52

Delveinsight

JANUARY 18, 2021

The company was running Phase III trials of the therapy for AS; however, the therapy flunked in the trial failing to meet its primary endpoint. The companies had to pause the trials of GTX-102 after the patients temporarily lost the ability to walk. GeneTx and Ultragenyx are co-developing the therapy.

Marketing 52

Marketing Gene Drugs Protein 52