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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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.

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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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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.

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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).

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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.

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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,

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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.

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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.

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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.

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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.

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Drug Discovery World

JULY 3, 2023

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

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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. .

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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.

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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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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.

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

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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).

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Drug Discovery World

JANUARY 24, 2024

Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024. Phase I of the clinical program will dose healthy volunteers with single ascending doses of FIB992 before proceeding to a multiple ascending dose study where the drug is administered for a two-week period.

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The Pharma Data

JANUARY 19, 2021

a privately-held neuron regeneration therapeutics company, today announced the publication of results of their novel pharmacotherapy: NNI-362 to allosterically stimulate neural regeneration in human cultures and in vivo models of aging and disease. CLARKSVILLE, Md., 20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. , About NNI-362.

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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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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.

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Drug Discovery World

FEBRUARY 22, 2024

According to Medicine Discovery Catapult, these include: “Navigating the complexity of the CNS; understanding the disease pathology, and accessing predictable in vitro and in vivo cell models 2 ”. For example, it can take up to it three years to recruit enough participants for a dementia clinical trial. to £104.7m

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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. demonstrated the ability to model clinical responses to ACT in autologous HIS mice 4. Jespersen et al.

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FDA Law Blog

OCTOBER 11, 2022

The Act defines substantial evidence as that consisting of “adequate and well-controlled [clinical] investigations” upon which qualified scientific experts could conclude that a drug will have its purported effect. More importantly, replication is but one means to substantiate the results of a clinical investigation or scientific study.

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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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Delveinsight

DECEMBER 21, 2020

The expressions of these receptors were detected in GBM cell lines – in ex-vivo primary cancer cells extracted and in-situ GBM tissue biopsies. Thus, there can be a possibility that Cannabis may have the potential to cure Glioblastoma, however, further research, clinical trials are required and underway for a clearer picture.

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Drug Discovery World

MAY 10, 2023

This stage is more highly regulated and consists of both preclinical testing and clinical trials. Until recently, drug carcinogenicity assessment required two different in vivo studies, one of which was typically a two-year lifetime study in rats. Drug discovery and development is an arduous process that can cost upwards of $2.6

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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., SAN MATEO, Calif.,

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Drug Discovery World

OCTOBER 13, 2022

The value of that versatility is reflected by the number of mRNA-based therapeutics in clinical trials. Up to July 2021, there were 17 mRNA therapeutics in clinical pipelines globally. Why mRNA has potential . One aspect that makes mRNA technology popular with drug developers is that its proteins can be easily edited.

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Delveinsight

JANUARY 12, 2021

Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. 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.

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Drug Discovery World

JANUARY 23, 2023

In cell therapy, regenerative and adoptive immunotherapies continue to bridge the gap between genetic engineering strategies and their clinical application. This circumvents several technical challenges inherent to the genetic manipulation of differentiated cells in ex vivo culture or intact tissues.

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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.

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Pharmaceutical Technology

SEPTEMBER 10, 2008

Before the inception of this institute, the facility was oriented towards pre-clinical toxicology and breeding of the laboratory animals. Before the inception of this institute, the facility was oriented towards pre-clinical toxicology and breeding of the laboratory animals. Dr Ivana Surovà: Biotest s.r.o.

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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. Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies.

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