The Pharma Data

MAY 3, 2021

In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year. . Posted 03 May 2021 | By Michael Mezher .

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pharmaphorum

FEBRUARY 13, 2022

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process.

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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 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. The cash will also help develop two other preclinical drugs, EBT-104 for Herpes Simplex Virus and EBT-107 for hepatitis B.

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Drug Discovery World

JULY 3, 2023

Key updates The findings presented by Dr Christian Klein, Head of Oncology Programs and Department Head of Cancer Immunotherapy Discovery, Roche Innovation Center Zurich, Roche Pharma Research & Early Development, pRED, bear major implications for the development of the next-generation of IL-2 therapies.

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Drug Discovery World

AUGUST 22, 2023

Originator pharma companies are developing ever more complex products, which are transforming the medical landscape, but their cost places an increasing burden on healthcare budgets worldwide. It could also include specialty products that are harder to develop compared to standard generic products. What are complex generics?

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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

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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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. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. §

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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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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. Proper planning of PK assessments can accelerate the development of both novel drugs and new formulations of previously approved drugs developed via the 505(b)(2) pathway.

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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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pharmaphorum

JANUARY 25, 2022

To demonstrate how quickly the digital therapeutics space is developing, it is easiest to state that the first such therapy was approved in 2018 and since that point the annual investment in the space has more than doubled in the intervening years. Developing a digital therapy. This equated to $21.3 This equated to $21.3

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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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

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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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?

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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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Drug Discovery World

FEBRUARY 22, 2024

Libra Therapeutics is a San Diego-based biotech focused on developing novel disease-modifying therapeutics, which restore the cellular balance that is disrupted in neurodegenerative diseases. This article is sponsored by Collaborative Drug Discovery. Security built in to CDD Vault is critical when working with multiple CROs.

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Delveinsight

JANUARY 12, 2021

Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. 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. R on macrophages.

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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. We look forward to advancing clinical development of KB-0742 to establish the dose, safety and efficacy of this investigational therapy as a potential treatment for MYC-amplified tumors.”.

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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. ” New projects we have been involved with have helped the company to accelerate its development in the field of pre-clinical research. Dr Ivana Surovà: Biotest s.r.o.

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Pharmaceutical Technology

MAY 16, 2023

The approval also includes clearance for a Phase I clinical trial protocol of NXP900. Nuvectis Pharma chairman and CEO Ron Bentsur stated: “The IND clearance by the FDA is a significant milestone for the NXP900 development programme and for our overall corporate strategy, further demonstrating our ability to execute our business plan.

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Pharmaceutical Technology

FEBRUARY 1, 2023

The dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance. 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.

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The Pharma Data

OCTOBER 22, 2020

The speed and rigor with which Veklury has been developed and approved in the U.S. 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.

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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

FEBRUARY 15, 2023

Further discovery of PD-1 and CTLA4 as negative immune regulators led to the development of a new class of cancer therapeutics, namely the immune checkpoint inhibitors 5,6. Between 2017 and 2020, the number of IO therapies being developed has increased significantly from 2030 (for 265 targets) to 4,720 (for 504 targets).

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Drug Discovery World

JANUARY 24, 2024

Fibrocor Therapeutics, a developer of novel therapeutics to treat fibrosis, recently appointed Piet Wigerinck as Chief Scientific Advisor. Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024.

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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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Drug Discovery World

OCTOBER 13, 2022

Samsung Biologics’ Senior Vice President, James Park, explores the opportunities emerging for CDMOs to support mRNA developers as they explore new therapeutic areas for patients. . One aspect that makes mRNA technology popular with drug developers is that its proteins can be easily edited. Why mRNA has potential .

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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. ,

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Delveinsight

DECEMBER 21, 2020

These develop from star-shaped glial cells (astrocytes and oligodendrocytes) responsible for providing nourishment to the nerve cells within the brain. The expressions of these receptors were detected in GBM cell lines – in ex-vivo primary cancer cells extracted and in-situ GBM tissue biopsies. What causes cancer to relapse?

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Delveinsight

JANUARY 18, 2021

The first sign of a child suffering from Angelman syndrome is a delay in development, such as the inability to sit without support or making incoherent babbling sounds. The gene is responsible for the normal and healthy development of an individual physically as well intellectually. GeneTx and Ultragenyx are co-developing the therapy.

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Drug Discovery World

JANUARY 23, 2023

Kevin Hemphill, R&D Manager at PerkinElmer’s Horizon Discovery explores how base editing has emerged as an attractive gene editing option for researchers wanting to develop stem cell-based therapies. Pioneering work in the mid-2000s, led by the Yamanaka group at Kyoto University, further advanced the field of PSCs.

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XTalks

OCTOBER 1, 2020

And although academia and industry have often been pitted against each other in the realm of scientific discovery and development, there may be more similarities and synergies between the two than we may think. WeiQi Lin, MD, PhD, executive vice president of research & development and principal scientist, DURECT Corporation.

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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

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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