Pharmaceutical Technology

JUNE 29, 2022

The next wave of medicine is well on course to be cell and gene-based. In September 2021, GlobalData figures revealed there to be 1,320 industry-sponsored regenerative medicine and advanced therapy trials ongoing worldwide. Meanwhile, the pharma industry is undergoing somewhat of a transformation itself.

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Pharmaceutical Technology

APRIL 5, 2023

More broadly however, several advancements are on the horizon for cell and gene therapies in 2023. This includes the first potential approval of a CRISPR-based gene therapy called exa-cel , which is developed by CRISPR Therapeutics and Vertex Pharmaceuticals. AZ: Cell and gene therapies often come with a high price.

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Drug Discovery World

SEPTEMBER 9, 2022

A new genetically engineered herpes virus has delivered a one-two punch against advanced cancers in initial findings from a Phase I trial. The genetically engineered RP2 virus, which is injected directly into the tumours, is designed to have a dual action against tumours.

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Drug Discovery World

SEPTEMBER 9, 2022

The National Institute of Health and Care Excellence (NICE) has confirmed its decision not to recommend olaparib for previously treated metastatic prostate cancer in patients with BRCA gene mutations. . Researchers successfully exploit virus against advanced cancers .

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NY Times

FEBRUARY 22, 2021

Two patients in a gene therapy study developed cancer years after treatment. It is not clear whether the therapy was responsible.

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Only after these trials are successful can sponsors seek market approval for mRNA-based products.

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Drug Discovery World

NOVEMBER 16, 2022

2 Phase I/II trial of TAC01-HER2 in patients with human epidermal growth factor receptor 2 (HER2) positive solid tumours. . TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognises HER2. .

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Bioengineer

JULY 19, 2021

These findings suggest that for therapies to be effective, they must be targeted at both gene products. KRAS encodes two gene products, KRAS4A and KRAS4B, whose levels can vary across organs and embryonic stages. ” KRAS genes in embryonic development. Credit: CNIO.

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The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. FBX-101 is a first-in-human AAV gene therapy.

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XTalks

MARCH 28, 2024

Early clinical trials have shown promising results and this therapy could become a valuable addition towards CRC treatment in the future. Gene Editing and CAR T-Cell Therapy Genetic engineering technologies, such as CRISPR-Cas9, are providing newer potential avenues for cancer treatment.

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WCG Clinical

MAY 28, 2024

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies. WCG has many ways to support cell and gene therapy clinical trials for lupus.

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Pharmaceutical Technology

FEBRUARY 15, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Gene splicing using nucleases. They are engineered to cut specific genomic targets in order to modify the expression of single genes and proteins.

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Roots Analysis

AUGUST 31, 2023

Overview of Gene Switch The notion that genes might be turned on and off was discovered several decades ago when studies revealed that E. Gene switches are sites on genes where regulatory molecules can bind to trigger transcription process, leading to expression of a particular gene.

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Drug Discovery World

NOVEMBER 17, 2022

The rapidly growing area of synthetic biology – including molecular biology, biotechnology, biophysics, and genetic engineering – is having a marked impact on the drug discovery landscape. The Brady lab has been finding antibacterial genes in soil and growing them within more lab-friendly bacteria.

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Advarra

AUGUST 8, 2023

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. Defining the Boom in Gene Therapy Research The gene therapy field is experiencing explosive growth in today’s competitive research environment.

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Drug Discovery World

MARCH 13, 2023

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach. One example: Zynteglo, a newly approved gene therapy priced at a record-breaking $2.8M

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Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% An IRB tends to get the most attention since all human trials need IRB approval.

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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. Clinical trials show feasibility in studying and treating solid tumours. Cancer Gene Ther. 2021;28(1-2):5-17.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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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. Adult fibroblasts were cultured in a cocktail of transcription factors to reactivate embryonic gene expression patterns 2.

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NY Times

SEPTEMBER 14, 2021

Will the Biden administration commit to spending that could speed clinical trial results? Such treatments are extraordinarily promising and costly.

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pharmaphorum

NOVEMBER 2, 2021

In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours. In the pipeline , Amgen has BiTE molecules targeting seven types of cancer in clinical trials, as well as further structures in the design stage. Simplified schematic overview of the proposed mechanisms of action for bsAbs.

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pharmaphorum

SEPTEMBER 13, 2022

Although clinical trials proved that chemicals could be used to treat cancer, the results of the study remained a closely guarded military secret until 1946. With the launch of the 100,000 Genomes Project in 2012, an international team of researchers studied the role that genes play in health and disease.

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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. Genetically engineered mouse models (GEMM) recapitulate the stromal biology of different human cancers including the tumour microenvironment that regulates the disease process.

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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. Although initial testing was carried out in five different transgenic mouse models, two models – the heterozygous p53 knockout mouse and the rasH2 mouse (also referred to as Tg.rasH2) – emerged as the most suitable models. Toxicologic Pathology.

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