Pharmaceutical Technology

MARCH 2, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The therapeutic candidate comprises allogeneic NK cells genetically engineered to express chimeric antigen receptors (CAR-NK) targeting cells CD33.

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Gene Editing Genetic Engineering Engineer Clinical Trials 100

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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Gene Therapy Gene Research Genetic Engineering 52

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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Gene Therapy Gene Research Genetics 52

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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Gene Therapy Gene Engineer Production 147

pharmaphorum

JULY 27, 2021

AstraZeneca has formed a partnership with Regeneron to investigate the potential of treating obesity using drugs directed at GPR75, a protective gene identified by scientists at the Regeneron Genetics Centre. The post Regeneron, AZ team up on drugs for obesity “superpower” gene appeared first on.

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Gene Drugs Genetic Engineering Genetics 52

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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Gene Gene Therapy Gene Expression Regulation 40

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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Gene Therapy Trials Research Gene 54

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Either way, occupational exposure to these gene delivery systems bears potential risks to the research staff.

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Engineer Genetics Clinical Research Research 52

WCG Clinical

NOVEMBER 17, 2023

Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. Since then, however, certain genetic engineering technologies (e.g.,

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Genomics Genome Gene Editing Genetic Engineering 52

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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Research Gene Genetic Engineering Genetics 52

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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Gene Therapy Trials Gene Clinical Trials 52

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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Gene Therapy Development Gene Drugs 52

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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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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Gene Editing Life Science Clinical Trials Clinical Trials 59

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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Genome Project Genomics Genome DNA 98

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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Antibody Immune Response Production Engineer 52

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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In-Vivo Clinical Trials Clinical Trials FDA Approval 40

Advarra

OCTOBER 10, 2024

These resistance genes are commonly found on small circles of DNA called plasmids. They often carry genes to help the bacteria succeed by giving it a selective advantage, such as bacterial toxins or antibiotic resistance genes. The progeny viruses are released into the environment to await another host to infect.

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Bacteria Genetics Genetic Engineering Gene 52

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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Gene Therapy Clinical Trials Clinical Trials Gene 93

XTalks

NOVEMBER 29, 2024

The acquisition also grants Roche access to Poseida’s P-CD19CD20-ALLO1, a dual-target CAR-T therapy currently in Phase I trials for B-cell malignancies. Additionally, Poseida’s solid tumor program, P-MUC1C-ALLO1, is advancing in Phase I trials, targeting antigen-expressing tumors with promising early results.

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