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.

Gene Therapy 52

Gene Therapy Development Gene Drugs 52

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.

Engineer 52

Engineer Genetics Clinical Research Research 52

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.

Gene Therapy 54

Gene Therapy Trials Research Gene 54

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.

Gene Therapy 52

Gene Therapy Trials Gene Clinical Trials 52

Advarra

JANUARY 11, 2024

Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer. Adoptive T Cell Therapies Adoptive T cell therapy is another form of cancer treatment leveraging the patient’s immune system.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Roots Analysis

AUGUST 31, 2023

The applications of gene switch platforms can be broadly classified into the following two categories: Endogenous Gene Regulation Exogenous Gene Regulation Endogenous Gene Regulation The ability to regulate endogenous genes has various applications in biological research and gene therapy development.

Gene 40

Gene Gene Therapy Gene Expression Regulation 40

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.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

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.

Gene Therapy 93

Gene Therapy Clinical Trials Clinical Trials Gene 93

Advarra

OCTOBER 10, 2024

While developing an entirely new class of antibiotic is challenging, making minor genetic modifications to a virus or phage is something fairly easily accomplished with modern technologies. Intra-venous delivery of phages has potential as therapeutics for a broad range of conditions caused by antibiotic-resistant E.

Bacteria 52

Bacteria Genetics Genetic Engineering Gene 52