Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets.

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Manufacturing Gene Therapy Genetic Engineering Gene 130

Advarra

JUNE 13, 2024

The standard policies and procedures for safe handling of other types of hazards, such as antineoplastic drugs and infectious material, may not accommodate the specific risks posed by recombinant therapeutics. The post The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering appeared first on Advarra.

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Genetic Engineering Clinical Trials Clinical Trials Engineer 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. The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases.

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Gene Therapy Development Gene Drugs 52

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% between 2020-2027.

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Gene Therapy Gene Research Genetic Engineering 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.

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Gene Gene Therapy Gene Expression Regulation 40

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.

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Vaccine Vaccination Protein Antibody 52

NY Times

SEPTEMBER 14, 2021

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

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Gene Therapy Clinical Trials Clinical Trials Gene 93

The Pharma Data

JANUARY 10, 2021

FBX-101 is a first-in-human AAV gene therapy. Krabbe disease is a rare and fatal pediatric leukodystrophy caused by mutations in the galactosylceramidase (GALC) gene. The drug is an RNA interference (RNAi) therapeutic. The company also received an ok to launch a Phase I trial of TH1902, its lead peptide-drug conjugate.

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Gene Therapy Trials Gene Clinical Trials 52

Advarra

OCTOBER 10, 2024

Another method of fostering antibiotic resistance is the prolonged low-level exposure to antibiotics, as is currently the case when people take prescribed antibiotics and excrete the unmetabolized drugs into the sewer. Also consider: Half the antibiotics produced in the U.S.

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Bacteria Genetics Genetic Engineering Gene 52

XTalks

NOVEMBER 29, 2024

Their pipeline includes P-BCMA-ALLO1, a promising therapy targeting multiple myeloma that has received Regenerative Medicine Advanced Therapy designation and Orphan Drug designation from the US Food and Drug Administration (FDA). Meanwhile, Novartis acquired Kate Therapeutics in a $1.1

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Gene Therapy Gene Gene Editing Genetic Engineering 100

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