Pharmaceutical Technology

MARCH 2, 2023

QN-023a is under clinical development by Hangzhou Qihan Biotechnology and currently in Phase I for Relapsed Acute Myeloid Leukemia. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Gene Editing 100

Gene Editing Genetic Engineering Engineer Clinical Trials 100

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.

Manufacturing 130

Manufacturing Gene Therapy Genetic Engineering Gene 130

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.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

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

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. These are also excellent models to study pharmacodynamics and for use in mechanistic studies, but the downside is that translation of the clinical outcomes in human is poor.

Research 52

Research In-Vitro In-Vivo Development 52