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QN-023a by Hangzhou Qihan Biotechnology for Relapsed Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

QN-023a is under clinical development by Hangzhou Qihan Biotechnology and currently in Phase I for Relapsed Acute Myeloid Leukemia. QN-023a overview QN-023a is under development for the treatment of relapsed or refractory acute myeloid leukemia (AML). The company develops gene-editing organ transplantation technology.

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AGC and RoosterBio partner for cell and exosome therapy manufacturing

Pharmaceutical Technology

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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Q&A: A decade on, what’s next for CAR-T therapies?

Pharmaceutical Technology

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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Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval

Advarra

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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PlateletBio Names Dr. Steven Altschuler as Chairman of its Board of Directors

The Pharma Data

As a clinician, healthcare administrator, biotech entrepreneur and venture capital investor, Steve’s leadership and breadth of experience in the clinical development of cell and gene therapies will be invaluable to PlateletBio as we progress our cell therapy platform into the clinic later this year,” said Sam Rasty, Ph.D.,

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The evolution of assays for immuno-oncology research

Drug Discovery World

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. These models have greatly contributed to the clinical development of several tumour immunotherapies. EMBO Mol Med 2017;9:137–53.doi:10.15252/emmm.201606857pmid:[link]

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Crescita Announces Licensing Agreement for Pliaglis; in China

The Pharma Data

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). For additional information, please visit [link].