FDA releases draft guidance for cell and gene therapies
BioPharma Reporter
APRIL 6, 2022
The FDA has released two draft guidance documents: for human gene therapy products incorporating human genome editing, and for CAR T cell products.
BioPharma Reporter
APRIL 6, 2022
The FDA has released two draft guidance documents: for human gene therapy products incorporating human genome editing, and for CAR T cell products.
BioPharma Reporter
JUNE 23, 2022
BIO, the worldâs largest trade association for the biotech industry, has responded to the US Food and Drug Administration's draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.
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XTalks
APRIL 24, 2023
Awareness of rare diseases is growing, and with a better understanding of the pathophysiology of many rare diseases, innovative treatment options are emerging, like gene therapies that can treat the root cause of rare genetic diseases and potentially provide long-term symptom relief, or even a definitive cure.
Drug Discovery World
DECEMBER 8, 2023
Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. The cell and gene therapy industry is no exception to this digital transformation. Here’s what this means for pharmaceutical leaders and patients.
Drug Discovery World
MARCH 16, 2023
The cell and gene therapy (CGT) market is rapidly expanding, and projections suggest it will reach over $90B by 2023. Challenges of cell and gene therapy manufacturing Compared to traditional biologics, CGTs are living drugs, making their development and manufacturing substantially more complex.
BioPharma Reporter
MARCH 13, 2023
The extremely high costs of gene therapies are unsustainable, and a global commitment to affordable, equitable access to these treatments is urgently needed, concluded the organising committee of a conference on human genome editing.
BioPharma Reporter
MAY 7, 2024
Broken String Biosciences, a genomics company driving cell and gene therapy developing, has entered a research collaboration with the Francis Crick Institute, a biomedical discovery institute dedicated to understanding the biology underlying health and disease.
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