Knowledge Base

What is somatic gene therapy?

8 December 2023
2 min read

Somatic cell gene therapy targets those cells of the body that are not involved in reproduction – the somatic cells. Examples include the cells that make up the retina, liver, or heart. Somatic cell gene therapies are being developed for a wide-range of diseases, but most gene therapies are not yet FDA approved for widespread use. Patients currently receiving somatic gene therapy do so through clinical trials which are subject to FDA oversight.

Carisma Therapeutics Reveals Regulatory Green Light for Experimental HER2-Focused CAR-Monocyte Therapy CT-0525 by FDA
Latest Hotspot
3 min read
Carisma Therapeutics Reveals Regulatory Green Light for Experimental HER2-Focused CAR-Monocyte Therapy CT-0525 by FDA
8 December 2023
Carisma Therapeutics Inc. has confirmed that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for their novel product, CT-0525.
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Deciphering MDM2 Inhibitors and Keeping Up with Their Recent Developments
Deciphering MDM2 Inhibitors and Keeping Up with Their Recent Developments
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MDM2 inhibitors are drugs that target the MDM2 protein, crucial for regulating the tumor suppressor protein p53.
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Bio-Thera Solutions announced positive results from its Phase 3 trial of BAT2206, a potential Stelara® biosimilar
Latest Hotspot
3 min read
Bio-Thera Solutions announced positive results from its Phase 3 trial of BAT2206, a potential Stelara® biosimilar
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Bio-Thera Solutions has reported encouraging outcomes from its pivotal Phase 3 clinical trial involving BAT2206, a candidate biosimilar for Stelara®.
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When transitioning to the PBRER, how should the MAH handle medicinal products whose current DLP is not synchronised to the new definition of the IBD?
Knowledge Base
2 min read
When transitioning to the PBRER, how should the MAH handle medicinal products whose current DLP is not synchronised to the new definition of the IBD?
8 December 2023
The definition of IBD in the Guideline refers to the date of the first marketing approval for any product containing the active substance granted to any company in any country in the world.
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