FDA Law Blog: Biosimilars

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. That option would not have been available to InvaGen had the FDA instead determined that Somatuline Depot and InvaGen’s product were biological products.”

FDA 95

FDA Regulations Production Small Molecule 95

Dark Matter Blog

JULY 16, 2021

Prior to that, I was CSO at RaNA Therapeutics (now Translate Bio), initially focused on targeting the function of long noncoding RNA in epigenetic regulation, and later transitioning to an mRNA therapeutics company. I had a first-hand role in raising money from Wall Street by being part of an IPO roadshow as Synta went public in 2007.

Small Molecule 52

Small Molecule RNA Clinical Trials DNA 52

Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S. & Xie X.S.

DNA 91

DNA Cell Biology Molecular Biology Engineering 91

Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S. & Xie X.S.

DNA 52

DNA Cell Biology Engineering Molecular Biology 52