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.”

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FDA Regulations Production Small Molecule 95

FDA Law Blog: Biosimilars

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. We’ve previously blogged about this ongoing battle here , here , here , and here.

Protein Production 59

Protein Production Production DNA Regulations 59

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 did a postdoc with Paul Berg at Stanford, studying transcriptional regulation. Arrakis is the capstone of my career.

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Small Molecule RNA Clinical Trials DNA 52

BMG Labtech

FEBRUARY 24, 2025

Post-translational modification of proteins, which includes the alteration of certain amino acid side chains by the introduction of different chemical groups, takes place in eukaryotic and prokaryotic cells. Advanced oxidation protein products were also determined (Fig. NPJ Parkinsons Dis. 2024 Dec 11;10(1):233. Nat Commun.

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Small Molecule Disease Licensing Licensing 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.

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DNA Cell Biology Molecular Biology Engineering 98

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.

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DNA Cell Biology Engineering Molecular Biology 52