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. As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.”

FDA 95

FDA Regulations Production Small Molecule 95

Codon

MARCH 24, 2024

This was the founding ethos of Moderna, the mRNA vaccine developer, when it was launched in 2010 by Noubar Afeyan and Doug Cole at Flagship Pioneering. In response to this hysteria, regulation was aggressively tightened. Tiamat Sciences harvests a variety of protein products in tobacco plants. “It was about 6 p.m.

Engineering 84

Engineering Vaccine Production RNA 84

Codon

AUGUST 10, 2023

Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Nucleic Acids Research (2010).

DNA 92

DNA Cell Biology Molecular Biology Engineering 92

Codon

AUGUST 10, 2023

Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Nucleic Acids Research (2010).

DNA 52

DNA Cell Biology Engineering Molecular Biology 52