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European regulators begin rolling review of AZ’s COVID-19 vaccine

pharmaphorum

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Why Plant-Based Meat Safety Differs From That of Animal Protein

XTalks

But several researchers and experts have brought to light some food safety concerns of plant-based meat, and why it must be treated differently than that of animal protein. Because of their near-neutral pH and high protein and moisture content, plant-based meats are susceptible to microbial growth. FDA Regulation.

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US FDA clears Transcenta’s IND for Rett syndrome treatment

Pharmaceutical Technology

The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology.

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The structure of DNA is found to be actively involved in genome regulation

Scienmag

The two meters of -stretched- DNA contained in human cells are continuously twisting and untwisting to give access to genetic information: when a gene is expressed to generate a protein, the two strands of DNA are separated to give access to all the machinery necessary for this expression, resulting in an excessive accumulation of coiling […]. (..)

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The Active Ingredient Stands Alone

FDA Law Blog

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.”

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Targeting a human protein may stop Ebola virus in its tracks

The Pharma Data

Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. The researchers discovered that Ebola virus polymerase hijacks a cellular protein called GSPT1. To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase.

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Egg Without the Chicken: How Clara Foods is Cracking Animal-Free Eggs

XTalks

While Clara Foods, a leader in animal-free proteins, worked for years to replicate the taste, function and proteins of eggs without the chickens, scaling the product has been difficult — until now. How these eggs will be regulated is another question. Making Animal-Free Eggs. The same can be said for lab-grown meat.

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