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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog: Biosimilars

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

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Accelerating Vaccine Development for the Novel Infectious Disease with Pseudoviruses

PerkinElmer

Time is of the essence when it comes to the development of a vaccine for the novel infectious disease in our current pandemic. The world has changed due to its impact – and the race to discover a vaccine is crucial for our return to normalcy.

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mRNA Cancer Vaccines and Therapies: An Overview

Advarra

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

Vaccine 52
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Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Promising new malaria vaccine for kids approved in Ghana. This is not the first vaccine approved to prevent malaria, but it is by far the most effective.

Vaccine 52
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Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Promising new malaria vaccine for kids approved in Ghana. This is not the first vaccine approved to prevent malaria, but it is by far the most effective.

Vaccine 52
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Codon Digest: Vaccine Printer Go Brrrrr!

Codon

Also, last week’s digest had an error: The country that approved the malaria vaccine was Ghana. Vaccines (basically little fat bubbles filled with mRNA and some dissolvable polymers) were physically printed onto microneedle patches using a robot. The patches have little spikes that help push the vaccines through the skin.

Vaccine 52
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Codon Digest: Vaccine Printer Go Brrrrr!

Codon

Also, last week’s digest had an error: The country that approved the malaria vaccine was Ghana. Vaccines (basically little fat bubbles filled with mRNA and some dissolvable polymers) were physically printed onto microneedle patches using a robot. The patches have little spikes that help push the vaccines through the skin.

Vaccine 52