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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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Research reveals therapeutic potential of mRNA in rare diseases

Drug Discovery World

Researchers have used messenger RNA (mRNA) to create an effective therapy for a rare liver disease in preclinical studies, demonstrating the technology’s potential therapeutic use in people. mRNA contains instructions that direct the cells to make proteins. We believe it can now do the same for rare diseases.”

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The Silent Mutations That Gave Coronavirus a Selective Advantage

XTalks

The answer may lie in the genetic code of the virus, which scientists at Duke University have found contains several silent mutations that affect protein folding. Moreover, Berrio says the changes likely affected the folding and function of viral RNA. So studying the genetics of the current coronavirus strain remains important.

RNA 98
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Molecular mechanisms of corona drug candidate Molnupiravir unraveled

The Pharma Data

The antiviral agent incorporates RNA-like building blocks into the RNA genome of the virus. If this genetic material is further replicated, defective RNA copies are produced and the pathogen can no longer spread. When it enters the cell, it is converted into RNA-like building blocks.

RNA 52
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Novartis signs initial agreement with CureVac to manufacture COVID-19 vaccine candidate

The Pharma Data

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway. Disclaimer.

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Thermo Fisher, Qiagen and Others Assure Their COVID-19 PCR Tests Detect Omicron

XTalks

Moreover, it is also not known how the current COVID-19 vaccines and drugs will hold up against Omicron. Qiagen said it will continue to monitor the potential impact of Omicron on its COVID-19 PCR tests by conducting bi-weekly surveillance of genetic variations. the severity of disease) and potential for immune evasion of Omicron.

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FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.