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DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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BioNTech Founders Predict Cancer Vaccine Is Only Years Away

AuroBlog - Aurous Healthcare Clinical Trials blog

The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade.

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RNA sequencing of amniotic fluid cells for prenatal diagnosis

Medical Xpress

A clinical research team from the University of Hong Kong (HKUMed) has used amniotic fluid cells obtained during 16-24 weeks of pregnancy as a novel sample type for RNA-sequencing in prenatal diagnosis to help more families with tailored clinical management.

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Biology opens up new frontiers in medicine to cure genetic diseases: Kiran Mazumdar Shaw

AuroBlog - Aurous Healthcare Clinical Trials blog

We are witnessing a revolution in healthcare, driven by advances in genetics, Omics, RNA and CRISPR gene-editing technology, to deliver precision and personalised medicine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon and Biocon Biologics. Biology is opening up new frontiers in medicine.

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Donidalorsen Shows Sustained HAE Attack Reduction According to New Trial Data

XTalks

Carlsbad, California-based Ionis Pharmaceuticals announced it will be sharing promising new trial data for its RNA-targeted prophylactic treatment donidalorsen for hereditary angioedema (HAE) at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, California.

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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

Among the various regulatory bodies providing oversight on clinical research, only the institutional biosafety committee (IBC) has a purview specific to research involving engineered genetic materials. The post Risk Assessment for use of Engineered Genetic Materials in Clinical Research appeared first on Advarra.

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Gritstone bio trumpets first data for ‘multivariant’ COVID jab

pharmaphorum

Gritstone’s candidate is a self-amplifying messenger RNA vaccine (samRNA), which uses a slightly different technology to the mRNA-based jabs from Pfizer/BioNTech and Moderna. The study in 20 people aged over 60 was run by the National Institute of Health Research Manchester Clinical Research Facility (NIHR Manchester CRF).

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