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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.

RNA 189
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Sartorius upscales gene therapy prowess with $2.6bn Polyplus acquisition

Pharmaceutical Technology

The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. to complete an in-house plasmid DNA facility in Marburg, Germany. “In In February 2023, the mRNA specialist BioNTech invested $43.8m

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Uptick in Clinical Trial Complexity: How Can You Achieve Your Clinical Trial Objectives Faster?

XTalks

Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. It’s important to make sure that with this increase in clinical trial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham.

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Gene Therapy and Pharmacokinetics

Camargo

It is a comprehensive term which encompasses a large variety of therapy products including viral and bacterial vectors, plasmid DNA, human gene editing technology, and patient-specific cellular gene therapy. For example, it is beneficial to administer RNA treatments for some lung diseases directly to the disease site through inhalation.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management.

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Rome Therapeutics raises $77m for junk DNA-targeting drugs

pharmaphorum

Startup Rome Therapeutics has raised $77 million in second-round financing to help mine sequences of DNA – which were dismissed for years as ‘junk’ – for hidden treasure. Much of this repeatome is thought to derive from viruses that embedded in our DNA millions of years ago.

DNA 52
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Generating Over a Billion Cells with CRISPR for Next Generation Cell Therapies

XTalks

Viral vectors have traditionally been used in gene editing where the shells of viruses carry the template DNA into cells, but this method has its disadvantages. It is difficult to control where the viral vectors insert genes in the genome, and it is difficult to manufacture large quantities of clinical-grade viral vectors.