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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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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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RNA interference method could treat muscular dystrophy

Drug Discovery World

Japanese researchers propose using RNA interference for correcting a mistake in the genetic code of patients with Fukuyama muscular dystrophy. . Using RNA interference, researchers restored the normal biological function of FKTN in patient-derived cells, offering hope for a new therapy. . Modifying RNA function.

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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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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.

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?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us. . The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. We need to consider how to use diverse populations in gene therapy trials.

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World AIDS Day 2023: New and Promising Treatments for HIV/AIDS

XTalks

Over 26 weeks of Sunlenca combined with other antiretroviral drugs, 81 percent of participants achieved HIV RNA suppression, reaching levels low enough to be considered undetectable. Both trials concluded with maintained virologic suppression, and no clinically significant change from baseline in CD4+ cell counts was observed.