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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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Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO  

Worldwide Clinical Trials

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

Antibody 162
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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

Trials 97
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Meet the company on a mission to transform research and advance healthcare

Pharmaceutical Technology

On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. of the clinical trial population globally. of the clinical trial population globally.

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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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How Advanced Diagnostics are Shaping the Future of Precision Medicine and Gene Therapy

Cloudbyz

This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care. The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics.

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Transitioning Between Academia and Industry: Advice from Leading Scientists That Made the Switch

XTalks

WeiQi Lin, MD, PhD, executive vice president of research & development and principal scientist, DURECT Corporation. Lin has made several transitions throughout her career, from being a clinician at an academic center, to academic research, to heading business development in industry. Key Moments.