INSIGHTS ON CELL & GENE CLINICAL TRIALS
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XyloCor’s Phase 2 EXACT Trial Success
XyloCor Therapeutics’ CEO, Albert Gianchetti provides updates about the clinical-stage biopharma’s EXACT clinical trial.
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Navigating Regulatory Pathways For Digital Therapeutics
This blog post will help sponsors gain clarity regarding what is and what is not considered a DTx and how to ensure they are following the correct regulatory pathway for their device.
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Seasonality: A Factor For Successful Patient Recruitment
Managing clinical trials requires extensive planning of patient enrollment. Clinical trials may be more cost-effective with better forecasts of recruitment.
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The Rise Of Radiotherapeutics: Brief History And Best Practices For Clinical Trials
Explore a brief history of radiopharmaceuticals and discover best practices for planning and executing clinical trials utilizing these novel drugs to treat cancer.
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Astellas Pharma: Moving On from Clinical Hold
Ha Tran, Executive Medical Director at Astellas Pharma, explains the cause of the clinical hold and the future of the program now that the hold has been lifted.
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FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials
The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.
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C3 Glomerulopathy: The Asia Pacific Clinical Trial Landscape
C3 Glomerulopathy (C3G) is a complex, rare complement-mediated renal disease. Find out its effects in the Asia Pacific.
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Diabetic Retinopathy: The Asia Pacific Clinical Trial Landscape
Diabetic Retinopathy (DR) is the leading cause of vision loss in working-age populations, and one of the main complications of Diabetes Mellitus (DM). Read about the effects of this disease.
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Glaucoma: Asia Pacific Clinical Trial Landscape
The world is heavily burdened by glaucoma, which is the second-leading cause of blindness and the primary cause of irreversible blindness. Learn about its effects in the Asia Pacific.
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Peanut Allergy: Asia Pacific Clinical Trial Landscape
Explore the differences between the common food allergies in Asia and the West, specifically the peanut allergy.