The recent resignation of Peter Marks as the head of the FDA's Center for Biologics Evaluation and Research (CBER) marks a significant moment for the cell and gene therapy industry. His departure has sparked widespread discussion about the future direction of the regulatory landscape and its
April 1, 2025Clinical trials have long been a cornerstone of medical research, essential for the development and approval of new drugs and treatments. However, they are often plagued by high costs, time constraints, and the complexities associated with patient recruitment. In recent years, the transformative
March 28, 2025The article delves into the intriguing potential of real-world evidence (RWE) to revolutionize the U.S. Food and Drug Administration’s (FDA) approval process for new drugs. By relying more on real-world data (RWD), regulatory decisions could become quicker, more economical, and maintain the current
March 28, 2025The recent bankruptcy announcement of 23andMe, a leading direct-to-consumer genetic testing company, has spurred significant discussions about the security and privacy of genetic data. As the company navigates financial turmoil and operational challenges, concerns mount over the future of the
March 27, 2025The National Farmers' Union (NFU) has recently called for enhanced biosecurity measures among farmers after detecting a case of avian influenza (H5N1) in a sheep in Yorkshire. This discovery came to light following routine surveillance, wherein avian influenza had previously been confirmed in
March 25, 2025Sepsis, a critical and often fatal condition resulting from the body's response to an infection, continues to pose significant challenges in both diagnosis and treatment. Researchers are increasingly focused on understanding the pivotal role of autophagy-related genes in sepsis, aiming to
March 21, 2025Human evolution has always captured our imagination, leading to discoveries that continuously reshape our understanding of our origins. Researchers at the University of Cambridge have made a significant breakthrough, revealing that all modern humans share DNA from two ancient populations. These
March 20, 2025Ivan Kairatov is a Biopharma expert, with deep knowledge of tech and innovation in the industry and experience in research and development. He joins us today to discuss Ori Biotech’s new Preferred Partner Network (PPN), the collaboration with various organizations, and the impacts on cell therapy d
March 19, 2025Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder that significantly impacts both liver and lung function, resulting in a rare but severe health burden. In an ambitious and promising development, Prime Medicine is leveraging its innovative gene editing technology to address this
March 19, 2025Resistant hypertension affects more than half of patients suffering from high blood pressure, presenting a significant challenge for healthcare providers. This condition often remains uncontrolled by multiple medications, typically linked to elevated levels of aldosterone, a hormone regulating
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