Ivan Kairatov is a recognized authority in the biopharma sector, with an extensive background in technological advancements and R&D. In this interview, Ivan shares his insights on the new FDA-approved treatment for IgA nephropathy (IgAN), shedding light on its significance in treating this rare
The U.S. Department of Health and Human Services (HHS) is experiencing a turbulent phase marked by extensive layoffs and a major reorganization under Secretary Robert F. Kennedy Jr. These moves have ignited substantial controversy and legal battles, drawing sharp reactions from various stakeholders
Innovation thrives at the intersection of regulatory flexibility and robust oversight, especially within the dynamic field of first-in-class drugs. Today, we delve into this critical topic with Ivan Kairatov, a seasoned biopharma expert with extensive experience in research and development. With a
The Healthcare Regulatory Check-Up Newsletter for February 2025 provides an in-depth overview of significant developments and updates in healthcare regulation, litigation, and policy changes in the United States. This article summarizes key settlements, legal actions, legislative proposals,
The 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
In a groundbreaking initiative aimed at transforming the health regulatory landscape across the African continent, the first African Regulators Leadership Program (ARLP) was convened at the Wits Business School in Johannesburg. This program is designed to elevate the leadership skills and
