Clinical Research Focus. 21st Edition Should All US Biosimilars Have an “Interchangeable” Designation? Debating the Role of Interchangeability in Biosimilar Development The world of biotechnology and pharmaceuticals has seen remarkable advancements in recent years, particularly in the development of biosimilars. Biosimilars, biologic drugs that are highly similar to already approved reference biologics, have become a pivotal part of modern medicine, Read more
Debating the Role of Interchangeability in Biosimilar Development Should All US Biosimilars Have an “Interchangeable” Designation? Introduction: The world of biotechnology and pharmaceuticals has seen remarkable advancements in recent years, particularly in the development of biosimilars. Biosimilars, biologic drugs that are highly similar to already-approved reference biologics, have become a pivotal part of modern medicine, offering cost-effective alternatives to expensive originator biologics. However, Read more
Clinical Research Focus. 20th Edition After Receiving First GMO Clinical Trial Approval in Georgia, Cromos Pharma Reflects on Complex International Regulatory Landscape for GMO Research Cromos Pharma has received the groundbreaking approval to conduct the first Genetically Modified Organism (GMO) clinical trial in Georgia. This pioneering accomplishment not only underscores the company’s commitment to scientific advancement but also prompts a Read more
EMA Releases a Reflection Paper on the Role of AI in Drug Development The European Medicines Agency (EMA) has released a reflection paper outlining its thoughts on integrating artificial intelligence (AI) in supporting the progression, oversight, and utilization of human and veterinary medicines. This document covers AI’s application from drug discovery to post-authorization. Part of the HMA-EMA Big Data Steering Group’s efforts, this paper is a collaborative endeavor Read more

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