Enhancing Oncology Drug Dosage Optimization: Project Optimus In the quest to balance timely access to new cancer drugs with a profound understanding of patient response variability, the FDA is taking pioneering steps within the realm of oncology. Factors such as patient diversity, disease variations, and the need for individualized dosages underscore the critical importance of dosage optimization. Project Optimus, a groundbreaking initiative Read more
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
