Clinical Outcome Assessments (COAs) play a pivotal role in the drug development process. These tools, which measure the impact of a treatment on patients' health status, encompass several types: Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes
In a significant development for global health preparedness, RedHill Biopharma Ltd. has partnered with the Biomedical Advanced Research and Development Authority (BARDA) to advance opaganib, a promising treatment for Ebola virus disease (EBOV). This collaboration marks a crucial step in combating
The approval of Bluebird bio's gene therapy, Skysona, in September 2022 by the FDA marked a significant milestone for treating cerebral adrenoleukodystrophy (CALD), a rare and fatal childhood brain disorder. Skysona's innovation generated hope for families dealing with CALD, yet recent developments
In a dynamic twist within the pharmaceutical industry, several companies are locked in a fierce race to develop the next generation of obesity drugs. As the battle heats up, each aims to outdo the other, with innovations that promise to revolutionize the way obesity is treated. This race isn't just
Oculopharyngeal Muscular Dystrophy (OPMD) is a rare, progressive muscle-wasting disease that significantly impacts patients' quality of life. Limited therapeutic options are available, with current treatments failing to address the underlying muscle weakness driving the disease's progression. This
Innovation in biotechnology, particularly within the realm of cell therapy, hinges significantly on the expertise of regulatory professionals. These experts are instrumental in navigating complex regulatory landscapes and ensuring that scientific advances transition into viable, market-ready
