Dr Leeza Osipenko and colleagues analysed the quality of clinical evidence submitted by companies to NICE technology appraisals (TAs) over the last 20 years.
Validating the regulatory expectations on evidential requirements for predictive biomarkers is not a trivial process, but quite conceptually challenging.
Neurological conditions like Multiple Sclerosis (MS) are an incredibly important area of research when it comes to drug discovery, but under that (sometim
Understanding commercial and market access risks and opportunities at an early stage in biopharmaceutical product development is essential for optimizing commercial success.
Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.
Investigator sites are essential for successful execution of clinical trials – ensuring studies are conducted ethically, safely, and in compliance with regulatory standards.