Gen Li is president and founder of Phesi, and OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and...
Decentralized clinical trials (DCTs) are gaining increasing interest as they have the potential to make clinical trial operations quicker, more efficient and more accessible to patients. Check out five DCT organizations that have raised big venture capital...
The pharmaceutical industry in 2023 has seen many investments, partnerships, acquisitions and more. As the year ends, industry leaders give the biggest trends to look for in 2024, with artificial intelligence being a hot topic.
The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).
New guidelines have been issued by the FDA called Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. Curavit was ahead of the game with its plans, find out how.
Sequana Medical has just announced additional data on safety, quality of life and survival from its North American alfapump study, called Poseidon which could signal an end to manual draining of ascites.
The US Food and Drug Administration (FDA) has announced this month (June) it is requesting feedback on draft recommendations and how they should be applied to increasingly diverse trial types and data sources.
Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
Eli Lilly and Company and Banner Alzheimer’s Institute have announced a strategic research collaboration as part of the planned Phase 3 study for donanemab in participants at risk from cognitive and functional decline related to Alzheimer’s disease.
Acting US FDA commissioner, Janet Woodcock, has called for an independent federal review of interactions between officials at her agency and representatives of Biogen, prior to the recent approval of the pharma company’s treatment for Alzheimer’s disease....
The clear evidence of increased risk of COVID-19 infection amongst ethnic minority groups, people from Black and Asian backgrounds, is of urgent public health importance, according to the authors of a paper published today by The Lancet.