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.
California’s data privacy law will provide clinical trial participants with confidence that their information will not be misused – though additional clarity is needed as the pharmaceutical industry faces mounting pressure to increase transparency.
The FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.
Two US Attorney Generals have opened an investigation into the data breach at AMCA that compromised a combined nearly 20 million patients at LabCorp and Quest Diagnostics – as the companies’ efforts to notify the public are called into question.
Hu-manity.co acquires Betterpath in a deal that will see both patients and pharma gain access to some 80% of health care’s “dark data” – information that comes with explicit consent under fair trade practices, which is not only a good ethical posture,...
An international coalition of health integrity groups today demands that European universities must make clinical trial results public – with 83% all of due trials still unreported, according to a new report.
The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.
Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.