The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.
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.
A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges.
A recent survey conducted by dosing technology firm found that the vast majority (85%) of patients think that personalized medicine stands to improve care.
The oncology-centered analytics firm will work with the DC-area healthcare provider to delve into discovery and development of novel cancer treatments.
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.
A representative from the medication management solutions company suggests patient behavior data can be used to improve adherence to trial drug regimens.
US President Joe Biden singled out the pharmaceutical industry in his recently issued Executive Order on Promoting Competition in the American Economy.
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....
A leader from clinical-stage pharma firm NuCana shares promising results for its ProTides therapies and hopes the drugs can elevate outcomes for patients.
A leader from the CRO talks about increased use of electronic patient-reported outcomes in research, challenges of adoption, and how ePRO benefits trials.
A leader from digital health solutions firm CitiusTech suggests use of fast healthcare interoperability resources is useful in the face of evolving tech.
The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics.
The two companies are integrating their technologies in a move designed to help hasten trial launches, and get promising new treatments to market faster.
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.
In order to effectively handle collection and analysis of huge volumes of vital data, a leader from IQVIA advises bringing on people up to the challenge.
A leader from the cancer patient matching and analysis solutions firm discusses how and other forces are pushing innovation in the oncology research space.
Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.
Due to the imperative for secure communication between stakeholders organizing clinical trials, a recent report suggests that blockchain technology could be a ‘perfect’ solution.
A study on the disclosure of the results of clinical trials found that a majority did not meet the publication deadline, with non-industry most likely to fail to publish.
The access that patients have to information nowadays is an opportunity for companies to integrate their direct feedback, says CSL Behring’s head for Europe.
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.
Arkivum to create an e-archive for Idorsia to store and manage its large amount of data regarding products returned from CROs, after the latter’s separation from Actelion.
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 EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”
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.
TrialScope this year awarded several companies for their clinical trial data transparency efforts as the industry makes strides to engage patients and the larger health care community.
The Pistoia Alliance hopes to facilitate “seamless data integration” between various industry stakeholders, including life sciences companies and CROs, via an open and freely available data format.
