Due to the enormous knowledge and expertise gained in the analysis and usage of big data driving digital innovation, it appears that the tech giants will be making a crucial impact in this sector.

Considering the growing interest supported by the improvement of technologies in this sector, the agency is currently investigating when the use of observational data “may be appropriate for evaluating effectiveness from a broad policy perspective and also how individual drug manufacturers submit proposals for using real world data to support marketing applications”.

A Phase I/Phase II Clinical Trial is ongoing to test the Italian version Car-T therapy, called Carcik, aimed at treating LLA – Acute Lymphoblastic Leukemia - at the San Gerardo Hospital in Monza and at the Papa Giovanni XIII Hospital in Bergamo.

The first Clinical Trial will be starting to test the gene-editing technique CRISPR in the United States this Fall.

Until now, companies have considered RWE studies useful mostly for post-approval safety; there are some big opportunities on the Real-World Evidence horizon that industry and regulators will be considering and implementing soon.

A new deep learning model, developed by a team from MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) and Massachusetts General Hospital (MGH), is attempting to detect patients at risk of breast cancer at an early stage, before the development of the disease, avoiding later diagnosis.

A review recently published in the Journal Trends in Pharmacological Sciences analyzed the potential improvements that AI could bring to drug development in the next decade

Evidilya has partnered market leaders and technology innovators in the life sciences sector worldwide. Thanks to strategic operation hubs around the world and partnerships with a global network of science specialists, we are able to implement both international and country-specific research projects.

Launched by Fitbit, Bring Your Own Device is the first digital health technology initiative. It is part of the National Institutes of Health’s All of Us research program and it is developed under the Precision Medicine Initiative. It consists in a fitness tracker that has the goal to collect data from a variety of populations drawing on surveys, physical measurements, EHRs, and digital health technologies.

The days when mobile phones were “simply” a tool used to connect people distant in space, seem so far away. A novelty that eradicates once again this definition, now outdated, is launched by a startup from Palo Alto, California.

Following a request by EFSA, the Panel on Nutrition, Novel Foods and Food Allergens has recently updated the scientific requirements for health claims related to muscle function and physical performance, originally published in 2012.

It’s been 60 years since the first implantable pacemaker was introduced into the market. Today a new monitoring process is available for patients and Hp’s: Medtronic – whose founder created some of the first pacemaker models – has designed a mobile app that enables pacemakers-communication via mobile phone or tablets.

FDA has recently taken action in the real-world evidence field by releasing a new health App: MyStudies App is a standardized digital platform where researchers can collect, organize and analyze a variety of data directly from the real-world environment.