Artificial Intelligence

A new face seconded to the European Commission's medtech unit and changes to several EU rules impacting medtech

Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.

Hanmi Pharm Group announces new mid-term strategy including expansion of its obesity focus to aging with goal of more than doubling revenue by 2030 and becoming a true global player.

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

Anat Cohen-Dayag explains how Compugen transformed from computational service provider to clinical-stage biotech by integrating AI with biology and structuring strategic pharma collaborations.

After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue.

The verdict from the front lines of drug development is unmistakable: RWD and AI won’t transform trials through hype alone – they deliver only when welded to airtight data practices, transparent models and accountable operations.

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.

Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.

Recursion recently announced the completion of a $30m microglia map and named Najat Khan as CEO, replacing co-founder Chris Gibson.