Protection of IP and trade secrets and the need for clarity around issues such as the rules on access to data and the sharing of clinical trial data are seen as key issues in the European Commission’s plans for a European Health Data Space.
The European pharmaceutical industry body EFPIA has welcomed the EU’s proposal to establish a European Health Data Space (EHDS), saying that it offers an “unprecedented opportunity to shape the future health data and digital ecosystem” and could pave the way to more personalized health care.
However, EFPIA has some reservations about the proposal. It says, for instance, that it must give clearer assurances on the...
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
