Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

Digital biomarkers using data collected with wearable devices are making their way into clinical trials, largely in cardiovascular, respiratory and rare disease settings around physical activity metrics.

REC 0545, for MSUD, and aztreonam-avibactam, for serious Gram-negative bacterial infections, are among the latest drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

Digital biomarkers using data collected with wearable devices are making their way into clinical trials, largely in cardiovascular, respiratory and rare disease settings around physical activity metrics.