Otsuka plans a slow, measured launch of Abilify MyCite, developed with Proteus Health. The product includes an ingested sensor that sends a signal to a wearable patch and an app that tracks ingestion, activity and mood to potentially improve management of psychiatric care.
Abilify MyCite (aripiprazole tablets with sensor) passed its first big test with US FDA approval of the digital atypical antipsychotic, but with a slow launch by Otsuka Pharmaceutical Co. Ltd. it may take a while for the product to receive passing grades from patients, doctors and payers.
Otsuka and partner Proteus Digital Health Inc. initially failed to win FDA approval in April 2016 for their digital...
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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.
