DuPont Merck's Cardiolite: Cardiac imaging agent receives approval for risk stratification of coronary artery disease patients at low risk or high risk for cardiac events, and for use in conjunction with pharmacologic stress testing for diagnosis and localization of CAD. In a study of 521 patients, normal Cardiolite scans were associated with a low cardiac event rate (.5%) compared to a 7.3% rate in patients who had abnormal scans. The new indications for Cardiolite (technetium Tc-99m sestamibi) were approved on Dec. 14...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
