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.’
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
