Clinical Trials
The US FDA’s oncology team is emphasizing a methodical approach to developing novel endpoints like MRD or ctDNA and that community buy-in is important, not just regulatory standards.
Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds
UniQure’s Huntington's disease filing plans are in disarray after the FDA reversed course on the company's regulatory strategy employing real-world evidence and accelerated approval.
NRTX-1001, taladegib and AZD0292 are the latest investigational products to make it onto PRIME, the European Medicines Agency’s priority medicines scheme for drugs for unmet medical needs.