FDA, EMA Lay Out Incretin Mimetic Safety Analysis In NEJM
This article was originally published in The Pink Sheet Daily
Editorial details the breadth of data that U.S. and European regulators examined in concluding that available data are “inconsistent” with assertions that a causal association exists between incretin-based diabetes drugs and pancreatic adverse events.
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Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study
US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.
The agency announces that it is evaluating unpublished findings based on pancreatic tissue specimens from a few deceased patients; clinicians say ongoing prospective studies will determine how diabetes drugs affect the pancreas.
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.