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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The agency announces that it is evaluating unpublished findings based on pancreatic tissue specimens from a few deceased patients; clinicians say ongoing prospective studies will determine how diabetes drugs affect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.
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