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Medical Journal Retracts Tavneos Study Over Data Concerns
- On Monday, The New England Journal of Medicine retracted a 2021 article on Amgen's Tavneos trial, citing evidence that patient data for nine individuals were altered and researchers were unblinded.
- The FDA's CDER proposed withdrawing Tavneos approval in April, citing false statements in the original application and lack of proven effectiveness; Eight deaths were reported.
- Safety data from March revealed 76 cases of drug-induced liver injury linked to Tavneos, including seven cases of VBDS, a rare condition causing permanent liver damage.
- Europe's drug regulator recommended revoking marketing authorization for the medication last week, citing concerns over trial data integrity and mirroring U.S. regulatory skepticism.
- Amgen said it "takes scientific integrity seriously," with re-adjudication results from the Duke Clinical Research Institute due for FDA submission by July 29 while Tavneos remains available.
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19 Articles
NEJM Retracts Pivotal Trial of FDA-Approved Drug
(MedPage Today) -- The New England Journal of Medicine (NEJM) retracted the pivotal study supporting FDA's approval of avacopan (Tavneos) for severe forms of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The journal said...
·New York, United States
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Medical journal retracts paper on Amgen’s Tavneos drug trial after FDA findings
The New England Journal of Medicine on Monday retracted an article on a pivotal clinical trial that supported approval of Amgen’s rare-disease drug, citing concerns that patient outcome data were altered and that some researchers had been unblinded.
·New York, United States
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Coverage Details
Total News Sources19
Leaning Left2Leaning Right0Center4Last UpdatedBias Distribution67% Center
Bias Distribution
- 67% of the sources are Center
67% Center
L 33%
C 67%
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