Medical Journal Retracts Tavneos Study Over Data Concerns

Amgen Drug Tavneos’ Main Study Retracted by Medical Journal

A clinical trial used to approve Amgen Inc.’s pill Tavneos was retracted Monday from the New England Journal of Medicine, putting the drug’s continued sales at risk.

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.

Amgen Drug Tavneos’ Main Study Retracted by Medical Journal (1)

A clinical trial used to approve Amgen Inc.’s pill Tavneos was retracted Monday from the New England Journal of Medicine, putting the drug’s continued sales at risk.

FDA hearing on Amgen's Tavneos will include findings from an independent review

A research firm is reviewing trial data on Amgen’s Tavneos as the company prepares for a hearing which may determine the fate of the pill.

Amgen faces Tavneos trial retraction as analysts debate outlook

Amgen stock trades near the upper $350s on Nasdaq as a pivotal Tavneos study is retracted by a leading medical journal after FDA findings, while Wall Street price targets for the biotech point to sizable upside from current levels.

Amgen’s Tavneos troubles continue as NEJM retracts pivotal publication

Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.