"In September, Tidmarsh went after Tang's Aurinia and its drug voclosporin that treats lupus nephritis, a disease in which the immune system attacks the kidneys. In a startling post on his LinkedIn account, Tidmarsh claimed that the FDA-approved drug had not been shown to provide "hard" clinical benefit and that the drugmaker had not performed necessary trials. Such a post from the FDA's top drugmaker turned heads."
"Aurinia claims its share price fell 20 percent in a matter of hours, dropping $350 million in market value. "Embarrassing" Aurinia pushed back in the lawsuit, saying that the drug had undergone a full FDA approval process-not an abbreviated one-and been assessed based on a validated surrogate endpoint that is known to predict clinical outcomes. Further, the drug has been approved for use in 36 other countries in addition to the US."
Tidmarsh publicly criticized Aurinia and its drug voclosporin for lupus nephritis, alleging the FDA-approved therapy lacked demonstrated "hard" clinical benefit and that necessary trials were not performed. Aurinia said its share price dropped 20 percent, losing $350 million in market value. Aurinia said the drug underwent a full FDA approval process and was assessed using a validated surrogate endpoint known to predict clinical outcomes, and noted approval in 36 other countries. Tidmarsh offered his resignation then reportedly informed FDA staff he would fight the investigation and reconsidered resigning. Industry investors said the episode damages FDA credibility and called leadership conduct embarrassing and destabilizing for the sector.
Read at Ars Technica
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