La Jolla Pulls Riquent EU Marketing Application Due To Clinical Data Needs
This article was originally published in The Pink Sheet Daily
Lupus renal disease treatment is still “approvable” in the U.S. pending submission of additional data to FDA.
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The company is still pursuing a Phase III trial in the U.S. under a Special Protocol Assessment with FDA.
Adiana uses a polymer matrix insert to block the fallopian tubes instead of a metal coil, offering a benefit over Essure, which carries a perforation risk on implantation, Hologic exec says.
The results show that cardiac resynchronization defibrillators "slow the progression of heart failure in asymptomatic and mildly symptomatic patients," potentially expanding the market by $600 million.