Ra Medical Systems Inc., of Carlsbad, Calif., reported that the U.S. FDA has granted investigational device exemption (IDE) approval to study its DABRA excimer laser system as an atherectomy device to treat peripheral vascular stenosis.
The latest global regulatory news, changes and updates affecting biopharma: Aegerion Pharmaceuticals Inc., Alexion Pharmaceuticals Inc., Insys Therapeutics Inc.
About a month-and-a-half earlier than expected, Horizon Therapeutics plc has won FDA approval for teprotumumab in thyroid eye disease (TED), a progressive autoimmune condition that disproportionately affects women.
Dublin-based Medtronic plc has snagged the U.S. FDA’s approval for its Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. The company said it will begin rolling out the device at a limited number of medical centers in the upcoming weeks, with a full, nationwide launch sometime this spring. About the size of a large vitamin pill, the leadless Micra AV is indicated for the treatment of patients with AV block, a disorder that occurs when the electrical signal traveling from the atria, or upper chambers of the heart, to the ventricles, or lower chambers, is impaired.
A new report by the Congressional Research Service (CRS) revives the question of U.S. FDA regulation of lab-developed tests (LDTs). However, attorney Jeffrey Shapiro, of Washington-based Hyman Phelps & McNamara PC, told BioWorld that the agency is no longer in a position to unilaterally impose a regulatory regime on LDTs, and that there is little likelihood that any enabling legislation will pass until at least 2021.
LONDON – Three years after the implementation of new U.S. legislation requiring clinical trials to report results within 12 months of completion, more than half are not published on time and compliance is not improving.
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