Glaukos (NYSE:GKOS) said yesterday that closed the nearly $3 million plus milestones to acquire former subsidiary Dose Medical and its drug-delivery technology for treating retinal diseases. Sam Clemente, Calif.-based Glaukos spun Dose out as a standalone company in 2010, but paid $26 million in July 2015 for Dose Medical’s glaucoma assets, including the cancellation of a $10.9 million […]
Medtronic recalls MiniMed pump models on cybersecurity risk
Medtronic (NYSE:MDT) today recalled two models of its MiniMed insulin pumps after researchers discovered cybersecurity risks that could allow a hacker to take control of the devices. The recall affects 11 models in Fridley, Minn.-based Medtronic’s line of MiniMed 508, MiniMed Paradigm and MiniMed Paradigm Veo pumps, according to the FDA. Medtronic said the pumps […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
Glaukos puts up nearly $3m to buy Dose Medical back
Glaukos (NYSE:GKOS) said yesterday that it agreed to pay nearly $3 million plus milestones to acquire former subsidiary Dose Medical and its drug-delivery technology for treating retinal diseases. Sam Clemente, Calif.-based Glaukos spun Dose out as a standalone company in 2010, but paid $26 million in July 2015 for Dose Medical’s glaucoma assets, including the cancellation […]
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]
Ginkgo puts $80 million into Synlogic
Ginkgo Bioworks put $80 million into Synlogic (NSDQ:SYBX) last week in a deal to use its cell programming technology to accelerate development of Synlogic’s synthetic biotic medicine program. Boston-based Gingko acquired some 6.3 million SYBX shares and warrants for another 2.5 million shares at $9 apiece; Synlogic then paid $30.0 million back to Gingko for […]
Inovio lands $8m Defense grant for intradermal delivery device
Inovio Pharmaceuticals (NSDQ:INO) said last week that it won an $8 million grant from a U.S. Defense Dept. agency for the intradermal delivery device it’s developing. The U.S. Defense Threat Reduction Agency agreed to put more than $8.1 million toward the development of Plymouth Meeting, Pa.-based Inovio’s Cellectra 3PSP, a portable, battery-powered intradermal device to deliver […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases […]
Becton Dickinson cuts earnings outlook on paclitaxel warning
Becton Dickinson & Co. (NYSE:BDX) missed the consensus sales forecast for its fiscal second quarter and cut its outlook for the rest of the year, sending its share price down today on Wall Street. The cut to its earnings guidance is due to “recent regulatory and market pressures related to paclitaxel-coated devices,” Franklin Lakes, N.J.-based BD […]
