Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical […]
Xeris launches Ph2 trial of ready-to-use liquid glucagon
Xeris Pharmaceuticals (NSDQ:XERS) said today that it dosed the first patients in a Phase II trial of its ready-to-use liquid glucagon in people with Type 1 diabetes. The Chicago-based company expects to report top-line data from the study in the second half of 2019. The trial is slated to assess Xeris’ room-temperature stable liquid glucagon as […]
Tandem addresses anomaly in pivotal trial for closed-loop tech
Tandem Diabetes Care (NSDQ:TNDM) said today that it plans to use its remote software update tool to address an anomaly found in an ongoing pivotal trial of its Control-IQ technology. The anomaly, according to Tandem, relates to how the company’s t:slim X2 insulin pump with Control-IQ technology handles continuous glucose monitoring data under undisclosed conditions. The […]
Medtronic updates on corrected safety analysis for paclitaxel-coated balloon
Medtronic (NYSE:MDT) said last week that a revised safety analysis of its In.Pact drug-coated balloon has been accepted by the Journal of the American College of Cardiology. Last month, the medtech titan reported that a programming error inadvertently caused mortality data to be omitted from a statistical analysis involving the company’s paclitaxel-coated balloon. The announcement came […]
Rani debuts human trial data for robotic pill tech
Rani Therapeutics this week touted the results of a first-in-human feasibility trial for its swallowable robotic pill, the RaniPill. Rani has developed a capsule that delivers an intestinal injection of medicine without exposing the drugs to digestive enzymes. The RaniPill device travels through the stomach and eventually reaches the intestine, where it injects the drug […]
Oyster Point raises $93m for intranasal dry eye disease therapies
Oyster Point Pharma said yesterday that it raised $93 million in a Series B round to support the clinical development of its intranasal dry eye disease therapies. The Princeton, N.J.-based company’s lead product candidates for dry eye disease are designed to stimulate the trigeminal parasympathetic pathway to trigger natural tear film production. The drugs, OC-01 and […]
Abbott touts real-world data for FreeStyle Libre glucose monitor
Abbott (NYSE:ABT) presented real-world data this week showing that use of its FreeStyle Libre glucose monitoring system reduced prolonged hypoglycemia and helped users achieve better glucose control. At the 12th Advanced Technologies & Treatments for Diabetes meeting in Berlin, the company showcased a real-world evidence data set that included roughly 500,000 FreeStyle Libre system users. Pulling […]
Propeller Health study suggests 84% of asthma inhaler use performed incorrectly
ResMed (NYSE:RMD) subsidiary Propeller Health today released results from a new study exploring real-world use of asthma rescue and controller inhalers that indicated that the majority of users did not use their inhalers properly. Results from the research were published in The Journal of Allergy and Clinical Immunology: In Practice, the Madison, Wisc.-based company said. Data in the study […]
Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people […]
Ocular Therapeutix doses first wet-AMD patient in implant trial
Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. The company’s investigational product is a bioresorbable hydrogel fiber implant formulated with a […]
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