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Clinical Trials

Philips touts Stellarex balloon study

October 1, 2019 By Sean Whooley

philips-stellarex-low-dose-drug-coated-balloon

Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty. The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured Tagged With: Royal Philips

TCT 2019 Roundup: Medtronic’s Resolute Onyx non-inferior to Biosensors BioFreedom stent

September 27, 2019 By Brad Perriello

TCT 2019

A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Stents Tagged With: biosensors, Medtronic, TCT 2019

Tandem Diabetes Care touts real-world t:slim X2 insulin pump data

September 19, 2019 By Sean Whooley

Tandem Diabetes Care - updated logo

Tandem Diabetes Care (NSDQ:TNDM) yesterday touted real-world data from users of the t:slim X2 insulin pump. The data, from more than 8,000 users, was published in the medical journal Diabetes Technology & Therapeutics. San Diego-based Tandem said the study showed a 45% relative risk reduction in hypoglycemia and a 71% relative risk reduction in hypoglycemic events, […]

Filed Under: Clinical Trials, Diabetes Tagged With: Tandem Diabetes Care

Pulmatrix doses first patient in Pulmazole trial

September 19, 2019 By Sean Whooley

Pulmatrix

Pulmatrix (NSDQ:PULM) said yesterday that it dosed the first patient in its Phase II trial of Pulmazole for the treatment of allergic bronchopulmonary aspergillosis asthmatics. The 64-patient study is a randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of three dose levels of the anti-fungal drug itraconazole formulation Pulmazole. The multi-center, four-arm trial will […]

Filed Under: Clinical Trials, Featured, Respiratory Tagged With: Pulmatrix Inc.

Halozyme-Genentech breast cancer pivotal meets endpoint

September 13, 2019 By Danielle Kirsh

halozyme-logo

Halozyme Therapeutics today announced positive endpoint results from its phase III intravenous chemotherapy trial. Genentech’s FeDeriCa study used Halozyme’s Enhanze drug-delivery technology for subcutaneous administration of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin), in combination with intravenous chemotherapy. The results showed non-inferior levels of Perjeta in the blood compared to standard IV infusion […]

Filed Under: Clinical Trials, Drug-Device Combinations, Oncology Tagged With: Genzyme, Halozyme Therapeutics

FDA approves ready-to-use liquid glucagon from Xeris

September 12, 2019 By Sean Whooley

Xeris Pharmaceuticals logo - updated

Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia. Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in pediatric and adult patients with Type 1 diabetes aged two years old or above. Chicago-based Xeris’ Gvoke may be administered with a pre-filled […]

Filed Under: Auto-injectors, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat Tagged With: FDA, Juvenile Diabetes Research Foundation (JDRF), xerispharmaceuticals

Cook Regentec launches blood filtration trial for critical limb ischemia

September 11, 2019 By Nancy Crotti

Cook Medical - updated logo

Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]

Filed Under: Clinical Trials, Featured, Research & Development, Uncategorized, Vascular Tagged With: cook medical, Cook Regentec

Cook Medical touts paclitaxel-coated stent PAD study results

September 10, 2019 By Nancy Crotti

Cook Medical - updated logo

Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Stents, Uncategorized Tagged With: cook medical, FDA

Satsuma Pharmaceuticals registers $75m IPO

September 9, 2019 By Nancy Crotti

satsuma-pharmaceuticals

Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for migraine. It intends to use the money to fund its Phase 3 safety and efficacy clinical trials for STS101, manufacturing costs, […]

Filed Under: Business/Financial News, Clinical Trials, Drug-Device Combinations, Featured, Funding Roundup, Pain Management, Uncategorized, Wall Street Beat Tagged With: satsumapharmaceuticals

Medtronic’s In.Pact AV DCB meets endpoints in trial

September 9, 2019 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Research & Development, Vascular Tagged With: Medtronic

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