A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, […]
Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug. The fast-track program aims to speed up the approval of therapies for unmet needs in serious conditions. Woburn, Mass.-based Frequency’s FX-322 candidate is designed to stimulate the regrowth of sensory hair cells […]
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
Boehringer Ingelheim touts Spiolto Respimat inhaler data
Boehringer Ingelheim said yesterday that results from a study of its Spiolto Respimat inhaler showed benefits including improving symptoms and lung function in treating chronic obstructive pulmonary disease. The Spiolto Respimat is a soft-mist inhaler designed for the treatment of airflow obstruction in patients with COPD. A pooled analysis exploring COPD treatment with the tiotropium-based […]
Philips touts Stellarex balloon study
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 […]
TCT 2019 Roundup: Medtronic’s Resolute Onyx non-inferior to Biosensors BioFreedom stent
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 […]
Tandem Diabetes Care touts real-world t:slim X2 insulin pump data
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, […]
Pulmatrix doses first patient in Pulmazole trial
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 […]
Halozyme-Genentech breast cancer pivotal meets endpoint
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 […]
FDA approves ready-to-use liquid glucagon from Xeris
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 […]
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