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NIH study: Tandem Diabetes artificial pancreas bests other treatments

October 17, 2019 By Sean Whooley

Tandem Diabetes Care - updated logo

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, […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured Tagged With: National Institutes of Health, Tandem Diabetes Care

Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA

October 10, 2019 By Brad Perriello

Frequency Therapeutics updated logo

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 […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Hydrogels, Regulatory/Compliance Tagged With: Frequency Therapeutics

Intersect ENT’s Ascend study misses endpoint

October 7, 2019 By Sean Whooley

Intersect ENT updated

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Otolaryngology Ear, Nose & Throat Tagged With: Intersect ENT Inc., SVB Leerink

Boehringer Ingelheim touts Spiolto Respimat inhaler data

October 2, 2019 By Sean Whooley

Boehringer Ingelheim

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 […]

Filed Under: Clinical Trials, Respiratory Tagged With: Boehringer Ingelheim Pharmaceuticals

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

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