Impel NeuroPharma said today that the FDA gave it the green light to proceed with its Phase III clinical trial of INP104 – a drug delivered by Impel’s intranasal delivery device for the treatment of acute migraine. The company expects to start enrolling patients in the pivotal trial in the second half of this year. The […]
Tandem wins FDA nod for insulin pump with predictive low glucose suspend feature
The FDA this week approved Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump with a predictive low glucose suspend feature designed to cut the frequency and duration of hypoglycemia. The San Diego, Calif.-based company said that upon launch, its new product will also feature Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitoring system. Tandem expects that the latest iteration of […]
FDA approves Senseonics’ implantable continuous glucose monitor
The FDA this week approved Senseonics‘ (NYSE:SENS) Eversense continuous glucose monitor for use in people ages 18 and older with diabetes. The device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. Get the full story at our sister site, Drug Delivery Business News.
Mercator MedSystems raises $11m in Series D for micro-infusion catheter system
Mercator MedSystems said this week that it raised $11 million in a Series D equity round led by Shenzhen Salubris Pharmaceuticals, with participation from current Mercator investors and other unnamed new investors. The Emeryville, Calif.-based company plans to use its newly-acquired funds to support the clinical development of its micro-infusion catheter system, the Bullfrog device. Get […]
Medtronic’s MiniMed system wins FDA nod for pediatric indication
The FDA this week expanded its approval for Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop diabetes management device to include people ages 7 to 13 with Type I diabetes. The system, which automatically monitors blood sugar levels and doses basal insulin accordingly, was initially approved in the U.S. for people ages 14 and older. Get the full […]
Cerebral Therapeutics raises $3m for epilepsy drug-device therapy
Cerebral Therapeutics closed a $3 million Series A financing round this week to support the development of its drug-device therapy designed for patients with refractory epilepsy. The Aurora, Co.-based company’s product uses an implanted, refillable catheter system to deliver a continuous, intracerebroventricular dose of an anti-epileptic drug – valproic acid. Get the full story at our […]
Companion Medical launches data management system for smart insulin pen
Companion Medical launched today Insights by InPen, a diabetes management system that aggregates and analyzes data from Companion’s connected insulin injection pen. The company’s Insights by InPen system provides users with their average glucose, average total daily insulin dose, dose calculator usage, missed doses and more, according to Companion Medical. Get the full story at our […]
Generic drug shows promise as diabetes vaccine in small, years-long study
A cheap, generic tuberculosis vaccine lowered blood glucose levels in nine patients with Type I diabetes and the effects lasted for years, according to a study published this week in npj Vaccines. The study was conducted at Massachusetts General Hospital by Dr. Denise Faustman – a name that has long been saddled with controversy in the diabetes community, […]
Anika shares plummet after Phase III trial misses endpoint
Shares in Anika Therapeutics (NSDQ:ANIK) fell more than -30% this week after the company reported that its osteoarthritis drug, Cingal, failed in a Phase III trial. The therapy, designed to treat osteoarthritis of the knee, is a combination of cross-linked hyaluronic acid and triamcinolone hexacetonide. The trial’s primary endpoint compared the pain reduction experienced by patients […]
ivWatch to integrate IV infiltration sensor into Philips’ patient monitors
For decades, nurses have sent drugs surging through a patient’s body using the power of the circulatory system. Catheters deliver medications destined to travel through a person’s veins – but it doesn’t always turn out that way. Sometimes, leaky veins cause drugs to seep into surrounding tissue or to back out of the insertion site, […]
Reva Medical wins CE Mark for full line of Fantom Encore bioresorbable scaffolds
Reva Medical (ASX:RVA) said this week that it won CE Mark clearance for its entire line of Fantom Encore bioresorbable, drug-eluting scaffolds. The new approval covers Reva’s Fantom 3.0 and 3.5 mm diameter devices, helping the company expand beyond its already-approved 2.5 mm diameter scaffold. Get the full story at our sister site, Drug Delivery Business News.
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