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, […]
Senseonics touts Eversense reimbursement win
Senseonics (NYSE:SENS) said this week that Health Care Service Corporation – Blue Cross Blue Shield is providing coverage for the Eversense continuous glucose monitoring system, effective as of yesterday. HCSC – Blue Cross Blue Shield is the fourth-largest health insurer in the U.S. and serves more than 16 million members, according to a news release. Last […]
Intarcia Therapeutics takes another run at FDA approval
Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee […]
Abbott inks inks diabetes tech partnerships with Tandem Diabetes, Omada Health
Abbott (NYSE:ABT) said today that it has entered into an agreement with Tandem Diabetes Care (NSDQ:TNDM) to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems. The news comes one day after Abbott announced a partnership with Omada Health to pair Abbott’s FreeStyle Libre continuous glucose monitoring system with Omada’s digital care program. Tandem designed its […]
Walmart brings One Drop wireless glucose meter kit to stores
One Drop said yesterday that its wireless glucose meter kit and supplies are now available at hundreds of Walmart stores in the U.S. The kits for sale at the retail store include a Bluetooth glucose meter, lancing device, carry case, test strips and lancets, along with a year of free access to One Drop’s certified […]
Dexcom wins FDA clearance for G6 Pro CGM
Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up. The San Diego-based company said the G6 Pro is designed to measure glucose data in real time over 10 days in either “blinded” or “unblinded mode,” depending on […]
Haselmeier licenses Axis-D pen injector to Stevanato Group
Haselmeier said today that it entered into an exclusive agreement with Stevanato Group to license the Axis-D pen injector and intellectual property for the development, manufacturing and supply of the device for diabetes care. Haselmeier’s Axis-D auto-injector pen is approved for use by the European Medical Agency and the FDA, among other regulatory bodies. The […]
LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus
LifeScan said yesterday that it entered into an agreement with Willis Towers Watson to expand the commercialization of its OneTouch Reveal Plus digital diabetes therapy system. The companies hope the collaboration will see LifeScan and Willis Towers Watson combine to support self-insured employers in helping their employees and dependents manage diabetes. The OneTouch Reveal Plus […]
Valeritas jumps on $25m refi, Q3 prelims
Valeritas (NSDQ:VLRX) said today that cut its debt load by $25 million in a refinancing move and released its third-quarter preliminary results, sending its share price up on Wall Street in early trading. The terms of refi saw the exchange of $25.0 million in senior debt owned by CR Group and another creditor for new […]
Dance Biopharm rebrands to Aerami Therapeutics
Dance Biopharm today said it rebranded as Aerami Therapeutics and will move its headquarters to Durham, N.C. The rebranding comes as the company seeks strategic partners for its Dance 501 inhaled human insulin. The company also hopes the rebranding will help progress into pivotal registration studies and expand to include inhaled therapeutics for endocrinology diseases. […]
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