Privately-held biopharma Intarcia Therapeutics revealed today that the FDA rejected its exenatide implant, ITCA 650, designed to treat Type II diabetes. The company said that it doesn’t think it will need to conduct new pivotal trials in order to address the concerns brought about by the FDA’s complete response letter. Intarcia hinted that the reason behind the […]
Diabetes
Dexcom CEO: Bringing meaningful data to the diabetes community
Kevin Sayer describes Dexcom‘s (NSDQ:DXCM) history as punctuated by “firsts” – its continuous glucose meter was the first to connect to a phone. Last year, the company’s tool became the first approved by the FDA as one from which a patient with diabetes can make insulin dosing decisions. When Sayer took the helm as president & […]
FDA approves first glucose sensing tech that doesn’t require routine finger sticks
Abbott (NYSE:ABT) said yesterday that the FDA approved its FreeStyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring for adults with diabetes. The company’s technology doesn’t require finger stick calibration and eliminates the need for users to routinely stick their fingers for samples. The blood glucose monitor replacement indication means that people […]
China OKs Novo Nordisks’ once-daily Tresiba basal insulin
Novo Nordisk (NYSE:NVO) said today that its once-daily insulin degludec won approval from the China Food and Drug Administration. The insulin-maker’s product is designed to be a once-daily basal insulin with an ultra-long duration of action for people with diabetes. “There are more adults with diabetes in China than anywhere in the world, and we are […]
Aspire Capital to acquire $20m worth of Valeritas stock
Valeritas (NSDQ:VLRX) said today that it inked a deal with Aspire Capital Fund to buy $20 million of Valeritas’ common stock. According to the deal, Aspire Capital is slated to purchase common stock at Valeritas’ request from time to time during a 30-month period at prices based on the market price at the time of each […]
Sanofi, Innovation Health to evaluate digital health solutions for Type II diabetes
Innovation Health and Sanofi (NYSE:SNY) said today that the companies are launching a pilot program to evaluate the impact of digital health solutions from One Drop and Common Sensing for people with Type II diabetes. The program hopes to enable pharmaceutical companies, tech companies and plan providers to work together to improve patient outcomes, according to […]
Convenience, compliance & control: How Insulet is changing insulin delivery tech
Shacey Petrovic spent nearly a decade trying to convince her diabetic father to switch to an insulin pump, rather than inject himself multiple times each day. But he was wary of the tubing and other challenges that come with constantly wearing a pump. So when Petrovic was tapped to serve as chief commercial officer at Insulet (NSDQ:PODD) in […]
DarioHealth joins Philips-backed accelerator for development of diabetes management tech
DarioHealth (NSDQ:DRIO) said today that it inked a strategic collaboration with Philips (NYSE:PHG)-backed accelerator, HighTechXL. The Netherlands-based program chose DarioHealth “because of its strong management team, innovative business model and smart solutions for diabetes management,” the company said. The three-month program is designed to accelerate startups into the next stage of development. Collaborating with HighTechXL could help […]
UK warns about alarm failure for Roche’s insulin pumps
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, […]
BD launches ultra-fine 6mm needle for injection pen devices
Becton Dickinson (NYSE: BDX) introduced today its ultra-fine micro pen needle for use with injection pen devices. The 6 mm x 32G pen needle is compatible with leading pen injection devices, the company said. “We added the BD Ultra-Fine micro pen needles to ensure BD has a comprehensive portfolio that provide options to patients and reinforces BD’s commitment […]