One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.
Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults.
Medtronic plc, of Dublin, reported good news in terms of its quarterly results Tuesday, with key revenue segments coming in line with or beating expectations. Wells Fargo's Larry Biegelsen noted that coronary and structural heart sales of $955 million exceeded the consensus of $949 million and his organization's $923 million estimate. The company pointed to its transcatheter aortic valves as helping in the boost, following the expansion into the low-risk patient population.
Fractyl Laboratories Inc. is pioneering a procedure known as duodenal mucosal resurfacing (DMR) to reverse chronic metabolic disorders. This month it has reported positive results from a couple of clinical trials that are shaping its planning for a pivotal trial that is slated to start next year in type 2 diabetes patients.
Senseonics Inc., of Germantown, Md., reported gloomy results for its 2019 third quarter, with revenue of $4.3 million, down 17% from the same period last year. The tally also fell far short of the consensus on Wall Street, which estimated third-quarter revenue of $6.07 million.
Virta Health Corp. reported 90-day data from a pilot study of its Virta Treatment for type 2 diabetes (T2D) in military veterans. Conducted jointly by Virta and the U.S. Department of Veterans Affairs (VA), the pilot shows 84% of participants who used the low carbohydrate and diabetes coaching model reduced their glycemic levels to below the diabetes threshold or experienced at least a one-point drop in HbA1c, a measure of blood sugar.
Most weight loss interventions target obese or super-obese patients who have adjacent comorbidities, such as type 2 diabetes or sleep apnea. But Boston-based Gelesis aims to change that with its hydrogel pill Plenity.
Diabetes management company Dexcom Inc. trounced Wall Street forecasts for the third quarter of 2019, with the company reporting worldwide sales of $396.3 million, up 49% from $266.7 million in the same period of 2018. Dexcom officials attributed the surge to volume growth plus new patient additions as providers and consumers become more aware of the benefits of real-time continuous glucose monitoring (CGM), where Dexcom's G6 has seen steady demand since launching in June 2018.
San Diego-based Tandem Diabetes Care Inc. reported financial results for the third quarter of 2019, with worldwide pump shipments soaring 112% to 17,839 pumps from 8,434 pumps in the same period a year ago. Revenue rose 105% to $94.7 million, up from $46.3 million in the third quarter of 2018.
Abbott Laboratories and Tandem Diabetes Care Inc. said Tuesday that they plan to develop and commercialize a line of integrated diabetes products based on Abbott's glucose sending technology and Tandem's insulin delivery systems. The collaboration comes as the U.S. FDA is encouraging medical device manufacturers to consider the ability to share and use information safely and effectively in the development and design of connected devices.
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