A series of cardiometabolic-related news items have been observed from Bayer, Medtronic, Novo Nordisk, and Ypsomed. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed from Altimmune, Lilly, 89bio, Ypsomed, and JDRF. Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items have recently been observed: Know Labs announced the addition of KnowU, a portable Bio-RFID glucose monitoring device, to the company’s portfolio of non-invasive diagnostic technology; Amarin announced an update to its Vascepa go-to-market strategy, including US field force layoffs; Welldoc announced FDA 510(k) clearance for the BlueStar Insulin Adjustment Program for bolus and premixed insulin titration; and CinFina Pharma announced an agreement with Janssen Sciences Ireland Unlimited Company to acquire exclusive WW rights to four QW anorectic agents for the treatment fo obesity. Below, FENIX provides highlights and insights for the respective news items.
A series of diabetes-related news items have been observed: Diamyd announced topline results from its Ph2b DIAGNODE-2 trial, and hosted a brief webcast to discuss the results; MicroTech received 510(k) clearance for its first BGM; and Voluntis secured €2M in financing. Below, FENIX provides highlights and insights related to the respective news items.
Sensyne Health announced it has developed a new diabetes remote management system called “DBm-Health,” which focuses on people at risk of diabetes, pre-diabetes, T1DM, and T2DM. Sensyne plans to launch DBm-Health in the UK over the coming months with a US launch scheduled “toward the end of the current financial year” (March 31, 2021). Of note, Sensyne already offers other remote monitoring solutions for gestational diabetes, hypertension, heart failure, COPD, and COVID-19 (view Sensyne website). According to Sensyne, the new DBm-Health solution was created in response to increasing HCP demand for remote monitoring systems. Below, FENIX provides thoughts on the Sensyne DBm-Health solution, including insight into how some perceived deficiencies of the platform may preclude its use with patients and HCPs.
Ahead of the ADA 2020 conference start, a series of diabetes-related press releases have been observed: Biocon/Mylan received FDA approval for its bs-glargine, Novo Nordisk is set to acquire Corvidia, Lannett provided an update on its meeting with FDA for bs-glargine, LifeScan launched the Verio Reflect BGM, Medtronic received CE Mark for the 780G system, Dexcom launches G6 Pro, and DarioHealth entered into new partnership agreements. Below, FENIX provides context and analysis for the announcements.
Approximately 1 week after i-SENS received 510(k) clearance for the Caresens S Fit BT BGM, FDA has cleared another i-SENS Bluetooth BGM called “Caresens S Clear BT.” Below, FENIX provides brief thoughts on the new i-SENS BGM.
DarioHealth has announced the launch and distribution of the Dario-powered digital diabetes program on Walmart.com. The day of the news, Dario’s stock jumped nearly 50%. Below, FENIX provides context and insights on the Dario system, including points of differentiation and the importance of its Walmart.com availability.
DarioHealth announced it has launched a new “membership-in-a box” retail program for its BGM connected platform. Dario piloted its brick and mortar retail program through a partnership with Best Buy which was first announced in November 2018. Below, FENIX provides insight on Dario’s strategy including thoughts on how why other connected glucose monitoring solutions (e.g. One Drop) are also moving in the same direction.
Roche hosted its Q2 ‘19 earnings call and provided brief updates to their diabetes business. Of note, Roche’s earnings press release stated that the Accu-Chek Guide Me, a low-cost version of the Accu-Chek Guide, has been launched in the US. Below, FENIX provides highlights from the call.