Category Archives: Insulin Delivery

AZ’s Qtrilmet Triple-combo Receives EC Approval; New Data from Fractyl, Dario, and Valeritas

Today, a series of diabetes-related news has been observed including the EC approval of AZ’s Qtrilmet (dapa+saxa+met triple FDC)as well as new data from Fractyl, Dario, and Valeritas related to the concurrent Diabetes Technology Meeting occurring in Bethesda. Below, FENIX provides highlights and insights on the respective news items.

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Livongo for Hypertension Demonstrates BP Benefit at 4 and 12 Weeks

Livongo announced results from a 12-week study evaluating the impact of its Livongo for Hypertension program. Full results from the study will be presented at the AHA conference on November 16, 2019. Below, FENIX provides brief thoughts on the new Livongo data.

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Patient Dies on t:slim X2 with Basal IQ; Tandem Denies Involvement

A report has been published on the FDA MAUDE database indicating a patient using Tandem’s t:slim X2 insulin pump with Basal IQ technology passed away on October 3, 2019. However, in an emailed statement to media outlets, Tandem said the t:slim X2 pump with Basal IQ was not involved in the patient’s death. Below, FENIX provides context and insight related to this news including potential read-through to the impending Control IQ approval.

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Insulet Q3 ’19 Earnings Update

Insulet hosted its Q3 ’19 earnings call and provided updates to its Omnipod business including the ongoing launch of Omnipod Dash as well as the development of the Omnipod Horizon hybrid closed-loop system. Below, FENIX provides highlights and insights from the call.

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Mylan and BD Q3 ’19 Earnings Updates

Mylan and Becton Dickinson hosted their respective Q3 ’19 earnings calls. Of note, Mylan provided a brief update on its insulin development program (in partnership with Biocon). Below, FENIX provides diabetes-related highlights and insights from the calls.

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Tandem Q3 ’19 Earnings Update

Tandem Diabetes Care hosted its Q3 ’19 earnings call and provided updates to its diabetes business including the regulatory status of t:slim X2 with Control IQ (hybrid closed loop) and development status of its t:sport. Below, FENIX provides highlights and insights from the call.

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Thoughts on Verily/Onduo Novel Diabetes Life Insurance Program

Verily, Onduo, and John Hancock recently launched a novel program, called “John Hancock Aspire,” which offers life insurance to patients with diabetes. As part of the program, eligible T2DM participants will have access to Onduo’s diabetes management and coaching solution. According to the press release, Aspire life insurance will be available starting November 18, 2019. Below, FENIX provides thoughts on this new program including insight into the motivating factors for each company and the potential business model.

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Livongo to Add Telehealth Functionality; Roche Appoints new NA Diagnostics CEO

Today, two major news items were observed including Livongo’s new partnerships with MDLIVE and Doctor On Demand telehealth platforms as well as Roche’s appointment of Matthew Sause as CEO for its North American diagnostics group. Below, FENIX provides thoughts and insights into the Livongo and Roche announcements.

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Omnipod Approved to use Novo’s Fiasp; Senseonics Now Covered on Humana

Insulet announced it has received 510(k) clearance to use Novo’s Fiasp in Insulet’s Omnipod patch pump. Recall, earlier this week, Novo announced it received FDA approval for Fiasp pump compatibility in adult patients requiring insulin therapy. Additionally, Senseonics announced that Humana will now be providing coverage for the Eversense implantable CGM system and insertion procedure (effective October 22, 2019). Below, FENIX provides brief thoughts and potential market implications for each news item.

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Thoughts on Medtronic Diabetes Leadership Change

Medtronic announced it has replaced Hooman Hakami as the head of its diabetes division with Sean Salmon, the former Senior Vice President and President of Medtronic’s Coronary and Structural Heart business. Below, FENIX provides brief thoughts on the change in Medtronic leadership and the potential impact to the diabetes business.

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