Tag Archives: Abbott

Abbott/Tandem Finalize AID Partnership; What is Tandem’s Role?

Abbott and Tandem Diabetes Care announced the finalization of an agreement for the two companies to develop and commercialize “integrated diabetes solutions.” Recall, the companies first announced their intention to work together in October 2019 (previous FENIX insight). Below, FENIX provides thoughts on the partnership, including potential insight into how Abbott may be leveraging the Tandem partnership to deal with the Libre 2 Vitamin C interference issue.

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Libre 2 AID Compatibility Issue Worse Than Expected

The Libre 2 FDA approval documents have been released, and the answer is now known as to why Libre 2 was not approved to be compatible with automated insulin delivery (AID) systems. Below, FENIX provides thoughts and insight into the issue and Abbott’s potential next steps.

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Libre 2 AID Compatibility Hypothesis

Earlier this week, Abbott announced FDA approval of Libre 2, its successor to the highly successful Libre 14 day CGM system (previous FENIX insight). Despite all of the indicated improvements that Libre 2 received, it was clearly worded that Libre 2 is not approved for use with automated insulin delivery (AID) systems. Below, FENIX hypothesizes as to the reason.

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Abbott Libre 2 Promotion Takes Shots at Dexcom G6; Libre 2 Digital DTC Initiated

Following the Libre 2 FDA approval (see previous FENIX insight), Abbott authored a blog post on its website (view here), which includes a patient DTC video (view on Youtube) as well as static images that directly counter-message Dexcom’s G6 CGM. Additionally, the Libre 2 website is now live with a “coming soon” message and webform to be notified when Libre 2 becomes available. Below, FENIX provides an analysis of Abbott’s early Libre 2 messaging/counter-messaging and potential insight into a Dexcom response.

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VERTIS-CV Questions Remain; Dexcom Partnered for COVID-19 Remote Monitoring; New Libre RWE; Nemaura Continues PR Blitz; ADA Key Press Releases (June 16)

On the final day of ADA 2020, four diabetes-related news items were observed: full results from the ertugliflozin VERTIS-CV study, Dexcom partnered with KORE for COVID-19 remote monitoring, additional Libre RWE, Nemaura continues on its ADA PR blitz. Below, FENIX provides context and analysis for the announcements.

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Libre 2 US Approval Was Worth the Wait for Abbott, but Not Its Pump Partners

Abbott announced FDA approval of the Libre 2 iCGM in patients 4 years of age and older; however, the initial approval comes without closed-loop compatibility. According to FDA’s 510(k) database, Libre 2 was approved on Friday, June 12, but FDA typically doesn’t update the database until Monday. Recall, Libre 2 approval had been delayed for undisclosed reasons, but FENIX recently anticipated a near-term US approval with the closure of Bigfoot’s Series C (previous FENIX insight). Below, FENIX provides thoughts on the Libre 2 approval, a comparative analysis with the Dexcom G6, and potential implications to other CGM manufacturers including Medtronic, Senseonics, Lifescan, Waveform, and Nemaura.

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Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE at ADA 2020; Sota T2DM CKD Data; vTv Presents TTP399 Ph2 Results; ADA 2020 Key Press Releases (June 13)

Today, nine diabetes-related news items were observed: Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE data were presented at ADA 2020 as well as new data from Lexicon (sota T2DM Ph3 CKD), vTv (Ph2 Simplici-T1), and Zealand (V-Go patch pump). Below, FENIX provides context and analysis for the announcements.

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Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

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Abbott’s Libre in Hospitalized Patients; Companion Medical Launches Fixed Dose and Meal Estimation

Two diabetes-related news items have been observed: Abbott issued a press release announcing the FreeStyle Libre 14 day CGM is now being utilized in the US for diabetes patients hospitalized during the COVID-19 outbreak and Companion Medical announced they have launched fixed dose and meal estimation options for the InPen app. Below, FENIX provides thoughts on how Abbott’s COVID-19 response may act as lead generation for Libre, Dexcom’s potential response to Abbott, and insights on Companion Medical’s updated InPen app.

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FDA Issues Final Rule on Definition of “biological product”; ATTD 2020 Key Press Releases (Feb 20)

On the second day of the ATTD 2020 conference, a series of diabetes-related press releases have been observed including Abbott Libre RWE, Tandem to file Control IQ for peds in March 2020, Roche’s new “InsulinStart” program, Companion Medical compatibility with Fiasp, and MannKind Afrezza PK and pulmonary function data. Separate from the conference, FDA announced that it has issued a final rule on the definition of a biological product ahead of the March 23, 2020 insulin reclassification from a drug to a biologic. Below, FENIX provides highlights and insights from the respective news items.

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