Category Archives: Other

Thoughts on FDA’s New Draft Guidance for T2DM Trials

FDA announced it has issued a new draft guidance titled “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” (download draft guidance here). Of note, this new draft guidance replaces two other FDA guidance documents – the famous Dec 2008 CV risk guidance and a Feb 2008 draft guidance. The new draft guidance provides recommendations on the size and nature of the safety databases needed to improve glycemic control in T2DM patients. Below, FENIX provides a brief overview of the FDA’s new draft guidance and its implications including a favors/disfavors analysis on specific market players.

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Voluntis Deprioritizes Diabetes in Favor of Oncology

Voluntis announced it is moving in a new strategic direction, which includes deprioritizing its Insulia diabetes solution in favor of its oncology business. Of note, the updated strategy comes a day after Voluntis entered into an agreement with BMS to create a mobile solution to support treatment and track symptoms for oncology patients. Below, FENIX provides thoughts on Voluntis’s reprioritization in the context of other digital health solutions from Onduo and Livongo.

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Livongo Q4 ’19 Earnings Update

Livongo hosted its Q4 and FY 2019 earnings call and provided updates to its business. Unsurprisingly, the vast majority of the call focused on the user and revenue growth outlook for the Livongo platform. Below, FENIX provides highlights and insights from the call.

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Insulet Q4 ’19 Earnings Update

Insulet hosted its Q4 ’19 earnings call (press release) and provided updates to its Omnipod business including the Omnipod Horizon closed-loop system. Of note, Insulet disclosed that it has completed enrollment in the Omnipod Horizon pivotal trial and indicated its intentions to deprioritize concentrated insulin development. Below are highlights and insights from the call.

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New Nemaura H2H CGM Study; Welldoc partners with Redox to integrate BlueStar with EHRs

A series of diabetes-related news has been observed including an announcement that Nemaura plans to initiate a H2H study comparing its sugarBEAT CGM with a “highly successful major incumbent CGM sensor” (press release) as well as Welldoc’s new strategic partnership with Redox Inc., to integrate BlueStar with EHRs (press release). Below, FENIX provides additional highlights and insights on Nemaura’s H2H study, especially in the context of the comparative CGM used in the study.

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Sanofi’s Head of Primary Care and 3 Other Execs Set to Leave

February 11, 2020

It is being reported by Bloomberg that a series of Sanofi executives are leaving the company as “part of the broader effort to shake up Sanofi.” The four execs are said to include Dieter Weinand (EVP Primary Care), Ameet Nathwani (EVP, CMO, and Chief Digital Officer), Kathleen Tregoning (EVP External Affairs), and Dominique Carouge (EVP Business Transformation). Sanofi is anticipated to issue a press release regarding the departures later today. Below, FENIX provides brief thoughts on the continued changes in Sanofi senior leadership.

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Zealand to Acquire Valeritas; vTv Positive Ph2 Data for TTP399 in T1DM

A series of diabetes-related news has been observed including an announcement that Zealand intends to acquire Valeritas’s assets (manufacturer of the V-Go insulin delivery device) as well as positive topline results from the vTv Therapeutics Ph2 Simplici-T1 study of TTP399, a novel glucokinase activator. Zealand and vTv hosted calls with investors to discuss their respective news items. Below, FENIX provides highlights and insights including thoughts on how vTv may have a difficult time finding a TTP399 Ph3 partner given the ongoing SGLT2i T1DM regulatory situation.

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Dexcom Non-intensive G6 CGM Updated Approval; Dexcom G5 Receiver Recall; FDA Concludes MET NDMA Impurity Investigation

A series of diabetes-related news has been observed including a new 510(k) clearance for Dexcom’s G6 iCGM in non-intensive diabetes management, Dexcom G5 Mobile Class 2 Device recall, and FDA finalized its investigation into potential metformin impurities. Below, FENIX provides highlights and insights for the respective news items.

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Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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Lilly to Donate Insulin Pens; Fractyl Launches Revita DMR in the UK

Two diabetes-related news items have been observed including an announcement from Lilly that the company is donating 200k insulin pens over 3 years and Fractyl is launching its Revita DMR device in the UK. Below, FENIX provides highlights and insights from the respective news items.

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