Tag Archives: Announcements

Tandem’s t:slim X2 pump approved with Basal-IQ; Medtronic 670G approved for ages 7-13

Tandem announced FDA approval of its t:slim X2 insulin pump with Basal-IQ technology which utilizes a predictive low-glucose suspend (PLGS) feature, curiously with Dexcom G6 rather than G5 as previously communicated. Additionally, FDA has expanded the approval of the Medtronic MiniMed 670G to include children aged 7 to 13 with T1DM.

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LifeScan Sold for $2.1B; New Business Model Possible

J&J announced it has accepted a final offer from Platinum Equity for the acquisition of the LifeScan BGM business. Recall, the offer was made in March 2018, and according to the press release, the transaction is anticipated to close by YE ’18.

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Xeris files for $75M IPO

Xeris Pharmaceuticals has filed with the SEC for a $75M IPO under the ticker XERS. Of note, the S1 IPO registration document states FDA filing of G-Pen is anticipated in Q3 ’18, which is later than previously stated by Xeris (late Q2 ’18).

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Beta Bionics to initiate in-home IDE for insulin-only AP system

Beta Bionics announced it received IDE approval from FDA to initiate in-home trials of the iLet insulin-only closed loop system. According to the press release, Beta Bionics plans to initiate pivotal studies in 2019 with launch of the first commercial device in 2020.

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New Novo CMO?

Novo Nordisk has announced its participation in the Hypo-RESOLVE research project. FENIX has made a curious observation based on the press release, which references Stephen Gough as Novo’s “Global Chief Medical Officer in Denmark.” This position was believed to be held by Alan Moses.

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Sanofi’s Head of Global R&D Retiring

Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.

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Livongo Acquires Digital Obesity Company

Livongo announced it has acquired Retrofit, a Chicago-based digital solutions company focusing on weight management and diabetes prevention. Livongo’s expansion into the obesity digital health market is the next logical step for the company as it seeks to provide a more holistic solution. Below, FENIX provides analysis of the Retrofit acquisition.

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Common Sensing and Haselmeier Thoughts

Common Sensing announced close of $6.6M in Series A funding. Of note, Haselmeier joined this funding round as a new investor along with other venture capital firms which is curious since Haselmeier is an injection delivery device engineering company.

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Lexicon Hosts R&D Day

Lexicon hosted its R&D Day and provided an overview of clinical and regulatory activities for its diabetes portfolio including sotagliflozin and LX2761 (selective SGLT1i). Below, FENIX provides highlights of the R&D day as well as thoughts on the impact of sotagliflozin on the T1DM and T2DM markets.

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Mylan IR Day Highlights; Biosimilar Victoza and Toujeo in Development

Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.

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