Tag Archives: Diabetes

Abbott Partners with Omada; New Senseonics BCBS Coverage; Adocia Receives €15M in Funding; Roche Partners with iHeartMedia

Today, three major news items were observed covering a new partnership between Abbott and Omada Health, Senseonics Eversense new BCBS coverage decision, €15 million in financing for Adocia, and a Roche/iHeartMedia diabetes awareness concert. Below, FENIX provides thoughts and analysis for each respective news item.

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Lilly Nasal Glucagon CHMP Opinion This Week (CHMP Agenda October 14-17)

The CHMP agenda for this week’s meeting (October 14-17) has been released, and it includes two notable items (Lilly nasal glucagon opinion and Toujeo age indication extension). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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Abbott Libre 2 US Approval Conspicuously Late?

The FDA approval of Abbott’s next-generation CGM, Libre 2, appears to be conspicuously late, which has created questions as to what the potential issue could be. Below, FENIX provides evidence and hypotheses surrounding the delayed Libre 2 US approval. See the full blast for more details on our 3 hypotheses.

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Intarcia Re-files ITCA-650; New Dexcom G6 Professional CGM; One Drop/Walmart Partnership

Intarcia announced FDA accepted the ITCA-650 re-filing, nearly 2 years after it received a CRL. Additionally, Dexcom announced it received FDA clearance for a new G6 professional CGM. Below, FENIX provides thoughts and insights on the respective news items.

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Jardiance T1DM Adcom Scheduled for Nov 13

FDA has requested an advisory committee on November 13, 2019 to discuss the use of empagliflozin in T1DM. Of note, the empa T1DM adcom appears to be part of a 2-day adcom with Amarin’s REDUCE-IT which is scheduled for November 14. As always, FENIX will provide full coverage and analysis of the adcom. Below, FENIX provides brief thoughts on the empa T1DM adcom including hypotheses as to why the empa T1DM review has progressed to an adcom while Lexicon and AZ received CRLs for sota and dapa, respectively.

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New Medtronic Extended Wear Infusion Set Trial

A trial has been posted on CT.gov evaluating a new Medtronic extended wear infusion set (EWIS). Recall, Medtronic recently announced it had received an IDE from FDA to initiate EWIS development. Below, FENIX provides thoughts on the trial in the context of a future infusion set/CGM combination.

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Mylan Faces Setback in Sanofi Bs-Glargine Lawsuit

According to new court documents, the presiding judge in the Sanofi v. Mylan glargine lawsuit has denied Mylan’s request to rule two Lantus formulation patents invalid. The trial to settle the ongoing patent dispute is scheduled to start on December 2, 2019. Below, FENIX provides thoughts on the judge’s ruling and the potential impact on the Mylan/Biocon bs-glargine US launch timeline.

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Sanofi to Unveil New Strategy in December; Novo Obesity Partnership; Lifescan to Expand BGM Access

A series of diabetes-related news has come out today including Sanofi’s plan to unveil its new business strategy during an Investor Day in December. Additionally, Novo Nordisk announced a partnership with Noom for a digital obesity coaching solution, and Lifescan is engaging with Willis Towers Watson to expand access to the OneTouch Reveal Plus digital platform. Below, FENIX provides thoughts and analysis for each respective news item.

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FENIX Analysis: Invokana CREDENCE Promotion

Yesterday, Janssen announced FDA approval of the Invokana renal protection indication based on results from the CREDENCE trial. Following the approval, Janssen has already updated the Invokana patient and HCP websites with CREDENCE being front and center. Below, FENIX analyzes the updated messaging and provides insights into the impending field launch for the new renal protection indication.

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Senseonics Completes Enrollment for 180-Day CGM Trial

Senseonics announced it has completed enrollment for its trial evaluating the 180-day configuration of its Eversense implantable CGM. Recall, Senseonics’s partner, Roche, is already commercializing the 180-day system (Eversense XL) in Europe. Below, FENIX provides thoughts on how the move from a 90 to 180-day sensor may impact Eversense uptake in the US.

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