Tag Archives: Positive

Novo’s oral semaglutide beats Jardiance in PIONEER 2

Novo Nordisk has announced topline results from the Ph3 PIONEER 2 study comparing oral semaglutide to BI/Lilly’s Jardiance. Interestingly, this is the second oral semaglutide trial to have topline results (PIONEER 1 FENIX insight); and in each case, Novo has only disclosed on-treatment results. Below, FENIX provides insight into PIONEER 2 results and the impact on oral semaglutide commercialization.

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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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Novo Nordisk Q1 ’18 Earnings Update

Novo hosted its Q1 ’18 earnings call (press release) and provided updates on its marketed and pipeline diabetes products. Of note, Novo discussed the relaunch of Tresiba based on the recent DEVOTE label update. Furthermore, Novo disclosed plans to initiate Ph2 for its QW basal insulin (LAI287) by YE ’18. Below are highlights from the call.

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Novo Nordisk Launches Rebinyn in the US for People with Hemophilia B

On February 8, 2018, Novo Nordisk officially launched REBINYN, a GlycoPEGylated, Recombinant Coagulation Factor IX, for the treatment of Hemophila B. The BLA for Rebinyn was initially approved on May 31, 2017, and is indicated for on-demand treatment and control of sporadic bleeding episodes and during surgery in adults and children with hemophilia B.

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Lilly: Thoughts on Connected Diabetes Ecosystem

Lilly disclosed major announcements about its diabetes connected care strategy, including intentions to develop an in-house automated insulin-delivery (AID) device as well as a wireless smart pen injection device. As a part of this endeavor, Lilly has engaged in collaborations with Deka R&D Corp., CGM-manufacturer Dexcom, and acquired Montreal-based algorithm startup Class AP. In light of these developments, Lilly has indicated plans to initiate trials by YE 2017 and has suggested it will take 2-3 years for these new devices to reach the market.

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