Category Archives: Basal Insulin

Lilly and Life for a Child Expand Partnership; ViaCyte Appoints Michael Yang as CEO

Two diabetes-related news items have been observed: Lilly and Life for a Child announced an expansion of their partnership to continue addressing inequity in accessing quality diabetes care for children and young adults around the world; and ViaCyte announced the appointment of Michael Yang as the company’s CEO and member of the Board of Directors. Below, FENIX provides highlights and insights for the respective news items.

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Adocia Reports Positive BC Lispro Data with Tonghua Dongbao Insulin; January 25-29 CHMP Agenda

A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. Below, FENIX provides highlights and insights from the respective news items.

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Biocon CY Q4 ’20 (FY Q3 ’21) Earnings Update; Biocon Biologics CEO Resigns

Biocon hosted its CY Q4 ’20 (FY Q3 ’21) earnings call and provided updates on its biosimilar insulin portfolio. Importantly, Biocon disclosed that Christiane Hamacher, the CEO of Biocon Biologics, has resigned “due to professional differences with the chairperson on strategic priorities and vision for the company.” Below, FENIX provides highlights and insights from the call relating to the corporate restructuring and Biocon’s bs-insulin portfolio.

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Oramed Randomizes First Patients in Ph3 Oral Insulin Trial; Dario Hires New Employer Sales Lead

Two diabetes-related news items have been observed: Oramed has begun randomizing patients into its Ph3 ORMD-0801 T2DM study (view press release) and Dario announced the hiring of Chris Chan as the company’s new SVP of employer sales (view press release). Below, FENIX provides highlights and insights from the respective news items.

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Metacrine NASH Fast Track Designation; Senseonics Receives Positive Coverage Decision for EmblemHealth; Insulet Launches Omnipod DASH in Canada

A series of cardiometabolic-related news items have been observed: Metacrine announced FDA granted Fast Track designation to MET642 for the treatment of NASH; Senseonics announced a positive coverage decision for its implantable CGM from EmblemHealth; and yesterday, Insulet announced the Canadian launch of Omnipod DASH. Below, FENIX provides highlights and insights for the respective news items.

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JPM 2021 Day 4: Lexicon Poised for a Strong Comeback; Lexicon, Viatris, and Intercept @ JPM; Poxel/Metavant Partnership Terminated

On the final day of JPM 2021, FENIX has provided coverage of presentations by cardiometabolic companies including Lexicon, Viatris, and Intercept. Additionally, two separate cardiometabolic-related news items have been observed: Lexicon announced it received FDA feedback stating SOLOIST and SCORED results support a sotagliflozin NDA submission for a broad HF indication; and Poxel/Metavant announced the termination of their partnership. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage, including Lexicon’s proposed broad HF label for sotagliflozin and Viatris’s biosimilar Toujeo.

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Tidepool Completes FDA Submission of Tidepool Loop; Diabeloop Partners with SFC Fluidics for AID Solution

Two diabetes-related news items have been observed: Tidepool announced it completed the FDA submission of Tidepool Loop, the company’s automated insulin dosing app for managing T1DM; and SFC Fluidics announced a partnership with Diabeloop to develop a system that integrates the SFC ACE insulin pod into Diabeloop’s AID solution for patients in the US. Below FENIX provides highlights and insights for the respective news items.

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Holiday Hangover: FDA Approves First Generic Glucagon; Novo High-dose Sema EU Filing; Novo Extends COVID-19 Relief Program; Eversense Implantable CGM Delayed by FDA; Provention Bio’s Teplizumab Filing Accepted by FDA; Teplizumab July 2, 2021 PDUFA

During the holiday break, a series of diabetes-related news items were observed from Amphastar, Novo Nordisk, Senseonics, and Provention Bio. Below, FENIX provides highlights and insights for the respective news items.

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Xeris Recieves Positive CHMP Opinion; Roche and Diabeloop Partner for AID Development

Two diabetes-related news items have been observed: Xeris announced it received a positive CHMP opinion for its ready-to-use (RTU) rescue glucagon product, called Ogluo, and Roche announced a partnership with Diabeloop to enhance Roche’s pump hardware platform. Below, FENIX provides highlights and insights for the respective news items.

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Novo Retracts CONCLUDE (H2H Tresiba vs. Toujeo) Press Release

Novo Nordisk announced the Danish Maritime and Commercial High Court ruled Novo’s September 19, 2019 press release regarding the full results from the CONCLUDE trial (H2H Tresiba vs. Toujeo in T2DM; view original press release here) violated the Danish Marketing Practices Act and the Danish Medicines Act. However, Novo did not disclose which specific portion of the September 2019 press release was in violation. In case you missed it, here is a link to FENIX’s insight on the CONCLUDE result following the presentation at EASD 2019.

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