Category Archives: Basal Insulin

Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

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Tandem, Lannett, Esperion, and Ionis Q1 ’21 Earnings Updates; Nemaura Receives Order for its Non-invasive CGM

A series of cardiometabolic-related news items have recently been observed: Tandem, Lannett, Esperion, and Ionis hosted their respective Q1 ’21 earnings calls; and Nemaura Medical announced it received an order from its UK licensee, DB Ethitronix Ltd, of 5,000 sugarBEAT transmitters and 200,000 sugarBEAT sensors. Below, FENIX provides highlights and insights for the respective news items.

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Novo Nordisk Q1 ’21 Earnings Update

Novo Nordisk hosted its Q1 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Rybelsus launch, the Ph3 semaglutide 2.4mg NASH trial initiation, and the impending Ph3 trial initiation of high-dose oral semaglutide in obesity. Importantly, Novo disclosed its sales force has primarily been having face-to-face interactions since February 2021. Below, FENIX provides highlights and insights from the call.

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New Dual GLP-1/GIP RA from Carmot Receives IND; Lilly ESG Strategy Highlights; Pfizer Q1 ’21 Earnings Update

Three diabetes-related news items have been observed: Carmot Therapeutics announced it has received IND clearance from FDA for its dual GLP-1/GIP RA, CT-868, in overweight and obese adults with T2DM; Lilly hosted an investor call outlining its commitments for the company’s newly updated environmental, social, and governance (ESG) strategy; and Pfizer hosted its Q1 ’21 earnings call but did not mention its metabolic pipeline during the webcast. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Ph4 Basal Insulin Titration Trial; Lilly Ph2 GGG Tri-agonist Trial; AZ Q1 ’21 Earnings Update; Xeris’s Ogluo Receives UK MHRA Approval

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph4 Lilly-sponsored trial investigating Basaglar titration in 50 adults with T2DM has been observed; a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) has been observed; AstraZeneca hosted its Q1 ’21 earnings call; and Xeris announced it received UK MHRA approval for its RTU rescue glucagon product, branded as Ogluo. Below, FENIX provides highlights and insights for the respective news items.

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Welldoc Receives New Patent; Nemaura Shareholder Update; Sanofi and Teva Q1 ’21 Earnings Updates

Four cardiometabolic-related news items have been observed: Welldoc announced it recently received its 20th patent for “database management and graphical user interfaces for measurements collected by analyzing blood”; Nemaura Medical hosted a webcast and provided investors with brief updates to its business; and Sanofi and Teva hosted their respective Q1 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective news items.

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Novo to Initiate Oral Sema Ph3a Obesity Program; Integrity Applications Appoints David Klonoff to Scientific Advisory Board; Roche, Poxel, and Adocia Q1 ’21 Earnings Updates

A series of diabetes-related news items have recently been observed: Novo Nordisk announced its intention to enter Ph3a development of oral semaglutide in obesity; Integrity Applications announced the appointment of notable diabetes device KOL, David Klonoff, to its Scientific Advisory Board; Roche hosted its Q1 ’21 earnings call; Poxel issued its Q1 ’21 earnings and provided an update across its business including imeglimin for T2DM and PXL770/PXL065 for NASH; and Adocia announced its Q1 ’21 earnings update. Below, FENIX provides highlights and insights for the respective news items.

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April 19-22 CHMP Agenda; EMPEROR-REDUCED Opinion?; Virta Health Raises $133M in Series E

Two cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (April 19-22, 2021) has been released and includes one notable item⁠, Jardiance HFrEF is listed under Type II Variations; and Virta Health announced it has raised $133M in a Series E equity financing round at a $2B valuation (up from $1.1B in December 2020). Below, FENIX provides highlights and insights from the respective news items.

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