Tag Archives: Diabetes

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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Zealand Ph3 RTU Dasiglucagon Results Published in Diabetes Care; Genfit Launches NASHnext Diagnostic Test

Two cardiometabolic-related news items have been observed: Zealand announced the results of its Ph3 trial evaluating its ready-to-use (RTU) dasiglucagon for the treatment of severe hypoglycemia in adults with diabetes were published in Diabetes Care; and Genfit announced the US and Canadian launches of its non-invasive diagnostic test for NASH, called NASHnext. 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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Lilly and Novartis Q1 ’21 Earnings Updates; New Trulicity TV DTC; Provention Meets with FDA

A series of cardiometabolic-related news items have been observed: Lilly and Novartis hosted their respective Q1 ’21 earnings calls; Lilly has initiated a new Trulicity DTC campaign; and Provention Bio announced it met with FDA on April 23, 2021 to discuss the ongoing teplizumab PK comparability issue. Importantly, Lilly disclosed that SURPASS-4 has accrued all of its pre-specified CV events and the trial is scheduled to close out in May with topline results expected by the end of Q2 ’21. Recall, Lilly has previously stated SURPASS 4 is the gating factor for tirzepatide T2DM global regulatory submissions later in 2021. Below, FENIX provides highlights and insights for the respective items.

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Better Therapeutics First Patient Enrolled in BT-001 Trial for T2DM; ProtoKinetix Resumes Islet Ph1 Trials in T1DM; Amarin Receives Great Britain Marketing Authorization Approval for Vazkepa CV Risk Reduction

Three cardiometabolic-related news items have been observed: Better Therapeutics announced the first patient has been enrolled in a pivotal study to evaluate the safety and efficacy of BT-001 for the treatment of T2DM; ProtoKinetix announced it has resumed the Ph1 trials of PKX-001 treated islet cells following a pause due to COVID-19; and Amarin announced it received Great Britain Marketing Authorization approval of Vazkepa (icosapent ethyl) to reduce the risk of CV events in high-risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor. Below, FENIX provides highlights and insights for the respective news items.

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