Tag Archives: Ozempic

Sanofi Acquires Provention Bio; Ozempic Takes Stage at Oscars

Two CVRM-related news items have been observed: Sanofi and Provention have entered a $2.9B acquisition deal (press release); and Ozempic takes center stage at the 2022 Oscar awards show (view article). Below, FENIX provides highlights and insights from the news items, including thoughts on how the Provention Bio acquisition fits into Sanofi’s diabetes strategy.

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Novo Nordisk Q4 ’22 Earnings Update

Novo Nordisk hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Wegovy/Ozempic supply, GLP-1RA market dynamics, new QW insulin icodec data, and more. Below, FENIX provides highlights and insights from the call.

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Abbott Q4 ’22 Earnings; Tidepool Loop Receives FDA Clearance; Lilly to Expand Incretin Manufacturing Capacity; Novo Receives Marketing Practices Complaint; AGC Biologics to Manufacture Tzield; Nemaura Reports Positive Miboko Data; J&J Q4 ’22 Earnings; and Embecta Opens New Headquarters

A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.

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SELECT Doesn’t Stop at Interim Analysis; Novo Nordisk Q2 ’22 Earnings Update

Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. Below, FENIX provides highlights and insights from the call.

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Ozempic 2.0mg Approved by FDA

Novo Nordisk announced its 2.0mg dose of Ozempic has been approved by FDA (view label), which is in line with FENIX’s projection. Recall, on May 28, 2021, Novo announced it resubmitted the sNDA to FDA following a Refusal to File Letter in January 2021 (previous FENIX insight). Of note, Novo indicated plans to launch 2.0mg Ozempic in Q2 ’22. Below, FENIX provides brief thoughts on the 2.0mg Ozempic approval.

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Wegovy Launch Impresses; Guidance Raised; Novo Q2 ’21 Earnings Update

Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. Below, FENIX provides highlights and insights from the call.

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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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Heart Failure: Tirzepatide vs. Semaglutide HFpEF Ph3 Trial Analysis

Lilly has recently initiated the Ph3 tirzepatide HFpEF trial, called SUMMIT (view CT.gov record). Recall, during Lilly’s 2021 guidance call (December 15, 2020), Lilly first disclosed plans to develop tirzepatide for the treatment of HFpEF (previous FENIX insight). Below, FENIX provides an overview of SUMMIT, including a comparative analysis with Novo’s semaglutide HFpEF trial (STEP HFpEF).

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Ozempic 4-dose Pen Back in the Label; Diamyd to Initiate DIAGNODE-3 Trial “Later This Year”; Nemaura Appoints New Global Head of Digital Programs

A series of diabetes-related news items have recently been observed: Novo Nordisk’s Ozempic label has been updated once again to include an NDC for a 1mg x 4 dose 3mL pen; Diamyd announced a contract with ICON plc for the Ph3 DIAGNODE trial evaluating its Diamyd diabetes vaccine; and Nemaura Medical announced the appointment of Samantha Sanders as Global Head of Digital Programs. Below, FENIX provides highlights and insights for the respective news items, including the curious thoughts on why Novo may have had the 1mg x 4 dose pen removed from the label and added back.

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High-Dose Ozempic Filing Refused by FDA

Novo Nordisk announced it received a Refusal to File letter from FDA regarding the sNDA for high-dose 2.0mg injectable semaglutide. Recall, Novo initially filed the application with FDA on January 20, 2021 (previous FENIX insight). Novo plans to re-file in Q2 ’21. Below, FENIX provides thoughts on the high-dose semaglutide delay in the context of Lilly’s high-dose Trulicity and tirzepatide assets.

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