Tag Archives: Ozempic

Novo Settles Counterfeit Semaglutide Lawsuits; New Ph2 Oral GLP-1RA Study from Jiangsu Hengrui Pharmaceuticals; CSL Fails CSL112 Pivotal Trial; Eversense E3 CGM Medicare Coverage; Biocon CY Q4 ’23 (FY Q3 ’24) Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Jiangsu Hengrui Pharmaceuticals, CSL, Ascensia, and Biocon. Below, FENIX provides highlights and insights for the respective news items.

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New Novo Once-Monthly Dual-Agonist; Icodec Delayed; Novo Q4 ’23 Earnings Updates

Novo Nordisk hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. The company made a number of important disclosures during the call, including a new QM GLP-1+GIP dual agonist in development, QW insulin icodec has been delayed in the US, STEP HFpEF has been filed in the US and EU, and more. Additionally, Novo reminded its 2024 CMD is being held on March 7, 2024. Of note, FENIX will also cover Novo’s London Q4 ’23 earnings call tomorrow, February 1, 2024. Below, FENIX provides highlights and insights from the call.

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JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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Holiday Hangover: FDA Issues Dasiglucagon CRL for CHI; Cytokinetics Ph3 Aficamten Results; NeuroBo Submits Obesity IND; New O5 Algorithm Trial Observed; Tirzepatide in T1DM Trial; Novo Warns Against Counterfeit Ozempic in US; Glucotrack Preclinical Implantable CGM Data

During the holiday break, a series of cardiometabolic-related news items were observed from Zealand, Cytokinetics, NeuroBo, Insulet, Royal North Shore Hospital, Novo Nordisk, and Glucotrack. Below, FENIX provides highlights and insights for the respective news items.

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Novo Expands Production Facilities in France; Novo to Reduce Production of Victoza for Ozempic Supply; Mounjaro vs. Ozempic in Real-World Study; Kaleido Launches AID System; Biodexa Acquires T1DM Asset; 89bio Long-term MASH Data; Dario Contracts for Cardiometabolic Solution

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Truveta, ViCentra, Biodexa, 89bio, and Dario. Below, FENIX provides highlights and insights for the respective news items.

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Zepbound (tirzepatide) Label and Website Analysis

FDA recently approved Lilly’s tirzepatide, branded as Zepbound, for the treatment of adults who are obese or overweight with weight-related comorbidities such as hypertension, T2DM, OSA, or CVD (view label; previous FENIX insight). Below, FENIX has conducted a Zepbound label, website, and pricing analysis, including thoughts on Lilly’s innovative targeting of employers.

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Novo Initiates Ph2 Cagrisema Trial in CKD and T2DM; Carmot Initiates Ph2 GLP-1/GIP RA Study in Obesity and T1DM; OptumRx Lowers Insulin Costs; Beta Bionics Gains Coverage for iLet Bionic Pancreas; Mark Estes Joins Biolinq; Belgium and Britain Ban Ozempic for Weight Loss

A series of cardiometabolic-related news items have been observed from Novo, Carmot Therapeutics, OptumRx, Beta Bionics, and Biolinq. Below, FENIX provides highlights and insights into the respective news items.

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SELECT Receives Priority Review; High-dose Oral Sema Delayed; Novo Q3 ’23 Earnings

Novo Nordisk hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Novo provided important new disclosures including SELECT’s priority review, a high-dose oral sema regulatory filing delay, and a new subcutaneous amycretin asset in Ph1 development. Below, FENIX provides highlights and insights from the call, including thoughts on why SC amycretin makes sense from a strategic standpoint.

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