Tag Archives: Novo Nordisk

FTC Investigating Diabetes and Obesity Orange Book Patent Listings; Pfizer and Amarin Q1 ’24 Earnings Update

Three cardiometabolic-related news items have been observed: FTC has expanded its investigation targeting “junk patent listings” for Novo’s diabetes and weight loss drugs, among others (view press release); Pfizer hosted its Q1 ’24 earnings (press release; slides; infographic); and Amarin hosted its Q1 ’24 earnings call (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly Initiates Retatrutide CV and Renal Outcomes Study; Novo Initiates New Ph3 Cagrisema Maintenance Dose Study; US Senate Investigates Ozempic/Wegovy Pricing; Teladoc Q1 ’24 Earnings; Vance Swanson Joins Beta Bionics

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, US Senate HELP Committee, Teladoc, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news items.

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Icodec FDA Adcom Scheduled for May 2024

FDA has requested an adcom meeting on May 24, 2024, to discuss Novo Nordisk’s QW insulin icodec (view unpublished FDA document here). Recall, Novo previously disclosed FDA extended the icodec regulatory review by three months, with a decision now anticipated in Q3 2024 (previous FENIX insight). Below, FENIX provides insight on the potential implications and reasoning for an icodec adcom, including readthrough to Lilly’s QW insulin, efistora alfa.

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Lilly Loses Counterfeit Tirzepatide Lawsuit; EMA Finds No Link Between GLP-1RAs and Suicide Ideation; Diamyd Ph3 Recruitment Update

Three cardiometabolic-related news items have been observed: Lilly loses counterfeit tirzepatide lawsuit (view article); EMA found no link between GLP-1RAs and suicide ideation (view meeting highlights); and Diamyd reached a recruitment milestone for its Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo Expands Ginkgo Partnership; Dexcom Integrates New Remote Care Platform; LIB Presents Ph3 PCSK9i Data at ACC 2024

Three cardiometabolic-related news items have been observed: Novo Nordisk expanded its partnership with Ginkgo Bioworks to improve manufacturing, including T2DM and obesity (view press release); Dexcom has partnered with MD Revolution to integrate Dexcom’s CGMs with MD’s remote care management platform (view press release); and LIB Therapeutics presented PCSK9i data at ACC 2024 (view press release). Below, FENIX provides highlights and insights for the respective news items.

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ACC 2024: Novo, Roche/Alnylam, Esperion, Novartis, and Amarin Present New Data; Novo Resubmits Catalent Acquisition Application; AZ Initiates Ph2 Balcinrenone/Dapa Trial in CKD; Silence Publishes Ph1 Lp(a) Results; Teladoc CEO Steps Down

A series of cardiometabolic-related news items have been observed from Novo Nordisk, AstraZeneca, Roche/Alnylam, Esperion, Novartis, Amarin, Silence Therapeutics, and Teladoc. Below, FENIX provides highlights and insights for the respective news items.

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Novo acquires Cardior Pharmaceuticals; Novo initiates Ph2 Dual Agonist Trials in T2DM and Obesity; Esperion CLEAR Outcomes Investor Call

Three cardiometabolic-related news items have been observed: Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for its heart failure asset (view press release); Novo initiated two trials evaluating its GLP-1/GIP dual agonist in obesity (view CT.gov record) and T2DM (view CT.gov record); and Esperion hosted an investor event to discuss the CLEAR Outcomes FDA approval (view presentation). Below, FENIX provides highlights and insights for the respective news items.

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Novo Initiates Additional Ph3 Cagrisema T2DM Trials; CLEAR Outcomes Approved by FDA and Received Positive CHMP Opinion

Two cardiometabolic-related news items have been observed: Novo Nordisk initiated REIMAGINE 1 (view CT.gov record) and REIMAGINE 3 (view CT.gov record) as the third and fourth trials in its cagrisema T2DM pivotal program; Esperion announced FDA approved CLEAR Outcomes (view press release) and CHMP adopted a positive opinion (view press release). Below, FENIX provides highlights and insights for the respective news items.

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