Tag Archives: CMS

Novo and Hims Take Another Turn at a Partnership; AbbVie Reports Topline Ph1 Amylin Data; Regeneron & Hansoh Share Ph3 Olatorepatide China Results; Lilly Releases Statement on CMS Obesity BALANCE Model; Zepbound KwikPen Available on Amazon; Veru Enrolls First Patient in Ph2b PLATEAU Study; Sequel Expands AID Launch 

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Hims & Hers, AbbVie, Regeneron Pharmaceuticals/Hansoh, Lilly, Amazon, Veru, and Sequel Med Tech. Below, FENIX provides highlights and insights into the respective news items.

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Trulicity on Medicare Negotiation List; Novo Outspends Lilly on GLP-1RA Advertising; Ro’s GLP-1RA Super Bowl Commercial

Three cardiometabolic-related news items have been observed: CMS included Lilly’s Trulicity for the third round of Medicare price negotiations (view press release); Novo spent nearly $500M on US advertising of Wegovy and Ozempic (view article); and Ro announced plans to air a “Healthier on Ro” Super Bowl commercial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Holiday Hangover: Novo Launches Wegovy Pill; Additional Companies Engage in MFN Deals; Pfizer Initiates Ph3 Obesity Program of MET097i; and More

Over the holiday period, a series of cardiometabolic news items were observed from Novo Nordisk, The White House, Pfizer, Cytokinetics, Resoundant, Sanofi, Skye Biosciences, MetaVia, Dexcom, Abbott, MannKind, BI/Rectify, Ascletis Pharma, Laekna Pharma, CMS, and Caliway Biopharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Novo Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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Lilly Requests to Join Compounding Lawsuit; 2026 Medicare/Medicaid Obesity Proposal; Novo Petitions FDA For Compounding

Three cardiometabolic-related news items have been observed: Lilly requested to join tirzepatide compounding lawsuit (view article); CMS and HHS released the 2026 policy and technical changes to the Medicare/Medicaid programs and included proposed guidance for anti-obesity medications (view document); and Novo Nordisk has continued to petition FDA to stop compounding of Victoza (view article). Below, FENIX provides highlights and insights for the respective news items.

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Study on Eligible Wegovy Patients through Medicare; Roche Q1 ’24 Earnings

Two cardiometabolic-related news items have been observed: a recent study from Kaiser showed that approximately 3.6M overweight or obese patients with heart conditions insured under Medicare could be eligible for Wegovy (view article); and Roche hosted its Q1 ’24 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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