Tag Archives: FDA

Regeneron Q2 ‘25 Earnings; Medicare + Medicaid Potentially to Cover AOMs; Leqvio Label Expansion as Monotherapy

Three cardiometabolic-related news items have been observed: Regeneron Pharmaceuticals hosted its Q2 ‘25 earnings call (press release; slides); Medicare/Medicaid announced it plans to cover AOMs as part of 5-year experiment (view article); and Novartis announced its Leqvio received FDA approval for a label expansion as a monotherapy to treat adults with hypercholesterolemia (view press release). Below, FENIX provides highlights and insights for the respective news items.

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July CHMP Agenda; MiniMed 780G CE Mark for Expanded Indication; Dexcom Receiver Recall  

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (July 21-24) has been released (view here); Medtronic announced its MiniMed 780G pump received CE Mark for ages 2+ years of age, T2DM, and during pregnancy (view press release); and FDA announced Dexcom’s CGM receivers have been recalled for faulty alert sounds (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s EU semaglutide MASH regulatory strategy.

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AstraZeneca Ph3 Baxdrostat Topline Results; FDA Approves Bayer’s Kerendia for HFpEF; Mattel Launches Barbie with T1DM 

Three cardiometabolic-related news items have been observed: AstraZeneca announced positive Ph3 topline results for baxdrostat in hypertension (view press release; view CT.gov record), Bayer announced FDA approval of Kerendia’s (finerenone) HEpEF indication (view press release), and Mattel announced the launch of a Barbie with diabetes (view press release). Below, FENIX provides highlights and insights for the respective news items.

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FDA Publishes Slew of CRLs in Effort to Increase Transparency

FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.

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Viking Initiates its Ph3 Study for VK2735; Rivus Shares Topline Ph2 Data in MASH; Lilly Initiates New Ph2 Study of Naperiglipron in Obesity and Ph3 Study of Retatrutide in CLBP; Letter to FDA Pushing for T1DM Treatments; MindRank Announces Ph2b Data for its Oral GLP-1RA 

A series of cardiometabolic-related events has been observed from Viking Therapeutics, Rivus Pharmaceuticals, Lilly, FDA, and MindRank. Below, FENIX provides highlights and insights for the respective news items.

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