Tag Archives: Bayer

Novo Nordisk and Heartseed Dose First Patient in Ph1/2 LAPiS Trial of HS-001; Finerenone Receives EU Approval for FIGARO-DKD Label Extension

Two cardiometabolic-related news items have been observed: Novo Nordisk and Heartseed announced the first patient has been dosed in the Ph1/2 LAPiS study (view CT.gov record) evaluating HS-001 in 10 patients with advanced HF caused by ischemic heart disease (view press release); and Kerendia (finerenone) has received EU approval for label extension to include CV outcomes in patients with CKD and T2DM (view Kerendia EPAR). Below, FENIX provides highlights and insights from the respective news items.

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Lilly Partners with Sosei Heptares for Metabolic Drug Discovery; FIGARO-DKD and DELIVER Positive CHMP Opinions

Three cardiometabolic-related news items have been observed: Sosei Heptares announced an R&D collaboration with Lilly for diabetes and metabolic diseases (view press release); Bayer announced Kerendia (finerenone) received a positive CHMP opinion for the FIGARO-DKD study (view press release); AZ’s Forxiga received a positive CHMP opinion to broaden its HF indication based on results from DELIVER (view opinion). Below, FENIX provides highlights and insights on the Lilly partnership and respective positive CHMP opinions.

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Amgen Post-AHA 2022 Pipeline Update; Senseonics, Bayer, and MannKind Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Amgen hosted a post-AHA investor call and provided updates on its General Medicine Portfolio (view slides; view webcast); and Senseonics (press release), Bayer (press release; slides), and MannKind (press release; slides) hosted their Q3 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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Dexcom Q3 ’22 Earnings Update; Kerendia Receives New Recommendations from ADA and KDIGO

A series of cardiometabolic-related news items have been observed: Dexcom hosted its Q3 ’22 earnings call (press release; slides); and Bayer announced that Kerendia (finerenone) received a favorable recommendation from both ADA and KDIGO for the treatment of CKD associated with T2DM. Below, FENIX provides highlights and insights for the respective new items.

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Kerendia Label Updated to Include FIGARO-DKD Data

Bayer announced Kerendia received FDA approval for an updated label to include findings from the FIGARO-DKD CVOT (view updated label). Recall, FIGARO demonstrated a 13% RRR in the primary composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hHF) in patients with CKD and T2DM (previous FENIX insight). For context, Kerendia was approved with data from the FIDELIO-DKD trial, a sister study to FIGARO. Below, FENIX provides thoughts on the new Kerendia CKD label extension, including read-through to the SGLT2i class.

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Insulet, Provention Bio, Bayer, and Regeneron Q2 ‘22 Earnings Updates; Abbott Partners with WeightWatchers

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), Bayer (press release; slides), and Regeneron (press release; slides) hosted their respective earnings calls; and Abbott announced a partnership with WeightWatchers for Libre CGM data integration. Below, FENIX provides highlights and insights for the respective new items.

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Novo Sues Orbicular Pharmaceuticals Over Generic Saxenda; Sema Ph2 NASH Trial Disappoints; Kerendia Receives New Recommendations from ADA; Sanofi Cuts Insulin Price and Partners with Direct Relief; Novartis to Cut 8,000 Jobs Worldwide; Lifescan Publishes Connected BGM RWE

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Bayer, Sanofi, Novartis, and Lifescan. Below, FENIX provides highlights and insights for the respective new items.

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Bayer Presents New Finerenone Analysis; Lilly to Invest $2.1B in Additional Manufacturing Capacity; Oramed Granted Combination Therapy Patent for Oral GLP-1+Insulin

Three cardiometabolic-related news items have been observed: During the ESC’s 2022 HF Congress, Bayer presented late-breaking data from an exploratory FIDELITY post hoc analysis; Lilly announced plans to invest $2.1B in new Indiana manufacturing sites; and Oramed recently announced it has been granted a US patent for its oral GLP-1RA+insulin combination therapy in T2DM. Below, FENIX provides highlights and insights for the respective new items.

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Senseonics, Viatris, and Bayer Q1 ’22 Earnings Updates; Novo and Flagship Pioneering Collaboration; First Patient Dosed in Adocia Ph3 BC Lispro Trial

A series of cardiometabolic-related news items have been observed: Senseonics hosted its Q1 ‘22 earnings call (press release); Novo Nordisk announced a strategic collaboration with Flagship Pioneering for the development of novel research programs in cardiometabolic and rare diseases; Viatris (press release; slides) and Bayer (press release; slides) hosted their respective Q1 ’22 earnings calls; and Adocia announced the first patient has been dosed in its Ph3 BC Lispro program being conducted by partner Tonghua Dongbao (THDB). Below, FENIX provides highlights and insights for the respective new items.

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AZ/Ionis Ph2b Data @ ACC 2022; Novartis Restructures Pharma Business; Eversense E3 Launched in the US; Dexcom ONE to Launch in UK; New Sota and Kerendia Subanalyses @ ACC 2022; Fractyl Receives IDE for Second Pivotal Trial

A series of cardiometabolic-related news items have been observed from AZ/Ionis, Novartis, Ascensia/Senseonics, Dexcom, Lexicon, Bayer, DiaMedica, and Fractyl. Below, FENIX provides highlights and insights for the respective new items.

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