Category Archives: Topics

Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into the respective news items.

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EASD Key Press Releases (Oct 5)

On the fourth day of EASD 2023, seven key news items were observed from BI/Zealand, Novo Nordisk, Fractyl, Sernova, Dexcom, and Biomea. The following topics are covered below (hyperlinks to external items):

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EASD Key Press Releases (Oct 4)

On the third day of EASD 2023, four key news items were observed from Lilly, Vertex, Phillips-Medisize, and Welldoc. The following topics are covered below (hyperlinks to external items):

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EASD 2023 Key Press Releases (Oct 03)

On the second day of EASD 2023, three key news items were observed from the Biden-Harris administration, Novo Nordisk, and Galectin Therapeutics. The following topics are covered below (hyperlinks to external items):

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EASD 2023 Key Press Releases (Oct 02)

On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external items):

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Structure Announces Positive Topline Results from Ph1b Oral GLP-1RA Study; Better Therapeutics Completes Enrollment of AspyreRX Clinical Program in T2DM; Madrigal Commences $500M Public Offering

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced positive topline results from its Ph1b MAD study evaluating QD doses of GSBR-1290, its oral GLP-1RA, in healthy overweight or obese individuals and provided updates regarding its GSBR-1290 development program (view press release); Better Therapeutics announced it completed enrollment of the AspyreRx clinical program to provide cognitive behavioral therapy for adults with T2DM (view press release); and Madrigal announced it commenced its $500M public offering in shares of its common stock and pre-funded warrants (view press release). Below, FENIX provides highlights and insights into the respective items.

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Ozempic Label Update; AZ, BMS, Merck, and BI to Participate in Medicare Price Negotiations; FDA and Health Canada Clear Expansion Portion of Biomea’s Ph2 Oral Menin Inhibitor Trial in T2DM

Three cardio-metabolic related news items have been observed: FDA updated the Ozempic label to include ileus (intestinal blockage) as an adverse reaction reported post-approval (view updated label); AZ, BMS, Merck, and BI have reportedly agreed to participate in the first round of Medicare price negotiations (view article); and Biomea Fusion announced FDA and Health Canada cleared the expansion portion of its Ph2 COVALENT-111 study evaluating BMF-219, an oral covalent menin inhibitor, in T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Rockley Photonics Progresses Non-Invasive, Optical Blood Glucose Monitoring; Intercept to be Acquired by Alfasigma; EMA to Discuss GLP-1RA-Associated Aspiration Risks; Kallyope Initiates Ph2 trial of Oral Obesity and T2DM Treatment

Four cardiometabolic-related news items have been observed: Rockley Photonics announced it is continuing to make progress on non-invasive glucose sensing with its wearable silicon photonics-based sensor (view press release); Intercept announced it has entered a definitive agreement to be acquired by Alfasigma (view press release); EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will reportedly be discussing aspiration-related risks associated with GLP-1RAs in its September 2023 meeting (view article); and Kallyope announced it initiated a Ph2 trial evaluating K-757 and K-833, oral nutrient receptor agonists, for the treatment of obesity and T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Novo Partners with Valo Health for CVD and Evotec for Cardiometabolic Drug Discovery Accelerator; Zucara Doses First Patient in Ph2a ZONE Trial; Merck Initiates Efinopegdutide Study in Hepatic Impairment; Senseonics Completes Adult Arm of ENHANCE Pivotal Study; NeuroBo Posts Ph2 DA-1241 Trial in NASH to CT.gov

A series of cardiometabolic-related news items have been observed from Novo, Zucara, Merck, and NeuroBo. Below, FENIX provides highlights and insights into the respective news items.

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FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. Below, FENIX provides highlights and insights into the respective news items.

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