Category Archives: Other

Dexcom G7 Super Bowl DTC; Medtronic Initiates 780G+DS5 GCM Trial; Forxiga Receives EU Approval for Chronic HF; Merck Initiates Vericiguat Pediatric HF Trial

Four cardiometabolic-related news items have been observed: Dexcom announced plans for a second Super Bowl DTC for the G7 CGM US launch (view press release; commercial); Medtronic initiated a trial evaluating the MiniMed 780G insulin pump used in combination with the DS5 CGM (Simplera) as well as the Medtronic extended infusion set and reservoir (view CT.gov record); Forxiga (dapagliflozin) has received EU approval to expand its HF indication regardless of LVEF (view Forxiga EPAR); and Merck initiated a Ph2/3 trial evaluating the vericiguat in pediatric patients aged 28 days to 18 years (VALOR; view CT.gov record). Below, FENIX provides highlights and insights from the respective news items including commentary on how the Medtronic study could suggest the company may not believe it can achieve iCGM designation.

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Sanofi and Regeneron Q4 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed: Sanofi (press release; slides) and Regeneron (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.

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Lilly, Merck, and Roche Q4 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Lilly (press release; slides), Merck (press release; slides), and Roche (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.

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GSK’s Daprodustat Approved by FDA

FDA announced the approval of GSK’s daprodustat as Jesduvroq for the treatment of CKD anemia in dialysis-dependent (DD) patients. The approval comes after multiple CRLs for Fibrogen/AZ’s roxadustat and Akebia/Otsuka’s vadadustat. The Jesduvroq label has not yet been observed. Below, FENIX provides brief thoughts on the Jesduvroq approval.

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Amgen, Novartis, and Lannett Q4 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed. Amgen (press release; slides), Novartis (press release; slides), and Lannett (press release) hosted their respective Q4 2022 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.

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Diabetes Research Institute Appoints Matthias von Herrath as Scientific Director; Nemaura Receives First proBEAT Purchase Order from HealthFleet

Two cardiometablic-related news items have been observed: The Diabetes Research Institute announced the appointment of its new scientific director, Matthias von Herrath (view press release; LinkedIn); and Nemaura Medical announced it has received an initial purchase order for 5,000 proBEAT subscriptions from HealthFleet Inc. (view press release). Below, FENIX provides highlights and insights including commentary on Matthias von Herrath’s potential impact on the DRI’s T1DM mission in the context of his current role as VP and Senior Medical Officer for Novo Nordisk.

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Abbott Q4 ’22 Earnings; Tidepool Loop Receives FDA Clearance; Lilly to Expand Incretin Manufacturing Capacity; Novo Receives Marketing Practices Complaint; AGC Biologics to Manufacture Tzield; Nemaura Reports Positive Miboko Data; J&J Q4 ’22 Earnings; and Embecta Opens New Headquarters

A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.

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Another Branded SGLT2i Approved by FDA; Tandem Completes AMF Medical Acquisition; January CHMP Agenda

Three cardiometabolic-related news items have been observed: TheracosBio announced FDA approved Brenzavvy (bexagliflozin), a QD 20mg oral SGLT2i, for the treatment of T2DM (view press release; label); Tandem announced it completed the acquisition of AMF Medical (view press release); and the CHMP agenda (view here) for this month’s meeting (January 23-26) has been released. Below, FENIX provides highlights and insights into the respective news items including an in-depth analysis of Brenzavvy could be another Nesina.

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FDA Accepts OCA NASH NDA; Palatin Initiates Ph2b DKD Trial

Two cardiometabolic-related news items have been observed: Intercept announced FDA has accepted the NDA for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to NASH (view press release); and Palatin Technologies announced that its Ph2b BREAKOUT study (CT.gov record not observed), evaluating melanocortin agonist bremelanotide in DKD, initiated enrollment in December 2022 (view press release). Below, FENIX provides highlights and insights for the respective news items, including commentary on the future of OCA’s NASH indication.

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Diamyd Initiates Ph2 Trial in At-risk Individuals; Teladoc Cuts 300 Jobs; Merck to Resolve Sitagliptin Contamination Issue

Three cardiometabolic-related news items have been observed: Diamyd initiated a new Ph2 trial evaluating its vaccine in individuals at risk for T1DM (DiaPrecise; view CT.gov record); Teladoc disclosed it is laying off 300 employees which represent 6% of its workforce (view Form 8-K); and Merck has determined the source of the sitagliptin NTTP contamination issue (view article). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Diamyd’s development plan in the context of the ongoing Tzield launch.

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