Tag Archives: Diabetes

AZ and Regeneron Collaborate on Obesity Treatment Development

AstraZeneca and Regeneron announced a collaboration for the research, development, and commercialization of small molecule compounds against the GPR75 gene to treat obesity and related comorbidities. For context, genetic mutations in GPR75 have been linked to patients having a lower BMI and experiencing a 54% lower risk of obesity than those without the mutation. According to the press release, AZ and Regeneron will evenly split the research and development costs as well as any future profits.

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Finerenone Label and Website Analysis

Bayer recently announced 10mg and 20mg finerenone, branded as “Kerendia,” received FDA approval. The approval of finerenone is based on the positive results of the FIDELIO-DKD study which demonstrated an 18% RRR in the primary composite endpoint. Below, FENIX has conducted a Kerendia label and website analysis.

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Bydureon BCise US Pediatric Approval; Biocon FY Q1 ’22 (CY Q2 ’21) Earnings Update; Afrezza Pediatric Ph3 Trial Observed

A series of diabetes-related news items have recently been observed: AZ announced FDA approval of Bydureon BCise for patients 10-17 years of age with T2DM; Biocon hosted its FY Q1 ’22 (CY Q2 ’21) earnings call; and a CT.gov record has been observed for MannKind’s first Afrezza Ph3 pediatric study, called INHALE-1. Below, FENIX provides highlights and insights for the respective news items.

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Abbott, Roche, and Adocia Q2 ’21 Earnings Updates

Abbott (press release; view infographic) and Roche (press release; slides) hosted their Q2 ’21 earnings calls and provided updates to their respective diabetes businesses and Adocia provided its Q2 ’21 financial update. Below, FENIX provides highlights and insights for the respective news items.

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Leqvio PDUFA Date Disclosed; Verquvo EC approval; Ph1b Trial to Delay the Onset or Progression of T1DM Meets Primary Endpoint; Novartis and J&J Q2 ’21 Earnings Updates

Four cardiometabolic-related news items have been observed: Novartis hosted its Q2 ’21 earnings call (press release; slides) and disclosed the Leqvio (inclisiran) PDUFA date is on January 1, 2022; Merck and Bayer received EC approval of vericiguat, branded as “Verquvo,” for the treatment of symptomatic chronic HF (Merck press release here and Bayer press release here); IM Therapeutics announced positive topline results from a Ph1b study evaluating IMT-002 in adults with T1DM and the HLA-DQ8 gene; and Johnson & Johnson hosted its Q2 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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Ascensia Launches Patient Assistance Program for Eversense; Dario Digital Health Contract; Xeris EU Distribution Agreement for Ogluo; Medtronic Extended Wear Infusion Set 510(k) Clearance; Nimium Partnership for G3PP Activator Development; TempraMed Launches Insulin Cooler Cap

Six cardiometabolic-related news items have been observed from Ascensia, Dario, Xeris, Medtronic, Nimium Therapeutics, and TempraMed. Below, FENIX provides context and analysis for the announcements.

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GSK Releases Positive Dapro Topline Results Day After Negative Roxa Adcom; Dexcom Cleared for Third-party Integration; New Medtronic Klue Trial Observed

A series of cardiometabolic-related news items have recently been observed: GSK announced positive topline results from five Ph3 studies in the ASCEND program evaluating daprodustat in patients with anemia due to CKD; Dexcom announced FDA has cleared Dexcom Partner Web APIs which now allows third-party integration with other digital health apps and devices; and a new Medtronic closed-loop trial leveraging its Klue acquisition has been observed. Below, FENIX provides highlights and insights for the respective news items.

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Novo Buys Cardiomyopathy Asset From Prothena; Teplizumab Receives UK Innovation Passport; Poxel Reorganizes Strategic Direction; Dario Announces New Employer Contracts; New Generic Sitagliptin Received Tentative Approval

Five cardiometabolic-related news items have recently been observed: Novo Nordisk and Prothena Corporation announced a definitive purchase agreement in which Novo has acquired Prothena’s clinical-stage antibody PRX004 and broader ATTR amyloidosis program; Provention Bio announced teplizumab was awarded an “Innovation Passport” in the UK for the delay of clinical T1DM in at-risk diabetes; Poxel announced a new strategic direction for its pipeline which focuses on high value, rare metabolic indications and NASH; Dario announced three new employer contracts; and Unichem Laboratories Limited announced tentative FDA approval of its generic sitagliptin. Below, FENIX provides highlights and insights for the respective news items.

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Finerenone Approved in US as “Kerendia”

Bayer announced the FDA approval of 10mg and 20mg finerenone, branded as “Kerendia,” to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal MI, and hHF in adults with CKD associated with T2DM (see logo below). The approval of finerenone is based on the positive results of the FIDELIO-DKD study and the timing comes in-line with FENIX’s projection. Recall, results from FIDELIO-DKD were presented at Kidney Week in October 2020 and demonstrated an 18% RRR in the primary composite endpoint. Finerenone is currently under review in the EU, China, and multiple other countries worldwide. FENIX will conduct a full label analysis of finerenone in the coming days once the label is available.

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