Tag Archives: iLet Bionic Pancreas

Novo Initiates Ph2 Cagrisema Trial in CKD and T2DM; Carmot Initiates Ph2 GLP-1/GIP RA Study in Obesity and T1DM; OptumRx Lowers Insulin Costs; Beta Bionics Gains Coverage for iLet Bionic Pancreas; Mark Estes Joins Biolinq; Belgium and Britain Ban Ozempic for Weight Loss

A series of cardiometabolic-related news items have been observed from Novo, Carmot Therapeutics, OptumRx, Beta Bionics, and Biolinq. Below, FENIX provides highlights and insights into the respective news items.

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Novo Hires Private Contract Manufacturer for Wegovy Assembly and Packaging; Roche’s Tubeless Patch Pump System Receives 510(k) Clearance; Beta Bionics Introduces iLet Bionic Pancreas; NeuroBo Doses First Patient for Ph2a DA-1241 Study in NASH

Four cardiometabolic-related news items have been observed: Novo Nordisk has reportedly hired PCI Pharma Services to handle Wegovy pen assembly (view article); Roche announced it has obtained 510(k) clearance from FDA for its Accu-Chek Solo micropump system for individuals aged 2 years and older with T1DM (view press release); Beta Bionics posted a video on LinkedIn introducing the iLet Bionic Pancreas in a webinar titled, “Introduction to the iLet Webinar” (view LinkedIn post); and NeuroBo Pharmaceuticals announced the dosing of the first patient in its Ph2a trial evaluating DA-1241, a novel G-protein-coupled receptor 119 (GPR119) agonist for the treatment of NASH (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Beta Bionics Secures $100M in Series D Funding; Senators Ask for Clarity on Lilly, Novo, and Sanofi’s Low-cost Insulin Products

Two cardiometabolic-related news items have been observed: Beta Bionics announced its Series D funding round has been closed at $100M (view press release); and senators have sent a letter to the CEOs of Lilly, Novo Nordisk, and Sanofi asking for greater clarification on how patients may participate in each company’s Patient Assistance Programs to obtain insulin at an affordable price (view letter; view article). Below, FENIX provides highlights and insights for the respective news items.

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FDA Clears Beta Bionics iLet ACE Pump and iLet Dosing Decision Software

FDA announced it has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software, which form the insulin-only iLet Bionic Pancreas. A press release from Beta Bionics has not yet been observed. Recall, in May 2022, Beta Bionics presented results from its pivotal iLet Bionic Pancreas trial (view CT.gov record) at ATTD 2023 and disclosed that data from the trial was included in the comprehensive submission packaged filed with FDA (previous FENIX insight). Below, FENIX provides initial thoughts on the iLet approval.

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