Category Archives: Bolus Insulin

Biocon Receives Even More Form 483 Observations; Roche and Alnylam Partner for Hypertension RNAi; Dario Issues Preliminary Q2 ’23 Results and Business Update

Three cardiometabolic-related news items have been observed: Biocon announced FDA conducted two cGMP inspections at Biocon’s insulin manufacturing facility in Malaysia and issued eight Form 483 observations (view press release); Roche and Alnylam announced a strategic agreement to co-develop and co-commercialize zilebesiran for the treatment of hypertension; and Dario announced a new agreement with an undisclosed large regional health plan as well as preliminary Q2 ’23 results (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Tandem Mobi Receives FDA Clearance; Better Therapeutics’s AspyreRx Receives FDA Authorization for T2DM

Two cardiometabolic-related news items have been observed: Tandem announced FDA clearance of the Tandem Mobi insulin pump for PWD ≥6 years of age (view press release); and Better Therapeutics announced FDA authorized AspyreRx to provide cognitive behavioral therapy for adults with T2DM and held an associated investor call (view press release; webcast). Below, FENIX provides highlights and insights into the respective news items.

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Lilly to Acquire Sigilon Therapeutics; FDA Approves First Beta Cell Replacement Therapy for T1DM

Two cardiometabolic-related news items have been observed: Lilly announced it entered into an agreement to acquire Sigilon Therapeutics for ~$309.6M (view press release); and FDA approved Lantidra as the first beta cell replacement therapy for the treatment of T1DM in adults with severe hypoglycemia (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the future of T1DM cell therapies.

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ADA 2023 Key Press Releases (June 24)

On the second day of ADA 2023, ten cardiometabolic-related news items were observed from Lilly, Zealand, BI, Novo Nordisk, Biomea Fusion, Sciwind Biosciences, Medtronic, Vertex, and Esperion. Below, FENIX provides context and analysis for the announcements.

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EMA Raises Thyroid Safety Concern Over GLP-1RAs; Madrigal Presents New MAESTRO-NASH Data; Expanded Libre 2 Coverage in France; Bayer Initiates Finerenone CKD + T1DM study; Bigfoot RWE Data Published; Mannkind Initiates INHALE-3 Switching Study

A series of cardiometabolic-related news items have been observed from EMA, Madrigal, Abbott, Bayer, Bigfoot, and Mannkind. Below, FENIX provides highlights and insights in the respective news items.

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June CHMP Agenda; AstraZeneca Discontinues Oral GLP-1RA Development; Lilly Launches Insulin Affordability Awareness Campaign

Three cardiometabolic-related news have been observed: the CHMP agenda (view here) for this month’s meeting (June 19-22) has been released, including Jardiance’s EMPA-KIDNEY and Mounjaro obesity indication extensions; AstraZeneca announced it is discontinuing development of its oral, AZD0186 (view article); and Lilly announced a partnership with ADA and Adam Duvall to increase awareness of Lilly’s insulin affordability programs (view press release). Below, FENIX provides context and insight on the respective news items, including insight into how Novo’s OASIS 1 readout likely influenced AZ’s decision.

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Wegovy Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

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Senate Targets PBMs and Insulin Manufacturers; Zealand and Dario Q1 ’23 Earnings; Cytokinetics Initiates Ph1 Trial for Potential HFpEF Therapy

Four cardiometabolic-related news items have been observed: On May 10, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a widely covered hearing with Sanofi, Lilly, and Novo Nordisk’s CEOs as well as executives from top PBMs (view broadcast here); Zealand Pharma (view press release; slides) and Dario (press release) hosted their respective Q1 ‘23 earnings calls; and Cytokinetics announced the initiation of a Ph1 trial evaluating CK-4021586 (CK-586) as a potential treatment for HFpEF (view press release). Below, FENIX provides highlights and insights into the respective news items. 

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Sanofi Follows Lilly and Novo’s Insulin Price Cuts

Sanofi announced it will cut the Lantus WAC price by 78% and cap the monthly out-of-pocket cost at $35 for commercially insured patients. Additionally, Sanofi will cut the WAC price of Apidra by 70%. The move follows similar insulin price cuts by Lilly (previous FENIX insight) and Novo Nordisk (previous FENIX insight). According to the press release, the price decreases will take effect on January 1, 2024. Below, FENIX provides an updated insulin pricing analysis.

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