Tag Archives: insulin

Abbott/Medtronic Strategic Partnership; Simplera Updates; Madrigal and MannKind Q2 ’24 Earnings

Three cardiometabolic-related news items have been observed: Abbott announced a partnership with Medtronic for the development of a new CGM that is exclusively compatible with Medtronic’s AID and smart insulin pens (press release); Medtronic announced the FDA approval of its Simplera CGM (press release); Madrigal (press release; slides) and MannKind (press release; slides) hosted their respective Q2 ’24 earnings. Below, FENIX provides highlights and insights for the respective news items, along with an analysis of the Abbott/Medtronic partnership.

This content is for Read Less members only.
Register
Already a member? Log in here

Tirzepatide SUMMIT HFpEF Topline Results; Regeneron, Alnylam, Ionis, Teladoc, Amarin, and Biomea Q2 ’24 Earnings; Antag Increases Series A Funding for GIP Antagonism; Sanofi Expands Insulin Manufacturing in Germany; Boston Pharmaceuticals MASH Updates

A series of cardiometabolic-related news items have been observed from Lilly, Regeneron, Alnylam, Antag Therapeutics, Sanofi, Boston Pharmaceuticals, Ionis, Teladoc, Amarin, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items, including initial thoughts on Lilly’s tirzepatide HFpEF results in the context of Novo’s STEP HFpEF and apparent regulatory delay.

This content is for Read Less members only.
Register
Already a member? Log in here

Lilly Partners for Cardiometabolic Drug Discovery; Insulet, 89bio, Arrowhead, and Akero Q1 ’24 Earnings; Medtronic Partners with Arecor for Implantable Pump; Senseonics Partners for Remote Care Platform; Noom Launches Movement Program for People on GLP-1RAs

A series of cardiometabolic-related news items have been observed from Lilly, Insulet, Arecor/Medtronic, Senseonics/Rimidi, 89bio, Arrowhead, Akero, and Noom. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Biocon CY Q3 ’20 (FY Q2 ’21) Earnings Update

Biocon hosted its CY Q3 ’20 earnings call (FY Q2 ’21) and provided updates to its biosimilar insulin portfolio. Unsurprisingly, much of the call was focused on COVID-19 treatments and the US Semglee (biosimilar glargine U100) launch. Of note, there was no mention of the biosimilar lispro or oral insulin tregopil programs. Below, FENIX provides highlights and insights from the call, including an analysis of the US Semglee weekly NRx.

This content is for Read Less members only.
Register
Already a member? Log in here

Biocon’s Malaysian Facility Passes Pre-Approval Glargine FDA Inspection

Biocon has issued a press release announcing they received the FDA “Establishment Inspection Report” for the bs-glargine pre-approval inspection of its Malaysian manufacturing facility. The closing of the inspection comes after several failed inspections over the past few years. Below, FENIX provides thoughts on Biocon passing its inspection, including the impact on the impending June 2020 bs-glargine FDA action date.

This content is for Read Less members only.
Register
Already a member? Log in here

Thoughts on FDA Bs-Insulin Draft Guidance; Did Development Just Get Easier?

Yesterday, FDA issued a new draft guidance titled, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” In the draft guidance, FDA outlines its updated thinking on the need for immunogenicity studies for biosimilar insulin products. Recall, on March 23, 2020, insulin products are being reclassified as biologics, and biosimilars will be governed by the 351(k) pathway. Below, FENIX provides an overview of the FDA’s new draft guidance and implications to the insulin market since it appears that the barriers to developing biosimilar insulins have been significantly reduced.

This content is for Read Less members only.
Register
Already a member? Log in here

New Ph1 LY900027 RAI Compound Could Be For Closed Loop

A Ph1 trial for a new Lilly compound (LY900027) has been observed on CT.gov. Below, FENIX provides thoughts on what the potential MOA could be particularly given the similarity in compound ID with Lilly’s ultra-rapid-acting insulin lispro (URLi), LY900014.

This content is for Read Less members only.
Register
Already a member? Log in here

New Biocon Ph1 Oral Insulin Trial

A CT.gov record for a new Ph1 trial evaluating Biocon’s oral insulin Tregopil has been observed. Of note, the trial is being conducted by Profil in Mainz, Germany. Below, FENIX provides thoughts and insights into insulin Tregopil’s development including the challenges and commercial opportunity particularly around cold chain storage in underdeveloped geographies.

This content is for Read Less members only.
Register
Already a member? Log in here