Endocrinology news this week covers major developments, updates, launches and progress across the biopharma sector.
In Today’s Newsletter
💸 ACHP lands Helmsley grant for diabetes improvement [1] [US • 13 Oct 2025]
Context: PR Newswire notes a $4.2M award to ACHP to improve diabetes care and outcomes.
Key point: ACHP announced a grant from the Helmsley Charitable Trust to advance diabetes programs (specific endpoints not stated).
Implication: May expand screening, initiation, and follow-up at scale.
🤖 AI’s evolving role in diabetes care, expert view + early RCT [2] [13 Oct 2025]
Context: Medscape overview cites FDA-cleared DR screening AI, AID algorithm advances, and a 52-week randomized program.
Key point: Experts highlight growing adoption of AI across screening, prediction, decision support, and devices, with a 52-week RCT showing improved A1c and med de-intensification in T2D (details per article).
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.
🧪 PANTHERx to distribute MYCAPSSA for Chiesi [3] [US • 13 Oct 2025]
Context: Pittsburgh-dated PR; MYCAPSSA is oral octreotide for maintenance in acromegaly.
Key point: Chiesi chose PANTHERx Rare as exclusive specialty pharmacy for MYCAPSSA distribution and patient support.
Implication: May expand screening, initiation, and follow-up at scale.
🌬️ FDA accepts Afrezza pediatric sBLA, PDUFA set [4] [US • 13 Oct 2025]
https://finance.yahoo.com/news/mannkind-announces-u-fda-accepts-120500519.html
Context: Submission based on Phase 3 INHALE-1 in ages 4–17; Afrezza currently adult-approved.
Key point: FDA accepted MannKind’s sBLA for Afrezza for children and adolescents, with PDUFA 29 May 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
📉 Orforglipron tops Farxiga, hits endpoints in two Phase 3s [5] [15 Oct 2025]
Context: Type 2 diabetes program; Week-40 topline.
Key point: Lilly reported A1C reductions up to 1.7% vs dapagliflozin and up to 2.1% vs placebo, meeting primary endpoints and key secondary endpoints at 40 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Biocon Biologics + Civica launch private-label glargine in US [6] [US • 16 Oct 2025]
Context: Bridgewater, NJ and Bengaluru, India dateline; product to carry Civica label, CalRx in California.
Key point: Biocon will supply insulin glargine, Civica will commercialize under a private label using Biocon’s existing approval, aiming to increase affordable supply.
Implication: Introduces competition that may affect pricing and formulary access.
🧬 Sogroya once-weekly now available in Canada (peds + adults) [7] [Canada • 15 Oct 2025]
Context: Health Canada approval 26 Jul 2023; REAL-4 supported pediatric indication.
Key point: Novo Nordisk launched Sogroya in Canada as first once-weekly GH for both pediatric and adult GHD.
Implication: May influence prescriber choice and payer reviews pending full data.
🏷️ California to offer $11 CalRx insulin glargine pens [8] [US • 17 Oct 2025]
https://www.medscape.com/viewarticle/california-offer-11-calrx-branded-insulin-pens-2025a1000s49
Context: State partnership with Civica and Biocon; plan for 01 Jan 2026 availability, $55 per 5-pack suggested retail.
Key point: California plans interchangeable glargine pens at transparent low price to expand equitable access.
Implication: May expand screening, initiation, and follow-up at scale.
🦴 MR study links plasma proteins to osteoporosis risk [9] [17 Oct 2025]
https://bioengineer.org/mendelian-randomization-reveals-plasma-proteins-role-in-osteoporosis/
Context: Bioengineer.org summary of a forthcoming Clinical Proteomics paper; genetic instruments used.
Key point: Two-sample and two-step Mendelian randomization suggests causal roles and mediated pathways for circulating proteins in osteoporosis.
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.
Why it matters
Oral GLP-1 progress and pediatric insulin options point to broader choice in diabetes management.
Private-label and state-backed insulin efforts target affordability and supply stability.
Once-weekly somapacitan could improve adherence in GHD, including pediatrics.
Real-world deployment of AI and early randomized evidence may shift diabetes workflows.
Protein-target insights in osteoporosis hint at new biomarkers and therapeutic angles.
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FAQ
What did ACHP receive funding for, and from whom?
ACHP announced a $4.2M grant from the Helmsley Charitable Trust to improve diabetes care and outcomes, with specifics on endpoints not stated in the release [1]
What exactly did FDA accept from MannKind, and when is the decision due?
FDA accepted MannKind’s sBLA for Afrezza in children and adolescents 4–17 years. The PDUFA target action date is 29 May 2026 [4]
How strong were Lilly’s orforglipron Phase 3 diabetes results?
Topline showed A1C reductions up to 1.7% vs dapagliflozin and up to 2.1% vs placebo at Week 40, meeting primary and key secondary endpoints. Full datasets are pending a future meeting [5]
What does the Biocon Biologics–Civica deal change for US insulin?
Civica will commercialize Biocon’s insulin glargine under a private label using Biocon’s approval, including CalRx branding in California, to increase affordable supply [6]
When and at what price will California’s CalRx insulin pens be available?
Planned availability is 01 Jan 2026. Suggested retail is no more than $55 per 5-pack of 3-mL pens, or $11 per pen, with pharmacies paying $45 per pack [8]
What is new about Sogroya’s Canadian launch?
Sogroya (somapacitan) is now available in Canada as the first once-weekly GH for both pediatric and adult GHD, supported by REAL-4 data for children [7]
Entities / Keywords
ACHP; Helmsley Charitable Trust • AI in diabetes; automated retinal screening; AID algorithms • PANTHERx Rare; Chiesi; MYCAPSSA; octreotide • MannKind; Afrezza; inhaled insulin; INHALE-1 • Eli Lilly; orforglipron; oral GLP-1; AstraZeneca; Farxiga; dapagliflozin • Biocon Biologics; Civica Rx; insulin glargine-yfgn; CalRx • Novo Nordisk; Sogroya; somapacitan; GHD; REAL-4 • California HCAI • Osteoporosis; Mendelian randomization; Clinical Proteomics.
References
- https://www.morningstar.com/news/pr-newswire/20251013dc96219/achp-receives-42m-grant-to-improve-diabetes-care-and-outcomes-from-the-helmsley-charitable-trust
- https://www.medscape.com/viewarticle/artificial-intelligences-evolving-role-diabetes-care-2025a1000rik
- https://www.prnewswire.com/news-releases/pantherx-rare-selected-by-chiesi-for-the-distribution-of-mycapssa-302582168.html
- https://finance.yahoo.com/news/mannkind-announces-u-fda-accepts-120500519.html
- https://www.fiercebiotech.com/biotech/eli-lillys-orforglipron-bests-farxiga-padding-oral-glp-1-case-pair-phase-3-diabetes-wins
- https://www.biocon.com/biocon-biologics-and-civica-expand-partnership-and-launch-private-label-insulin-glargine-to-broaden-u-s-diabetes-treatment-options/
- https://www.newswire.ca/news-releases/sogroya-r-somapacitan-injection-now-available-in-canada-as-the-first-and-only-once-weekly-treatment-for-both-children-and-adults-living-with-growth-hormone-deficiency-869531625.html
- https://www.medscape.com/viewarticle/california-offer-11-calrx-branded-insulin-pens-2025a1000s49
- https://bioengineer.org/mendelian-randomization-reveals-plasma-proteins-role-in-osteoporosis/