Endocrinology Today—November 25, 2025

LucidQuest

5 days ago

This week’s Endocrinology update covers regulatory opinions, fundraising for novel therapeutics, real-world screening data, emerging cell-based treatments, academic trial findings, and public-health initiatives—plus more.

In Today’s Newsletter

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💉 EMA backs biosimilars for insulin glargine and denosumab [1] [EU • 17 Nov 2025]

https://www.medscape.com/viewarticle/eu-clears-path-biosimilars-diabetes-bone-health-2025a1000vxz
Context: CHMP positive opinions for Ondibta (insulin glargine; Gan & Lee) and Osqay (denosumab; Theramex). Final EC decisions pending.
Key point: Both candidates met biosimilarity criteria vs Lantus/Toujeo and Prolia, with comparable efficacy, safety, and PK/PD (endpoint specifics summarized by source).
Implication: Introduces competition that may affect pricing and formulary access.

🧪 AMH in PCOS IVF not tied to perinatal risk [2] [17 Nov 2025]

https://www.emjreviews.com/reproductive-health/news/high-amh-levels-do-not-impact-perinatal-outcomes-in-pcos/
Context: Retrospective cohort, 1,952 PCOS patients, first live birth after embryo transfer, 2016–2023.
Key point: No association between AMH level and adverse perinatal outcomes across fresh and frozen cycles, after adjustment.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🩺 Gestational diabetes screening program implementation report [3] [17 Nov 2025]

https://research.itg.be/en/publications/implementation-of-a-new-program-of-gestational-diabetes-screening/
Context: Report on implementing a new gestational diabetes screening program (details not stated).
Key point: Source flags implementation experience for a new screening approach; quantitative outcomes not provided.
Implication: May expand screening, initiation, and follow-up at scale.

💸 Skeletalis raises $8M for bone-targeted osteoporosis therapeutics [4] [17 Nov 2025]

https://femtechinsider.com/skeletalis-raises-8m-to-transform-osteoporosis-treatment-for-post-menopausal-women/
Context: Pillar VC led; platform aims for localized, bone-surface drug delivery; lead asset SKE-001.
Key point: Company cites FDA SABRE shift to BMD endpoints as enabling development path, per source.
Implication: Signals pipeline investment and modality expansion.

🦴 Romosozumab BMD gains independent of age in older women [5] [17 Nov 2025]

https://www.auntminnie.com/clinical-news/digital-x-ray/article/15772057/dexa-study-supports-use-of-romosozumab-in-older-women
Context: Prospective, multi-center analysis, 186 postmenopausal women, 12 months of therapy; Bone journal Jan 2026.
Key point: Mean BMD increased at spine and hip, with no significant association between response and age. Safety not assessed in scope.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 “Universal” iPSC line for islet therapies, immune-cloaked with safety switch [6] [17 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/17/3189000/0/en/Pluristyx-Collaborates-with-Breakthrough-T1D-to-Make-Immune-Cloaked-and-Safety-Switch-Enabled-Allogeneic-Cell-Line-for-Type-1-Diabetes-Therapies.html
Context: Pluristyx–Breakthrough T1D collaboration, up to $1.4M; iACT immune cloaking + FailSafe safety switch engineered into FDA DMF-registered iPSC line.
Key point: Goal is an allogeneic, licenseable starting material to enable islet replacement without chronic immunosuppression.
Implication: Signals pipeline investment and modality expansion.

🍬 Oral insulin slowed progression to clinical T1D in at-risk kids (POInT) [7] [18 Nov 2025]

https://www.miragenews.com/oral-insulin-delays-type-1-diabetes-onset-in-at-1571904/
Context: European, phase II, randomized, placebo-controlled, 1,050 children with genetic risk; The Lancet.
Key point: Did not prevent autoantibody development, but delayed progression among those who developed autoantibodies; genotype-specific signal noted.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

📣 Digital advocacy in women’s hormonal health, clinician-led [8]

https://endocrinenews.endocrine.org/reaching-out-digital-advocacy-in-womens-hormonal-health/
Context: Profile of Omodamola Aje, MD, building evidence-based social content on menopause, PCOS, thyroid, diabetes.
Key point: Platform aims to counter misinformation, improve health literacy, and guide clinic conversations, without diagnosis or prescribing.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.

🌍 World Hormone Day set for 24 Apr 2026, ESE to lead campaign [9] [21 Nov 2025]

https://www.eurekalert.org/news-releases/1107012
Context: European Society of Endocrinology announcement; resources available from Jan 2026; #BecauseHormonesMatter.
Key point: Global awareness initiative following 2025 campaign reach cited by source.
Implication: May expand screening, initiation, and follow-up at scale.

🧬 FDA approves Redemplo (plozasiran) for FCS triglyceride reduction [10] [US • 20 Nov 2025]

https://www.endocrinologyadvisor.com/news/fda-approves-redemplo-for-familial-chylomicronemia-syndrome/
Context: ApoC-III-directed siRNA; PALISADES phase 3 randomized, placebo-controlled, double-blind trial in adults with FCS on low-fat diet.
Key point: Met primary endpoint, significant TG reduction vs placebo; common AEs included hyperglycemia, headache, nausea, injection-site reactions.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 “Hybrid” immune system cures T1D in mice with gentle conditioning + islet transplant [11] [18 Nov 2025]

https://med.stanford.edu/news/all-news/2025/11/type-1-diabetes-cure.html
Context: Stanford preclinical study; low-dose conditioning, donor blood stem cells plus islets; JCI publication.
Key point: Prevented or reversed autoimmune diabetes without chronic immunosuppression or GVHD in mice, per source.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Biosimilars in diabetes and osteoporosis may broaden access and affect EU pricing dynamics.
Romosozumab real-world BMD data could support use in the oldest patients where fracture risk is highest.
FDA approval of plozasiran adds an RNAi option for a rare, high-burden lipid disorder with pancreatitis risk.
Oral insulin signals progress toward antigen-specific prevention strategies in pediatric T1D.
New iPSC tools and preclinical transplant approaches point to accelerating cell-therapy development paths.

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FAQ

What did EMA’s CHMP recommend for diabetes and bone health?

Ondibta (insulin glargine biosimilar to Lantus/Toujeo) and Osqay (denosumab biosimilar to Prolia) received positive opinions, now pending EC decision [1]. These met biosimilarity criteria on efficacy, safety, and PK/PD per source.

Does AMH predict perinatal outcomes in PCOS IVF patients?

In a 1,952-patient retrospective cohort, AMH level was not associated with adverse perinatal outcomes across fresh and frozen cycles after adjustment, per EMJ summary [2].

How strong is the romosozumab evidence cited here?

Prospective, multi-center analysis of 186 older postmenopausal women found significant BMD gains with no age-response association; safety and adherence were outside scope, and larger cohorts are ongoing [5].

What is Redemplo (plozasiran) approved for and on what data?

FDA approved Redemplo to reduce triglycerides in adults with FCS, based on PALISADES phase 3 showing significant TG reduction vs placebo; common AEs included hyperglycemia, headache, nausea, and injection-site reactions [10].

Did oral insulin prevent T1D entirely in at-risk children?

No. In POInT, oral insulin did not prevent autoantibody development but delayed progression to clinical diabetes among children who became autoantibody-positive; a genotype-specific signal was noted [7].

What is the Pluristyx–Breakthrough T1D project building?

A genetically engineered, FDA DMF-registered iPSC line with immune cloaking (iACT) and a drug-inducible FailSafe safety switch to enable allogeneic islet manufacturing without chronic immunosuppression [6].

Entities / Keywords

EMA CHMP; Ondibta insulin glargine; Osqay denosumab; Prolia; Lantus; Toujeo; PCOS; AMH; IVF; romosozumab (Evenity); BMD; Pluristyx; Breakthrough T1D; iPSC; iACT; FailSafe; POInT trial; oral insulin; Redemplo; plozasiran; apoC-III; FCS; World Hormone Day; European Society of Endocrinology; digital health advocacy.