Watch Our Video Summary Capturing Top Endocrinology News from the Last Two Weeks
From the EASD’s landmark guideline on diabetes distress and FDA approval of the oral acromegaly therapy Palsonify to CHMP’s positive opinion for the denosumab biosimilar AVT03—this episode’s signals are strong. We span clinical practice, biologics, diagnostics, and endocrine science, with regulatory milestones and therapeutic innovations across metabolic and endocrine care, underscoring patient-centered approaches and broader global access.
Top Stories Covered in This Video
🧠 EASD issues first guideline on diabetes distress [1] [EU • 22 Sep 2025]
Context: Developed under GRADE and RIGHT; panel included adults with T1D and T2D.
Key point: Recommends routine distress assessment and evidence-based psychological or psychoeducational support (specific tools not specified).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🦴 CHMP positive for AVT03 denosumab biosimilar (Prolia/Xgeva) [2] [EU • 24 Sep 2025]
Context: Alvotech develops and supplies; Dr. Reddy’s to register and commercialize in US/EU; EC decision pending.
Key point: Positive opinion spans osteoporosis and oncology-related bone indications, with planned UK filing via IRP.
Implication: Introduces competition that may affect pricing and formulary access.
🇨🇦 Celltrion wins Canada approval for denosumab biosimilars [3] [Canada • 25 Sep 2025]
https://biz.chosun.com/en/en-science/2025/09/25/7YNXZNDBZBHQFFL6BXI4PNFQ24/
Context: Health Canada approvals for STOBOCLO (osteoporosis) and OSENVELT (oncology bone complications, GCTB); full label per source.
Key point: Adds Canada to prior KR, EU, US clearances cited by the company.
Implication: Introduces competition that may affect pricing and formulary access.
💊 FDA approves Palsonify (paltusotine) for acromegaly in adults [4] [US • 25 Sep 2025]
Context: First once-daily oral SST2 agonist; supported by PATHFNDR-1 and PATHFNDR-2 Phase 3 trials; OLE data presented at ENDO 2025.
Key point: Indicated for adults not controlled by, or unsuitable for, surgery; company reports biochemical and symptom control.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Revvity–Sanofi to advance 4-plex T1D autoantibody IVD [5] [06 Oct 2025]
https://www.medtechdive.com/news/Revvity-Sanofi-diabetes-test-Kihealth-seed-round/802133/
Context: Assay to run on Revvity GSP; expands from existing 3-plex RUO; global submissions planned; access via Revvity labs.
Key point: Collaboration supports clinical validation and regulatory filings in US, Europe and other regions.
Implication: May expand screening, initiation, and follow-up at scale.
🧫 Hypothyroidism linked to higher SIBO risk, mitigated by LT4 [6] [06 Oct 2025]
Context: Prospective observational cohort plus TriNetX analyses; JCEM publication referenced; mechanisms not established.
Key point: Higher SIBO risk in hypothyroidism and autoimmune thyroiditis; lower risk observed among levothyroxine users.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Icovamenib 52-week durability signal in T2D subgroups [7] [06 Oct 2025]
Context: COVALENT-111 randomized, placebo-controlled Phase 2; efficacy centered on small 12-week cohorts after prior hold.
Key point: Sustained HbA1c reductions through Week 52 reported in severe insulin-deficient and GLP-1-treated subgroups (n small).
Implication: May influence prescriber choice and payer reviews pending full data.
🇨🇦 Zydus gets Health Canada nod for liothyronine tablets [8] [Canada • 06 Oct 2025]
Context: NOC for 5 mcg and 25 mcg T3; manufacturing at Ahmedabad SEZ; separate USFDA deflazacort approval noted.
Key point: Enables Canadian marketing of generic liothyronine, expanding North America footprint.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Emotional health is moving into routine diabetes care via formal EU guidance, not just best practice [1].
- Denosumab biosimilars are stacking up across EU and Canada, adding payer leverage against reference products [2, 3].
- An oral acromegaly option may shift away from depot injections if access aligns with reported efficacy and safety [4].
- Earlier T1D detection via multi-autoantibody IVDs could shift care upstream and standardize screening pathways [5].
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FAQ
What sets the EASD guideline apart?
It is the first to center on diabetes distress, urging routine assessment and structured interventions, developed under GRADE/RIGHT with patient input [1].
What is AVT03 and what did CHMP say?
AVT03 is a denosumab biosimilar referencing Prolia/Xgeva. CHMP issued a positive opinion; EC decision is pending. UK filing planned via IRP reliance route [2].
Which denosumab biosimilars did Celltrion get approved in Canada?
STOBOCLO for osteoporosis and OSENVELT for oncology-related bone indications and GCTB, with full label per source [3].
How does paltusotine change acromegaly management?
It is the first once-daily oral SST2 agonist approved in the US for adults not controlled by, or unsuitable for, surgery, potentially reducing injection burden [4].
What are Revvity and Sanofi developing?
A 4-plex autoantibody IVD for early Type 1 diabetes screening on the Revvity GSP platform, with validation and submissions planned in multiple regions [5].
Entities / Keywords
EASD; Diabetes distress; GRADE; RIGHT; Dr. Reddy’s; Alvotech; AVT03; Denosumab; Prolia; Xgeva; Celltrion; STOBOCLO; OSENVELT; Health Canada; Crinetics; Paltusotine; Palsonify; Acromegaly; Revvity; Sanofi; Autoantibody IVD; GSP platform; Hypothyroidism; SIBO; Levothyroxine; Biomea Fusion; Icovamenib; COVALENT-111; Zydus Lifesciences; Liothyronine.
References
- https://pharmacyupdate.online/2025/09/easd-launches-its-first-ever-clinical-practice-guideline-the-worlds-first-to-focus-on-diabetes-distress/
- https://www.indianpharmapost.com/news/lite/dr-reddys-receives-positive-chmp-opinion-from-ema-for-denosumab-avt03-17865
- https://biz.chosun.com/en/en-science/2025/09/25/7YNXZNDBZBHQFFL6BXI4PNFQ24/
- https://crinetics.com/crinetics-announces-fda-approval-of-palsonify-paltusotine-for-the-treatment-of-acromegaly-in-adults/
- https://www.medtechdive.com/news/Revvity-Sanofi-diabetes-test-Kihealth-seed-round/802133/
- https://www.gastroenterologyadvisor.com/news/hypothyroidism-history-linked-to-small-intestinal-bacterial-overgrowth/
- https://www.investing.com/news/sec-filings/biomea-fusion-reports-52week-results-from-phase-ii-diabetes-trial-93CH-4273690
- https://www.cnbctv18.com/market/zydus-lifesciences-share-price-gets-nod-from-health-canada-for-liothyronine-tablets-19704238.htm