This week’s Endocrinology update highlights regulatory approvals, obesity and diabetes clinical findings, AI-driven risk prediction, and emerging metabolic disease strategies.

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💉 Sandoz wins EU approval for insulin biosimilars [1] [EU • 15 May 2026]

https://lesechos-comfi.lesechos.fr/press-release/sandoz-group-ag-etr-sandoz-confirms-european-commission-approval-for-biosimilars-bysumlog-insulin-lispro-and-dazparda-insulin-aspart-strengthening-position-in-diabetes-yU0l4dkOVov
Context: Sandoz said the European Commission granted marketing authorisation across the reference-medicine diabetes indications.
Key point: Bysumlog (insulin lispro) and Dazparda (insulin aspart) are prefilled-pen biosimilars developed by Gan & Lee Pharmaceuticals.
Implication: Introduces competition that may affect pricing and formulary access.

🧬 Rhythm reports setmelanotide data at ECE 2026 [2] [EU • 12 May 2026]

https://firstwordpharma.com/story/7423728
Context: Real-world France data and Phase 3 analyses linked setmelanotide with BMI, hunger, and cardiometabolic improvements.
Key point: Rhythm Pharmaceuticals presented six ECE 2026 posters, including acquired hypothalamic obesity and Bardet-Biedl syndrome analyses.
Implication: May influence prescriber choice and payer reviews pending full data.

🦶 Singapore builds diabetes amputation-risk AI [3] [Singapore • 15 May 2026]

https://www.healthcareitnews.com/news/asia/singapore-develops-diabetes-amputation-risk-ai-and-more-briefs
Context: The model aims to classify diabetes patients by lower-extremity amputation risk three to five years before ulcers or infections.
Key point: Singapore General Hospital, SingHealth, and MOHT developed LEA-Net using anonymised SingHealth patient-record data.
Implication: May expand screening, initiation, and follow-up at scale.

🧪 Thyroid hormone profiles linked to liver failure prognosis [4] [14 May 2026]

https://www.news-medical.net/news/20260514/Thyroid-hormone-profiles-provide-critical-prognostic-clues-for-patients-facing-liver-failure.aspx
Context: Low T3 and related thyroid profiles were described as complementary prognostic markers, not standalone treatment triggers.
Key point: A review examined thyroid hormone dysfunction, non-thyroidal illness syndrome, and acute-on-chronic liver failure.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧫 Genprex reports preclinical Type 2 diabetes gene therapy data [5] [US • 14 May 2026]

https://www.prnewswire.com/news-releases/genprex-collaborators-present-positive-preclinical-data-on-diabetes-gene-therapy-for-type-2-diabetes-at-the-2026-american-society-of-gene-and-cell-therapy-annual-meeting-302771907.html
Context: The preclinical study reported reversal of hyperglycemia and improved beta-cell function after pancreatic delivery.
Key point: Genprex collaborators presented AAV-Pdx1/MafA, also called GPX-002, data at ASGCT 2026 in Type 2 diabetic mouse models.
Implication: Signals pipeline investment and modality expansion.

🔁 PCOS renamed PMOS in global consensus [6] [Global • 12 May 2026]

https://www.prnewswire.com/news-releases/global-experts-establish-new-name-for-pcos-to-reflect-multisystem-disease-302768983.html
Context: Experts said PMOS better reflects endocrine, metabolic, reproductive, dermatological, and psychological features.
Key point: A global consensus study in The Lancet renamed polycystic ovary syndrome as Polyendocrine Metabolic Ovarian Syndrome.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🏥 Lupin receives US FDA approval for famotidine injection [7] [US • 13 May 2026]

https://www.prnewswire.com/news-releases/lupin-receives-us-fda-approval-for-famotidine-injection-usp-302771378.html
Context: The US FDA approved Lupin’s ANDA for IV famotidine in hospitalized patients and short-term oral-therapy alternatives.
Key point: Lupin’s Famotidine Injection USP, 20 mg/2 mL, is bioequivalent to Pepcid Injection and will be manufactured in Nagpur, India.
Implication: Introduces competition that may affect pricing and formulary access.

📲 Glooko and mylife expand diabetes data partnership [8] [Sweden–Switzerland • 12 May 2026]

https://www.businesswire.com/news/home/20260512745029/en/Glooko-and-mylife-Diabetes-Care-Expand-Diabetes-Data-Management-Partnership
Context: The agreement supports connected data management for mylife Loop powered by CamAPS FX and care teams.
Key point: Glooko will serve as mylife Diabetes Care’s primary data management platform for mylife products.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

Why It Matters

  • Diabetes access and affordability remain active themes, with Sandoz adding two EU-approved rapid-acting insulin biosimilars.
  • Diabetes technology is moving upstream, from device data management to AI-enabled risk prediction before complications appear.
  • Rare obesity care is becoming more data-rich, with setmelanotide analyses spanning real-world outcomes, Phase 3 measures, and disease burden.
  • Endocrine terminology is shifting toward multisystem framing, as PCOS becomes PMOS in a global consensus process.
  • Earlier-stage modalities remain active, with Genprex positioning GPX-002 as a beta-cell-focused gene therapy concept.

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FAQ

What did Sandoz receive approval for in Europe?

Sandoz said the European Commission approved Bysumlog (insulin lispro) and Dazparda (insulin aspart), both biosimilar insulins for diabetes mellitus. [1]

What did Rhythm report for setmelanotide at ECE 2026?

Rhythm described real-world and Phase 3 analyses in acquired hypothalamic obesity, plus research on hyperphagia in Bardet-Biedl syndrome. The source reports BMI, hunger, and cardiometabolic findings. [2]

What is Singapore’s LEA-Net diabetes AI intended to do?

LEA-Net is intended to predict lower-extremity amputation risk in diabetes patients three to five years before foot ulcers and infections develop. [3]

What is Genprex’s GPX-002?

GPX-002 is Genprex’s Pdx1/MafA diabetes gene therapy candidate. Collaborators reported preclinical mouse-model data showing reversal of hyperglycemia and improved beta-cell function. [5]

Why was PCOS renamed PMOS?

Experts said Polyendocrine Metabolic Ovarian Syndrome better reflects the condition’s endocrine, metabolic, reproductive, dermatological, and psychological features. [6]

What does the Glooko and mylife agreement cover?

Glooko will serve as mylife Diabetes Care’s primary data management platform, including support for mylife Loop powered by CamAPS FX. [8]

Entities / Keywords

Sandoz, Bysumlog, insulin lispro, Dazparda, insulin aspart, Gan & Lee Pharmaceuticals, Humalog, NovoRapid, insulin biosimilars
Rhythm Pharmaceuticals, setmelanotide, IMCIVREE, acquired hypothalamic obesity, Bardet-Biedl syndrome, hyperphagia, TRANSCEND
Singapore General Hospital, SingHealth, Ministry of Health Office for Healthcare Transformation, LEA-Net, diabetes amputation risk AI
Thyroid hormones, T3, FT3, FT4, TSH, non-thyroidal illness syndrome, acute-on-chronic liver failure, MELD, CLIF-C
Genprex, GPX-002, Pdx1, MafA, AAV-8, Type 2 diabetes, beta-cell function, ASGCT 2026
PCOS, PMOS, Polyendocrine Metabolic Ovarian Syndrome, University of Colorado Anschutz, The Lancet
Lupin, Famotidine Injection USP, Pepcid Injection, ANDA, US FDA, GERD, Zollinger-Ellison Syndrome
Glooko, mylife Diabetes Care, mylife Loop, CamAPS FX, CamDiab, automated insulin delivery, diabetes data management

References

  1. https://lesechos-comfi.lesechos.fr/press-release/sandoz-group-ag-etr-sandoz-confirms-european-commission-approval-for-biosimilars-bysumlog-insulin-lispro-and-dazparda-insulin-aspart-strengthening-position-in-diabetes-yU0l4dkOVov
  2. https://firstwordpharma.com/story/7423728
  3. https://www.healthcareitnews.com/news/asia/singapore-develops-diabetes-amputation-risk-ai-and-more-briefs
  4. https://www.news-medical.net/news/20260514/Thyroid-hormone-profiles-provide-critical-prognostic-clues-for-patients-facing-liver-failure.aspx
  5. https://www.prnewswire.com/news-releases/genprex-collaborators-present-positive-preclinical-data-on-diabetes-gene-therapy-for-type-2-diabetes-at-the-2026-american-society-of-gene-and-cell-therapy-annual-meeting-302771907.html
  6. https://www.prnewswire.com/news-releases/global-experts-establish-new-name-for-pcos-to-reflect-multisystem-disease-302768983.html
  7. https://www.prnewswire.com/news-releases/lupin-receives-us-fda-approval-for-famotidine-injection-usp-302771378.html
  8. https://www.businesswire.com/news/home/20260512745029/en/Glooko-and-mylife-Diabetes-Care-Expand-Diabetes-Data-Management-Partnership

 

 

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