Biweekly Endocrinology video recap covering regulatory actions, clinical progress, data releases, and partnerships across global markets. Themes include new approvals and launches, late-stage readouts, AI-enabled tools, and precision-medicine initiatives.
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Top Stories Covered in This Video
Chapters
0:00 Introduction
0:09 China approves Sciwind Biosciences Xianyida for type 2 diabetes
0:29 FDA clears Phase 3 program for pilavapadin in DPNP
1:02 $4.7M AI closed-loop insulin project, UVA–CU Anschutz–UCSF collaboration
1:37 BioMed X and Government of Barbados launch DKD precision initiative
2:08 Eli Lilly’s Mounjaro, tirzepatide, now available in New Zealand after Medsafe priority review
2:31 Dexcom Stelo adds AI nutrition logging and personalized insights
2:55 Novo Nordisk CagriSema tops Ozempic in head-to-head T2D trial, REIMAGINE 2
3:31 Roche unveils Accu-Chek SmartGuide predictive CGM in Kuwait, Saudi Arabia, and Qatar
3:58 How to reach us
Transcript
Welcome to the latest edition of Endocrinology updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
China has approved Sciwind’s Xianyida for type 2 diabetes. The world’s largest adult diabetes population now has another incretin option, entering a crowded market with major global players already active. Expect competitive pressure that could influence pricing and formulary access.
In the United States, the FDA has cleared a Phase 3 path for pilavapadin in diabetic peripheral neuropathic pain. Following an end-of-Phase 2 meeting, the program will run two 12-week, placebo-controlled trials at 10 mg daily. Phase 2b showed pain reduction versus placebo using ADPS as the primary endpoint. With no objections from the agency, prescriber choice and payer reviews may shift as full data emerge.
A $4.7 million multicenter effort led by University of Virginia with CU Anschutz and UCSF aims to advance fully closed-loop insulin delivery. Backed by Breakthrough T1D and Helmsley, and supported in kind by Tandem and Arecor, the project will develop adaptive algorithms paired with ultra-rapid insulin to reduce the burden of meal and exercise inputs. Study design and control of confounders will determine how practice and reimbursement interpret outcomes.
BioMed X and the Government of Barbados have launched a precision project focused on early diabetic kidney disease in Barbadian patients with type 2 diabetes. Supported by an EU PharmaNext call, the team plans an AI driven “digital African twin” approach to biomarker discovery and stratified therapy. This signals upstream pipeline investment and modality expansion in an underrepresented population.
Access developments continue in Oceania. Eli Lilly reports that Mounjaro, tirzepatide, is now available in New Zealand for obesity and type 2 diabetes after Medsafe priority review. Label specifics were not detailed. Availability could affect local pricing dynamics and placement on formularies.
On the consumer technology front, Dexcom’s Stelo platform adds AI powered nutrition logging, a food database, meal tracking, and personalized daily insights with a nationwide rollout. By linking glucose data to everyday metabolic choices, these features may streamline initiation, adherence, and remote prescribing workflows.
Novo Nordisk’s CagriSema, the cagrilintide plus semaglutide combination, topped Ozempic in the Reimagine 2 head-to-head trial in type 2 diabetes over 68 weeks. Reported results show greater HbA1c reduction, minus 1.91 versus minus 1.76, and greater weight loss, 14.2 percent versus 10.2 percent, both statistically significant. Pending full data, these deltas could influence treatment ladders and payer negotiations.
Roche has unveiled Accu-Chek SmartGuide, an AI predictive CGM solution in the Middle East. It forecasts glucose trends from 30 minutes ahead to overnight, with availability reported in Kuwait, Saudi Arabia, and Qatar. Officials in the UAE highlight potential public health value, with the goal of reducing stress and improving adherence through anticipatory guidance.
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