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Samsung Bioepis and Epis NexLab Collaborate with G2GBIO on Long-Acting Semaglutide Development

Shots: Samsung Bioepis & Epis NexLab have entered a research collaboration & license agreement with G2GBIO to develop novel therapeutics using proprietary microsphere-based sustained-release technology As per the deal, Samsung Bioepis will receive full licensing rights to a long-acting Semaglutide asset, an option to license another asset, & first negotiation rights for three additional assets,…

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Novo-Nordisk

Novo Nordisk Reports P-III (REIMAGINE 2) Trial Data on CagriSema for Type 2 Diabetes

Shots: The P-III trial evaluated CagriSema (SC; QW), a fixed-dose combination of cagrilintide & semaglutide, at two dose levels (2.4mg/2.4mg & 1mg/1mg) vs semaglutide (2.4 & 1mg), cagrilintide (2.4mg) alone, & PBO in 2,728 pts with T2D inadequately controlled with metformin ± an SGLT2 inhibitor At 68wks., CagriSema (2.4/2.4mg) outperformed semaglutide (2.4mg), reducing HbA1c by…

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Novo-Nordisk

Novo Nordisk Reports the US FDA’s NDA Submission of CagriSema for Weight Management

Shots: The U.S. FDA has accepted the NDA for Novo's CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg) to support long-term weight loss & maintenance in adults with obesity or overweight & ≥1 related comorbidity, alongside lifestyle intervention NDA was supported by the P-III (REDEFINE 1) trial assessing CagriSema (QW) vs semaglutide 2.4mg alone, cagrilintide 2.4mg alone,…

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Ascletis Advances ASC37 as an Oral Triple Agonist for Metabolic Disease

Shots: Ascletis Pharma has selected ASC37 tablets (PO), a GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate ASC37, utilizing Ascletis’ POTENT tech, showed an average of 4.2% absolute oral bioavailability, higher than semaglutide, tirzepatide, & retatrutide in oral SNAC formulations, & ~57-fold greater AUC vs retatrutide (PO) in NHP studies, with an observed t½ of…

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Novo-Nordisk

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…

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Novo-Nordisk

Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data on CagriSema for Cardiovascular Risk Factors

Shots: The post hoc analysis of P-III (REDEFINE 1) trial assessed CagriSema (cagrilintide 2.4mg & semaglutide 2.4mg) vs PBO & individual components effects on CV risk factors in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without T2D Trial showed CagriSema reduced systolic BP by -10.9 mmHg over 68wks. (vs -8.8 with semaglutide, & -2.1 with PBO),…

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Novo-Nordisk

Novo Nordisk Reports the Health Canada’s Approval of Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in T2D & CKD Adults

Shots: Health Canada has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes (T2D) & chronic kidney disease (CKD) Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…

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