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NEWS

MannKind Reports the US FDA’s sBLA Acceptance of Afrezza (Inhaled Insulin) for Children and Adolescents with Diabetes

Shots:The US FDA has accepted sBLA of Afrezza (insulin human) Inhalation Powder for the treatment of children & adolescents with type 1 or type 2 diabetes (PDUFA: May 29, 2026)sBLA was supported by P-III (INHALE-1), assessing Afrezza vs multiple daily injections (MDI), both in addition to basal insulin among type1/2 diabetic pts (4-17yrs.)…
October 14, 2025

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Novo-Nordisk
NEWS

Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data of Cagrilintide for Weight Loss in Obese/Overweight 

Shots:Novo Nordisk has reported a sub-analysis of P-III (REDEFINE 1) trial assessing cagrilintide monotx. (2.4mg) with lifestyle intervention vs PBO in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without type 2 diabetesTrial showed 11.8% superior weight loss vs 2.3% after 68wks., while 31.6% lost ≥15% of body weight vs 4.7%. However, weight…
September 16, 2025

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NEWS

Remedium Bio Joins Forces with Eli Lilly to Advance Gene Therapies for Obesity and Type 2 Diabetes

Shots:Remedium Bio has entered into a multi-target research & development collaboration with Eli Lilly to develop gene therapies targeting multiple targets for the treatment of Obesity & Type 2 Diabetes, leveraging Remedium’s Prometheus platformAs per the deal, Remedium will receive an upfront, equity investment as well as development & commercial milestone payments, with tiered…
September 9, 2025

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Replicate Bioscience Collaborates with Novo Nordisk to Develop Novel srRNA Therapies for Cardiometabolic Diseases

Shots:Replicate has entered into a multi-year research collaboration with Novo Nordisk to develop novel self-replicating RNA (srRNA) therapies for obesity, T2D & other cardiometabolic diseases, leveraging Replicate’s srRNA platformAs per the deal, Novo & Replicate will collaborate on certain cardiometabolic targets, granting Novo an exclusive global license to Replicate’s srRNA platform to devlelop…
August 29, 2025

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Novo-Nordisk
NEWS

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…
August 20, 2025

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Novo Nordisk and Septerna
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Novo Nordisk Enters a ~$2.2B Deal with Septerna to Develop Oral Small Molecules for Cardiometabolic Diseases

Shots:Septerna & Novo Nordisk to identify, develop & market oral small molecules for obesity, T2D & other cardiometabolic diseases under an exclusive global collaboration & license agreementAs per the deal, Septerna will receive ~$2.2B, incl. over $200M in upfront & near-term milestones, plus research, development, & commercial milestones, along with net sales-based tiered…
May 15, 2025

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Novo-Nordisk
NEWS

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Shots:Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks. Trial met its co-1EPs demonstrated 15.7% superior weight loss…
March 11, 2025

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