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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 diabetes
Trial showed 11.8% superior weight loss vs 2.3% after 68wks., while 31.6% lost ≥15% of body weight vs 4.7%. However, weight…
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The STEER real-world study data assessed the risk of major adverse cardiovascular events (MACE) with Wegovy (semaglutide 2.4mg) vs tirzepatide among overweight or obese pts with CVD, but no diabetes in the US
Study showed that continuous treatment (>30 days no gap) with Wegovy reduced risk of heart attack, stroke, CV or all-cause death…
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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 platform
As per the deal, Novo & Replicate will collaborate on certain cardiometabolic targets, granting Novo an exclusive global license to Replicate’s srRNA platform to devlelop…
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Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being
The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
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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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The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectively
Approval was based on Part…
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The US FDA has approved label expansion of Alhemo (concizumab-mtci) to prevent or reduce the frequency of bleeding episodes in pts (≥12yrs.) with HA/HB without inhibitors
Approval was based on P-III (Explorer8) trial assessing Alhemo (n=42, 1mg/kg followed by 0.2mg/kg QD) vs no prophylaxis (n=21) in 156 males with HA/HB, where median duration of…
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The EMA has received an application for a higher dose of Wegovy (semaglutide 7.2mg, SC) to treat obesity
Application was backed by the 72wk. STEP UP trial assessing Wegovy (7.2mg) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 adults without diabetes (BMI ≥30kg/m²), & the 72wk. STEP UP T2D trial assessing Wegovy…
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Deep Apple & Novo have partnered to discover, develop, & commercialize oral small molecules targeting novel non-incretin GPCRs for cardiometabolic diseases, incl. obesity, using Deep Apple’s drug discovery tech
Novo will gain exclusive global rights to develop, manufacture, & commercialize assets discovered & optimized by Deep Apple for ~$812M in upfront, research costs, &…
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Septerna & Novo Nordisk to identify, develop & market oral small molecules for obesity, T2D & other cardiometabolic diseases under an exclusive global collaboration & license agreement
As 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…

