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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…
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The P-III (REAL8) basket trial assessed Sogroya (0.24mg/kg, QW or 0.05 mg/kg, QD) in pre-pubertal children with NS, TS, or ISS; SGA-born children were randomized to Sogroya 0.24mg/kg QW or QD dosing (0.035 or 0.067mg/kg)
Trial met its 1EP, showing QW dosing was non-inferior to GH therapy (QD) at Wk. 52, with superior HV…
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The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25)
Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

