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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 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…
5 hours ago

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NEWS

Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

Shots: The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
6 hours ago

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NEWS

VarmX Inks a ~$2.2B Strategic Collaboration and Option Agreement with CSL for VMX-C001 to Advance Coagulation Treatment

Shots: VarmX has collaborated with CSL to advance its lead asset, VMX-C001 (commercial launch expected in 2029), & granted CSL an exclusive option agreement with its shareholders to acquire all issued & outstanding shares of the company As per the collaboration, CSL will fully fund the global P-III (EquilibriX-S) trial of VMX-C001 in FXa DOAC…
9 hours ago

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Akesobio
NEWS

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Shots: Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…
1 day ago

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Ionis
NEWS

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Shots: The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndrome Designation was based on P-I/II (HALOS) trial assessing ION582 in pts with Angelman syndrome, which showed improvements across all functional domains incl. communication, cognition & motor function; safety was favorable Additionally, ION582 is being investigated in…
4 days ago

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Merck
NEWS

Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease

Shots: Merck has reported P-III (STRIDE-13) trial evaluating Capvaxive (21-valent pneumococcal conjugate vaccine) vs PPSV23 in pts (n=882; 2 to <18yrs.) with prior pediatric pneumococcal vaccination & chronic conditions increasing pneumococcal disease risk Trial showed that Capvaxive induced immune responses to all 21 serotypes per opsonophagocytic activity (OPA) geometric mean titers (2EP), plus was noninferior…
September 11, 2025

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