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ITM Announces Positive Topline Results of Phase 3 COMPETE Trial with ITM-11, a Targeted Radiopharmaceutical Therapy, in Patients with Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
28 Jan 2025 10:00 GMT
… gastroenteropancreatic neuroendocrine tumors in a Phase 3 clinical trial. The patients included represent a … anticipates discussing a potential New Drug Application (NDA) submission with the … . ITM-11 was granted orphan drug designation in the EU and …
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How are Antibody-Drug Conjugates Shaping the NSCLC Treatment Paradigm? With David Gerber, MD
28 Jan 2025 04:30 GMT
… the evolving role of antibody-drug conjugates (ADCs) in non–small … findings from key clinical trials. He highlighted results from the phase 3 TROPION-Lung01 …
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LIB Therapeutics Announces Publication of Phase 3 Study of Lerodalcibep in Homozygous Familial Hypercholesterolemia (HoFH) in Lancet Diabetes & Endocrinology
27 Jan 2025 14:13 GMT
… today announced the publication of Phase 3 LIBerate-HoFH study of Lerodalcibep … with both drugs, reinforcing the rationale and guidelines for a clinical trial of … enhance plasma half-life.
In clinical trials, Lerodalcibep has demonstrated sustained LDL …
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Alpha Tau Announces Cornerstone Interim Data Across Multiple Clinical Trials to be Shared at R&D Update Day
27 Jan 2025 14:00 GMT
… to commence French multicenter clinical trial of Alpha DaRT alongside … interim data from multiple clinical trials, including safety and feasibility … U.S. Food and Drug Administration (FDA), to conduct … a randomised, open-label, phase 3 study. The Lancet. doi: …
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ILiAD and hVIVO Sign LOI for Pivotal Phase 3 Trial of BPZE1 Pertussis Vaccine Following FDA Meeting
27 Jan 2025 13:23 GMT
… with conducting traditional Phase 3 field studies, which … using human challenge clinical trials. The Group provides … manufacturing capabilities, specialist drug development and clinical … leverages its unique clinical trial recruitment capability via its …
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Exelixis presents positive results from subgroup analysis of phase 3 CABINET study of cabozantinib in advanced GI neuroendocrine tumours at ASCO GI 2025
27 Jan 2025 12:47 GMT
… accepted the supplemental New Drug Application (sNDA) for … (Randomized, Double-Blinded phase III Study of CABozantinib versus … NCI-funded Alliance for Clinical Trials in Oncology with … double-blinded, placebo-controlled phase 3 pivotal trial that had …
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Akero Smashes Expectations in MASH, Showing Its Drug Reverses Fibrosis in Fatty Livers
28 Jan 2025 01:46 GMT
… drug in development for the fatty liver disease MASH now has clinical trial … due do MASH, pending Phase 3 trial results and if approved … year, Yale said.
Three Phase 3 studies are already underway evaluating … in mind that our Phase 3 SYNCHRONY outcome study is …
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Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis
27 Jan 2025 12:00 GMT
… has been granted Orphan Drug Designation and Regenerative … the Company’s planned Phase 3 AURORA trial, statements regarding … completion and cost of clinical trials including proof of concept … results from a particular clinical trial will be predictive of …
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US Patent Office Granted Can-Fite Namodenoson Patent for Use as anti-Obesity Drug
27 Jan 2025 12:00 GMT
… a pivotal Phase III. Can-Fite's liver drug, Namodenoson, … of our preclinical studies, clinical trials and other product candidate … our product candidates into clinical trials or to successfully … our preclinical studies or clinical trials; our receipt of …
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Akeso's Gumokimab Monoclonal Antibody (IL-17) New Drug Application For The Treatment Of Moderate To Severe Psoriasis Accepted By NMPA
27 Jan 2025 03:28 GMT
… plaque psoriasis, including one pivotal Phase III clinical trial (AK111-301) and three supportive … gumokimab in clinical trials and the successful submission of its new drug application …