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Novartis Announces the Positive Results of Phase III NATALEE Trial Evaluating Kisqali; FDA Approves Pharming’s Joenja for APDS; FDA Orphan Drug Designation to Cyclerion’s Zagociguat; Iovance Completes BLA Submission for Lifileucel in Advanced Melanoma; BPGbio Announces Partnership with debra of America
Novartis Announces the Positive Results of Phase III NATALEE trial Evaluating Kisqali Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at risk of recurrence. The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. Kisqali plus ET reduced the risk of disease recurrence significantly more…
Viz.ai’s AI Algorithm for Abdominal Aortic Aneurysm; BrainTale Unveils the New Version of Its Digital Biomarkers Platform brainTale-care; Medtronic and NVIDIA Announces Collaboration; Median Technologies Announces Update for its iBiopsy Lung Cancer Screening CADe/CADx Software as Medical Device
Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA). Viz AAA is the first FDA-cleared AI-powered solution for the detection and triage of suspected AAA. Viz AAA uses artificial intelligence to automatically search for the presence of an abdominal aortic aneurysm from computed tomography angiography (CTA)…
Potential of APOCIII Inhibitors for Severe Hypertriglyceridemia and Familial Chylomicronemia Syndrome Treatment
Triglycerides, the energy-providing lipids consumed from fat-containing food, have been known to cause severe health conditions in high levels, including acute pancreatitis. It is also associated with apolipoprotein C-III (APOCIII) and high probability of coronary artery disease (CAD). Triglyceride levels above a certain level are termed as severe hypertriglyceridemia (sHTG). Elevated triglycerides may also result from genetic factors, Familial chylomicronemia syndrome (FCS) is one such disorder. What are APOC III Inhibitors? Long-recognized APOC III is a small protein that functions as a key regulator of triglyceride metabolism by inhibiting lipoprotein…