Prognosis is a horizon scanning service that monitors emerging health technologies as they go through clinical trial development and the regulatory approval process.
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Elzonris (tagraxofusp-erzs; formerly SL-401) is a recombinant protein consisting of IL-3 conjugated with diphtheria toxin that is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm. This protein binds to the IL-3Rα chain (CD123), preventing protein synthesis and prompting cell death. Elzonris is administered via intravenous infusion.
The Sonata Sonography-Guided Transcervical Fibroid Ablation System is a “next-generation” incisionless, intrauterine radiofrequency ablation (RFA) platform for the treatment of symptomatic uterine fibroids (the previous generation is known as VizAblate). The FDA cleared the Sonata System for market in August 2018. The system combines a miniaturized reusable intrauterine ultrasound probe and a single-use RFA handpiece that contains an introducer and needle electrode array. The RFA component also contains a proprietary graphical guidance software that provides the operating gynecologist with real-time graphic overlay on the live ultrasound image for treatment planning and precision. The RFA handpiece and intrauterine ultrasound probe snap...
Sacituzumab govitecan (formerly IMMU-132 and hRS7-SN38) is an intravenously administered antibody-drug conjugate (ADC) in development for treatment of metastatic triple negative breast cancer (TNBC) in patients who have previously received 2 or more therapies. If approved by the FDA, sacituzumab will be the first ADC indicated for the treatment of TNBC.
Caplacizumab is a subcutaneously injected biologic agent proposed as an adjunct to standard care for acquired thrombotic thrombocytopenic purpura. It is a bivalent single-domain anti-von Willebrand factor (VWF) nanobody that inhibits the binding of VWF to platelets to prevent the early stages of blood clot formation. Nanobodies are much smaller than conventional monoclonal antibodies, allowing for more rapid distribution, onset of action, and clearance.
Ultomiris is a long-acting humanized murine monoclonal antibody that is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris binds with high affinity to the complement protein C5, thereby inhibiting its cleavage of C5a and C5b. This inhibition prevents the generation of the terminal complement complex C5b9, preventing complement-mediated hemolysis in patients with PNH.