Tivdak (tisotumab vedotin-tftv) is an intravenously administered tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Horizon ScanningIt is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.
The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
Inclisiran is a subcutaneously administered, investigational RNA interference (RNAi) therapeutic that decreases hepatic synthesis of proprotein convertase subtilisin kexin type 9 (PCSK9), leading to increased low-density lipoprotein (LDL) receptor expression on the hepatocyte cell surface and subsequently to greater removal of LDL-C from circulation.
Lecanemab (formerly, BAN2401) is an investigational, intravenously administered anti-amyloid beta (Aβ) protofibril antibody proposed for the treatment of early Alzheimer disease.
The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the preservation of donor-after-brain-death (DBD) donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).
Kerendia (finerenone) is a nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
The Vivistim Paired VNS System is an implanted neurostimulator system intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
Mitapivat is an investigational oral drug designed to increase the activity of the pyruvate kinase (PK) enzyme in red blood cells. It is proposed for the treatment adults with PK deficiency.
Donanemab is an intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer disease.
The HistoSonics System is an ultrasound histotripsy system intended for noninvasive mechanical destruction of malignant cells via acoustic cavitation. It is under investigation for the treatment of primary or metastatic hepatocellular tumors.
Oportuzumab monatox is an antibody-drug conjugate that targets epithelial cell-adhesion molecule (EpCAM) in development for the treatment of bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer. It is an intravesical treatment, administered through a catheter directly into the bladder.