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.
Horizon Scanning
It 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?
Vivistim Paired VNS System for Stroke Rehabilitation
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.
Oportuzumab Monatox for Non-muscle Invasive Bladder Cancer
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.
Viveve System for Stress Urinary Incontinence in Women
The Viveve System is a cryogen-cooled monopolar radiofrequency device proposed for treatment of stress urinary incontinence in premenopausal women.
Saphnelo (Anifrolumab-fnia) for Systemic Lupus Erythematosus
Saphnelo (anifrolumab-fnia) is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of all type I IFNs. It is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
Retifanlimab for Squamous Cell Anal Cancer
Retifanlimab is an investigational intravenous humanized monoclonal antibody that inhibits the activity of programmed death-1 (PD-1). By blocking PD-1, retifanlimab acts as an immune checkpoint inhibitor, freeing T cells to kill cancer cells and boosting immune system response against certain cancers. Retifanlimab is proposed as a monotherapy for locally advanced and metastat…
Ryplazim (Plasminogen, Human-tmvh) for Plasminogen Deficiency Type 1
Ryplazim is plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). Ryplazim is recovered from healthy donor plasma; plasminogen is extracted using a proprietary process. Purified isolated plasminogen is administered by intravenous infusion.
Lumakras (Sotorasib) for Non-Small Cell Lung Cancer
Lumakras (sotorasib) is an oral KRAS G12C inhibitor designed to block the abnormal proliferative action of mutant KRAS protein. It is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who hav…
IpsiHand Upper Extremity Rehabilitation System
The IpsiHand Upper Extremity Rehabilitation System is a brain-computer-interface/robotic arm exoskeleton system for use in chronic stroke patients (≥ 6 months post-stroke) aged ≥ 18 years undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
Breyanzi (Lisocabtagene Maraleucel) for Large B-Cell Lymphoma
Breyanzi (lisocabtagene maraleucel [liso-cel]) is an autologous chimeric antigen receptor (CAR) T-cell therapy, a novel type of immunotherapy in which a patient’s own immune cells are genetically re-programmed to target and attack cancer cells. It is indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after 2 or more lines of …