Sotatercept-csrk (Winrevair; Merck &Co. Inc.) is an activin signaling inhibitor indicated for the treatment of adults with World Health Organization (WHO) Group 1 pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.
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?
Afamitresgene Autoleucel (Adaptimmune Therapeutics) for Advanced Synovial Sarcoma
Afamitresgene autoleucel is an investigational autologous engineered T-cell therapy for the treatment of HLA-A*02 positive patients with advanced synovial sarcoma expressing the MAGE-A4 antigen.
Atidarsagene Autotemcel (Lenmeldy; Orchard Therapeutics) for Metachromatic Leukodystrophy
Atidarsagene autotemcel (Lenmeldy; Orchard Therapeutics) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of children with presymptomatic late infantile, presymptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy (MLD).
Blarcamesine (Anavex 2-73; Anavex Life Sciences Corp.) for Alzheimer Disease
Blarcamesine (Anavex 2-73; Anavex Life Sciences Corp.) is an investigational oral small molecule sigma-1 receptor agonist for treatment of early Alzheimer disease.
AGENT Drug-Coated Balloon (Boston Scientific Corp.) for Coronary In-stent Restenosis
The AGENT Drug-Coated Balloon (Boston Scientific Corp.) is a paclitaxel-coated balloon catheter indicated for treatment of coronary in-stent restenosis (ISR). It is intended to be used after appropriate vessel preparation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 millimeters (mm) to 4.0 mm in diameter and lesions up to 26 m…
ProSense System (IceCure Medical) for Low-Risk Early-Stage Breast Cancer
The ProSense system (IceCure Medical) is a minimally-invasive, imaging-guided, cryoablation system proposed for treatment of low-risk early-stage breast cancer in patients who are not suitable candidates for surgical alternatives.
Donanemab (Eli Lilly and Co.) for Alzheimer Disease
Donanemab (Eli Lilly and Co.) is an investigational, intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer disease.
Nemolizumab (Galderma) for Prurigo Nodularis
Nemolizumab (Galderma) is a subcutaneously injected interleukin-31 receptor alpha antagonist under investigation for the treatment of adult patients with prurigo nodularis.
Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) for Advanced Melanoma
Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Marnetegragene Autotemcel (Rocket Pharmaceuticals Inc.) for Severe Leukocyte Adhesion Deficiency-I
Marnetegragene autotemcel (Rocket Pharmaceuticals Inc.) is an investigational gene therapy administered by intravenous infusion for the treatment of severe leukocyte adhesion deficiency-I.