Inolimomab (proposed name, Leukotac) is an immunotherapy monoclonal antibody targeting the interleukin-2 receptor (IL-2) in development for the treatment of acute graft versus host disease (aGVHD).
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?
Humacyl is an off-the-shelf bioengineered human acellular vessel proposed for use as a hemodialysis access graft in patients with end stage renal disease (ESRD). This technology uses a process to decellularize donated human vascular smooth muscle cells, while preserving extracellular matrix proteins. This results in a tubular scaffold that is acellular at the time of implanta…
The bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR) implant is a proprietary bio-engineered bridging scaffold made from bovine collagen. It is intended to facilitate healing of a complete ACL tear. It was developed as an alternative to the current standard reconstruction treatment for torn ACLs.
Berotralstat is an oral plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
A radiolabeled monoclonal antibody targeting tumor antigen B7-H3 in development for intraventricular radioimmunotherapy for treatment of neuroblastoma central nervous system/leptomeningeal metastases.
Vosoritide is a longer-acting C-type natriuretic peptide (CNP) analog that modulates activity of the fibroblast growth factor receptor 3 (FGFR3) by inhibiting a signaling pathway that mediates its effects, thereby stimulating endochondrial growth, resulting in enhanced growth velocity. It is proposed for the treatment of achondroplasia.
Tazverik is an oral methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication …
Remestemcel-L is an investigational allogeneic liquid cell suspension of ex-vivo cultured adult human mesenchymal stem cells derived from healthy donor bone marrow proposed for the treatment of pediatric patients with acute graft-versus-host-disease (aGVHD) refractory to standard first-line steroid therapy.
Viltepso (viltolarsen) is an intravenously administered antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Retevmo (selpercatinib) is a novel oral highly selective RET inhibitor for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic read more