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.
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?
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…
Efgartifimod is an investigational, intravenously administered neonatal Fc receptor antagonist in development for the treatment of generalized myasthenia gravis.
Tezepelumab is an investigational, subcutaneously injected, human monoclonal antibody that inhibits thymic stromal lymphopoietin. It is proposed for treatment of patients with severe, uncontrolled asthma.
Oleogel-S10 is a semisolid gel containing 10% betulin-rich extract from birch bark and 90% refined sunflower oil. Betulin is a naturally occurring triterpene with medicinal properties believed to help modulate the inflammation response and encourage formation of new skin during wound healing. It is in development for the treatment of skin wounds associated with epidermolysis …
Aduhelm (aducanumab) is an intravenously administered amyloid beta-directed antibody for the treatment of Alzheimer disease.
Teplizumab is an intravenously administered anti-CD3 monoclonal antibody in development for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
RBX2660 is a microbiota-based investigational product for fecal microbiota transplantation proposed to treat recurrent Clostridium difficile infection. It is derived from fresh stool from multiple donors; both donors and stool samples are methodically screened. Pooled stool samples are commercially prepared under good manufacturing processes. RB…
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) 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…