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…
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?
Avacopan is an oral complement component 5a (C5a) antagonist for treatment of adult patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis (AAV).
Efgartifimod is an investigational, intravenously administered neonatal Fc receptor antagonist in development for the treatment of generalized myasthenia gravis.
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.
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.
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…
The Paradise Renal Denervation System uses ultrasound energy delivered via a balloon-cooled catheter to perform targeted circumferential denervation to the renal afferent and efferent sympathetic nerves. The system is proposed for the treatment of hypertension.
Mavacamten is an investigational oral myosin inhibitor that targets the underlying molecular mechanisms of hypertrophic cardiomyopathy (HCM). It is proposed for the treatment of patients with symptomatic obstructive HCM.
The Ventura implant is a transcatheter interatrial shunt for treatment of chronic heart failure with both preserved and reduced ejection fraction.