Amondys 45 (casimersen) 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 45 skipping.
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?
Elivaldogene autotemcel (eli-cel) is a lentiviral-based gene therapy for treatment cerebral adrenoleukodystrophy (CALD).
The WiSE CRT system is a wireless left ventricular pacing system that works with an implanted right ventricular pacemaker and/or defibrillator for patients in whom cardiac resynchronization therapy (CRT) is indicated.
TissueGene-C is an injectable solution of normal and genetically modified allogeneic human chondrocytes in development for the treatment of knee osteoarthritis.
Beta thalassemia is blood disorder caused by sequent variants in the beta-globin (HBB) gene that threaten normal production of hemoglobin. Lentiviral Autologous Beta-Globin Gene Therapy (Proposed Name: Zynteglo, formerly LentiGlobin) aims to reduce or eliminate the need for regular blood transfusions in patients with transfusion-dependent beta-t…
Evkeeza (evinacumab-dgnb) is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).
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.
The eXciteOSA Daytime Therapy Device (formerly known as Snoozeal) is a noninvasive electrical muscle stimulation device that delivers electrical pulses through a mouthpiece that sits around the tongue. The system consists of a mouthpiece, a rechargeable control unit that connects to the mouthpiece via a USB interface, and a mobile app that allows the user to control and track…
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 …
Aducanumab is an investigational human monoclonal anti-amyloid beta antibody in development for the treatment of Alzheimer disease.