Abrysvo (respiratory syncytial virus vaccine; Pfizer Inc.) is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.
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?
Spring Distraction System (Cresco Spine) for Early Onset Scoliosis
The Spring Distraction System (Cresco Spine) is an investigational, growth-friendly implant in development for the treatment of early onset scoliosis (EOS). It is designed to provide continuous distraction and avoid the need for repeated lengthening procedures as the patient grows.
Palovarotene (Sohonos; Ipsen Biopharmaceuticals Inc.) for Fibrodysplasia Ossificans Progressiva
Palovarotene (Sohonos; Ipsen Biopharmaceuticals Inc.) is an oral retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for female persons and 10 years and older for male persons with fibrodysplasia ossificans progressiva.
Atidarsagene Autotemcel (Orchard Therapeutics) for Metachromatic Leukodystrophy
Atidarsagene autotemcel is an investigational gene therapy administered by intravenous infusion for the treatment of metachromatic leukodystrophy.
Eplontersen (Ionis/AstraZeneca) for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Eplontersen is an investigational, injectable, ligand-conjugated antisense drug for treatment of hereditary transthyretin amyloidosis with polyneuropathy.
Hepzato Kit (Melphalan/Hepatic Delivery System; Delcath Systems Inc.) Liver-Directed Therapy for Metastatic Uveal Melanoma
The Melphalan/Hepatic Delivery System (Hepzato Kit; Delcath Systems Inc.) is a melphalan drug pack and catheter-based chemofiltration delivery kit indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymp…
Nirsevimab-alip (Beyfortus; AstraZeneca and Sanofi) to Prevent Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus
Nirsevimab-alip (Beyfortus; AstraZeneca) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Avasopasem Manganese (Galera Therapeutics Inc.) for Radiotherapy-induced Oral Mucositis
Avasopasem manganese (Galera Therapeutics Inc.) is an investigational intravenous superoxide dismutase mimetic intended to reduce the incidence and severity of radiation-induced oral mucositis in patients undergoing radiotherapy for head and neck cancer.
Bulevirtide (Gilead Sciences Inc.) for Chronic Hepatitis Delta Virus
Bulevirtide (Gilead Sciences Inc.) is an investigational, first-in-class, subcutaneously injected virion entry inhibitor proposed for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Humacyl Acellular Vessel for Dialysis Access
Humacyl (Humacyte Inc.) is a bioengineered human acellular vessel proposed for use as a conduit for hemodialysis in patients with end stage renal disease.