Inebilizumab is an anti-CD19 monoclonal antibody. It was developed in response to the unmet treatment needs of patients with neuromyelitis optica spectrum disorder (NMOSD), a rare and debilitating autoimmune demyelinating disease that primary affects the optic nerves and spinal cord. Inebilizumab is administered every 6 months by intravenous infusion.
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?
Remestemcel-L is an 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.
Remdesivir is an investigational, intravenously administered antiviral agent proposed for treatment of COVID-19.
Satralizumab is an investigational anti-IL-6 receptor monoclonal antibody under FDA review for the treatment of neuromyelitis optica spectrum disorder in adults and adolescents. It is administered by subcutaneous injection.
Ryplazim is an investigational intravenous plasminogen replacement therapy for treatment of congenital plasminogen deficiency in children and adults. Ryplazim is recovered from healthy donor plasma; plasminogen is extracted using a proprietary process. Purified isolated plasminogen is administered by intravenous infusion.
Chloroquine (and its metabolite, hydroxychloroquine) is an oral 4-aminoquinoline antimalarial agent that has demonstrated antiviral effects on SARS-CoV and SARS-CoV-2 in vitro. It is being evaluated for the treatment of COVID-19.
Trodelvy (sacituzumab govitecan-hziy) is an intravenously administered antibody-drug conjugate (ADC) indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease. Trodelvy is the first FDA-approved ADC indicated for the treatment of TNBC.
Reblozyl is an erythroid maturation agent administered via subcutaneous injection indicated for the treatment of patients with transfusion-dependent beta thalassemia. This recombinant fusion protein is believed to help immature cells develop into red blood cells, thereby preventing anemia and reducing or eliminating the need for frequent blood transfusions.
Ayvakit (avapritinib) is an oral potent and selective inhibitor of activated KIT and PDGFRA mutant kinases, particularly activation loop mutations and highly resistant PDGFRA D842V mutation. It is indicated for the treatment of adults with unresectable or metastatic gastrointestinal s…
Vazegepant is an intranasal novel small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist (“gepant”) drug proposed for the acute treatment of migraine headache. CGRP is involved in vasodilation and sensory transmission and is a validated target for the treatment of migraine headache.