Givlaari is a subcutaneously administered ribonucleic acid interference (RNAi) agent that inhibits delta-aminolevulinate synthase 1 (ALAS1) synthesis, a key regulator of the heme biosynthetic pathway in the liver. Givlaari is believed to reduce ALAS1 levels, thereby decreasing delta-aminolevulinic acid (ALA) and porphobilinogen (PBG) levels. Decreasing ALA and PBG levels to n…
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?
Lisocabtagene Maraleucel for Large B-Cell Lymphoma
Lisocabtagene maraleucel (liso-cel) is an investigational, 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 proposed to treat adults with relapsed or refractory large B-cell lymphoma after at least 2 prior therapies. This patient…
Chloroquine and Hydroxychloroquine for COVID-19
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.
Uplizna (Inebilizumab-cdon) for Neuromyelitis Optica Spectrum Disorder
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.
Remestemcel-L for Acute Graft-Versus-Host Disease
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 for COVID-19
Remdesivir is an investigational, intravenously administered antiviral agent proposed for treatment of COVID-19.
Satralizumab for Neuromyelitis Optica Spectrum Disorder
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.
Glu-Plasminogen (Proposed Name: Ryplazim) for Congenital Plasminogen Deficiency
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 Hydroxychloroquine for COVID-19
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) for Metastatic Triple Negative Breast Cancer
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.