Nubeqa is a nonsteroidal second-generation androgen receptor inhibitor that competes with androgen by binding to the androgen receptor. It reduces the ability of androgen to promote the growth of prostate cancer cells. Nubeqa is indicated for the treatment of patients with nonmetastatic castration-resistant prostate cancer.
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?
Brineura (Cerliponase Alfa)
Brineura is recombinant human tripeptidyl peptidase 1 (TPP1) replacement enzyme to slow loss of walking ability in symptomatic pediatric patients aged 3 years and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). Brineura is infused into the cerebrospinal fluid (CSF) via an intraventricular access device implanted in the patient’s head. It is administere…
Brineura (Cerliponase Alfa)
Brineura is recombinant human tripeptidyl peptidase 1 (TPP1) replacement enzyme to slow loss of walking ability in symptomatic pediatric patients aged 3 years and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). Brineura is infused into the cerebrospinal fluid (CSF) via an intraventricular access device implanted in the patient’s head. It is administere…
Onpattro (Patisiran)
Onpattro (patisiran) is an intravenous RNA interference (RNAi) therapeutic agent for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. RNAi is a natural cellular process of gene silencing. Onpattro is designed to silence specific messenger RNA, potentially blocking the production of TTR protein before it is made. This may help to …
Onpattro (Patisiran)
Onpattro (patisiran) is an intravenous RNA interference (RNAi) therapeutic agent for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. RNAi is a natural cellular process of gene silencing. Onpattro is designed to silence specific messenger RNA, potentially blocking the production of TTR protein before it is made. This may help to …
Ultomiris (Ravulizumab-cwvz) for Paroxysmal Nocturnal Hemoglobinuria
Ultomiris is a long-acting humanized murine monoclonal antibody that is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris binds with high affinity to the complement protein C5, thereby inhibiting its cleavage of C5a and C5b. This inhibition prevents the generation of the terminal complement complex C5b9, preventing complement-mediated hemolys…
Ultomiris (Ravulizumab-cwvz) for Paroxysmal Nocturnal Hemoglobinuria
Ultomiris is a long-acting humanized murine monoclonal antibody that is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris binds with high affinity to the complement protein C5, thereby inhibiting its cleavage of C5a and C5b. This inhibition prevents the generation of the terminal complement complex C5b9, preventing complement-mediated hemolys…
Luxturna (Voretigene Neparvovec-rzyl) for Inherited Retinal Dystrophies
Luxturna (voretigene neparvovec-rzyl) is an adenovirus-associated viral vector serotype 2 gene therapy containing the human RPE65 gene for treatment of patients with vision loss due to RPE65-mediated inherited retinal disease. Gene therapy utilizes a viral vector to carry the desired genetic information to target c…
Luxturna (Voretigene Neparvovec-rzyl) for Inherited Retinal Dystrophies
Luxturna (voretigene neparvovec-rzyl) is an adenovirus-associated viral vector serotype 2 gene therapy containing the human RPE65 gene for treatment of patients with vision loss due to RPE65-mediated inherited retinal disease. Gene therapy utilizes a viral vector to carry the desired genetic information to target c…
Libtayo (Cemiplimab)
Libtayo (cemiplimab) is an intravenous programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.