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.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
Dextenza (Dexamethasone Ophthalmic Insert)
Dextenza is a sustained-release dexamethasone hydrogel intracanalicular insert for the treatment of ocular pain and inflammation after ophthalmic surgery. The insert is a rod-shaped biodegradable hydrogel intracanalicular device that delivers 0.4 mg dexamethasone in sustained and tapered release over 4 weeks. The hydrogel is conjugated with fluorescein to enable visualization…
Dextenza (Dexamethasone Ophthalmic Insert)
Dextenza is a sustained-release dexamethasone hydrogel intracanalicular insert for the treatment of ocular pain and inflammation after ophthalmic surgery. The insert is a rod-shaped biodegradable hydrogel intracanalicular device that delivers 0.4 mg dexamethasone in sustained and tapered release over 4 weeks. The hydrogel is conjugated with fluorescein to enable visualization…
Zulresso (Brexanolone) for Postpartum Depression
Zulresso (brexanolone) is a sterile solution of allopregnanolone for intravenous infusion in development for the treatment of postpartum depression (PPD). Allopregnanolone is a positive allosteric modulator of the neurotransmitter gamma-aminobutyric acid (GABAA) receptors. Plasma allopregnanolone concentrations rise in concert with progesterone…
Zulresso (Brexanolone) for Postpartum Depression
Zulresso (brexanolone) is a sterile solution of allopregnanolone for intravenous infusion in development for the treatment of postpartum depression (PPD). Allopregnanolone is a positive allosteric modulator of the neurotransmitter gamma-aminobutyric acid (GABAA) receptors. Plasma allopregnanolone concentrations rise in concert with progesterone…
Celiprolol (Proposed Name: Edsivo) for Vascular Ehlers-Danlos Syndrome
Celiprolol is an oral beta-1 adrenoceptor antagonist with partial beta-2 agonist activity proposed for the prevention of complications of vascular Ehlers-Danlos syndrome (EDS). Celiprolol has antihypertensive and antianginal properties, in addition to influencing vascular tone and smooth muscle. Celiprolol is believed to provide clinical benefit for people with vascular EDS b…
Celiprolol (Proposed Name: Edsivo) for Vascular Ehlers-Danlos Syndrome
Celiprolol is an oral beta-1 adrenoceptor antagonist with partial beta-2 agonist activity proposed for the prevention of complications of vascular Ehlers-Danlos syndrome (EDS). Celiprolol has antihypertensive and antianginal properties, in addition to influencing vascular tone and smooth muscle. Celiprolol is believed to provide clinical benefit for people with vascular EDS b…
Polivy (Polatuzumab Vedotin-piiq) for Diffuse Large B-Cell Lymphoma
Polivy (polituzumab-vedotin-piiq) is an intravenously administered CD79b-directed antibody-drug conjugate indicated in combination with a rituximab product and bendamustine for adult patients with relapsed/refractory diffuse large B-cell lymphoma after at least 2 prior therapies.
Polivy (Polatuzumab Vedotin-piiq) for Diffuse Large B-Cell Lymphoma
Polivy (polituzumab-vedotin-piiq) is an intravenously administered CD79b-directed antibody-drug conjugate indicated in combination with a rituximab product and bendamustine for adult patients with relapsed/refractory diffuse large B-cell lymphoma after at least 2 prior therapies.
Tegsedi (Inotersen) for Hereditary Transthyretin Amyloidosis
Tegsedi (inotersen) is an antisense oligonucleotide (ASO) that inhibits production of transthyretin that is intended for the treatment of polyneuropathy due to hereditary transthyretin (TTR) amyloidosis. Inotersen is administered weekly via subcutaneous injection.