An oral epidermal growth factor receptor inhibitor for the treatment of non-small cell lung cancer in patients with initial activating epidermal growth factor receptor mutations as well as the T790M dominant acquired resistance mutation.
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.
Nuplazid (Pimavanserin)
A novel oral 5HT2A inverse agonist for the treatment of psychosis associated with Parkinson disease.
SurgiBot System
A single-port, patient-side robotic surgery system for use in laparoscopic surgery.
TOPAS (Transobturator Posterior Anal Sling) System
An implantable transobturator posterior anal sling proposed to treat women with fecal incontinence that fails to respond to more conservative treatments.
Inflectra (Formerly CT-P13; Infliximab Biosimilar)
A biosimilar to Remicade (infliximab) for treatment of adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis.
ETC-1002 (Bempedoic Acid)
An oral adenosine triphosphate-citrate lyase inhibitor and adenosine monophosphate-activated protein kinase activator intended for low-density lipoprotein cholesterol-lowering therapy.
ALD403 to Prevent Migraine Headache
ALD403 is a novel monoclonal antibody targeted to calcitonin gene-related peptide (CGRP) for migraine headache prevention. CGRP is involved in vasodilation and sensory transmission and is a validated target that is believed to play a key role in migraine headache. ALD403 is administered intravenously.
Barostim neo for Drug-Resistant Hypertension
A surgically implanted device for the treatment of medically resistant hypertension that delivers chronic stimulation to baroreceptors located within the carotid sinus. Also being developed for the treatment of heart failure.
Mongersen (GED-0301) for Crohn’s Disease
An oral Smad7 antisense oligonucleotide for treatment of moderate to severe Crohn’s disease.
DIAM Spinal Stabilization System
A surgically implanted, compressible, posterior interspinous spacer for relief of low back and/or leg pain due to moderate single-level lumbar degenerative disc disease.