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.

Relyvrio (Sodium Phenylbutyrate/Taurursodiol) for Amyotrophic Lateral Sclerosis (ALS)

Relyvrio (formerly AMX0035) is an oral fixed-dose combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO). PB is a prescription drug used to treat urea cycle disorders and TURSO (also known as tauroursodeoxycholic acid [TUDCA]) is a widely available non-prescription supplement. Relyvrio is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults…

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Etranacogene Dezaparvovec for Hemophilia B

Etranacogene dezaparvovec (formerly AMT-061) is an investigational recombinant gene transfer therapy product designed to help patients with hemophilia B produce sufficient plasma levels of endogenous coagulation factor IX (FIX). The main therapeutic goal is long-term expression of FIX at levels steady enough to eliminate the need for routine prophylactic replacement therapy w…

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