Prognosis is a horizon scanning service that monitors emerging health technologies as they go through clinical trial development and the regulatory approval process.
I am looking for…
View a sampling of our Prognosis reports.
Plazomicin (ACHN-490) is an intravenously (IV) administered next-generation broad-spectrum aminoglycoside. This class of antibiotics includes drugs such as gentamicin, tobramycin, and amikacin. Aminoglycosides exert concentration-dependent bactericidal effect through inhibition of protein synthesis, and are particularly effective against difficult-to-treat Gram-negative infections.
Aimovig is a novel monoclonal antibody targeted to calcitonin gene-related peptide (CGRP) for migraine 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. Aimovig targets the CGRP receptor; this mechanism differentiates it from other investigational anti-CGRP antibodies, which bind to the ligand. Aimovig is administered via subcutaneous injection once monthly.
Lofexidine is an oral alpha-2 adrenergic agonist for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. Lucemyra is the first non-opiod drug indicated to alleviate symptoms of opioid withdrawal.
Encorafenib is an investigational BRAF inhibitor and binimetinib is an investigational MEK inhibitor. Encorafenib plus binimetinib combination therapy is proposed for the treatment of patients with BRAF-mutant, advanced, unresectable or metastatic melanoma.
Andexxa is an inactive modified recombinant factor Xa molecule that competes with circulating levels of factor Xa to bind directly with factor Xa inhibitors. It is administered intravenously. The FDA approved Andexxa in May 2018 for use in patients being treated with Xarelto and Eliquis, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The FDA granted Andexxa an accelerated approval for this indication, based on the change from baseline in anti-factor Xa activity in healthy volunteers. Continued approval may be contingent upon the results of FDA mandated postmarket studies to demonstrate an improvement in hemostasis in...