Remove Bioequivalency Remove Gene Remove Genetics Remove Protein
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Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Worldwide Clinical Trials

Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.

Gene 154
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Clinical Catch-Up: December 21-25 | BioSpace

The Pharma Data

The drug is a topical ointment applied to the lower lid to address the build-up and shedding of proteins at the opening of the Meibomian gland. TSHA-101 is an investigational gene therapy designed to deliver the HEXA and HEXB genes driven by a single promoter within the same AAV9 construct, dubbed a bicistronic vector.

Trials 52