pharmaphorum

JANUARY 18, 2023

NewAmsterdam said it is now selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe that will be tested in a phase 3 trial, as well as a study to make sure the formulation is bioequivalent to each drug delivered separately.

Bioequivalency 57

Bioequivalency Trials Licensing Licensing 57

Worldwide Clinical Trials

MAY 30, 2024

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 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

DECEMBER 27, 2020

GM2 gangliosidosis is a rare and fatal monogenic lysosomal storage disorder and a family of neurodegenerative genetic diseases that includes Tay-Sachs and Sandhoff diseases. Acer Therapeutics announced full enrollment of trial evaluating the bioequivalence of ACER-001 compared to Buphenyl (sodium phenylbutyrate) for urea cycle disorders.

Trials 52

Trials Antibody Gene Therapy Clinical Trials 52