Drug Patent Watch

DECEMBER 12, 2024

Case Study 1: Orphan Drug for Rare Genetic Disorder A mid-sized pharmaceutical company identified a branded orphan drug treating a rare genetic disorder. Case Study 2: Novel Formulation of Existing Drug A biotech firm discovered a branded drug with a novel formulation that significantly improved patient compliance.

Licensing 94

Licensing Licensing Branding Drugs 94

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 59

Bioequivalency Trials Licensing Licensing 59

FDA Law Blog

JULY 9, 2024

For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). by sex, age or by genetic variations). . § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). For devices, the requirement is a bit more nuanced.

Clinical Trials 59

Clinical Trials Clinical Trials Development Drugs 59

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 Gene 52