Orphan drugs

CBER Orphan Drug Approvals for 2023 - Lachman Consultants

CBER Orphan Drug Approvals for 2023

According to an updated post on the Center for Biologics Evaluation and Research (CBER) webpage, there were twelve Biologics License Applications (BLAs) approved for products that had orphan drug (OD) status. Just to cite a few: Two were for treatment of sickle cell disease (SCD). One was for enzyme replacement therapy (ERT) in adult and […]

Read More

Slicing the Bologna Too Thin Leads to Appeals Court’s Overturning District Court’s Ruling – Harkens Back to Skinny Label in Recent “Inducement to Infringe” Decisions – I’m Confused

Everyone knows that I am not a lawyer; I’m just a regulatory geek.  But in the case of Catalyst Pharmaceuticals v. FDA and Jacobus in an orphan drug dispute, where the case rested on whether the phrase “same disease or condition” is ambiguous, there are few things that confuse me. The central issue is the […]

Read More