Section 101 Screens Out Claims of Using Biomarkers to Identify Drugs That May Cause Rare Disorder

Lysosomal storage disorders are a group of inherited diseases that range from treatable (Fabray Disease and Gaucher disease) to fatal (Niemann-Pick disease and Tay-Sachs disease). Drug-induced phospholipidosis (DIP) is mechanistically related to some of these diseases but, as the name suggests, caused by certain drugs. Drugs known to cause DIP include some antibiotics, antidepressants and cardiac medications. Because the ability of any given drug to cause DIP is not readily predictable from its... By: Holland & Knight LLP