Brian Park, PharmD

All articles by Brian Park, PharmD

Diagnostic Test for Rapid MRSA Detection Gets Market Clearance

The Food and Drug Administration (FDA) has authorized marketing of a new diagnostic test, cobas vivoDx MRSA (Roche Molecular Systems Inc), to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization and aid in the prevention and control of MRSA infections in healthcare settings. The cobas vivoDx MRSA test provides rapid phenotypic detection of MRSA colonization through…

Reloxaliase Reduces Urinary Oxalate in Patients With Enteric Hyperoxaluria

Allena Pharmaceuticals announced positive topline results from the phase 3 URIROX-1 trial of reloxaliase for the treatment of enteric hyperoxaluria (EH), as well as additional data from the phase 2 trial (Study 206) in high-risk patients with EH and advanced chronic kidney disease (CKD). Reloxaliase is a first-in-class, crystalline formulation of the enzyme oxalate decarboxylase…

Microbiome-Derived Therapy Gets Orphan Drug Status for Hepatocellular Carcinoma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to SFA001 (SFA Therapeutics) for the treatment of hepatocellular carcinoma (HCC). SFA001 is an investigational microbiome-derived drug that is developed from natural substances using the Company’s proprietary discovery process to match metabolites and adjuvants to treat chronic inflammatory diseases.  The designation is based on…