Other Diseases

Eli Lilly and Company completes acquisition of Versanis Bio

Eli Lilly and Company (Lilly) has completed the acquisition of clinical-stage biopharmaceutical firm Versanis Bio.

BioCryst signs agreement with Er-Kim Pharmaceuticals to commercialise ORLADEYO in Turkey

BioCryst Pharmaceuticals has signed a collaboration agreement with Er-Kim Pharmaceuticals for commercialising ORLADEYO (berotralstat) in Turkey.

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Intercept Pharmaceuticals gets ODD for fixed dose of OCA-bezafibrate to treat PBC

Intercept Pharmaceuticals has received orphan drug designation from US Food and Drug Administration (FDA) for the fixed-dose combination of obeticholic acid (OCA) and bezafibrate to treat individuals with primary biliary cholangitis (PBC).

Abliva’s NV354 receives ODD from US FDA

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease.

AcelRx Pharmaceuticals completes divestment of DSUVIA to Alora Pharmaceuticals

California-based AcelRx Pharmaceuticals has completed the divestment of DSUVIA to Alora Pharmaceuticals. 

FDA grants fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 to reduce triglycerides

The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS).

Mediar Therapeutics announces $105m financing to advance fibrosis therapies

Biotechnology firm Mediar Therapeutics has announced a $105m financing, which includes a recent $85m Series A round.

Nexus Pharmaceuticals gets FDA approval for Emerphed pre-filled syringe

US Food and Drug Administration (FDA) has given approval to Nexus Pharmaceuticals for its Emerphed (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes.