Drugs in the Pipeline

Drugs in the Pipeline

Nuplazid Designated Breakthrough Therapy for Parkinson's Disease Psychosis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Nuplazid (pimavanserin; Acadia Pharmaceuticals) for the treatment of Parkinson's disease psychosis.

Alirocumab Demonstrates Efficacy in Four Phase 3 Trials

Sanofi and Regeneron announced positive results from four Phase 3 ODYSSEY trials of alirocumab in patients with hypercholesterolemia.

FDA Grants Qualified Infectious Disease Product Status to Two Anti-Infectives

The Food and Drug Administration (FDA) has granted Wockhardt Limited's investigational anti-infectives, WCK 771 and WCK 2349 Qualified Infectious Disease Product (QDIP) status.

Updated Phase 3 Efficacy Results for Ampio

Ampio announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.

APD811 Designated Orphan Drug for Pulmonary Arterial Hypertension

The Food and Drug Administration (FDA) has granted Orphan Drug designation to APD811 (Arena Pharmaceuticals) for the treatment of pulmonary arterial hypertension (PAH).

Combination Ovarian Cancer Therapy Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to motolimod (VTX-2337; VentiRx) in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.

BLA for Novel Cholesterol Drug Submitted to FDA

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol.

FDA Fast Tracks Clostridium Difficile Vaccine

The Food and Drug Administration (FDA) has granted Fast Track status for Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).

First Treatment for Common Anemia Shows Promise

A recent study has demonstrated potential for lexaptepid pegol as the first treatment for anemia of inflammation, the most common form of anemia.

Chronic Heart Failure Drug Designated Priority Review Status

The Food and Drug Administration (FDA) has granted Priority Review to Amgen's New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure.