Regulatory delays are growing ever more likely as the threat of coronavirus ramps up globally. The US FDA announced earlier this month that it was postponing certain manufacturing facility inspections, and some advisory committee meetings have been cancelled; drug approvals are surely next to be hit.

Vantage took a look at US regulatory decisions remaining for this month and those expected in April − bellwethers for the future regulatory landscape.

Neurocrine Biosciences, Inc. NBIX announced that the FDA has accepted its new drug application (NDA) for opicapone as an adjunct therapy to levodopa/carbidopa to treat patients with Parkinson's disease (PD), who are experiencing OFF episodes.

San Diego-based Neurocrine Biosciences presented data from two Phase III clinical trials of opicapone, a once-daily, oral catechol-O-methyltransferase (COMT) inhibitor for Parkinson’s disease. They found that patients receiving opicapone 50 mg with levodopa, the standard of care, had a significant and sustained improvement in symptoms.