A once-daily add-on therapy for Parkinson's disease (PD) used in Europe for years has now gained clearance in the U.S. with FDA approval of Ongentys (opicapone). The drug, an improvement upon generics in its class, will be sold by Neurocrine Biosciences Inc. The medicine, a catechol-O-methyltransferase (COMT) inhibitor first approved by the EMA in 2016, extends the half-life of levodopa, increasing doses of which are required to achieve motor control as PD progresses. Portugal-based Bial-Portela & Ca SA, from which Neurocrine licensed North American rights to the drug, will receive a $20 million award from its partner. Shares of San Diego-based Neurocrine (NASDAQ:NBIX), a neuroscience company focused on treating movement disorders, rose 3.5% following the approval, closing at $101.67 on April 27.

The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.

Immunomedics Inc. gained accelerated FDA clearance for Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior therapies. It’s the first antibody-drug conjugate (ADC) given the go-ahead specifically in relapsed/refractory TNBC and the first anti-Trop-2 ADC bound for the market. Trodelvy, which was granted breakthrough therapy designation and priority review, moved along faster thanks to the objective response rate (ORR) and duration of response (DoR) turned up by Morris Plains, N.J.-based Immunomedics in a single-arm, multicenter phase II study. Continued approval may be contingent on verifying clinical benefit in the confirmatory phase III experiment called Ascent, recently halted by the independent data safety monitoring committee due to compelling evidence of efficacy across multiple endpoints.