Hospitals may be providing patient care outside of normal clinical settings during the COVID-19 outbreak, but this raises the question of how to access patient data systems in these makeshift settings. Arthur Young, president and CEO of Interbit Data Inc., of Natick, Mass., told BioWorld that the company’s solution is to add Internet-based access to its Netsafe system.

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.

Given all the public-private partnerships responding to the need for timely COVID-19 therapies, diagnostics and vaccines, the demands to forgo patents or exclusive licenses for coronavirus products and the clamor that industry shouldn’t “profit” from U.S. taxpayer-supported research are growing louder.

Assignor estoppel doesn’t enjoy the glamour of subject matter eligibility in the U.S. patent system, but a case heard recently at the Court of Appeals for the Federal Circuit has resurrected this relatively arcane bit of patent doctrine. The outcome of the case of Hologic v. Minerva addressed the less-than-princely sum of roughly $5 million, but Judge Kara Stoll of the Federal Circuit said this issue calls for a deeper examination by a 12-judge panel.

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.

Molecular diagnostics firm Caris Life Sciences has launched a next-generation sequencing-based assay to analyze the whole exome of 22,000 DNA genes. Known as MI Exome, it builds on the existing whole transcriptome sequencing product MI Transcriptome that analyzes 22,000 RNA genes, as well as its microbiome analysis.

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. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.

Cytovale Inc., a San Francisco-based medical technology company, has snagged an additional $3.83 million in funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to conduct a pilot study of its Rapid Sepsis Diagnostic System for patients with potential respiratory infections, including SARS-CoV-2, the novel coronavirus responsible for COVID-19. The patented technology, which can diagnose sepsis in less than 10 minutes, could speed up triaging and treatment of critically ill patients suspected of having the life-threatening condition.

The Main Street Lending Program (MSLP) was designed to ensure that small businesses are able to stay in business during the economic damage incurred by the COVID-19 pandemic, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA) says the program’s provisions are leaving some small device makers out in the cold, a predicament MDMA is working to resolve.

The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.