How U.S. health care emerges from the COVID-19 pandemic is a million-dollar question, as patients, providers, payers and drug manufacturers are adapting to a new reality that’s advancing telehealth and changing how providers interact with patients.

The FDA’s 15-day deadline for responses to warning letters has long been a sore spot for device makers, who might argue that some of the more complex regulatory findings require more than 15 days to analyze and address. That same timeline was found in both the draft and final versions of the non-binding feedback guidance for device inspections despite industry’s pleas that such a tight deadline leads to rushed judgment and potentially inadequate responses by managers at the manufacturing site.

Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.

The Trump administration has posted an update to its plan to reopen the U.S. economy, this time with a slightly different twist on testing. This plan not only calls on local governments to administer tests for the SARS-CoV-2 virus, but also calls for two antibody tests per person under some circumstances, an approach that should beef up both the positive and negative predictive values compared to a single antibody test.

Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV technology for use in COVID-19 treatment.

Armonk, N.Y.-based International Business Machines Corp. (IBM) launched the Rapid Supplier Connect network to help government agencies and health care organizations tap into new, non-traditional suppliers now producing devices and equipment needed to battle COVID-19. Membership in the blockchain-based network is free through Aug. 31, 2020, to qualified participants.

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.