While many biopharma companies are holding the line on U.S. drug prices during the COVID-19 pandemic, a few are providing more fuel to fire up lawmakers over prescription drug prices. The latest flames were stoked by last month’s 220% increase in the price of Jaguar Health Inc.’s Mytesi (crofelemer), a botanical drug used to treat the gastrointestinal side effects of HIV antiretroviral treatments. Two days after the FDA denied an emergency use authorization (EUA) for the drug to be used to treat diarrhea in COVID-19 patients who were given antivirals, Jaguar raised the price of Mytesi from $688.52 per bottle to $2,206.52 per bottle.
The capacity of U.S. medical providers and testing capacity for the unfolding COVID-19 pandemic continues to be sorely tested. But there is now a new route for people to pursue serological testing to detect who has already been exposed to the SARS-CoV-2 virus.
Despite a drop off in elective procedures due to the COVID-19 pandemic, Stryker Corp., of Kalamazoo, Mich., unveiled first-quarter results that came in better than analysts had presumed. BTIG’s Ryan Zimmerman noted that, unlike other companies, Stryker did not pre-announce preliminary revenue. And while investors were concerned that the company would be adversely affected by the slump in elective procedures, "the diversity of the portfolio helped to offset procedure declines in late March.”
Hologic Inc., of Marlborough, Mass., is introducing another tool to help combat COVID-19, revealing the impending launch of a new Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its Panther system. The company expects to be able to provide its lab customers with about 3 million Aptima tests next week. In addition, it anticipates producing about 1 million tests a week starting late next month.
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.