LONDON – Research and health emerged as the biggest losers following a marathon four days of negotiations by EU leaders on the bloc’s €1.1 trillion (US$1.3 trillion) 2021 - 2027 budget and the formation of a €750 billion (US$872 billion) pandemic recovery fund. Rather than €94.4 billion over the next seven years as proposed, the R&D program Horizon Europe, will get €80.9 billion.
The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.
If there’s a readily visible upside to the COVID-19 pandemic, it may be that telehealth is not only much more accessible, it’s also supremely topical among policymakers. However, privacy concerns are still a significant source of drag in some respects, a consideration that extends to digital medicine as well in the context of contact tracing used to corral the SARS-CoV-2 virus.
Just the name, Strategic National Stockpile (SNS), evokes the image of a huge warehouse, or a series of warehouses spread across the U.S., strategically stocked with all the medical supplies, diagnostics and drugs that will be needed nationwide to respond to any health emergency brought on by terrorists, nuclear attacks, pandemics or other public health hazards. The reality is so much more – and so much less.
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising. As the chair of the Senate Health, Education, Labor and Pensions Committee, the senator issued a white paper Tuesday identifying areas that must be addressed.
The climate crisis in the time of COVID-19 illustrates the difference between the important and the urgent. There is, of course, no alternative to focusing on the current pandemic. But at the same time, the SARS-CoV-2 coronavirus has not changed the fact that the climate crisis is a coming wave whose health consequences will ultimately dwarf those of any single infectious agent.
DUBLIN – Can an investigational drug best known for reducing itch in dermatitis patients really lower the risk of COVID-19 patients progressing to acute respiratory distress syndrome (ARDS)? It might seem like a stretch, even in the midst of a pandemic, but New York’s largest health care provider, Manhasset-based Northwell Health, appears sufficiently convinced by the biological rationale to get behind a phase III trial of tradipitant, a neurokinin-1 (NK1) receptor blocker, which Washington-based Vanda Pharmaceuticals Inc. is already testing in phase III trials in atopic dermatitis, gastroparesis and motion sickness.