Gilead expands trials on promising antiviral in coronavirus fight

The coronavirus threat continues to grow, with two confirmed deaths in the United States and more infections around the globe, particularly in Europe and the Middle East. Meanwhile, President Trump held another press briefing with infectious disease experts to attempt to alleviate panic as well as announce more travel restrictions on countries with major outbreaks.

While all signs point to the virus continuing to spread in the United States and the world, it's not all dismal: Gilead is expanding trials of an antiviral drug showing promise in treating COVID-19, reports The New York Times. 

The drug: During the Ebola outbreak a few years ago, BIO member Gilead Sciences developed a promising antiviral, remdesivir, which they think could be an effective treatment for the new coronavirus. 

The trials: They’re currently testing the experimental drug in Wuhan, China, where the virus is believed to have originated, and plan to launch two more trials in March involving approximately 1,000 patients, including patients in Asia as well as in Nebraska, according to the New York Times. 

The results: The Wuhan results are expected as early as April—though already, a patient in Washington State seemed to improve after receiving remdesivir. 

What’s policy got to do with it? Everything. This kind of R&D is risky and expensive—and drug policy proposals on the table, like an international price index, would make it more difficult for companies like Gilead to move so quickly on research and trials. We’re hopeful drug manufacturers will drive this point home when they meet with Trump at the White House today. 

Check out our new infographic about what BIO members are doing to fight the coronavirus.

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The Wall Street Journal: Big drugmakers warn about coronavirus impact on business
“To get ahead of any disruptions to supplies from China, some pharmaceutical companies have begun looking for alternative sources of drug ingredients and supplies.”

The Food and Drug Administration (FDA) regulates animal biotech the way they regulate drugs—but the U.S. Department of Agriculture and industry would prefer USDA take over regulation of animals for food. Here’s the latest on where FDA stands and what we’re doing about it, from Agri-Pulse.

The background: FDA has been responsible for assessing and approving animal biotech with their “risk-based approach”—and in the face of criticism about it, they recently published commentary and a press release to stand firm in their view they should continue to oversee animal biotech. 

BIO responded, writing in Agri-Pulse that while we agree on the need for pre-market review of animal biotech, the current regulatory system is opaque and cumbersome, needlessly bureaucratic, and vastly disproportionate to actual risk. 

After all, only one animal biotech product has been approved in 20 years. “Their record stands for itself—one approval,” said Tad Sonstegard, CEO of BIO member Acceligen. 

USDA seems to want to take the reins, as Secretary Sonny Perdue reportedly said he’s working on an agreement to ideally allow the USDA to oversee “food animal breeding.” 

What’s next: FDA will host a “series of meetings” TBA, “to explain the process and FDA’s regulatory intentions to farmers,” according to Agri-Pulse. 

What FDA’s saying: “[T]here’s a lot of confusion and misinformation out there about what we plan on doing,” said Laura Epstein, senior policy adviser in FDA’s Center for Veterinary Medicine. “We got word back that farmers seemed to think we’re going to require them to register them as drug manufacturers. We want to assure them that’s absolutely not the case.” 

What industry’s saying: “There is nothing fundamentally hazardous about genetic variation in food, and suggesting intentional alterations are equivalent to drugs will frighten consumers who might logically infer the presence of drugs in their food,” said Alison Van Eenennaam of the Animal Genomics and Biotechnology Laboratory at UC-Davis. 

BIO stands firm, too—in our view we need a regulatory process that’s science-based and allows innovation to thrive. While we’re encouraged by the talks between USDA and FDA, and FDA’s upcoming meetings, nothing’s final quite yet. We’ll be watching this issue closely, so stay tuned.