Gilead expands trials on promising antiviral in coronavirus fight

March 2, 2020
What was more shocking: the South Carolina primary and how it changed the Democratic race just days ahead of Super Tuesday, or Trump’s third-ever appearance in the press briefing room on Saturday? Tweet us your thoughts at @IAmBiotech. The coronavirus continues to…

What was more shocking: the South Carolina primary and how it changed the Democratic race just days ahead of Super Tuesday, or Trump’s third-ever appearance in the press briefing room on Saturday? Tweet us your thoughts at @IAmBiotech

The coronavirus continues to dominate the news today. BIO member companies are in town to join President Trump at the White House to discuss efforts to contain the outbreak, and Vice President Pence will close the day with a media briefing at 5:00 PM. Keep an eye out for a “Special Edition” of Good Day BIO with breaking news from the day, depending on what we learn.

We’ve also got an update on the animal biotechnology “turf war” between the USDA and FDA, in about 870 words, or 4 minutes, 20 seconds.

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.


More Health Care News: 

STAT: Partisan bickering delayed Zika funding for months. With coronavirus, experts worry history will repeat itself
“Congress… dawdled for seven months because of an acrimonious fight over funding for Zika in 2016. That left health departments around the country cash-strapped and forced to cut back on existing public health programs, like responding to STD outbreaks. The long delay left the federal government no choice but to plunder funds meant for cancer research, heart disease, and fighting HIV to pay for their response efforts.” 

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.”


Moo-ve over, FDA

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.

BIO Beltway Report

President Trump’s Monday: As he said in his press conference on Saturday, he’ll meet with the heads of several pharmaceutical companies today to discuss the coronavirus response and drug pricing. Also, he’s meeting with the President of Colombia, then holding a campaign rally tonight in Charlotte, North Carolina.

What’s Happening on Capitol Hill: The House and Senate are in session this week, and several committees are expected to hold hearings on the coronavirus response and impacts, starting tomorrow (Tuesday) with Senate Health, Education, Labor & Pensions. Congress worked through the weekend but have not reached a deal on coronavirus funding, though we do expect one soon.

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