Your go-to guide on potential Covid-19 treatments
The latest on remdesivir
A key trial testing Gilead’s potential Covid-19 treatment, remdesivir, could be read out as early as this week. STAT’s biotech brain trust has all your burning questions in advance of that data dump, from how statisticians are likely to interpret the data, to what happens if the trial produces “mixed results.” More here.
In other remdesivir news: Gilead disclosed Saturday that it has produced 1.5 million doses of the drug. It also announced it will provide the drug to hospitals for treatment of gravely ill patients with Covid-19 — at no charge to patients. So far Gilead has treated about 1,700 patients through so-called expanded access and compassionate use programs. Get the latest from Pharmalot here.
Some not-so-subtle FDA nudging
Former FDA Commissioner Scott Gottlieb is out with a new op-ed urging the agency he used to helm to collaborate with Gilead and other drug makers “in innovative ways” to get treatments to market as soon as possible. Gottlieb plugs the idea of real-time-reviews, where regulators review data as it comes out of a clinical trial, rather than waiting for a formal FDA application after a trial is completed. The FDA has been piloting that idea for cancer drugs.
The government agency you should really be paying attention to
By the way, did you know there’s a tiny government office with a checkered past that is tasked with investing in treatments for infectious diseases like Covid-19? Congress just so happened to triple its budget in its last coronavirus response package. Check out my deep dive into whether that office, known as BARDA, is ready to absorb that exponential increase in responsibility. More here.
Meanwhile at the White House …
President Trump is still touting hydroxychloroquine, the malaria drug he seems convinced will help with Covid-19 — and in a late-night White House briefing on Sunday, he didn’t hold back his enthusiasm. STAT’s Lev Facher fact-checked the president’s latest claims, including that the FDA has approved the drug, that patients have nothing to lose, and that the so-called right-to-try law he helped spearhead is the only option for terminally ill patients seeking experimental drugs. More here.
Keep an eye on this idea
There’s a new startup helping generic drug makers repurpose their drugs for treating Covid-19. STAT’s Ed Silverman talked to the man behind the idea, former Novartis IP lawyer Paul Fehlner. More here.
Other coronavirus stories from STAT
STAT’s Helen Branswell asked the hard questions in an interview with CDC Director Robert Redfield.
Martin Shkreli is trying to use the coronavirus to get out of prison. Yes, really.
Americans are underestimating how long the coronavirus will disrupt everyday life.
The CDC is beginning studies to determine how many Americans have already been infected with Covid-19.
STAT digs in to Trump’s unenthusiastic endorsement of Americans wearing masks in public.
A look at the heartbreaking coronavirus ritual of one nurse.
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