Building trial trust among underrepresented minorities

One of the top priorities, and challenges, facing the largest Covid-19 vaccine trials has been ensuring diverse representation. Researchers are working to include members of Black, Latino, and Native American communities in Phase 3 trials, in part because they’ve been the hardest hit by the pandemic. But in their recruitment efforts, scientists are being forced to grapple with the reality of health inequities, STAT’s Eric Boodman writes.

Many people in these communities have a long-standing distrust in the medical establishment — and many don’t have health insurance, or the ability to step away from work for a sick day. Yet recruiters have now been explicitly tasked with bringing on thousands of diverse participants.

“We recognize that building trust is not something we’re going to do in a couple of weeks. This is going to take years,” one researcher said. “We’re not trying to reach out to underserved communities to say, ‘We should talk about the AstraZeneca trial.’ We’re reaching out to build trust, period.”

Trump moves on importation and $200 drug coupons for seniors

Late yesterday, the FDA finalized a closely watched regulation that will pave the way for states to import cheaper drugs from Canada. Under the proposal, states can contract with a Canadian pharmacy to import certain drugs, subject to FDA approval. HHS Secretary Alex Azar also formally “certified” to Congress that importation could be done safely, clearing a major legal roadblock, as STAT Washington correspondents Lev Facher and Nicholas Florko report.

But Americans likely won’t be getting drugs from Canada any time soon: States will need to submit detailed plans for how they would import drugs safely. The drug industry is also likely to sue to block the proposal from going into place.

Trump also announced Thursday that he would be sending $200 cards to seniors to help them pay for their drugs, a clear political ploy aimed at currying favor with seniors who view drug prices as a priority. A White House spokesperson said the cards should be mailed out within a few weeks, but other questions about the new cards, and how the administration will pay for them, abound.

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Is superspreading an Olympic event?

Will Covid-19 forever change health tech? And what are the limits of Anthony Fauci's patience? We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, STAT’s Andrew Joseph talked to dozens of experts about how the Covid-19 crisis will play out over the next year, and he joins us to explain what he learned.

Then, our colleague Erin Brodwin calls in to tell us about the technologies that allow people’s health to be tracked continuously from wherever they are. Finally, we embark upon a lightning round, going over the latest political squabbles over the U.S. Covid-19 response and potential vaccine approvals.

Listen here.

Novavax is growing to meet Covid-19 demand

Novavax, the Gaithersburg, Md., based vaccine maker is vastly expanding its workforce after receiving $1.6 billion from Operation Warp Speed, the company’s president and CEO, Stanley Erck, said during a press conference hosted by the Biotechnology Innovation Organization and Maryland Governor Larry Hogan.

Novavax, which had 165 employees globally before the Covid-19 pandemic, is expecting to boost that total to more than 1,000 by March of next year, Erck said. The company has expanded its physical footprint, too. Novavax already has signed one new lease in Maryland and is in the process of negotiating another 200,000-square-foot facility.

The company also now has agreements to manufacture the vaccine in the Czech Republic, India, Spain, the U.S., South Korea, Japan, and the United Kingdom, Erck said.

Exact Sciences CEO talked his shares up $4 billion

Exact Sciences saw its stock surge yesterday after CEO Kevin Conroy shared some of the company’s data at Cowen’s Liquid Biopsy Summit, Bloomberg writes. Shares were up 29% — some $4 billion in market value — after Conroy showcased some “still very early” findings of the company blood test to detect multiple cancers.

Exact Sciences already develops the Cologuard stool test for colon cancer, but Cowen analyst Doug Schenkel wrote in a client note that the company “could be well-positioned as a major player in the liquid biopsy-based cancer screening market."

The company’s data were for a test meant to detect lung, liver, ovarian, pancreatic, esophageal, and stomach cancers. It showed a sensitivity of 86% and a specificity of 95% — and though it worked for early stage cancers, the company said the samples were biased toward later-stage disease.