| |   | Found a new favorite drug name: sabizabulin. Just rolllllls off the tongue. We write about the seemingly impressive Covid drug, dig into a Paxlovid quandary, and highlight some serious concerns about the 340B program.
- Meghana | | | Doctors need more clarity on prescribing Paxlovid The FDA yesterday widened the pool of Paxlovid prescribers, allowing pharmacists to authorize the Covid-19 antiviral. But physicians tell STAT that prescribing guidelines for the drug still aren't clear-cut. Among other issues, there are questions about when to prescribe Paxlovid and the criteria that separates those who need it from those who do not. “There is a real dearth of evidence right now out there, and obviously there’s a lot of confusion,” one virology expert told STAT. “And even amongst people who are immersed in the literature, and who are infectious disease experts, you’ll see actually a fairly wide range in opinions.” Read more. | Another entrant among Covid drugs When the pandemic began, many small biotechs touted medicines they were already developing as potential Covid treatments. Impressive-looking results from one of them, Veru, were published yesterday in NEJM Evidence, a medical journal. Patients who received the drug, sabizabulin, were half as likely to die as those that received placebo. The drug seems to have both anti-viral and anti-cancer activity. However, as Covid researcher David Boulware notes, the trial was small and the confidence intervals on that estimate range from a 5% benefit to a 70% one, and the death rate in the placebo group is surprisingly high. Veru stock closed up 13%. | Democrats' Last Chance for Drug Pricing Reform? The drug pricing debate remains a central conversation in Congress. On July 20, STAT sits down with key decision-makers about the latest developments from Capitol Hill and the White House. Join them. | Some hospitals and PBMs exploiting 340B The 340B Drug Pricing Program was designed to help hospitals that care for underserved communities by keeping medications affordable. But some large hospitals and for-profit pharmacy benefit managers are diverting billions of these dollars, reaping savings meant exclusively for patients in need. “They buy drugs at steep 340B discounts, then charge insurers, the uninsured, and cash-paying patients a huge markup,” writes Ted Okon, who leads a nonprofit representing community oncology practices. In an opinion piece, he calls on Congress to regulate the “bad actors who are taking advantage of it.” Read more. | Guardant Health offering genomic profiling to Chinese trials Liquid biopsy player Guardant Health is expanding to China, FierceBiotech writes. Partnering with Hangzhou-based clinical lab company Adicon Holdings Limited, Guardant will offer its blood and tissue genomic cancer assays to biotechs that are conducting trials in the country.
The Guardant tests are meant to help researchers identify the molecular profile of tumors in prospective clinical trial participants — streamlining the screening and enrollment process. The hope, they say, is to hasten the development of new cancer therapies in China. “Increasing incidence rates have made cancer a high priority in China and have led to a rising number of clinical trials in the region,” Adicon’s CFO said in a statement. Lung, colorectal, and stomach tumors are particularly prevalent. | More reads - The FDA owes parents an explanation about why it delayed authorizing Moderna’s Covid-19 vaccine for young kids. STAT
- U.S. Senate Democrats advance deal to lower drug prices. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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