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The U.S. Justice Department has launched a criminal investigation into Eli Lilly and Co (LLY.N) focused on alleged manufacturing irregularities and records tampering at a factory in Branchburg, New Jersey, that produces the pharmaceutical giant’s COVID-19 therapy and other drugs, three people familiar with the matter said. The probe represents a significant escalation of the government scrutiny on Lilly. The pharmaceutical company, one of the world's largest, has been under examination for more than a year by the U.S. Food and Drug Administration over alleged manufacturing and records violations at the Branchburg factory. (Taylor, Spector and Levine, 5/27)

In an unexpected move, the Food and Drug Administration is reversing a decision by the Trump administration to end a controversial program that forces drug makers to win regulatory approval for medicines already on the market, but were never actually approved. At issue is the Unapproved Drugs Initiative, which was launched in 2006 to gather data on numerous medicines that had been available for years on a grandfathered basis because they predated stricter approval requirements. But the program prompted complaints that some companies established monopolies after winning approval for a drug that, in some cases, led to big price hikes or shortages. (Silverman, 5/27)

In the case of Elizabeth Holmes apparently all publicity isn’t good publicity. Attorneys for the former Theranos CEO are citing widespread negative coverage as a reason to expand selection for the pool of jurors in her upcoming criminal fraud trial. A 21-page motion filed late Thursday spelled out example after example of highly descriptive and unflattering stories in the past several years about Holmes. (Khorram, 5/28)

CARB-X announced today that it is awarding up to $3.9 million to a Danish microbiome biotechnology company to develop a CRISPR-based drug to prevent Escherichia coli infections in cancer patients. The award will help Copenhagen-based SNIPR BIOME ApS develop its lead drug candidate, SNIPR001, which uses CRISPR/Cas DNA editing technology to selectively eradicate E coli bacteria in the gut and prevent translocation of the bacteria to the bloodstream while sparing other beneficial bacteria in the patient's microbiome. (5/27)

A West Virginia sheriff testified Thursday during a landmark trial against three large opioid distributors that he is worried the scourge of the pain pill epidemic will remain a very real part of life. “It’s long from being over,” Cabell County Sheriff Chuck Zerkle said. “I fear for what comes for my grandchildren and the next generation. This is not about me. I’m an old guy. I’m done. What comes down the road, that’s what I worry about.” A civil lawsuit filed by Cabell County and the city of Huntington accuses drug distributors AmerisourceBergen Drug Co., Cardinal Health Inc. and McKesson Corp. of fueling the U.S. crisis. (5/28)

KHN: Opioids Like ‘Lean’ Permeate Hip-Hop Culture, But Dangers Are Downplayed

Nykerrius Williams knows about the close relationship between hip-hop and opioid use. Williams, 27, an independent rapper from Gibsland, Louisiana, who goes by the name Young Nyke, took oxycodone pills for the first time when he was 16 and has continued patterns of misuse of those pills, as well as Lortabs, Xanax and codeine cough syrups, until recently. To him, it’s part of the business. “If you ain’t rapping about being on no drugs, or you out here in the streets selling some drugs,” he said of his chosen profession, “you ain’t got some of that going on — like, don’t nobody wanna hear what you talking about.” (Giles, 5/28)