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With Johnson & Johnson's COVID-19 vaccine rollout off to a slower than expected start, the recent news that millions of doses were ruined in a production error came as a rude awakening. But the Emergent BioSolutions plant at the heart of the issue has faced scrutiny for its shortcomings from federal regulators before...An FDA investigator last April discovered improper training, record keeping, testing procedures and more at Emergent BioSolution's Baltimore Bayview facility...The inspection came just two months before the CDMO snared an eye-popping $628 million deal from the U.S. government to scale up production capacity...READ MORE

An FDA inspector-turned-whistleblower claims the agency soft-pedaled violations at a range of pharma manufacturing plants, including a Merck & Co. vaccine facility in Durham, North Carolina, where staff allegedly destroyed evidence of unsanitary practices. Those allegations have now been passed along to the White House… The whistleblower alleged that employees at Merck's plant were moving between cleanrooms and uncontrolled areas without properly ungowning, and that a biohazard bin contained employee uniforms soiled with blood, urine and feces. Employees were soiling their uniforms rather than taking restroom breaks, the whistleblower claimed, citing a confidential informant, because staffers would have otherwise needed to remove sterile gowning and leave manufacturing areas…READ MORE

Eli Lilly faced a high-level personnel scandal last month when CFO Josh Smiley left under a cloud of "inappropriate" communications with employees. But a sex discrimination lawsuit from a former internal lobbyist uncovers an entirely new controversy—and offers an alleged look inside the culture of a key team...Sonya Elling, a longtime biopharma lobbyist who worked in Lilly's government affairs operation, sued the company alleging mistreatment by her supervisors on the basis that she is a female...During Elling's time at the company, her first- and second-level supervisors called her “mean,” “nasty,” “disruptive,” “rude,” “aggressive,” and a “bitch,” according to the suit. They did so because she is a "strong, assertive female," who didn't "conform to traditional gender stereotypes," the suit says...READ MORE

Democrats...are united behind an idea that Republican lawmakers and major drugmakers fiercely oppose: empowering the Department of Health and Human Services to negotiate the prices of brand-name drugs covered by Medicare...Democrats hope to authorize Medicare negotiations on payments for at least some of the most expensive brand-name drugs and to base those prices on the drugs’ clinical benefits...READ MORE

FDA granted an emergency use authorization for the first machine learning–based COVID-19 nondiagnostic screening device. The Tiger Tech COVID Plus Monitor identifies certain biomarkers that may be indicative of SARS-CoV-2 infection. It can also detect hypercoagulable conditions, such as sepsis or cancer, or hyper-inflammatory states in asymptomatic individuals over the age of 5 years...FDA said the device, which is an armband embedded with light sensors and a small computer processor, is intended for use by trained personnel to help prevent exposure to and the spread of COVID-19...READ MORE

Hospitals and health system pharmacists are urging the Biden administration to review insurer "white bagging" policies...Payers use white bagging to dispense drugs to hospitals, requiring these medications come from select network specialty pharmacies. AHA and ASHP said in the letter that doing so circumvents hospital supply chain protocols aimed at patient safety..."White bagging has surged in frequency over the past decade, creating what amounts to a shadow inventory that hospitals and health systems do not legally own and which exists largely outside of the DSCSA’s track and trace requirements,"...READ MORE

A new legislation recently passed by the Michigan’s House of Representatives would require reforms to many pharmacy benefit manager reimbursement practices in the state...The provisions listed in HB 4348 would prohibit PBMs from reimbursing pharmacies affiliated with the PBM more than non-affiliate pharmacies; prohibit patient steering to PBM-owned pharmacies; prohibit retroactive clawbacks; require reimbursement be based on the National Average Drug Acquisition Cost; and establish fair audit procedures for community pharmacies...READ MORE

Throughout the frantic response to the pandemic last year, drugmakers worldwide tested hundreds of potential treatments. Gilead’s antiviral remdesivir quickly rose to the top of treatment guidelines, and with the pandemic spiraling out of control, advocacy groups called on the U.S. government to step in and enforce patents against the company...But it turns out the government has no intellectual property covering remdesivir, the Government Accountability Office concluded in a new report...READ MORE

Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine ingredients weeks ago and ruined a large batch of the vaccine containing up to 15 million doses...The FDA is investigating the mistake, but the episode has led to a temporary halt of future J&J shot deliveries from the site...In a statement, J&J said it's working with federal authorities to deliver 24 million doses of the vaccine in April...The mistake happened early in the production process, so none of the doses made it out to distribution...READ MORE

In their clinical trials, the Pfizer and Moderna vaccines did okay, well enough for the FDA to grant emergency use authorization. But in a real-world study, where participants were all on the front lines fighting Covid, the vaccines proved 90% effective against the virus – not just the symptomatic disease. In the clinical studies, Pfizer and Moderna were testing against disease...According to the CDC-sponsored study released today, it didn’t matter which vaccine the participants received. What mattered was that both vaccines were designed using messenger RNA to repel the coronavirus. The results showed that the vaccines were even effective against asymptomatic virus...READ MORE