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In a regulatory filing on Wednesday, Mallinckrodt disclosed that it had reached a plan to file for bankruptcy for the second time in three years. The plan would cancel a majority of the $1.25 billion that the company still owes under the original settlement agreement, in exchange for a final payment of $250 million that would be made before the company enters its second bankruptcy. The plan to cancel a majority of the outstanding payments was devised with backing from hedge funds that would control the company under a second bankruptcy. The funds had lent money to Mallinckrodt and were in a position to force the company to prioritize paying back its lenders over compensating victims. (Robbins, 8/23)

Health agencies and law enforcement are turning to artificial intelligence (AI) in their efforts to combat widespread opioid addiction, according to a report. Data-driven monitoring systems such as NarxCare offer numerical ratings of patients' medication history that give doctors a rudimentary idea of their risks, but professionals are split on their effectiveness, according to a report from MarketPlace. "We need to see what’s going on to make sure we’re not doing more harm than good," health economist Jason Gibbons told the outlet. (Nerozzi, 8/23)

The Food and Drug Administration (FDA) has sent warning letters to 15 companies for selling "unauthorized e-cigarette products" — otherwise known as vapes — disguised as school supplies, food and drinks, toys and other kid-enticing designs, according to a Wednesday press release. The letters were sent to 15 online sellers. (Rudy, 8/23)

Federal health regulators are warning consumers to immediately stop using two additional eye drop products because of potential bacterial or fungal contamination. The Food and Drug Administration is advising people not to buy "Dr. Berne's MSM Drops 5% Solution" and "LightEyez MSM Eye Drops – Eye Repair," warning that they could pose a serious health risk, including vision- and life-threatening infections. The agency noted that it doesn't know of anyone who has reported a problem due to the products. (Cerullo, 8/23)

CVS Health Corp said on Wednesday it has launched a new company called Cordavis that will work directly with manufacturers to commercialize and co-produce biosimilar medicines for the U.S. market. The company next year will partner with Swiss drugmaker Novartis' Sandoz unit to market Hyrimoz, a version of AbbVie's blockbuster arthritis drug Humira, at a list price that is more than 80% lower than the branded drug. (Wingrove and Jain, 8/23)

Saint-Gobain Performance Plastics announced Wednesday that it will be closing its facility in Merrimack, N.H. The plant has been at the center of controversy and concern after the PFAS chemicals the company uses to produce stain and water resistant materials were found in nearby drinking water in 2016. A 2021 state report found cancer rates in Merrimack were higher than expected. (Gokee, 8/23)

An advisory panel to the Food and Drug Administration delivered a split decision on a surgical system used in a controversial blood pressure treatment called renal denervation. The panel, whose advice the FDA typically follows, voted that the system developed by ReCor Medical was safe and effective. It voted that the benefits of a system developed by Medtronic, however, did not outweigh the risks. (Lawrence, 8/23)

The multibillion-dollar hunt for what many drugmakers hope will be the next big immunotherapy target has had no shortage of twists and tea-leaf-reading. In the wee hours of Wednesday morning, it got another. Roche confirmed it accidentally released interim data from a closely watched clinical trial testing whether blocking that target — a protein on T cells known as TIGIT — can enable non-small lung cancer patients to live longer than standard immunotherapy alone. (Mast, 8/23)

If you want to get vaccinated against Lyme disease today, your choices are limited. In fact, you’d have to find a rogue veterinarian willing to experiment on you. The only options on the market are for dogs. This wasn’t always the case. (Brown and Cattan, 8/24)

The youngest candidate on Wednesday night’s debate stage didn’t make any friends among his fellow Republican presidential hopefuls, questioning their morality, mocking their promises, and suggesting that he, by virtue of his inexperience in government, was ideally suited to solve a nation’s problems. For Vivek Ramaswamy, it was familiar territory. Long before he was explaining Perestroika to Mike Pence and congratulating Nikki Haley on a future career in the defense industry, Ramaswamy brought a similar brashness to biotech. (Garde, 8/24)