The AMS Blog

Dive Brief: The last major legal standoff for a Humira biosimilar has ended, as AbbVie and Boehringer Ingelheim announced Tuesday a settlement of patent litigation over the U.S. entry date. Boehringer can begin selling its copycat of the world’s best-selling drug on July 1, 2023, paying royalties to AbbVie for the U.S. license, according to the settlement. Eight companies have now settled with AbbVie over Humira biosimilars. While Humira competition started this year in Europe, the deals reached in the…

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Patients treated at hospitals that earned “D” or “F” grades when it comes to patient safety face a 92% higher risk of death from avoidable medical errors than at hospitals with an “A” grade, according to a new report from The Leapfrog Group. In Leapfrog’s Annual Hospital Safety Grades, about 32% of the 2,600 hospitals evaluated received an “A” grade for safety, 26% earned a “B” grade and 36% earned a “C” grade. The hospital safety group awarded a “D” or an “F” grade to…

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It might be the biggest price-fixing scheme in U.S. history. On Friday, Connecticut and a coalition of more than 40 states filed a 500-page lawsuit accusing the biggest generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. It’s a more sweeping version of a similar lawsuit the states filed in 2016 that’s still being litigated. The generic industry vehemently denies the allegations. Congress established the current generic industry in 1984 to push prices…

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When women get a mammogram they may be offered one of two types. The older type of mammogram takes a single straightforward X-ray image of the breast. The newer 3D takes pictures from many angles. Now, more evidence shows that 3D mammography offers a more thorough picture of breast tissue and is more accurate.  When Mary Hu, an administrator in communications with Yale School of Medicine, went to get a mammogram two years ago, she didn’t even know she was…

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Two whistleblowers at a pharmaceutical company responsible for one of the largest drug price increases in US history said the company bribed doctors and their staffs to increase sales, according to newly unsealed documents in federal court.  The effort, the whistleblowers said in a lawsuit against the company, was part of an intentional “multi-tiered strategy” by Questcor Pharmaceuticals, now Mallinckrodt, to boost sales of H.P. Acthar Gel, cheating the government out of millions of dollars. The price of the drug,…

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U.S. health authorities will allow a type of breast implant linked to a rare form of cancer to stay on the market, saying its risks do not warrant a national ban. But the Food and Drug Administration said Thursday it is considering bold warnings for the implants and requiring stricter reporting of problems by manufacturers. The announcement is the latest in the government’s decades-long effort to manage implant risks and complications that can include scarring, pain, swelling and rupture. In…

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BALTIMORE—When patients have skin cancer, their doctors will often perform what’s called Mohs micrographic surgery (MMS)—a technique of removing cancerous tissues from the skin one layer at a time. But there are wide variations between surgeons when it comes to just how much tissue is removed, with some doctors regularly removing more amounts of tissue than others. It’s a phenomenon that not only creates large cost differences for some patients but raises questions about the appropriateness of the care patients…

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The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public. The agency said it will open past records to the public within weeks. A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The program, which began about 20 years ago,…

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(CNN) — Out-of-pocket costs for Americans with neurologic conditions have risen so rapidly over 12 years, a new study says, that doctors need better access to drug price information “to minimize patient financial burden.” The study, published Wednesday in the journal Neurology, found that the average out-of-pocket costs for people taking medications for multiple sclerosis had risen the greatest over the past 12 years, costing 20 times more in 2016 than in 2004. “Out-of-pocket costs have risen to the point…

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Many older Americans may remember “Fantastic Voyage” — the 1966 film where scientists and the vessel they were in shrank to microscopic size and traveled through the human body. Now, science fiction may be getting closer to reality. Researchers say they’ve created a tiny medical robot that’s able to navigate on its own in and around a beating heart. The programmed robotic catheter was able to independently find its way to leaky heart valves in live pigs, according to bioengineers…

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