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In a high-tech lab on Johns Hopkins University’s Homewood campus in Baltimore, engineers have been building a robot that may be able to stitch back together the broken vessels in your belly and at some point maybe your brain, no doctor needed. The robot has a high-tech camera on one arm and a high-tech sewing machine on a second arm. It’s already reattached halves of a pig’s intestines. “It’s like park-assist in a car,” said Axel Krieger, an assistant professor of mechanical engineering in Hopkins’ Whiting School of Engineering. “Performs the procedure autonomously.” (Cohn, 3/22)

A high-profile, experimental therapy for ALS is teeing up a crucial test of the Food and Drug Administration’s ability to withstand political pressure. The drug, from Amylyx Pharmaceuticals, has been the subject of an immense pressure campaign from ALS patients and advocacy organizations — one with roots in the broader “right-to-try” movement’s successful efforts to weaken the agency’s ability to limit patients’ access to drugs to treat deadly diseases. ALS advocates charge that the FDA has stubbornly blocked access to therapies that might add even a glimmer of hope to a diagnosis that is otherwise a death sentence — an argument that the FDA has worked hard to counter. (Florko, 3/22)

The FDA's conditional approval of a controversial Alzheimer's drug last year has sparked heightened scrutiny and an attempted overhaul of a popular regulatory pathway used to fast-track cancer drugs and certain other treatments. Accelerated approval allows patients to access new drugs deemed to meet unfilled needs much faster than if the drug went through the regular approval process. But critics say that more needs to be done to prove these drugs actually work in the real world, which could have big implications for the pharmaceutical industry. (Owens, 3/21)

Alex Schmelzer didn’t think he’d be the most-hated person in drug pricing negotiations, but he was. Schmelzer founded a consulting firm in 2016 to help companies battle their pharmacy benefit managers, the behemoth intermediaries that negotiate drug prices, process claims, and create networks of pharmacies. Schmelzer and his colleagues pored through data and discovered many employers were paying too much for their workers’ drugs. But after three years, in 2019, Schmelzer had to shut down his shop. It turns out his clients didn’t want him to battle as hard as he did — even if they were getting overcharged. (Herman, 3/22)

Fresenius Medical Care AG is creating a new kidney-care business with InterWell Health LLC and Cricket Health Inc. that the companies say is valued at $2.4 billion. Fresenius Medical will be majority owner of the new entity, which will operate under the InterWell Health brand, according to a statement Monday. The move comes as German health-care conglomerate Fresenius seeks ways to spur growth after suffering from higher costs and lower demand during the pandemic. The parent entity is considering initial public offerings for two of its four business units and has said it’s open to fielding offers for its controlling stake in the kidney-dialysis division Fresenius Medical. (Loh, 3/21)

The prototypical biotech company is easy to envision: think Moderna, Alnylam, and Genentech. But what about Pfizer, which claims “biotechnology is [the company’s] foundation?” What about Twist Bioscience, which doesn’t make therapeutics but was dubbed one of the “most innovative biotechnology companies of 2021”? And what about diagnostics companies, like Exact Sciences, a key element of its local biotech ecosystem? Historically, experts distinguished between biotech and pharmaceutical companies based on how a therapeutic was made. But the line that once separated these categories has become fuzzier over time, and the biotech umbrella has expanded to cover far more than therapeutics. (Sheridan, 3/21)

An extensive analysis of thousands of pediatric trials found one in 10 ended early — and among the studies that were completed, the vast majority of results still hadn’t been reported or published years later, raising concerns about incomplete knowledge about treatments for children. Moreover, the problems existed regardless of the funding sources, although studies supported by the pharmaceutical industry were significantly more likely to be discontinued. And industry-sponsored trials also had lower odds of being published three years after completion, according to the analysis, which looked at 13,200 studies conducted from October 2007 to March 2020 and was published Tuesday in Pediatrics. (Silverman, 3/22)