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STAT+: Pharmalittle: We’re reading about a Supreme Court hearing on ‘skinny labels,’ AstraZeneca U.K. expansion, and more
Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus, but our spirits remain sunny, nonetheless. And why not? As the Morning Mayor suggested to us long ago, “Every day should be unwrapped like a precious gift.” While you tug on the ribbon, we will fire up the trusty kettle for a cuppa elderberry hibiscus. Of course, you are invited to join us. Remember, no prescription is required. This is strictly cash money. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …
AstraZeneca will resume expansion of its research and development operations in a Cambridge, U.K. facility, the first such project to be revived following the trade deal with the U.S. that included measures to lift U.K. spending on medicines, The Financial Times writes. Pascal Soriot, AstraZeneca’s chief executive, said on Wednesday that the drugmaker would invest $400 million to complete the Rosalind Franklin building that it put on hold last year, and build a new laboratory in the town of Macclesfield that would use “digital and data tools to advance drug development.” The company was one of several drugmakers that postponed or cancelled U.K. investments over disagreements with the government about increased medicines spending. As part of a trade deal agreed with the Trump administration, the U.K. agreed to lift the thresholds it uses to determine whether medicines are cost-effective for use on the National Health Service.
After months of anticipation, U.S. Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver, STAT explains. At issue is skinny labeling, which refers to moves by generic companies that seek regulatory approval to market a drug for a specific use, but not other patented uses for which a brand-name medicine is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement. The court heard arguments concerning a case involving Amarin, which markets a drug called Vascepa for treating different heart problems, and Hikma Pharmaceuticals, one of the largest generic manufacturers.
Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus, but our spirits remain sunny, nonetheless. And why not? As the Morning Mayor suggested to us long ago, “Every day should be unwrapped like a precious gift.” While you tug on the ribbon, we will fire up the trusty kettle for a cuppa elderberry hibiscus. Of course, you are invited to join us. Remember, no prescription is required. This is strictly cash money. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …
AstraZeneca will resume expansion of its research and development operations in a Cambridge, U.K. facility, the first such project to be revived following the trade deal with the U.S. that included measures to lift U.K. spending on medicines, The Financial Times writes. Pascal Soriot, AstraZeneca’s chief executive, said on Wednesday that the drugmaker would invest $400 million to complete the Rosalind Franklin building that it put on hold last year, and build a new laboratory in the town of Macclesfield that would use “digital and data tools to advance drug development.” The company was one of several drugmakers that postponed or cancelled U.K. investments over disagreements with the government about increased medicines spending. As part of a trade deal agreed with the Trump administration, the U.K. agreed to lift the thresholds it uses to determine whether medicines are cost-effective for use on the National Health Service.
After months of anticipation, U.S. Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver, STAT explains. At issue is skinny labeling, which refers to moves by generic companies that seek regulatory approval to market a drug for a specific use, but not other patented uses for which a brand-name medicine is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement. The court heard arguments concerning a case involving Amarin, which markets a drug called Vascepa for treating different heart problems, and Hikma Pharmaceuticals, one of the largest generic manufacturers.
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Court dismisses part of Lilly lawsuit against Empower, some claims can proceed
Court dismisses part of Lilly lawsuit against Empower, some claims can proceed
A federal judge has dismissed part of Eli Lilly’s lawsuit alleging Empower Pharmacy misled customers about its compounded versions of the obesity drug tirzepatide.
But the court said some of Lilly’s claims involving whether Empower … Read More
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STAT+: As artificial intelligence show off diagnostic chops, scientists reckon with the way forward
Getting a paper published in Science is a highlight of many researchers’ careers. But for internist and clinical AI researcher Adam Rodman, it’s also been a source of some agita.
On Thursday, Rodman and his colleagues published a compilation of experiments, including one using real-world data from a Boston emergency department, that show a large language model from OpenAI can outperform physicians in case-based diagnostic and clinical reasoning evaluations. To Rodman, the paper’s co-senior author, it’s a response to a gauntlet thrown down in Science in 1959. That paper “described how you would know that a clinical decision support system was capable of doing diagnosis better than humans,” he said. “And they can do it.”
But as generative AI tools like chatbots are heavily marketed — both to patients and clinicians — it makes him worried that the science experiments, all based on simulated and historical cases, will be misconstrued as proof of AI’s safety and efficacy when used to treat real patients.
Getting a paper published in Science is a highlight of many researchers’ careers. But for internist and clinical AI researcher Adam Rodman, it’s also been a source of some agita.
On Thursday, Rodman and his colleagues published a compilation of experiments, including one using real-world data from a Boston emergency department, that show a large language model from OpenAI can outperform physicians in case-based diagnostic and clinical reasoning evaluations. To Rodman, the paper’s co-senior author, it’s a response to a gauntlet thrown down in Science in 1959. That paper “described how you would know that a clinical decision support system was capable of doing diagnosis better than humans,” he said. “And they can do it.”
But as generative AI tools like chatbots are heavily marketed — both to patients and clinicians — it makes him worried that the science experiments, all based on simulated and historical cases, will be misconstrued as proof of AI’s safety and efficacy when used to treat real patients.
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Lilly’s weight loss pill reaches brand new patients, even without full-court marketing press
Foundayo became available on April 9 and has already reached 20,000 patients as Eli Lilly builds its marketing machine for the weight loss pill.
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
Court dismisses part of Lilly lawsuit against Empower, some claims can proceed
STAT+: As artificial intelligence show off diagnostic chops, scientists reckon with the way forward
Lilly’s weight loss pill reaches brand new patients, even without full-court marketing press
Merck still sees ‘compelling’ outlook for Terns leukemia drug
UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy
Pathogenic Bacterium Rewires Gut Environment to Colonize and Cause Disease
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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