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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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STAT+: Pharmalittle: We’re reading about Pfizer’s emergency penicillin program, a Sanofi diabetes drug, and more
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. But what can you do? The world, such as it is, continues to spin. So time to give it a little nudge in a better direction by firing up our spiffy new kettle — the last one overheated — for a cup of stimulation. Given this is the start of the week, we are reaching for Jack Daniels. Yes, this is a real option for aspiring connoisseurs. Feel free to join us. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …
The Trump administration proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs, STAT tells us. The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation. Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. Iif a company adds a second drug to one that is eligible for negotiation, the FDA considers the resulting combination drug a new product, giving it additional time before price negotiation. Now, the administration is proposing to subject certain types of combination biologics to negotiation in some cases.
German Health Minister Nina Warken said that drugmakers will not be exempted from cost-cutting measures, after some companies warned they may be unable to launch innovative medicines in Europe unless governments agree to pay more than they historically have, Reuters writes. Proposed legislation in Germany will cap rapidly growing costs in the statutory health insurance system. Warken said she realizes many drug companies are under pressure, and the planned legislation is not going to bring them any extra revenue. But she maintained Germany remains an attractive location for the pharmaceutical industry thanks to reimbursement under the statutory health insurance scheme and opportunities for clinical trials. So exempting the industry from the proposed legislation is out of the question.
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. But what can you do? The world, such as it is, continues to spin. So time to give it a little nudge in a better direction by firing up our spiffy new kettle — the last one overheated — for a cup of stimulation. Given this is the start of the week, we are reaching for Jack Daniels. Yes, this is a real option for aspiring connoisseurs. Feel free to join us. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …
The Trump administration proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs, STAT tells us. The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation. Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. Iif a company adds a second drug to one that is eligible for negotiation, the FDA considers the resulting combination drug a new product, giving it additional time before price negotiation. Now, the administration is proposing to subject certain types of combination biologics to negotiation in some cases.
German Health Minister Nina Warken said that drugmakers will not be exempted from cost-cutting measures, after some companies warned they may be unable to launch innovative medicines in Europe unless governments agree to pay more than they historically have, Reuters writes. Proposed legislation in Germany will cap rapidly growing costs in the statutory health insurance system. Warken said she realizes many drug companies are under pressure, and the planned legislation is not going to bring them any extra revenue. But she maintained Germany remains an attractive location for the pharmaceutical industry thanks to reimbursement under the statutory health insurance scheme and opportunities for clinical trials. So exempting the industry from the proposed legislation is out of the question.
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STAT+: Where ‘democracy met science,’ 50 years ago
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Good morning. At a Cambridge bar on Saturday, I watched straight-seeming couples congregate by a television showing basketball, while a more queer-coded crowd lingered at another showing soccer. I don’t think that’s anything, really, but it was fun.
This ‘never event’ is happening more frequently
A child born with congenital syphilis could suffer dire consequences: bone deformities, brain damage, blindness, deafness, and more. But that should be a ‘never event’ as public health officials say: A pregnant person can receive an injectable form of penicillin to prevent the infection. Somehow, rates keep going up anyway. Between 2012 and 2024, the U.S. saw an 800% increase in babies born with the disease. And since last year, there’s been a shortage of the drug.
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
Good morning. At a Cambridge bar on Saturday, I watched straight-seeming couples congregate by a television showing basketball, while a more queer-coded crowd lingered at another showing soccer. I don’t think that’s anything, really, but it was fun.
This ‘never event’ is happening more frequently
A child born with congenital syphilis could suffer dire consequences: bone deformities, brain damage, blindness, deafness, and more. But that should be a ‘never event’ as public health officials say: A pregnant person can receive an injectable form of penicillin to prevent the infection. Somehow, rates keep going up anyway. Between 2012 and 2024, the U.S. saw an 800% increase in babies born with the disease. And since last year, there’s been a shortage of the drug.
Sanofi makes no mention of the Commissioner’s National Priority Voucher. Tzield was awarded the ticket in October 2025, but Sanofi requested withdrawal from the program after former CDER head Tracy Beth Høeg reportedly expressed skepticism of the drug.
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Meet Superman’s grandfather in new trailer for Krypton
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STAT+: Pharmalittle: We’re reading about Pfizer’s emergency penicillin program, a Sanofi diabetes drug, and more
STAT+: Where ‘democracy met science,’ 50 years ago
Sanofi wins type 1 diabetes nod for Tzield after requesting to revoke CNPV
Rhythm’s obesity drug scores ‘better than expected’ weight loss in rare genetic disease
Lilly sees quick return on $2.3B Ajax buy as blood cancer drug shows early efficacy
Celiac disease is entering a new era of therapeutic innovation
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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