Category: Pharmaceuticals
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STAT+: Novo Nordisk links to telehealth providers for patients seeking Wegovy
STAT+: Novo Nordisk links to telehealth providers for patients seeking Wegovy Novo Nordisk has taken the next step in selling its drugs directly to patients by pointing them to telehealth providers that can write prescriptions for its popular obesity medication Wegovy. The company now links to select virtual providers on the NovoCare direct-to-patient pharmacy website…
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STAT+: New report details the state of the biotech industry in Mass. The results are grim
STAT+: New report details the state of the biotech industry in Mass. The results are grim The industry group MassBio has released its annual temperature check on the biotech industry in Massachusetts, and the results are grim. Both public and private funding have plummeted as federal policy changes have thrown the biotech sector into an…
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STAT+: AbbVie to buy Gilgamesh’s psychedelic drug for up to $1.2 billion
STAT+: AbbVie to buy Gilgamesh’s psychedelic drug for up to $1.2 billion AbbVie on Monday said it will buy Gilgamesh Pharmaceuticals’ investigational psychedelic drug to treat major depression, a sign that pharma companies are warming up more to the burgeoning field. The pharma giant will acquire the treatment, called bretisilocin, for up to $1.2 billion,…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis
STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis WASHINGTON — The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting…
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STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds
STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s…
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Viking’s obesity flop, ‘pharma to table’ drug sales
Viking’s obesity flop, ‘pharma to table’ drug sales On this week’s episode of “The Readout LOUD”: vikings. No, not the seafaring Norse people of the 10th century, or the Minnesota football team. The gang will discuss obesity drug developer Viking Therapeutics and the investor cult that embraces it, both of which performed a painful belly…
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What updated thresholds for statin use could mean for patients
What updated thresholds for statin use could mean for patients It’s a math problem with life-and-death consequences. When a new and improved model for estimating the risk of developing atherosclerotic cardiovascular disease emerged in November 2023, the calculator won raves for drawing on a larger, more contemporary, and more diverse population of Americans than its…
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STAT+: How Trump may use Democrats’ drug-price negotiation law
STAT+: How Trump may use Democrats’ drug-price negotiation law You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. I’m happy to report that Last Week Tonight with John Oliver did a segment on…
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STAT+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds
STAT+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds Conflicts of interest on federal government vaccine panels have declined to “historically low levels” in recent years according to a new study, findings that are likely to increase debate over a contentious issue pushed by Health and…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: Novo Nordisk’s obesity drug Wegovy cleared to treat MASH
STAT+: Novo Nordisk’s obesity drug Wegovy cleared to treat MASH Novo Nordisk’s obesity drug Wegovy was cleared by U.S. regulators on Friday to treat an increasingly common liver disease, adding to the list of conditions for which the blockbuster therapy is now approved. The Food and Drug Administration granted accelerated approval to Wegovy for patients…
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STAT+: Eli Lilly says it will raise drug prices in Europe to ‘make them lower’ in U.S.
STAT+: Eli Lilly says it will raise drug prices in Europe to ‘make them lower’ in U.S. Eli Lilly said Thursday that it would increase the prices of medicines in Europe and other developed markets “in order to make them lower” in the U.S., an apparent response to the Trump administration’s calls to do so.…
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Vinay Prasad’s return, animal testing alternatives, and mRNA upended
Vinay Prasad’s return, animal testing alternatives, and mRNA upended Have investors soured on mRNA biotechs? How will Vinay Prasad approach his role at the Food and Drug Administration the second time around? And how do you pronounce “bronchiectasis”? We address all that and more on this week’s episode of “The Readout LOUD.” We discuss the…
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STAT+: Drugmakers form new group to lobby on impact of Medicare drug price negotiations
STAT+: Drugmakers form new group to lobby on impact of Medicare drug price negotiations WASHINGTON — A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records. The group is called the IRA Watchdog…
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STAT+: Dear Vinay: Please embrace dissent and fade into the background
STAT+: Dear Vinay: Please embrace dissent and fade into the background Dear Vinay: My editors asked me to explain your return to the Food and Drug Administration to readers. But I’m more interested, right now, in giving advice to you. Look, any claim I have to clairvoyance is void. I was surprised as anyone by…
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STAT+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals
STAT+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals Patient advocacy groups are urging the South African government to reopen an antitrust investigation into Vertex Pharmaceuticals over allegations the company misled authorities into closing a high-profile case last year over access to a cystic fibrosis treatment. Last December, the Competition Commission ruled…
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STAT+: AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills
STAT+: AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills A patient advocacy group is suing the Trump administration for failing to disclose details of a recent settlement with Gilead Sciences over the patent rights to a pair of HIV prevention pills. The deal, which was reached last January, capped…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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Trump escalates demands that pharma companies lower their drug prices
Trump escalates demands that pharma companies lower their drug prices President Trump escalated his demands that pharma companies lower U.S. drug prices in line with what other countries pay, sending letters to 17 major drug companies Thursday that called on them to take actions by Sept. 29. He specifically asked the firms to: provide their…
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STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse
STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse Vinay Prasad’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But his forced departure is probably worse. It will likely be celebrated in many corners: by the many people who…
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STAT+: U.S. judge blocks first-in-the-nation law barring companies from owning PBMs and pharmacies in Arkansas
STAT+: U.S. judge blocks first-in-the-nation law barring companies from owning PBMs and pharmacies in Arkansas In a closely watched case, a U.S. federal court judge has temporarily blocked a first-in-the-nation law that would prohibit companies that own pharmacy benefit managers from also operating both retail and mail-order pharmacies in Arkansas. The state law is designed…
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STAT+: Pharma firms will face 15% tariffs in Trump’s E.U. trade deal
STAT+: Pharma firms will face 15% tariffs in Trump’s E.U. trade deal WASHINGTON — President Trump’s tariffs on pharmaceuticals coming from the European Union will be set at 15% and will not go into effect until a national security investigation has been completed, according to a White House official familiar with the plans. Once the…
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STAT+: FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
STAT+: FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt In a sharp reversal, the Food and Drug Administration on Monday said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to some patients. The therapy, called Elevidys, will once…
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STAT+: HHS orders thimerosal out of all flu vaccines
STAT+: HHS orders thimerosal out of all flu vaccines You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Alex Hogan did yeoman’s work of taste testing beef-tallow-fried chicken wings and fries, soda pop…
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A mother’s perspective on Sarepta’s gene therapy halt
A mother’s perspective on Sarepta’s gene therapy halt How are families of patients reacting to the removal of Sarepta’s gene therapy from the market? Why are investors excited about narcolpesy drugs? And why has there been less financing in oncology startups? We chat about all that and more on this on this week’s episode of…
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STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak
STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak Jennifer Hill Blair recognized the Cincinnati number on her buzzing phone and slipped out of the school meeting, excited to finally learn when her son Cayse would receive a therapy she believed would change his life. Blair, a second-grade teacher in southern…
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STAT+: FDA’s new top drug regulator hails from industry
STAT+: FDA’s new top drug regulator hails from industry You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. I scream! You scream! We all scream for ice cream without artificial dyes! Tell us…
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STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and…
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STAT+: The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear
STAT+: The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear In a matter of a few days last week, Sarepta Therapeutics announced major layoffs, acknowledged the death of another patient receiving one of its gene therapies, and was urged by the Food and Drug Administration to suspend shipments of a…
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Opinion: STAT readers weigh in on marijuana-related vomiting, drug prices, and more
Opinion: STAT readers weigh in on marijuana-related vomiting, drug prices, and more First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others. To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters…
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Opinion: We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress
Opinion: We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress They say death is one of life’s few certainties. For a boy or young man living with Duchenne muscular dystrophy, that certainty has a cruel twist: the anticipation of dying young. As mothers of children with this disease, we have…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: Sarepta Therapeutics crisis is huge blow to Duchenne families, company
STAT+: Sarepta Therapeutics crisis is huge blow to Duchenne families, company Sarepta Therapeutics confronted one of the most serious crises in its history on Friday, as the Food and Drug Administration prepared to ask the company to halt all shipments of its gene therapy for Duchenne muscular dystrophy — a treatment that had been a…
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Inside an FDA drug rejection, and layoffs at Sarepta
Inside an FDA drug rejection, and layoffs at Sarepta Just how many employees is Sarepta Therapeutics laying off? And why did the Food and Drug Administration reject Ultragenyx’s rare disease drug over manufacturing qualms? We discuss all that and more on this week’s episode of “The Readout LOUD”. Read the rest… Allison DeAngelis, Adam Feuerstein,…
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STAT+: Kailera drug shows notable weight loss in China trial
STAT+: Kailera drug shows notable weight loss in China trial Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We have a short and sweet newsletter today. And if you are in any areas hit by the flash foods, I hope…
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STAT+: A troubled Sun Pharma plant fails yet another FDA inspection
STAT+: A troubled Sun Pharma plant fails yet another FDA inspection A Sun Pharmaceutical plant in India that has been repeatedly cited by the U.S. Food and Drug Administration for serious quality control issues failed another inspection last month over concerns the company was not doing enough to prevent medicines from becoming contaminated. The problems…
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STAT+: ViiV expands licensing deal for its HIV drug in low-income countries
STAT+: ViiV expands licensing deal for its HIV drug in low-income countries Once again, ViiV Healthcare has announced steps to widen access to a sought-after HIV medicine in low- and middle-income countries, reflecting ongoing pressure to respond to criticism. Under the latest arrangement, the company is expanding a licensing agreement reached three years ago with…
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STAT+: FDA declines to approve Ultragenyx gene therapy
STAT+: FDA declines to approve Ultragenyx gene therapy Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! It’s Meghana today, writing about GLP-1s being deployed for addiction, weighing the FDA commissioner’s vision versus reality, and more. The need-to-know this morning AstraZeneca said its experimental…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: FDA publishes rejection letters sent to drugmakers, with a big caveat
STAT+: FDA publishes rejection letters sent to drugmakers, with a big caveat The Food and Drug Administration on Thursday published more than 200 letters that it sent to companies when it rejected their medicines, focusing attention on what’s often an opaque part of the drug review process. The agency only highlighted letters that went to…
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STAT+: HHS backtracks on pledge to disclose new vaccine advisers’ conflicts of interest
STAT+: HHS backtracks on pledge to disclose new vaccine advisers’ conflicts of interest WASHINGTON — The Department of Health and Human Services is sitting on information about new vaccine advisers’ conflicts of interest, and seemingly backtracking on its vow to make key disclosure documents public. Agency officials previously said they would release ethics forms for…
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STAT+: Novartis wins approval for newborn malaria treatment
STAT+: Novartis wins approval for newborn malaria treatment Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, I hope everyone had a great holiday weekend. Let’s get into the news today. The need-to-know this morning Foundering CAR-T therapy developer Cargo Therapeutics is being acquired and…
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STAT+: Fed-up and demoralized, FDA staff are leaving.
STAT+: Fed-up and demoralized, FDA staff are leaving. You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Between innings of the July 4 Chesapeake Baysox game against the Richmond Flying Squirrels there was…
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STAT+: Memo said to describe biotech industry meeting calls RFK Jr. a ‘direct threat to public health’
STAT+: Memo said to describe biotech industry meeting calls RFK Jr. a ‘direct threat to public health’ A memo that purports to summarize a meeting held by members of a leading biotech trade group suggests deep concern about health secretary Robert F. Kennedy Jr.’s stance on vaccines, and describes him as a “direct threat to…
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STAT+: Sage Therapeutics cuts most of its workforce following acquisition
STAT+: Sage Therapeutics cuts most of its workforce following acquisition Sage Therapeutics is laying off most of its employees after announcing its planned acquisition earlier this month. The Cambridge, Mass.-based biotech firm will cut 338 jobs effective Aug. 22, according to state filings. In February, the company reported employing 353 full-time staff, including 122 working in research…
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STAT+: Supreme Court declines to review Oklahoma law regulating PBMs
STAT+: Supreme Court declines to review Oklahoma law regulating PBMs The U.S. Supreme Court has declined to review an appeals court ruling that struck down key parts of an Oklahoma law regulating the retail networks created by pharmacy benefit managers, a victory for the controversial middlemen in the pharmaceutical supply chain that may create uncertainty…
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STAT+: J&J suffers a loss over 340B drug discount program
STAT+: J&J suffers a loss over 340B drug discount program In a setback to Johnson & Johnson, a federal judge ruled that a U.S. government agency did not violate the law when it required the company to seek approval before offering rebates to hospitals and clinics that participate in a drug discount program. The decision…
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STAT+: Senator launches investigation into GSK’s asthma inhaler maneuvers
STAT+: Senator launches investigation into GSK’s asthma inhaler maneuvers Amid ongoing controversy, U.S. Sen. Maggie Hassan (D-N.H.) is investigating GSK for replacing a popular asthma inhaler with a so-called authorized generic at a much higher price in order to avoid paying Medicaid rebates. In a letter sent to the company, the lawmaker maintained that the…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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Opinion: Proposed cuts could have ‘catastrophic effect,’ 110 biomedical, health sciences industry leaders tell Congress
Opinion: Proposed cuts could have ‘catastrophic effect,’ 110 biomedical, health sciences industry leaders tell Congress As leaders of United States companies positioned in the biomedical/health sciences landscape, we are well aware that our companies are but one component of an expansive and interconnected scientific ecosystem requiring federal, industry, and academic partnership. Government funding of research…
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Vaccine policy frays, CDC nominee in the hot seat, & obesity drug side effects
Vaccine policy frays, CDC nominee in the hot seat, & obesity drug side effects What does the fracturing of vaccine advice and policy mean for the U.S. health care ecosystem? Will the potential head of the Centers for Disease Control and Prevention stand up to her boss? And can Amgen overcome its obesity drug’s side…
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Generic cancer drugs used around the world fail quality tests, investigation shows
Generic cancer drugs used around the world fail quality tests, investigation shows Vital chemotherapy drugs used around the world have failed quality tests, putting cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, an investigation by the Bureau of Investigative Journalism (TBIJ) reveals. The generic drugs in…
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STAT+: Insurance coverage of vaccines at risk in RFK Jr.’s reshuffling of CDC’s vaccine advisers
STAT+: Insurance coverage of vaccines at risk in RFK Jr.’s reshuffling of CDC’s vaccine advisers The decision by Health and Human Services Secretary Robert F. Kennedy Jr. to remove and replace all members of the government’s independent vaccine advisory committee doesn’t just change how the nation will approach vaccine policy. It could also take money…
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STAT+: Regeneron seeks to revamp the controversial relationships between pharma and patient charities
STAT+: Regeneron seeks to revamp the controversial relationships between pharma and patient charities In a bid to rework the controversial relationship between drugmakers and patient charities, Regeneron Pharmaceuticals has announced a new program in which it will match up to $200 million in donations this year to a leading foundation called Good Days. The move…
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STAT+: Top FDA drug regulator tells staff much is still in flux, as she prepares to retire
STAT+: Top FDA drug regulator tells staff much is still in flux, as she prepares to retire WASHINGTON — Outgoing Food and Drug Administration regulator Jacqueline Corrigan-Curay acknowledged to staff that much is still in flux at the agency, weeks before she retires. “We are leaner and therefore we have to find ways to be…
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STAT+: Amgen’s obesity drug led to high discontinuation rates in mid-stage trial, as company plans to adjust dosing
STAT+: Amgen’s obesity drug led to high discontinuation rates in mid-stage trial, as company plans to adjust dosing CHICAGO — Amgen’s monthly obesity candidate led to substantial weight loss but a high rate of side effects and discontinuations in a mid-stage trial, results that support the company’s decision to use a slower dosing schedule to…
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STAT+: Novo Nordisk’s amylin obesity drug keeps performing like Zepbound
STAT+: Novo Nordisk’s amylin obesity drug keeps performing like Zepbound CHICAGO — Late-stage results of Novo Nordisk’s obesity candidate CagriSema suggest the drug is comparable to Eli Lilly’s Zepbound on safety and efficacy, further data indicating that CagriSema may not be the standout treatment that investors had hoped for. Novo previously reported that patients on…
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STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official The ouster of the Food and Drug Administration’s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has…
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STAT+: Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout
STAT+: Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout This story is an excerpt from Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. Cogent Biosciences and Blueprint Medicines are direct competitors who hate each other. During a talk at the recent…
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STAT+: What’s next for Sarepta Therapeutics with gene therapy under fire?
STAT+: What’s next for Sarepta Therapeutics with gene therapy under fire? This story is an excerpt from Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. The Duchenne muscular dystrophy community is reeling following the second death of a patient from liver failure caused by Sarepta Therapeutics’…
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FDA’s gene therapy turmoil, and an alternative model for funding research
FDA’s gene therapy turmoil, and an alternative model for funding research Why did the Food and Drug Administration suddenly oust one of its top gene therapy regulators? Is the agency growing too political? And should private firms fund academic research? We chat about all that and more on this on this week’s episode of “The…
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Opinion: Bill Gates: I lost my father to Alzheimer’s. But I’m more optimistic than ever about fighting the disease
Opinion: Bill Gates: I lost my father to Alzheimer’s. But I’m more optimistic than ever about fighting the disease Father’s Day without my dad never gets easier. Although he is on my mind every day, I always find myself thinking about him even more often this time of year. My dad was a giant in…
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STAT+: George W. Bush drops by BIO, and so does the FDA commissioner
STAT+: George W. Bush drops by BIO, and so does the FDA commissioner This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here, and sign up for our morning biotech news roundup newsletter here. Happy Tuesday, folks! I have an exciting update for you: Friend…
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STAT+: FDA announces a new priority review program in bid to further administration goals
STAT+: FDA announces a new priority review program in bid to further administration goals WASHINGTON — The Food and Drug Administration is launching a program to reward companies with accelerated drug review and speedy agency feedback, if their actions align with the agency’s national health priorities. Those priorities include addressing unmet public health needs or health…
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STAT+: What we’re hearing on Chinese NewCos, AI, and BIO’s executive ranks
STAT+: What we’re hearing on Chinese NewCos, AI, and BIO’s executive ranks This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here, and sign up for our morning biotech news roundup newsletter here. Hello everyone! Allison DeAngelis here, coming to you from Boston’s…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: Trump administration demands pharma companies begin drug price negotiations, a day after key deadline
STAT+: Trump administration demands pharma companies begin drug price negotiations, a day after key deadline WASHINGTON — The Trump administration is pushing pharmaceutical companies to begin negotiations to bring their drug prices in line with what other countries pay — usually far less than Americans. “Under President Trump’s direction, HHS is demanding that pharmaceutical companies…
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STAT+: Pharma wins a victory over a Minnesota law designed to provide transparency into drug pricing
STAT+: Pharma wins a victory over a Minnesota law designed to provide transparency into drug pricing In a victory for the pharmaceutical industry, a U.S. appeals court upheld a lower court decision to halt a controversial Minnesota law that is designed to provide transparency into prescription drug pricing. The decision was issued as the result…
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RFK Jr. names new members of CDC’s vaccine advisory panel
RFK Jr. names new members of CDC’s vaccine advisory panel WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday unveiled the names of the eight new members who will sit on the panel of experts that advises the Centers for Disease Control and Prevention on vaccine policy, and said they would review the current…
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STAT+: Braced for details on Trump’s ‘most favored nation’ policy, pharma industry is still waiting
STAT+: Braced for details on Trump’s ‘most favored nation’ policy, pharma industry is still waiting WASHINGTON — Executives at pharmaceutical companies have been bracing for more information from the Trump administration this week about how it planned to lower drug prices. That information has not yet arrived, despite the administration’s self-imposed deadline to disclose by…
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STAT+: Cassidy is circulating a proposed law to push down U.S. drug prices, backing a key Trump ambition
STAT+: Cassidy is circulating a proposed law to push down U.S. drug prices, backing a key Trump ambition WASHINGTON — Senate health committee Chair Bill Cassidy (La.) is the latest Republican to take an interest in legislation that would tie U.S. brand drug prices to lower prices in other wealthy countries, according to seven people…
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STAT+: National Resilience, startup hoping to reinvent drug manufacturing, to ‘wind down’ many of its facilities
STAT+: National Resilience, startup hoping to reinvent drug manufacturing, to ‘wind down’ many of its facilities National Resilience, a startup that has raised over $2 billion by promising to transform drug manufacturing, said Monday that it would “wind down” many of its facilities. But what remains of the firm has raised an additional $250 million…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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GLP-1 drugs may be linked to elevated risk of serious eye disease, study finds
GLP-1 drugs may be linked to elevated risk of serious eye disease, study finds People with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness, a new observational study concludes, adding to a short list of concerns about eye health in…
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STAT+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda
STAT+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment. The dispute with Halozyme…
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STAT+: On ASCO Day 4, J&J bets on Rybrevant and airs ‘innovation ecosystem’ concerns
STAT+: On ASCO Day 4, J&J bets on Rybrevant and airs ‘innovation ecosystem’ concerns This is the web version of STAT’s special newsletter from the annual meeting of the American Society of Oncology. For more updates on the latest in cancer news, sign up for our Cancer Briefing newsletter here. ASCO ends tomorrow, but alas, dear readers,…
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STAT+: At ASCO Day 3, AstraZeneca dominates, Takeda reveals experimental drug data, Eli Lilly serves salad
STAT+: At ASCO Day 3, AstraZeneca dominates, Takeda reveals experimental drug data, Eli Lilly serves salad This is the web version of STAT’s special newsletter from the annual meeting of the American Society of Oncology. For more updates on the latest in cancer news, sign up for our Cancer Briefing newsletter here. We’re going to get to…
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STAT+: AstraZeneca’s CEO balances cancer-fighting opportunities with political uncertainty
STAT+: AstraZeneca’s CEO balances cancer-fighting opportunities with political uncertainty CHICAGO — Each year, 40,000 cancer researchers, doctors, and industry executives gather here for the biggest meeting in oncology. And for seven years, it has been almost assumed that the medicines generating the most buzz will come from AstraZeneca. Perhaps that’s why, in a wood-paneled conference…
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STAT+: ASCO day 2: A tragic paradox, Gilead updates, and lots of Pfizer news
STAT+: ASCO day 2: A tragic paradox, Gilead updates, and lots of Pfizer news This is the web version of STAT’s special newsletter from the annual meeting of the American Society of Oncology. For more updates on the latest in cancer news, sign up for our Cancer Briefing newsletter here. ASCO is usually sweltering, but it’s…
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STAT+: Combination treatment reduces risk of tumor progression in aggressive form of breast cancer, study shows
STAT+: Combination treatment reduces risk of tumor progression in aggressive form of breast cancer, study shows CHICAGO — A treatment that combines two different types of cancer-fighting medicines — Gilead Sciences’ Trodelvy with Merck’s Keytruda — reduced the risk of tumor progression by more than one-third in women with an aggressive form of breast cancer. …
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STAT+: As Trump proposes NIH cuts, a top Merck executive sees fragility in a ‘super-highway for biomedicine’
STAT+: As Trump proposes NIH cuts, a top Merck executive sees fragility in a ‘super-highway for biomedicine’ CHICAGO — Amid ongoing uncertainty around funding for the National Institutes of Health, and what it could mean for U.S. innovation, a top Merck executive stressed that the agency is “an incredible super-highway for biomedicine,” and that it’s “a…
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FDA approves a next-generation Covid vaccine from Moderna, with restrictions
FDA approves a next-generation Covid vaccine from Moderna, with restrictions The Food and Drug Administration approved Moderna’s new Covid-19 vaccine late Friday, though it placed restrictions on its use that the company’s existing Covid shot, Spikevax, does not currently face. The new vaccine, which will be marketed under the name mNexspike, will not immediately replace…
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Opinion: STAT+: The World Health Assembly’s giant leap on rare diseases
Opinion: STAT+: The World Health Assembly’s giant leap on rare diseases On May 24, the World Health Assembly, the governing body of the WHO, ratified landmark legislation that, if implemented fully, will change the future for people living with rare diseases. It calls for concrete action plans that will have far-reaching impacts across health care…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: RFK Jr.’s latest moves on vaccines
STAT+: RFK Jr.’s latest moves on vaccines You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. NIH is terminating research grants left and right, impeding early career paths and leading some young scientists…
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Opinion: Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements
Opinion: Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements President Trump often touted during his first term that his administration had “approved more affordable generic drugs than any administration in history.” He had good reason to highlight these accomplishments. Over the first two years of his presidency, the Food and…
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STAT+: Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce
STAT+: Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce Amid ongoing controversy over pharmaceutical advertising, one lawmaker wants to know how the U.S. government will enforce regulations after the Food and Drug Administration let go of numerous employees from the office that oversees prescription drug promotions. In a…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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Uncertainty in CRISPR world and the start of more M&A
Uncertainty in CRISPR world and the start of more M&A What was the mood like at a big gene therapy conference last week? Why is Novo Nordisk’s CEO stepping down? And why has Adam been in such a good mood? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s…
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STAT+: Five burning questions on the FDA’s new Covid-19 vaccine framework
STAT+: Five burning questions on the FDA’s new Covid-19 vaccine framework WASHINGTON — Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine framework would answer all of their questions. But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval…
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STAT+: Maryland governor signs law to expand powers of the state’s prescription drug affordability board
STAT+: Maryland governor signs law to expand powers of the state’s prescription drug affordability board In a notable development, Maryland Gov. Wes Moore signed a bill that will allow a state board to extend its mandate for lowering prescription drug costs to all residents, not just those employed by government agencies. The move was hailed…
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STAT+: Novavax wins narrowed approval for its Covid-19 shot after delay
STAT+: Novavax wins narrowed approval for its Covid-19 shot after delay The Food and Drug Administration has finally approved Novavax’s Covid-19 vaccine, but in doing so has placed restrictions on it that its two competitors in the U.S. market do not face. The long-awaited license limits use of the vaccine to people 65 and older…
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STAT+: Eli Lilly and AstraZeneca top a consultancy’s ranking of drug company R&D
STAT+: Eli Lilly and AstraZeneca top a consultancy’s ranking of drug company R&D A consultancy’s new ranking of drug company R&D shows Eli Lilly has risen to the top of the drug development heap — but when it comes to invention, AstraZeneca, with its wealth of experimental cancer and rare disease therapies, ranks above its…
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STAT+: Trump order on drug pricing appears to issue subtle threat to pharma
STAT+: Trump order on drug pricing appears to issue subtle threat to pharma File this under “Lower your price — or else!” Tucked inside the executive order on drug pricing from President Trump is a sentence that appears to threaten pharmaceutical companies that their medicines may be withdrawn if they do not lower prices. Specifically,…
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STAT+: Our biggest burning questions on Trump’s order to bring down drug prices
STAT+: Our biggest burning questions on Trump’s order to bring down drug prices WASHINGTON — President Trump’s executive order to lower drug prices through sweeping, cross-agency action left leaders in the pharmaceutical industry scrambling Monday to make sense of what may be ahead — and how to respond. The announcement was long on messaging, but…
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STAT+: Trump’s drug-pricing order takes a hard line against pharma. Investors shrugged
STAT+: Trump’s drug-pricing order takes a hard line against pharma. Investors shrugged President Trump on Monday unveiled his plan to dramatically overhaul the way the U.S. pays for drugs by lowering what he calls “inflated” prices to those paid by other countries. Pharma investors didn’t seem to care. The XBI, a closely tracked index of…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…