Category: Pharma
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STAT+: Who are the richest people in health care right now?
STAT+: Who are the richest people in health care right now? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we examine the plush pay packages of health care’s top CEOs in 2024. Also, we discuss Stealth BioTherapeutics’ efforts to rally…
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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 hike list prices for drugs abroad. Now what?
STAT+: Eli Lilly says it will hike list prices for drugs abroad. Now what? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we see march-in rights return to the headlines, ponder how Eli Lilly’s plan to hike list prices in Europe…
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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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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+: Stoke Therapeutics release new data on Dravet syndrome drug
STAT+: Stoke Therapeutics release new data on Dravet syndrome drug 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. As AI becomes more widely used in health care, could it actually lead doctors to lose some of their skills? One new…
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STAT+: Duke scientists seemed to have developed a ‘Holy Grail’ of cancer treatment. Then the truth came out
STAT+: Duke scientists seemed to have developed a ‘Holy Grail’ of cancer treatment. Then the truth came out By the time Walter and Juliet Jacobs went to see Dr. Anil Potti, Juliet’s lung cancer was spreading through her torso. She was short of breath, could no longer play tennis, and was afraid she wouldn’t make…
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STAT+: Prasad returns to the FDA, Attack on the CDC
STAT+: Prasad returns to the FDA, Attack on the CDC 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. Normally I keep the intro to this newsletter light-hearted. But today I feel compelled…
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STAT+: Vinay Prasad returns to the FDA, weeks after his ouster
STAT+: Vinay Prasad returns to the FDA, weeks after his ouster WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene therapy, and blood product regulation. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and…
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In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings
In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings WASHINGTON — Top drug regulator George Tidmarsh assured Food and Drug Administration staff this week that he and other leaders are trying to bring operations back to normal. “I know that I’m coming in here at a challenging time,” Tidmarsh said at…
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STAT+: Unpacking Trump’s approach to health care oversight
STAT+: Unpacking Trump’s approach to health care oversight 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 was reminded recently of why I dig mass transit upon overhearing the train conductor and…
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STAT+: Trump demands drugmakers slash U.S. price now
STAT+: Trump demands drugmakers slash U.S. price now 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, and happy birthday to me! Today, we see the Senate Appropriations Committee look to increase NIH funding, despite the Trump administration’s request to slash…
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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+: Inside the fall of Vinay Prasad at the FDA
STAT+: Inside the fall of Vinay Prasad at the FDA Vinay Prasad had a problem. Several, actually. His staff at the Food and Drug Administration kept leaking to the press. He was under attack by President Trump’s allies after moving to pull a gene therapy off the market. Democrats were not happy with his Covid…
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STAT+: Preventive care panel could be restructured ‘imminently’ as RFK Jr. vets new members
STAT+: Preventive care panel could be restructured ‘imminently’ as RFK Jr. vets new members WASHINGTON — Health secretary Robert F. Kennedy Jr. could “imminently” overhaul a key federal advisory panel that recommends which preventive services insurers must pay for, according to a person familiar with the plans. The person said that federal health officials are…
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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 panel stirs backlash for SSRI use during pregnancy
STAT+: FDA panel stirs backlash for SSRI use during pregnancy Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics’ gene therapy, see an FDA panel…
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STAT+: Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more
STAT+: Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more Good morning dearest readers, this is Allison, filling in for Mr. Pharmalittle. I’m coming to you with a little bit of coffee envy — yesterday, one of the investors I follow on LinkedIn revealed that he was recently…
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STAT+: FDA opens applications for new voucher program
STAT+: FDA opens applications for new voucher program 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’ve got more developments with Sarepta today. My colleagues got exclusive comments from a senior FDA official — read on for what the official said.…
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STAT+: Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more
STAT+: Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more Good morning everyone, it’s Jason Mast, filling in for Ed again. Here’s a fun fact about drugs, pulled from Anne Harrington’s “The Mind Fixers,” a fascinating history of psychiatry I’ve recently picked up: After Albert Hoffman synthesized LSD, Sandoz…
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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+: RFK Jr. gives vaccine skeptics plum HHS posts
STAT+: RFK Jr. gives vaccine skeptics plum HHS posts 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. Mr. Medicare Dr. Oz suggests 10 minutes of yoga straight out of bed, preferably with…
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STAT+: Pharmalittle: We’re reading about GLP-1 drugs for addiction, FDA funding, and lots more
STAT+: Pharmalittle: We’re reading about GLP-1 drugs for addiction, FDA funding, and lots more Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause button to stop…
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STAT+: Questions about the FDA’s ‘radical transparency’ efforts
STAT+: Questions about the FDA’s ‘radical transparency’ efforts Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of complete response letters. FDA…
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STAT+: Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
STAT+: Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We…
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STAT+: Brawl over Eylea gets biosimilar industry’s attention
STAT+: Brawl over Eylea gets biosimilar industry’s attention Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Today, we talk about a cool experimental enzyme therapy, observe more patent maneuvers over Eylea, and see an ‘underdog’ startup get a huge seed round 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+: Pharmalittle: We’re reading about Medicare drug negotiations, a Novartis malaria drug, and more
STAT+: Pharmalittle: We’re reading about Medicare drug negotiations, a Novartis malaria drug, and more Rise and shine, another busy — and steamy — day is on the way. We can tell because the official mascots are spending less time on the dusty Pharmalot grounds and, instead, have curled up by the indoor cool-air blowing machines.…
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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+: Khosla Ventures sets sights on $4 billion in new funds
STAT+: Khosla Ventures sets sights on $4 billion in new funds Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, friends! We’re back. Hope you are having a delightful summer (or winter, I suppose, depending on your hemisphere). Today, we talk about morale…
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STAT+: Pharmalittle: We’re reading about Novo’s Wegovy launch gaffes, a former Pfizer exec’s subpoena, and more
STAT+: Pharmalittle: We’re reading about Novo’s Wegovy launch gaffes, a former Pfizer exec’s subpoena, and more Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation; our choice today is marshmallow magic,…
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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+: 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+: 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+: 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+: Vertex stem cell therapy spurs insulin independence
STAT+: Vertex stem cell therapy spurs insulin independence Good morning! Today, we get deeper into the ousting of Nicole Verdun at the FDA, see promise from Vertex’s cell therapy for diabetes, and unpack the story of developing the newly approved Gilead PrEP drug lenacapivir. The need-to-know this morning Novo Nordisk terminated its marketing relationship with…
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STAT+: GLP-1 drug helped type 1 diabetes patients keep healthy glucose levels and lose weight
STAT+: GLP-1 drug helped type 1 diabetes patients keep healthy glucose levels and lose weight Obesity drugs were first approved to treat type 2 diabetes, but there’s a growing movement to test them in type 1 diabetes, too. Research presented Monday at a large diabetes meeting showed some promise for this approach. Patients who took…
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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+: More universities open to private equity deals, and emerging companies turn to new targets
STAT+: More universities open to private equity deals, and emerging companies turn to new targets 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 all, I have a fresh double…
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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+: 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+: HHS tries pushing pharma to the negotiating table
STAT+: HHS tries pushing pharma to the negotiating table 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. Today, we’re hearing more about President Trump’s “most-favored nation” plan for drug pricing, Recursion’s case for why the company laid off 20% of…
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STAT+: RFK Jr.’s new vaccine panel raises questions of how Kennedy defines conflicts of interest
STAT+: RFK Jr.’s new vaccine panel raises questions of how Kennedy defines conflicts of interest WASHINGTON — When health secretary Robert F. Kennedy Jr. dismissed the 17 members of the key panel that advises the federal government on vaccine recommendations, he claimed that their ties to the pharmaceutical industry had damaged public trust. However, new members…
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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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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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Merck’s RSV antibody treatment for infants is approved by FDA
Merck’s RSV antibody treatment for infants is approved by FDA A third monoclonal antibody product to protect babies against respiratory syncytial virus was approved by the Food and Drug Administration on Monday, a development public health experts hope may eventually help to bring down the price of this effective but costly way of reducing the…
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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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After groundbreaking CRISPR therapy, a homecoming
After groundbreaking CRISPR therapy, a homecoming Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Baby KJ is back home! Also, we discuss the questionable efficacy of ctDNA blood tests, see what Vinay Prasad has to say at NORD, and more. Read…
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STAT+: Pharmalittle: We’re reading about a FDA AI tool, mRNA as a political reject, and more
STAT+: Pharmalittle: We’re reading about a FDA AI tool, mRNA as a political reject, and more Top of the morning to you, and a fine one it is. Clear blue skies and pleasant breezes are wafting across the Pharmalot campus, where the official mascots are foraging for their breakfast and rousing the neighbors. This means…
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Pluvicto pushes earlier in prostate cancer play
Pluvicto pushes earlier in prostate cancer play Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! Today, STAT’s Matthew Herper chats with J&J’s R&D chief, we see the radiopharmaceutical Pluvicto being considered earlier for prostate cancer, and more. Read the rest… Meghana…
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Illumina’s PromoterAI unlocks rare disease clues in noncoding genome
Illumina’s PromoterAI unlocks rare disease clues in noncoding genome 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. Today, we discuss how one Brown contrarian and cancer researcher wants $50 billion for the NCI, we see a UniQure case study that…
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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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Post-TIGIT flop, iTeos Therapeutics is shuttering
Post-TIGIT flop, iTeos Therapeutics is shuttering Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we look at the implications of BARDA cutting a major vaccine contract with Moderna, hear why former FDA chief Scott Gottlieb thinks agency layoffs will impede…
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Lilly to acquire biotech developing pain drugs
Lilly to acquire biotech developing pain drugs 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’re seeking nominations for our annual Wunderkinds list, which aims to honor some of the most promising early-career scientists out there. If you have someone in mind, submit…
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RFK Jr. rolls back Covid vaccine recommendations for healthy children, pregnant people
RFK Jr. rolls back Covid vaccine recommendations for healthy children, pregnant people Health secretary Robert F. Kennedy Jr. announced Tuesday that he has unilaterally struck the recommendation that healthy children and healthy pregnant people get Covid-19 booster shots — a move that experts say is unprecedented. Kennedy made the announcement on the social media site X,…
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STAT+: Pharmalittle: We’re reading about Trump’s drug-pricing claims, FDA’s Covid vaccine directive, and more
STAT+: Pharmalittle: We’re reading about Trump’s drug-pricing claims, FDA’s Covid vaccine directive, and more And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to manicure…
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GSK drug’s new approval sets up competition with Dupixent
GSK drug’s new approval sets up competition with Dupixent 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. Apologies that this newsletter is coming late to you this morning — we had some technical difficulties. But we’ve still got the news…
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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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How do we know mRNA vaccines are safe and effective? An explainer
How do we know mRNA vaccines are safe and effective? An explainer Messenger RNA vaccines fueled the response to the worst pandemic the world has faced in a century and led to a Nobel Prize. This week, they’re set to face intense scrutiny from critics doubtful of the safety and efficacy of these shots. On…
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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+: 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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FDA approves Verastem’s ovarian cancer treatment
FDA approves Verastem’s ovarian cancer treatment Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today, we talk about the FDA’s new artificial intelligence effort in the wake of mass layoffs, see AI darling Insitro cut staff, and more. Read the rest… Meghana…
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STAT+: Pharmalittle: We’re reading about a Trump drug-pricing plan, an AstraZeneca court loss, and more
STAT+: Pharmalittle: We’re reading about a Trump drug-pricing plan, an AstraZeneca court loss, and more And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda involves saluting our shortest person — aka the…
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STAT+: Here’s how Trump might approach his drug pricing plan
STAT+: Here’s how Trump might approach his drug pricing plan WASHINGTON — President Trump is widely expected to try to advance a “most-favored nation” policy next week in an effort to reduce U.S. drug prices — a move that is likely to significantly rattle the pharmaceutical industry, cheer his political base, and, possibly, leave open…
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STAT+: 5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review
STAT+: 5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review The Food and Drug Administration said it will rapidly roll out a generative artificial intelligence model to assist scientific reviews across the agency, setting up a high-stakes test of the technology’s use in vetting products used in the care of millions of…
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RSV sent fewer babies to the hospital last winter, after new treatment and vaccine arrived
RSV sent fewer babies to the hospital last winter, after new treatment and vaccine arrived A new report from the Centers for Disease Control and Prevention shows there was a substantial drop in hospitalizations for respiratory syncytial virus this winter among very young children, who are at the highest risk of becoming severely ill if they contract…
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STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies
STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies WASHINGTON — Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply. Prasad, previously an epidemiology professor at…
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STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA
STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA People seeking roles in government are often careful about what they say in public, or at least somewhat hesitant to freely share their opinions. It’s difficult to know exactly what’s going on in their heads. Not Vinay Prasad. The new…
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STAT+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices
STAT+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices 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. A horse named Journalism was favored to win the…
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Opinion: STAT+: Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy
Opinion: STAT+: Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy Having grown up in rural Arkansas, I have an acute awareness of the challenges many in our country face when it comes to health care. Quality care wasn’t always accessible, and the decision of whether to pay medical or utility bills…
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STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial
STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial Vertex Pharmaceuticals on Monday reported disappointing first-quarter earnings impacted by weaker-than-expected sales of its drugs for cystic fibrosis, and little or no contributions from a gene therapy for sickle cell disease and a recently launched pain medicine. A “tolerability issue” caused a temporary…
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STAT+: Pharmalittle: We’re reading about Makary rejecting a reorganization, pharma lobbying against PBMs, and more
STAT+: Pharmalittle: We’re reading about Makary rejecting a reorganization, pharma lobbying against PBMs, and more Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far so we are determined to hang on for…
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STAT+: Collins and fellow GOP senators speak out in opposition to Trump’s cuts to biomedical research
STAT+: Collins and fellow GOP senators speak out in opposition to Trump’s cuts to biomedical research WASHINGTON — There was broad bipartisan support at a Senate hearing Wednesday to reverse course on the Trump administration’s cuts to federally funded biomedical research. Sen. Susan Collins (Maine), the Republican chair of the Senate Appropriations Committee, kicked off…
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STAT+: Pharmalittle: We’re reading about tariffs increasing U.S. drug costs, Trump cuts on drug safety, and more
STAT+: Pharmalittle: We’re reading about tariffs increasing U.S. drug costs, Trump cuts on drug safety, and more Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause…
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STAT+: Research grants as political ammo; Death to dyes?
STAT+: Research grants as political ammo; Death to dyes? 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. STAT won its first National Magazine Award for General Excellence. Not bad, huh? Help us…
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STAT+: Pharmalittle: We’re reading about FDA layoffs hurting user fee programs, pharma tariffs, and more
STAT+: Pharmalittle: We’re reading about FDA layoffs hurting user fee programs, pharma tariffs, and more And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up. We expect to promenade with…
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STAT+: RFK Jr. is back to criticizing vaccines, and Trump’s new drug-cost plan
STAT+: RFK Jr. is back to criticizing vaccines, and Trump’s new drug-cost plan 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 cast my leafy-green seeds already, and my mint, chives and…
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More proposed cuts to the NIH
More proposed cuts to the NIH Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we talk about Arkansas making a bold move to curb PBM power, analyze Trump’s executive order in regards to drug prices, and more. Read the rest… Meghana…
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STAT+: Trump’s plans to lower drug prices have echoes of past efforts
STAT+: Trump’s plans to lower drug prices have echoes of past efforts WASHINGTON — The Trump administration has an expansive view for how it can lower drug prices for Americans. It has been here before. The question is whether this time will be different. During his first term, President Trump tried to tie U.S. drug…
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‘The same Bobby Kennedy’: How RFK Jr.’s vaccine criticism came rushing back
‘The same Bobby Kennedy’: How RFK Jr.’s vaccine criticism came rushing back WASHINGTON — Robert F. Kennedy Jr. downplayed his past criticism of vaccines as he sought to become the nation’s health secretary. Now, just two months after winning confirmation, he’s frequently returning to rhetoric from his time as perhaps the most prominent vaccine critic…
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RFK Jr. plans changes to vaccine injury reporting system
RFK Jr. plans changes to vaccine injury reporting system WASHINGTON — Health secretary Robert F. Kennedy Jr. said Tuesday that he plans to roll out changes to the vaccine injury monitoring system that would automate and increase data collection as well as look for negative impacts of the shots. Reforming the current Vaccine Adverse Event…
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STAT+: Pharmalittle: We’re reading about Pfizer halting GLP-1 work, FDA use of contractors, and more
STAT+: Pharmalittle: We’re reading about Pfizer halting GLP-1 work, FDA use of contractors, and more Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and refreshing because, once again, that predictable routine of meetings, deadlines, and the like has returned. After all, the world keeps spinning. And to…
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Pfizer discontinues its experimental GLP-1 pill
Pfizer discontinues its experimental GLP-1 pill Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we discuss interesting new gene-editing data from Verve, see the NIH starting to convene advisory councils again, and more. Read the rest… Meghana Keshavan Go to statnews
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STAT+: Pharmalittle: We’re reading about a plan to boost U.S. biotech funding, FDA user fees, and more
STAT+: Pharmalittle: We’re reading about a plan to boost U.S. biotech funding, FDA user fees, and more Top of the morning to you, and a fine one it is. Blue skies and comfortable breezes are enveloping the Pharmalot campus, where the official mascots are dozing in their respective corners and assorted wildlife can be seen…
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STAT+: Trump administration declines to expand Medicare coverage for obesity drugs
STAT+: Trump administration declines to expand Medicare coverage for obesity drugs The Trump administration has chosen not to finalize a rule proposed by the Biden administration that would have allowed Medicare to cover blockbuster weight loss drugs. The rule would have brought in tens of billions of dollars in new sales for drugs like Novo…
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NIH hit with chaos, cuts, and contractor purge
NIH hit with chaos, cuts, and contractor purge Hello. Today, we dive into the implications of the ongoing cuts to various health and science agencies….It’s a doozy. Oh, and if you like talking about neuroscience and happen to be near San Diego this weekend, come hang with me and my colleagues at STAT@AAN: The Future…
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STAT+: Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease
STAT+: Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease WASHINGTON — Marty Makary’s first address to staff as FDA commissioner on Wednesday afternoon sounded a bit like an introduction to one of his books. It included sweeping declarations about the need to challenge scientific norms, and to identify the root…
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STAT+: FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs
STAT+: FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs WASHINGTON — Marty Makary’s first official day as commissioner of the Food and Drug Administration began with employees in tears, learning from security guards that they were losing their jobs. The news release announcing the start of his…
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STAT+: Cassidy gave himself a difficult task. RFK Jr. isn’t making it any easier on him
STAT+: Cassidy gave himself a difficult task. RFK Jr. isn’t making it any easier on him WASHINGTON — Sen. Bill Cassidy (R-La.) said he would be Robert F. Kennedy Jr.’s keeper, but the physician-turned-politician is struggling to stop the nation’s health secretary from undermining public trust in vaccines. Cassidy has taken the lead for his…
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STAT+: Texas judge strikes down FDA’s plan to regulate lab-developed tests
STAT+: Texas judge strikes down FDA’s plan to regulate lab-developed tests WASHINGTON — A federal judge in Texas squashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds. “The Court VACATES and SETS ASIDE, in its entirety,…
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Emotional whiplash for PTC Therapeutics
Emotional whiplash for PTC Therapeutics Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we process the shockwaves in biotech following the ouster of CBER chief Peter Marks, see a radiopharmaceutical expand its reach, and more. Read the rest… Meghana Keshavan…
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STAT+: Ouster of FDA’s Peter Marks alarms a biopharma industry that saw him as an ally
STAT+: Ouster of FDA’s Peter Marks alarms a biopharma industry that saw him as an ally When Robert F. Kennedy Jr., a longtime and visceral critic of pharmaceutical and biotech companies, was nominated by President Trump to be the nation’s health secretary, the head of biotech’s largest trade group issued a statement saying that he…