Category: Pharma
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STAT+: Pfizer closes $10 billion Metsera deal
STAT+: Pfizer closes $10 billion Metsera deal Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! If you’re still wondering “What the heck happened with Moderna?” the latest episode of the video series STATus Report spells it out quite nicely. Also, a KFF…
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Judge says he’ll approve opioid settlement with OxyContin maker Purdue and Sackler family
Judge says he’ll approve opioid settlement with OxyContin maker Purdue and Sackler family NEW YORK — A federal bankruptcy court judge on Friday said he will approve OxyContin-maker Purdue Pharma’s latest deal to settle thousands of lawsuits over the toll of opioids that includes some money for thousands of victims of the epidemic. The deal…
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STAT+: Makary, Prasad outline pathway for bespoke gene therapy
STAT+: Makary, Prasad outline pathway for bespoke 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. Today, we learn AbbVie has ended its partnership with Calico, the FDA outlines how bespoke gene-editing treatments can make it through the regulatory pipeline,…
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STAT+: Why is Eli Lilly worth nearly $1 trillion?
STAT+: Why is Eli Lilly worth nearly $1 trillion? 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 big FDA news to get into today — let’s get straight into it. FDA names Richard Pazdur as top drug regulator The…
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STAT+: AbbVie cuts ties with Google-backed longevity company, lays off scientists
STAT+: AbbVie cuts ties with Google-backed longevity company, lays off scientists AbbVie is ending a decade-long partnership with Calico Life Sciences, an Alphabet-funded biotech company focused on aging research, and laying off chemists working on discovering new drugs. The moves, detailed in internal emails sent Tuesday and viewed by STAT, come as the pharmaceutical giant…
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STAT+: Richard Pazdur, longtime cancer regulator, named drug center director at FDA
STAT+: Richard Pazdur, longtime cancer regulator, named drug center director at FDA WASHINGTON — The Food and Drug Administration on Tuesday named Richard Pazdur, its longtime overseer of cancer therapies, as its top drug regulator. Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who exited the agency earlier this month amid…
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STAT+: At ‘hush-hush’ MAHA summit, RFK Jr. and deputies to mix with biotech leaders
STAT+: At ‘hush-hush’ MAHA summit, RFK Jr. and deputies to mix with biotech leaders WASHINGTON — Health secretary Robert F. Kennedy Jr. and many top deputies are scheduled to speak alongside industry executives and health activists at a daylong MAHA event on Wednesday that has not been publicly disclosed by administration officials or event organizers.…
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STAT+: Chinese government’s support for biotech fuels huge rally
STAT+: Chinese government’s support for biotech fuels huge rally 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 just had our first snow of the season in Chicago, I just ordered a pie for Thanksgiving, and I’m still in denial that…
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STAT+: Merck’s pill to reduce cholesterol on top of statins matches results from injectables
STAT+: Merck’s pill to reduce cholesterol on top of statins matches results from injectables NEW ORLEANS — A pill designed to further lower cholesterol in people already on statins but at risk of a serious cardiovascular event — their first or a recurrence — reduced LDL cholesterol by up to 60%, a new late-stage trial…
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STAT+: Amgen’s cholesterol shot prevented first heart attacks and strokes, more detailed data affirm
STAT+: Amgen’s cholesterol shot prevented first heart attacks and strokes, more detailed data affirm NEW ORLEANS — A cholesterol-lowering injection that’s been on the market for nearly a decade has now shown its power to cut cardiovascular events in people considered at high risk but who haven’t yet suffered a heart attack or stroke. A…
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STAT+: States might not get cheaper drugs in Trump’s most-favored nation Medicaid pilot program
STAT+: States might not get cheaper drugs in Trump’s most-favored nation Medicaid pilot program WASHINGTON — When President Trump announced the administration’s deal to cut prices for weight-loss drugs, he proclaimed that “you will pay the lowest price anywhere in the world.” But state Medicaid programs might already be getting lower prices, according to a research…
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STAT+: FDA broadens search for new top drug regulator after early setbacks
STAT+: FDA broadens search for new top drug regulator after early setbacks WASHINGTON — The Food and Drug Administration is struggling to select a new head of its drug center after the sudden and chaotic exit of the previous director, George Tidmarsh. Richard Pazdur, the director of the FDA’s Oncology Center for Excellence, was approached about…
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STAT+: Seven burning questions about Trump’s big deal for cheaper weight loss drugs
STAT+: Seven burning questions about Trump’s big deal for cheaper weight loss drugs WASHINGTON — The Trump administration’s deal to expand access to and lower the cost of weight loss drugs has left industry leaders, public health experts, and patients with a host of open questions. The administration’s agreements with Eli Lilly and Novo Nordisk…
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STAT+: Kennedy, a longtime pharma critic, embraces Trump deal to expand access to obesity drugs
STAT+: Kennedy, a longtime pharma critic, embraces Trump deal to expand access to obesity drugs WASHINGTON — Health Secretary Robert F. Kennedy Jr. was uncharacteristically chummy with pharma executives at the White House on Thursday as he cheered the Trump administration’s plan for lowering obesity medication prices. Kennedy has railed against drugmakers in the past, and…
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STAT+: FDA announces next round of priority review vouchers
STAT+: FDA announces next round of priority review vouchers WASHINGTON — The Food and Drug Administration on Thursday announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to speedier reviews of drug candidates aligned with U.S. priorities. The announcement came as the Trump administration unveiled agreements with Eli Lilly and…
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STAT+: Pharmalittle: We’re reading about a Trump deal with Lilly and Novo, fewer U.S. generic drug plants, and more
STAT+: Pharmalittle: We’re reading about a Trump deal with Lilly and Novo, fewer U.S. generic drug plants, and more Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all,…
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STAT+: Pfizer’s view on the Metsera bidding war
STAT+: Pfizer’s view on the Metsera bidding war 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 hosting a virtual event tomorrow about the rise and unraveling of Moderna. My colleagues Jason Mast and Damian Garde will be there to talk about…
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STAT+: Scandal and controversy take toll on FDA credibility
STAT+: Scandal and controversy take toll on FDA credibility 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 another busy week of earnings — Pfizer reported this morning and Novo Nordisk will be reporting tomorrow. We’ll be watching for any…
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STAT+: Trump administration nears deals for cheaper weight loss drugs with Novo Nordisk, Eli Lilly
STAT+: Trump administration nears deals for cheaper weight loss drugs with Novo Nordisk, Eli Lilly WASHINGTON — The Trump administration is nearing deals with Eli Lilly and Novo Nordisk to lower the prices of their weight loss drugs and expand access to them, people familiar with the talks told STAT. The companies have been close to…
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STAT+: Pharmalittle: We’re reading about feuds at FDA’s CBER, an antibiotic warning in Europe, and more
STAT+: Pharmalittle: We’re reading about feuds at FDA’s CBER, an antibiotic warning in Europe, 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 coming into focus, but we…
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STAT+: Alnylam raises guidance as sales of heart drug match expectations
STAT+: Alnylam raises guidance as sales of heart drug match expectations 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 have a deep probe into Moderna’s travails from STAT’s tireless Jason Mast. Also, a pharma bidding war, thoughts on psychedelic regulation,…
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STAT+: Pharmalittle: We’re reading about a bidding war for Metsera, HHS plans for speeding biosimilars, and more
STAT+: Pharmalittle: We’re reading about a bidding war for Metsera, HHS plans for speeding biosimilars, and more Hello, everyone, and how are you today? We are just fine, thank you, despite the steady rain drenching the sleepy Pharmalot campus. Our spirits remain sunny thanks, in part, to sage advice from the Morning Mayor: “Every new…
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STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs
STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs WASHINGTON — The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients. The framework will shorten the path…
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STAT+: Natera, known for spotting cancer recurrence, wades into early detection
STAT+: Natera, known for spotting cancer recurrence, wades into early detection 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. It seems everyone I know has been getting sick lately — hope you are all taking care of yourselves! Onto the news…
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STAT+: Casey Means faces confirmation hearing for surgeon general
STAT+: Casey Means faces confirmation hearing for surgeon general 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. The wife and I went to the Rehoboth Beach Sea Witch Festival dressed as a…
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STAT+: Pharmalittle: We’re reading about a GSK drug’s comeback, a buyer’s club for a Vertex drug, and more
STAT+: Pharmalittle: We’re reading about a GSK drug’s comeback, a buyer’s club for a Vertex drug, 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…
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STAT+: How the first nine drug companies won priority review vouchers from Marty Makary’s FDA
STAT+: How the first nine drug companies won priority review vouchers from Marty Makary’s FDA WASHINGTON — Commissioner Marty Makary wants the Food and Drug Administration to move more quickly. The launch of a new priority review voucher program in June was no exception. The agency promised winners a one- to two-month review of their drug…
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At a gathering of biopharma executives, a moment of wonder — and also of worry
At a gathering of biopharma executives, a moment of wonder — and also of worry Sometimes the biggest moments at a conference happen backstage. At the annual STAT Summit on Oct. 15-16, that kind of moment came when one of the top biopharmaceutical executives in the world met a toddler in a tuxedo. Read the…
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STAT+: Ro wants to measure ‘food noise’ in obesity care
STAT+: Ro wants to measure ‘food noise’ in obesity care 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, you’ve made it Friday! We’ve got some more news to get through before heading into the weekend. FDA delivers split decision on…
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STAT+: Pharmalittle: We’re reading about a Moderna setback, CVS playing hardball with Gilead, and more
STAT+: Pharmalittle: We’re reading about a Moderna setback, CVS playing hardball with Gilead, 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 after chasing varmints. As for us, we are engaged in the usual…
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STAT+: Trump’s IVF deal spurs hopes — and adjustments — across fertility sector
STAT+: Trump’s IVF deal spurs hopes — and adjustments — across fertility sector WASHINGTON — The Trump administration’s push to make in vitro fertilization more affordable is changing the outlook and offerings in the fertility sector, even as some details of its policies remain confidential and others have yet to be released. The administration’s changes…
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STAT+: Alector’s dementia drug fails to slow patient decline in late-stage trial
STAT+: Alector’s dementia drug fails to slow patient decline in late-stage trial An experimental drug from Alector Inc. failed to slow the decline of patients with frontotemporal dementia in a late-stage study, the company announced Tuesday. Alector said it would lay off 49% of its employees as a result. The company employed 238 people as…
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STAT+: mRNA Covid shots may boost the effects of certain cancer treatments, study suggests
STAT+: mRNA Covid shots may boost the effects of certain cancer treatments, study suggests mRNA-based Covid vaccines from Pfizer-BioNTech or Moderna may have an unexpected benefit for cancer patients who undergo immunotherapy. A new study suggests that these vaccines might boost the effects of immunotherapy drugs, perhaps by alerting the immune system and helping direct…
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STAT+: FDA announces first nine recipients of priority drug review vouchers
STAT+: FDA announces first nine recipients of priority drug review vouchers WASHINGTON — The Food and Drug Administration on Thursday announced the first nine recipients of the Commissioner’s National Priority Review vouchers, a program offering an expedited drug review to companies with products that align with the agency’s national health priorities. President Trump highlighted one…
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STAT+: Biotech leaders say uncertainty at FDA threatens drug development
STAT+: Biotech leaders say uncertainty at FDA threatens drug development BOSTON — Replimune Group and Capricor Therapeutics both seemed on track to receive long-awaited drug approvals from the Food and Drug Administration earlier this year. Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies’ CEOs talked…
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STAT+: CEO of GSK plays down its role in FDA effort to approve therapy for autism-related condition
STAT+: CEO of GSK plays down its role in FDA effort to approve therapy for autism-related condition BOSTON — The CEO of the drugmaker GSK on Wednesday said the company has had a minimal role in the Food and Drug Administration’s effort to update the prescribing information of a long-shelved drug so that it can…
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STAT+: J&J reportedly in talks to buy Protagonist
STAT+: J&J reportedly in talks to buy Protagonist 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. My colleagues were hard at work throughout the weekend reporting on major firings across the CDC. We’ve also got a ton of biopharma news…
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STAT+: Pharmalittle: We’re reading about a troubled Novo plant, pressure on the Novavax board, and much more
STAT+: Pharmalittle: We’re reading about a troubled Novo plant, pressure on the Novavax board, and much more Top of the morning to you. Gray skies are hovering overhead right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day…
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STAT+: Sarepta to seek approval for gene therapy in rare form of muscular dystrophy
STAT+: Sarepta to seek approval for gene therapy in rare form of muscular dystrophy An experimental gene therapy from Sarepta Therapeutics increased levels of the gene missing in an ultra-rare form of muscular dystrophy, according to data the company presented Friday. The company has said it plans to file for approval in the disease, known…
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STAT+: AstraZeneca strikes drug pricing deal with Trump
STAT+: AstraZeneca strikes drug pricing deal with Trump WASHINGTON — President Trump on Friday said he struck a drug pricing deal with AstraZeneca aimed at fulfilling his plan to bring U.S. drug prices in line with what other countries pay, the second agreement after Pfizer’s last week. Similar to Pfizer’s deal, the British pharma company…
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STAT+: Key GOP lawmaker tones down rhetoric on medical care for immigrants
STAT+: Key GOP lawmaker tones down rhetoric on medical care for immigrants 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. Three cheers for Johns Hopkins epidemiologist Caitlin Rivers, who spent her Saturday…
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STAT+: Billionaire-backed VC firm launches, led by former Flagship associate
STAT+: Billionaire-backed VC firm launches, led by former Flagship associate 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. At the start of this week, my editor said the news flow was looking slow. He’s jinxed us yet again. Let’s get…
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STAT+: Pharma companies scramble to make deals with Trump after Pfizer scored White House praise
STAT+: Pharma companies scramble to make deals with Trump after Pfizer scored White House praise WASHINGTON — The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal. Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to…
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STAT+: Orca submits T cell therapy for FDA approval
STAT+: Orca submits T cell therapy for FDA approval Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. We’ve got some exciting news of our own this morning: the return of Damian Garde, who once authored this very newsletter and who is coming…
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STAT+: Peter Marks, FDA vaccine regulator ousted by RFK Jr., joins Eli Lilly
STAT+: Peter Marks, FDA vaccine regulator ousted by RFK Jr., joins Eli Lilly WASHINGTON — Peter Marks, the former top vaccine regulator at the Food and Drug Administration, has joined Eli Lilly to oversee molecule discovery and infectious diseases — a move that quickly drew criticism for the revolving door between the agency and industry. Marks confirmed…
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STAT+: TCGX closes $1.3 billion fund amid investor surge
STAT+: TCGX closes $1.3 billion fund amid investor surge 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 talk about the big regulatory changes afoot in Europe, how telehealth upended the drug market, and more. The need-to-know this morning …
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Acting CDC director calls for MMR vaccine to be broken up into three shots
Acting CDC director calls for MMR vaccine to be broken up into three shots Jim O’Neill, acting director of the Centers for Disease Control and Prevention, called for drastic changes to the measles, mumps, and rubella vaccine that aren’t supported by medical research, intensifying the Trump administration’s criticism of a shot that’s a cornerstone of…
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STAT+: Pharmalittle: We’re reading about another generic abortion pill, pharma layoffs, and more
STAT+: Pharmalittle: We’re reading about another generic abortion pill, pharma layoffs, 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 plan to indulge in…
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STAT+: A second generic version of the abortion pill mifepristone approved by FDA
STAT+: A second generic version of the abortion pill mifepristone approved by FDA Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hullo! Today, we talk about Amgen’s positive new PCSK9 data, learn more about the new NIH office meant to reduce reliance…
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STAT+: Which biotechs are affected by the government shutdown?
STAT+: Which biotechs are affected by the government shutdown? 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 can’t believe it either, but we’re in the fourth quarter of the year. We’ve got a guide for you on the key…
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STAT+: The government is shut down. Now what?
STAT+: The government is shut down. Now what? 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. Are you in a betting pool for how long the government shutdown will last? Send your…
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STAT+: Trump administration backs off 100% pharma tariffs threatened to start today
STAT+: Trump administration backs off 100% pharma tariffs threatened to start today WASHINGTON — President Trump told pharmaceutical companies last week that they should start building infrastructure in the U.S. — or face a 100% tariff, starting Wednesday. But a White House official told STAT on Wednesday that the tariffs have not gone into effect…
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STAT+: Pharmalittle: We’re reading about Trump’s drug-pricing plans, Medicare talks, and more
STAT+: Pharmalittle: We’re reading about Trump’s drug-pricing plans, Medicare talks, and more Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you…
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STAT+: Trump, Pfizer, and the art of a drug pricing deal
STAT+: Trump, Pfizer, and the art of a drug pricing deal Amid all the hand-shaking and back-patting, it was perhaps the word “friendship” that stood out the most when the CEO of Pfizer joined President Trump to address a drug pricing deal in the Oval Office. “But most of all, Mr. President, I want to…
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Trump strikes deal with Pfizer aimed at lowering prescription drug prices
Trump strikes deal with Pfizer aimed at lowering prescription drug prices WASHINGTON — President Trump announced on Tuesday that Pfizer has agreed to offer lower prices on its drugs to the Medicaid program and directly to patients, the first in what he said would be a series of deals intended to secure cheaper prescription medicines…
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STAT+: Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging
STAT+: Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging Is George Tidmarsh, the Food and Drug Administration’s top regulator, trying to exact revenge on a prominent Wall Street investor after a run-in with him six years ago? It’s the question biotech investors were wagging about all Monday after Tidmarsh used…
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STAT+: Pharmalittle: We’re reading about a new GSK CEO, AstraZeneca’s stock listing, and more
STAT+: Pharmalittle: We’re reading about a new GSK CEO, AstraZeneca’s stock listing, 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 deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such…
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STAT+: Days before Trump deadline to lower prices, companies push a flurry of initiatives. Will it be enough?
STAT+: Days before Trump deadline to lower prices, companies push a flurry of initiatives. Will it be enough? Pharmaceutical companies are scrambling to make last-minute announcements ahead of a Trump administration deadline on Monday for the firms to lower U.S. drug prices. But it’s not clear if the initiatives — which include investments in the…
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STAT+: Pharmalittle: We’re reading about Trump’s drug pricing plans, pharma tariffs, and much more
STAT+: Pharmalittle: We’re reading about Trump’s drug pricing plans, pharma tariffs, and much 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 may rendezvous with…
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STAT+: Pharmalitte: We’re reading about a Huntington’s gene therapy success, a low-cost HIV drug, and more
STAT+: Pharmalitte: We’re reading about a Huntington’s gene therapy success, a low-cost HIV drug, and more Good morning, this is Allison, substituting for Mr. Pharmalot. We may have three months left in the year, but I’m already starting to think about 2026, thanks to a handful of concert announcements and ticket sales opening up over…
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STAT+: Veru update shows FDA still values weight loss over body composition
STAT+: Veru update shows FDA still values weight loss over body composition 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 big news on a gene therapy for Huntington’s disease, so let’s get straight to it. Uniqure hails ‘groundbreaking’…
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STAT+: With Trump’s anti-vaccine comments, Kennedy’s influence grows
STAT+: With Trump’s anti-vaccine comments, Kennedy’s influence grows WASHINGTON — President Trump’s anti-vaccine comments on Monday signal health secretary Robert F. Kennedy Jr.’s growing influence — and raise new questions about how far the pair may go to upend vaccine policy. Standing with Kennedy beside him at the White House, Trump called the childhood vaccine…
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STAT+: FDA’s leucovorin approval could be a boon for supplement makers
STAT+: FDA’s leucovorin approval could be a boon for supplement makers Parents may flock to a dietary supplement with the same key ingredient as leucovorin, which the FDA just approved for children with autism. But there are drawbacks. The Food and Drug Administration has reapproved GSK’s branded version of leucovorin to treat a neurological condition…
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STAT+: FDA brings back GSK’s leucovorin drug that RFK Jr. touted as autism treatment
STAT+: FDA brings back GSK’s leucovorin drug that RFK Jr. touted as autism treatment In a highly unusual move, the Food and Drug Administration reapproved a drug on Monday that stopped being sold more than 25 years ago, part of a push from the Trump administration to identify the causes of and potential treatments for…
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STAT+: Doctors are more tied to pharma as trust erodes
STAT+: Doctors are more tied to pharma as trust erodes 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 read about a big acquisition fueled by obesity, doctors shifting their views on biopharma marketing, see a rare disease drug win approval after…
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In a chaotic meeting, RFK Jr.’s handpicked advisers begin altering the childhood vaccine schedule
In a chaotic meeting, RFK Jr.’s handpicked advisers begin altering the childhood vaccine schedule ATLANTA — Health and Human Services Secretary Robert F. Kennedy Jr. has said he wants his handpicked panel of vaccine advisers to restore declining public trust in vaccines. What that looked like was on full display on Thursday and Friday: The…
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Winner of mRNA Nobel Prize says ACIP member’s claim that Covid vaccines persist is “absolutely impossible”
Winner of mRNA Nobel Prize says ACIP member’s claim that Covid vaccines persist is “absolutely impossible” On Thursday and Friday, the Centers for Disease Control and Prevention held a meeting of its Advisory Committee on Immunization Practices, a key panel that gives the CDC’s director guidance about what vaccines to recommend to the public. The…
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Federal vaccine panel remade by RFK Jr. votes to maintain insurance coverage for Covid shots
Federal vaccine panel remade by RFK Jr. votes to maintain insurance coverage for Covid shots WASHINGTON — A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated. The decision falls…
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Key federal vaccine panel debates delay to newborn hepatitis B shot, risking resurgence
Key federal vaccine panel debates delay to newborn hepatitis B shot, risking resurgence A key government advisory committee discussed on Thursday whether to recommend delaying the first hepatitis B vaccine shot, currently given at birth, by at least one month for babies who are born to mothers that test negative for the virus. Experts fear…
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STAT+: With Trump in the U.K., GSK touts $30 billion investment in U.S. over 5 years
STAT+: With Trump in the U.K., GSK touts $30 billion investment in U.S. over 5 years LONDON — The U.K.-based drugmaker GSK said early Wednesday that it planned to invest $30 billion in the U.S. over five years, an announcement timed to this week’s state visit here by President Trump. The company, which said the…
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STAT+: Hill staff gets briefed on implications of Trump’s drug pricing plan
STAT+: Hill staff gets briefed on implications of Trump’s drug pricing plan WASHINGTON — Congress is again discussing the Trump administration’s plan to force drug companies to lower their U.S. prices, at least behind the scenes. Congressional staffers and health policy experts from major think tanks held a closed-door meeting to discuss policy options that…
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STAT+: U.S. pressures U.K. as pharma pauses investments there
STAT+: U.S. pressures U.K. as pharma pauses investments there 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 moves to potentially dismantle FDA ad comms, see the U.S. pressuring the U.K. over its stringent drug-pricing policy, and more. The…
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FDA leaders moving to abandon advisory committee reviews of specific new drugs
FDA leaders moving to abandon advisory committee reviews of specific new drugs FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny. The agency “would like to get away” from assembling panels…
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STAT+: FDA pushing non-opioid path for chronic pain
STAT+: FDA pushing non-opioid path for chronic pain 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 note that psychedelics are suddenly a hot topic for larger pharmaceutical companies, dissect Patrick Soon-Shiong’s claims on his lung cancer drug, and more.…
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STAT+: Merck halts U.K. research operations and bails on new facility in London
STAT+: Merck halts U.K. research operations and bails on new facility in London LONDON — In a blow to the U.K., Merck said Wednesday it was halting research operations in the country and bailing on a major London research center, in part to protest how the U.K. pays for medicines. The U.K. has been trying…
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STAT+: Pig kidneys to enter FDA-backed human trial next year
STAT+: Pig kidneys to enter FDA-backed human trial next year Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello there. Today, we learn the FDA is advancing a trial for gene-edited pig organs in humans, see geographical discrepancies in lung cancer trial…
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STAT+: Pharmalittle: We’re reading about FDA and imported GLP-1 drugs, a race to develop sleep meds, and more
STAT+: Pharmalittle: We’re reading about FDA and imported GLP-1 drugs, a race to develop sleep meds, 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 deadlines, online meetings, and phone calls has predictably returned. But what can you…
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STAT+: Pharmalittle: We’re reading about Trump’s post on Covid data, a Merck cholesterol pill, and more
STAT+: Pharmalittle: We’re reading about Trump’s post on Covid data, a Merck cholesterol pill, 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 deadlines, online meetings, and phone calls has predictably returned. But what can you do? The…
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STAT+: Trump pressures drugmakers amid CDC turmoil
STAT+: Trump pressures drugmakers amid CDC turmoil Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Welcome back from the holiday weekend. Today we have some candor in ALL CAPS from Trump on Covid vaccines, glowy data from Ionis that could lead to…
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STAT+: Pharmalittle: We’re reading about Lilly and a China tech giant, Cassidy and a CDC vaccine panel, and more
STAT+: Pharmalittle: We’re reading about Lilly and a China tech giant, Cassidy and a CDC vaccine panel, 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,…
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FDA issues narrower approvals for Covid boosters, revokes emergency authorizations
FDA issues narrower approvals for Covid boosters, revokes emergency authorizations WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations for the vaccines, in a set of moves that could make the shots more difficult to obtain for children under 5, in particular. The moves were announced…
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STAT+: Third Rock tops STAT’s annual VC ranking
STAT+: Third Rock tops STAT’s annual VC ranking 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. My colleague Allison DeAngelis has been working for months on our annual VC rankings report. Read on for what she found. Third Rock tops…
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STAT+: Pharmalittle: We’re reading about an AbbVie deal for a psychedelic, Lilly obesity pill trial results, and more
STAT+: Pharmalittle: We’re reading about an AbbVie deal for a psychedelic, Lilly obesity pill trial results, 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.…
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STAT+: Pharmalittle: We’re reading about FDA reporting side effects, pharma plants near disaster zones, and more
STAT+: Pharmalittle: We’re reading about FDA reporting side effects, pharma plants near disaster zones, 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 deadlines, online meetings, and phone calls has predictably returned. But what can you do? The…
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STAT+: Supreme Court lets Trump slash NIH research funds
STAT+: Supreme Court lets Trump slash NIH research funds 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. The Supreme Court is allowing the Trump administration to cut $783 million in research grants tied to DEI work. Also, STAT just unveiled…
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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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STAT+: Was the reaction to Viking’s oral data overblown?
STAT+: Was the reaction to Viking’s oral data overblown? 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 learned yesterday that Walmart has recalled some of its frozen shrimp after the FDA warned that they may have been contaminated with…
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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+: Pharmalittle: We’re reading about conflicts on U.S. vaccine panels, pharma DTC sales, and much more
STAT+: Pharmalittle: We’re reading about conflicts on U.S. vaccine panels, pharma DTC sales, and much more Top of the morning to you, and a fine one it is. Blue skies and unusually cool breezes for this time of year are enveloping the Pharmalot campus, where the official mascots are bounding about the grounds in search…
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STAT+: FDA delays decision on Regenxbio gene therapy
STAT+: FDA delays decision on Regenxbio 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. Good morning. Today we look at what some people in the industry are calling a “pharm to table” trend. Read on to learn more about it.…
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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+: Pharmalittle: We’re reading about a setback for Pfizer, a boost for Novo Nordisk, and much more
STAT+: Pharmalittle: We’re reading about a setback for Pfizer, a boost for Novo Nordisk, and much 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 deadlines, online meetings, and phone calls has predictably returned. But what can you do?…