Category: Pharmaceuticals
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STAT+: More Medicare plans cover Humira biosimilars, but do little to encourage patient use
STAT+: More Medicare plans cover Humira biosimilars, but do little to encourage patient use Medicare drug plans significantly boosted coverage of biosimilar versions of the Humira rheumatoid arthritis medicine this year, but nearly all of them failed to take steps that would encourage greater use of these alternative treatments, a new government watchdog report finds.…
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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+: The state of antibiotic development: ‘Deplorable comes to mind’
STAT+: The state of antibiotic development: ‘Deplorable comes to mind’ Four years ago, an ambitious pharmaceutical industry venture to tackle antibiotic resistance launched to invest in small companies that can develop two to four novel antibiotics by 2030 — and replenish the global supply chain with needed treatments. The effort began with $1 billion in backing…
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STAT+: Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list
STAT+: Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list A federal judge has sided with the U.S. Food and Drug Administration over a decision last year to remove two Eli Lilly drugs — the Zepbound weight loss medicine and the Mounjaro diabetes treatment — from…
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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+: Few drugmakers embrace a newer test for contamination, placing horseshoe crabs at risk
STAT+: Few drugmakers embrace a newer test for contamination, placing horseshoe crabs at risk Many large drugmakers are still using a decades-old test — derived from horseshoe crabs — as a go-to tool for detecting contamination in medicines and vaccines, rather than switching to a cheaper and equally effective alternative, according to a survey by…
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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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STAT+: Trump signs order in bid to boost pharma manufacturing in the U.S.
STAT+: Trump signs order in bid to boost pharma manufacturing in the U.S. Amid ongoing anticipation over tariffs on pharmaceuticals, President Trump on Monday signed an executive order designed to lower regulatory hurdles and make it faster for drug companies to manufacture their products in the U.S. The move also includes plans to place more…
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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+: 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+: MilliporeSigma will add temporary tariff surcharges on products shipped to the U.S.
STAT+: MilliporeSigma will add temporary tariff surcharges on products shipped to the U.S. MilliporeSigma, one of the largest suppliers of medical research products, will start adding a temporary tariff surcharge to all product orders shipped to the United States. The company, which sells a wide array of items from chemical reagents to centrifuges and syringe…
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STAT+: Lack of access to antibiotics for drug-resistant infections often blamed on poor care, study says
STAT+: Lack of access to antibiotics for drug-resistant infections often blamed on poor care, study says Only 6.9% of people with drug-resistant infections in eight large, low- and middle-income countries received an appropriate antibiotic in 2019 and the lack of access was largely attributed to insufficient care, according to a new analysis. The researchers examined…
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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+: Gilead will pay $202 million to settle charges of paying kickbacks to docs for boosting HIV drug sales
STAT+: Gilead will pay $202 million to settle charges of paying kickbacks to docs for boosting HIV drug sales Gilead Sciences agreed to pay $202 million to settle allegations of paying kickbacks to doctors in exchange for prescribing several of its HIV medicines, the latest example of a controversial practice that has come back to…
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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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Pharma tariffs, and a ‘sunshine day’ for biotech stocks
Pharma tariffs, and a ‘sunshine day’ for biotech stocks How did Ireland become a hotspot for pharmaceutical manufacturing? What are the products that will come out of Flagship’s latest startup centered around “preemptive medicine”? And who among the co-hosts is the best singer? We discuss all that and more on this week’s episode of “The…
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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+: 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+: GSK blood cancer therapy, once pulled from the market, is approved in the U.K.
STAT+: GSK blood cancer therapy, once pulled from the market, is approved in the U.K. GSK’s blood cancer drug Blenrep won regulatory approval in the U.K. on Thursday, marking the medicine’s return to the market after it was withdrawn several years ago. The drug, which treats multiple myeloma, will be used in combination with other…
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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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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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STAT+: Arkansas adopts first-in-the-nation law forcing companies to choose between running a PBM or pharmacies
STAT+: Arkansas adopts first-in-the-nation law forcing companies to choose between running a PBM or pharmacies Arkansas Gov. Sarah Sanders has signed a first-in-the-nation law that prohibits pharmacy benefit managers from operating both retail and mail-order pharmacies, a move designed to eliminate a conflict of interest that has been blamed for boosting the price of medicines…
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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+: Trump administration launches probe into pharmaceutical imports
STAT+: Trump administration launches probe into pharmaceutical imports The Trump administration disclosed it formally opened an investigation into the extent to which the importation of certain pharmaceuticals may threaten national security, a move that is a widely anticipated prelude to imposing tariffs on a potentially large number of medicines. In a Federal Register notice published…
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STAT+: Canada advances an antitrust probe into Express Scripts over ‘patient steering’ and pharmacy fees
STAT+: Canada advances an antitrust probe into Express Scripts over ‘patient steering’ and pharmacy fees Canadian officials have obtained a court order that requires Express Scripts to produce documents in connection with an investigation into whether the pharmacy benefits manager violated antitrust laws. The Competition Bureau is examining whether the company forced or induced Canadians…
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STAT+: Tennessee officials find Express Scripts violated law governing commercial pharmacy claims
STAT+: Tennessee officials find Express Scripts violated law governing commercial pharmacy claims In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents. Specifically, 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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STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’
STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’ In an unexpected move, the U.S. Food and Drug Administration announced plans this week to reduce — and possibly replace — animal testing with other methods for developing certain medicines in a bid to lower R&D costs and,…
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STAT+: Arkansas may force companies to choose between running a PBM or pharmacies
STAT+: Arkansas may force companies to choose between running a PBM or pharmacies File this under “You can’t have it both ways.” An Arkansas bill that would prohibit pharmacy benefit managers from operating retail and mail-order pharmacies was passed by the state senate and is now headed to Gov. Sarah Sanders, the first time such…
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BIO’s John Crowley on RFK Jr. and tariffs, plus calls for more federal biotech funding
BIO’s John Crowley on RFK Jr. and tariffs, plus calls for more federal biotech funding Is there more funding coming for the biotech industry? Will the pharmaceutical industry be hit with tariffs? And is it possible to reason with RFK Jr.? We talk about all that and more on this week’s episode of “The Readout…
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STAT+: Why the closure of an FDA office may impact generics manufacturers — and everyday Americans
STAT+: Why the closure of an FDA office may impact generics manufacturers — and everyday Americans Amid the hard-to-follow cutbacks at the U.S. Food and Drug Administration, a little-known but important office was eliminated — and the implications will be felt not only by drugmakers, but consumers. The Division of Policy Development in the Office…
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STAT+: RFK Jr.’s Senate hearing delayed, living with more measles
STAT+: RFK Jr.’s Senate hearing delayed, living with more measles 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 is cutting the price of an annual subscription in half. Click here for…
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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 tells drugmakers to redo studies run by a contract research firm due to data integrity issues
STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues In a rare move, the Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by…
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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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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+: FDA’s ‘key man’ Peter Marks is out. Biotech investors will now deal with the consequences
STAT+: FDA’s ‘key man’ Peter Marks is out. Biotech investors will now deal with the consequences Robert F. Kennedy Jr. forcing Peter Marks out of the Food and Drug Administration has blown a hole in the agency’s leadership ranks and threatens to unmoor the oversight of drugs and vaccines from bedrock scientific principles. For biotech…
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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…
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STAT+: Amgen loses its battle against Colorado over a prescription drug affordability board
STAT+: Amgen loses its battle against Colorado over a prescription drug affordability board In a blow to the pharmaceutical industry, a U.S. court judge ruled that a Colorado state board can proceed with plans to place limits on the prices paid for medicines, the first such decision to support the controversial attempts by some states…
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STAT+: Wyden claims Pfizer used a ‘colossal’ scheme to avoid paying billions in U.S. taxes
STAT+: Wyden claims Pfizer used a ‘colossal’ scheme to avoid paying billions in U.S. taxes In what one U.S. lawmaker described as possibly the “largest tax-dodging scheme” by a pharmaceutical company in history, Pfizer sold $20 billion in medicines to U.S. customers six years ago, but did not report any profits from those sales on…