Category: Pharmalot
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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?…
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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+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals
STAT+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals Patient advocacy groups are urging the South African government to reopen an antitrust investigation into Vertex Pharmaceuticals over allegations the company misled authorities into closing a high-profile case last year over access to a cystic fibrosis treatment. Last December, the Competition Commission ruled…
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STAT+: AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills
STAT+: AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills A patient advocacy group is suing the Trump administration for failing to disclose details of a recent settlement with Gilead Sciences over the patent rights to a pair of HIV prevention pills. The deal, which was reached last January, capped…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: U.S. judge blocks first-in-the-nation law barring companies from owning PBMs and pharmacies in Arkansas
STAT+: U.S. judge blocks first-in-the-nation law barring companies from owning PBMs and pharmacies in Arkansas In a closely watched case, a U.S. federal court judge has temporarily blocked a first-in-the-nation law that would prohibit companies that own pharmacy benefit managers from also operating both retail and mail-order pharmacies in Arkansas. The state law is designed…
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STAT+: 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+: 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+: 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+: A troubled Sun Pharma plant fails yet another FDA inspection
STAT+: A troubled Sun Pharma plant fails yet another FDA inspection A Sun Pharmaceutical plant in India that has been repeatedly cited by the U.S. Food and Drug Administration for serious quality control issues failed another inspection last month over concerns the company was not doing enough to prevent medicines from becoming contaminated. The problems…
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STAT+: ViiV expands licensing deal for its HIV drug in low-income countries
STAT+: ViiV expands licensing deal for its HIV drug in low-income countries Once again, ViiV Healthcare has announced steps to widen access to a sought-after HIV medicine in low- and middle-income countries, reflecting ongoing pressure to respond to criticism. Under the latest arrangement, the company is expanding a licensing agreement reached three years ago with…
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STAT+: 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+: 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+: 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+: 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+: 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+: Supreme Court declines to review Oklahoma law regulating PBMs
STAT+: Supreme Court declines to review Oklahoma law regulating PBMs The U.S. Supreme Court has declined to review an appeals court ruling that struck down key parts of an Oklahoma law regulating the retail networks created by pharmacy benefit managers, a victory for the controversial middlemen in the pharmaceutical supply chain that may create uncertainty…
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STAT+: 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+: 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+: Regeneron seeks to revamp the controversial relationships between pharma and patient charities
STAT+: Regeneron seeks to revamp the controversial relationships between pharma and patient charities In a bid to rework the controversial relationship between drugmakers and patient charities, Regeneron Pharmaceuticals has announced a new program in which it will match up to $200 million in donations this year to a leading foundation called Good Days. The move…
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STAT+: 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+: Pharma wins a victory over a Minnesota law designed to provide transparency into drug pricing
STAT+: Pharma wins a victory over a Minnesota law designed to provide transparency into drug pricing In a victory for the pharmaceutical industry, a U.S. appeals court upheld a lower court decision to halt a controversial Minnesota law that is designed to provide transparency into prescription drug pricing. The decision was issued as the result…
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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+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda
STAT+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment. The dispute with Halozyme…
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STAT+: 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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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+: Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce
STAT+: Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce Amid ongoing controversy over pharmaceutical advertising, one lawmaker wants to know how the U.S. government will enforce regulations after the Food and Drug Administration let go of numerous employees from the office that oversees prescription drug promotions. In a…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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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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STAT+: Maryland governor signs law to expand powers of the state’s prescription drug affordability board
STAT+: Maryland governor signs law to expand powers of the state’s prescription drug affordability board In a notable development, Maryland Gov. Wes Moore signed a bill that will allow a state board to extend its mandate for lowering prescription drug costs to all residents, not just those employed by government agencies. The move was hailed…
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STAT+: Trump order on drug pricing appears to issue subtle threat to pharma
STAT+: Trump order on drug pricing appears to issue subtle threat to pharma File this under “Lower your price — or else!” Tucked inside the executive order on drug pricing from President Trump is a sentence that appears to threaten pharmaceutical companies that their medicines may be withdrawn if they do not lower prices. Specifically,…
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STAT+: 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+: 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+: 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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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+: 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+: 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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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+: 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+: 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+: 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+: 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+: 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+: 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+: 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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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+: 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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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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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+: 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+: 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+: 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…