Category: Pharmaceuticals
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STAT+: FDA removes longtime over-the-counter drugs regulator from her position
STAT+: FDA removes longtime over-the-counter drugs regulator from her position WASHINGTON — The Food and Drug Administration removed the longtime director of the office of over-the-counter drugs from her position on Wednesday, six agency sources told STAT. Theresa Michele, director of the Office of Nonprescription Drugs, has worked at the FDA since at least 2015.…
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STAT+: Top drug regulator Richard Pazdur set to leave the FDA
STAT+: Top drug regulator Richard Pazdur set to leave the FDA WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency. Pazdur informed leaders at the FDA’s drug center of his intention to leave…
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STAT+: Top contributors to leading psychiatry journals fail to disclose industry payments, analysis finds
STAT+: Top contributors to leading psychiatry journals fail to disclose industry payments, analysis finds Amid ongoing concern over conflicts of interest that may affect medical practice, a new study found that 14% of the $4.5 million paid to authors in two leading psychiatry journals was undisclosed and nearly all of the payments were made to…
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Opinion: Public health should embrace GLP-1 drugs without abandoning obesity prevention
Opinion: Public health should embrace GLP-1 drugs without abandoning obesity prevention Following the White House’s recent announcement of price reductions and expanded coverage for GLP-1 medications like Wegovy and Zepbound, many patients searching for obesity treatments are about to gain access to highly effective options. The implications for U.S. public health are vast. Read the…
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In Medicare drug negotiations, Trump administration embraces a policy the GOP once despised
In Medicare drug negotiations, Trump administration embraces a policy the GOP once despised WASHINGTON — On Tuesday, the Trump administration celebrated drug price cuts it had secured through a Democrat-created program — despite Republicans’ longstanding antipathy toward the policy. The Inflation Reduction Act, a 2022 law supported solely by Democrats and signed into law by…
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STAT+: FDA approves Otsuka kidney disease therapy
STAT+: FDA approves Otsuka kidney disease therapy The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with chronic, autoimmune kidney disease, according to a notice on the agency’s website. The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared…
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STAT+: J&J’s novel Alzheimer’s drug fails in key trial, dimming hopes for a hot target
STAT+: J&J’s novel Alzheimer’s drug fails in key trial, dimming hopes for a hot target A promising Alzheimer’s disease treatment from Johnson & Johnson failed to slow the progress of the disease in a closely watched study, news that could dampen enthusiasm for a new class of potential medicines. J&J terminated its mid-stage study of…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug
STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month drug review, culminating in a one day “tumor board” style meeting where leaders decide whether to approve the drug. …
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STAT+: Cassidy and other Republicans have little to say about change to CDC’s position on vaccines and autism
STAT+: Cassidy and other Republicans have little to say about change to CDC’s position on vaccines and autism WASHINGTON — Health secretary Robert F. Kennedy Jr. broke another promise to Senate health committee Chair Bill Cassidy (R-La.) this week. So far, there don’t seem to have been any consequences. To secure Cassidy’s decisive confirmation vote,…
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How Mark Cuban plans to ‘f— up’ health care
How Mark Cuban plans to ‘f— up’ health care How much time does Mark Cuban spend thinking about health care? Why does he think TrumpRx, a direct drug purchasing platform that the Trump administration aims to launch, is “the most incredible program ever”? And what are his thoughts on sports betting? We discuss all that…
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STAT+: South Africa is urged by advocates to issue a compulsory license for Gilead’s HIV prevention drug
STAT+: South Africa is urged by advocates to issue a compulsory license for Gilead’s HIV prevention drug Patient advocacy groups have urged the South African government to issue a compulsory license for a groundbreaking HIV prevention treatment after the Trump administration refused to include South Africa in a new program to distribute the drug to…
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STAT+: Pfizer and Tris agree to $41.5 million settlement with Texas over ADHD drug for children
STAT+: Pfizer and Tris agree to $41.5 million settlement with Texas over ADHD drug for children Pfizer and Tris Pharma have agreed to pay $41.5 million to settle allegations by Texas Attorney General Ken Paxton that they provided an ADHD medicine to children on Medicaid while knowing about “flawed” manufacturing practices. The companies were accused…
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STAT+: A revelatory profile of RFK Jr.
STAT+: A revelatory profile of RFK Jr. 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 haven’t read Olivia Nuzzi’s new book, but I dare say my favorite line about her relationship…
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STAT+: Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds
STAT+: Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds Numerous medicines are not accessible in many of the countries where they were tested before approval by the Food and Drug Administration, raising concerns about whether pharmaceutical companies are adhering to ethical standards, a new study finds. The researchers reviewed 172…
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STAT+: Johnson & Johnson acquires Halda Therapeutics for $3 billion, a big win for a buzzy new technology
STAT+: Johnson & Johnson acquires Halda Therapeutics for $3 billion, a big win for a buzzy new technology Johnson & Johnson said Monday it will purchase Halda Therapeutics and its experimental prostate cancer drugs for $3.05 billion, marking the first major buyout for a startup built around a field that has attracted significant investment but not…
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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+: 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+: The $10 billion question: Will Pfizer hit it big with Metsera, or have regrets?
STAT+: The $10 billion question: Will Pfizer hit it big with Metsera, or have regrets? At a price of up to $10 billion, Pfizer has claimed victory in its bidding war against Novo Nordisk to acquire Metsera and its investigational obesity treatments. But in doing so, the company has also taken on significant risks. Will…
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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 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+: 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+: FTC raises concern about Novo Nordisk attempt to acquire obesity startup Metsera
STAT+: FTC raises concern about Novo Nordisk attempt to acquire obesity startup Metsera The Federal Trade Commission has raised concerns about Novo Nordisk’s attempt to outbid Pfizer to acquire obesity startup Metsera, the latest complication in a dramatic bidding war between two pharma giants. Companies normally have to seek FTC review for acquisitions under a…
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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+: Arena BioWorks, an ambitious biomedical institute backed by billionaires, abruptly shuts down
STAT+: Arena BioWorks, an ambitious biomedical institute backed by billionaires, abruptly shuts down Arena BioWorks, the buzzy research institute that launched nearly two years ago with $500 million to support a decade of scientific R&D, is abruptly shutting down, the institute confirmed to STAT. Approximately 50 staff members, including co-founder Stuart Schreiber and CEO Harvey…
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STAT+: Lawsuit against top FDA drug regulator is packed with incendiary texts, emails
STAT+: Lawsuit against top FDA drug regulator is packed with incendiary texts, emails On the day the top drug regulator at the Food and Drug Administration resigned amid an investigation into his conduct, he also faced an explosive lawsuit that includes a series of incendiary texts and emails he is said to have sent to…
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STAT+: Novo Nordisk spent millions on weight loss searches that took people to its Ozempic website, analysis found
STAT+: Novo Nordisk spent millions on weight loss searches that took people to its Ozempic website, analysis found Over a recent two-year period, Novo Nordisk spent an estimated $7.5 million on more than 15,000 paid keywords related to weight loss searches and generated more than 2.4 million visits to Ozempic.com, even though the medicine is…
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STAT+: FDA’s top drug regulator placed on leave amid investigation
STAT+: FDA’s top drug regulator placed on leave amid investigation WASHINGTON — George Tidmarsh, the Food and Drug Administration’s top regulator of drugs, has been placed on administrative leave after being accused of using his regulatory authority to inflict financial harm on a former business associate, STAT has learned. FDA Commissioner Marty Makary relieved Tidmarsh of…
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STAT+: Pfizer sues Novo Nordisk, Metsera for breach of merger agreement
STAT+: Pfizer sues Novo Nordisk, Metsera for breach of merger agreement Pfizer said Friday it’s suing Novo Nordisk and obesity biotech Metsera, a day after Novo set off a bidding war against Pfizer to acquire Metsera. A month ago, Pfizer said that it would acquire Metsera for $4.9 billion. But Novo on Thursday launched 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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Texas lawsuit against companies behind Tylenol asserts unproven claims of autism risk
Texas lawsuit against companies behind Tylenol asserts unproven claims of autism risk Texas Attorney General Ken Paxton on Tuesday accused the companies behind Tylenol of deceptively marketing the pain reliever to pregnant mothers in a lawsuit that asserted unproven claims that early exposure to acetaminophen increased risk of autism and other disorders. Paxton, an ally of President…
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STAT+: Bausch Health leaves Medicaid and 340B programs as drugmakers face changing calculus on pricing
STAT+: Bausch Health leaves Medicaid and 340B programs as drugmakers face changing calculus on pricing In an unexpected move, Bausch Health recently stopped participating in Medicaid and a federal government drug discount scheme known as 340B, a step that suggests more drugmakers may rethink decisions to provide their medicines to these widely used programs. Bausch…
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STAT+: Novartis to buy RNA-focused Avidity in $12 billion deal
STAT+: Novartis to buy RNA-focused Avidity in $12 billion deal LONDON — Novartis said Sunday it would buy Avidity Biosciences, which is developing RNA-based therapies for neuromuscular diseases, for roughly $12 billion in cash. The deal, at $72 a share, represents a 46% premium on Avidity’s closing share price on Friday of $49.15. With 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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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+: 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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STAT+: FDA delivers split decision on GSK’s blood cancer drug Blenrep, approving its use in some cases
STAT+: FDA delivers split decision on GSK’s blood cancer drug Blenrep, approving its use in some cases The Food and Drug Administration on Thursday delivered a split decision on a blood cancer drug from GSK, approving its use in one combination regimen but rejecting another. The mixed ruling is the latest twist in the turbulent…
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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+: Moderna says key study of its CMV vaccine, expected to be its next big win, failed
STAT+: Moderna says key study of its CMV vaccine, expected to be its next big win, failed Moderna said Wednesday afternoon that its experimental vaccine for cytomegalovirus, a cause of disability in newborns, failed in a Phase 3 trial, a significant setback for a company already facing pressure from Wall Street and the federal government.…
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STAT+: CVS Caremark tells AIDS activists Gilead needs to lower the price of its new HIV drug to get on formularies
STAT+: CVS Caremark tells AIDS activists Gilead needs to lower the price of its new HIV drug to get on formularies For the past three months, CVS Caremark has resisted adding a new Gilead Sciences HIV prevention drug to its formularies, repeatedly explaining there are “clinical, financial, and regulatory considerations” that must be reviewed before…
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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+: Gilead agrees not to raise prices on HIV medicines for state AIDS drug programs
STAT+: Gilead agrees not to raise prices on HIV medicines for state AIDS drug programs After months of tense negotiations, Gilead Sciences has agreed not to boost prices next year for HIV medicines that are sold to state AIDS Drug Assistance Programs, an outcome that lessens the financial strains for agencies that are relied on…
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STAT+: CBO says revised cost of orphan drug exemptions will add $3.9 billion to Medicare
STAT+: CBO says revised cost of orphan drug exemptions will add $3.9 billion to Medicare The Congressional Budget Office has revised its forecast showing the recently enacted One Big Beautiful Bill Act will cost taxpayers as much as $8.8 billion — up from earlier estimates of $4.9 billion — over 10 years thanks to provisions…
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STAT+: FDA review of drugs is slowing while application delays are growing, analysis finds
STAT+: FDA review of drugs is slowing while application delays are growing, analysis finds The upheaval at the Food and Drug Administration appears to be taking a toll on the pharmaceutical industry, according to a new analysis of key agency metrics. There was a significant drop in drug approvals in the recently ended third quarter,…
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STAT+: At ESMO, AstraZeneca and Gilead square off in triple-negative breast cancer
STAT+: At ESMO, AstraZeneca and Gilead square off in triple-negative breast cancer BERLIN — Patients with a highly aggressive form of breast cancer will likely have new treatment options for the first time in years after AstraZeneca and Gilead Sciences both presented successful trial results here Sunday, dual achievements that will also leave clinicians having…
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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+: Roche suffers a fresh blow as India’s Supreme Court allows generic sales of its pricey rare disease drug
STAT+: Roche suffers a fresh blow as India’s Supreme Court allows generic sales of its pricey rare disease drug In a case that was billed as profits versus patients, India’s Supreme Court dismissed a petition in which Roche sought to prevent a generic drugmaker from selling a lower-cost version of a pricey rare disease medication.…
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STAT+: Roche, Celcuity detail successful advanced breast cancer studies
STAT+: Roche, Celcuity detail successful advanced breast cancer studies BERLIN — They may be working on vastly different scales — the biotech Celcuity has a market cap of about $2 billion, while Roche reaped more than $60 billion in sales last year — but both companies unveiled data here Saturday that they hope will win…
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STAT+: Enhertu pushes into early breast cancer, as antibody-drug conjugates move up the line
STAT+: Enhertu pushes into early breast cancer, as antibody-drug conjugates move up the line BERLIN — Enhertu has become a staple treatment in advanced breast cancer, but new data presented Saturday at the European Society for Medical Oncology’s annual conference show the drug can have powerful benefits for patients when given earlier in the disease,…
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STAT+: Turkey antitrust regulator fines several big drugmakers for ‘no-poach’ agreements
STAT+: Turkey antitrust regulator fines several big drugmakers for ‘no-poach’ agreements Antitrust regulators in Turkey have fined more than a dozen large pharmaceutical companies — including global drugmakers such as Pfizer, AstraZeneca, and Novartis — for agreeing not to poach employees from one another, a move that disrupted the domestic labor market. The Turkish Competition…
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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 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+: Kailera Therapeutics, an obesity drug startup, raises $600 million
STAT+: Kailera Therapeutics, an obesity drug startup, raises $600 million Investors announced one of the biggest private financing rounds of the year for a biotech company Tuesday, pouring $600 million into obesity startup Kailera Therapeutics. Bain Capital’s private equity group led the financing, which also included Royalty Pharma, the sovereign wealth fund in Qatar, and the…
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STAT+: FDA declares Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance
STAT+: FDA declares Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance A troubled Indiana contract manufacturing plant recently acquired by Novo Nordisk is considered to not be in compliance with the Food and Drug Administration standards, a serious designation that could further delay the approval of drugs made in the…
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STAT+: Canadian lawmakers urge the government to suspend imports of long-tailed macaques
STAT+: Canadian lawmakers urge the government to suspend imports of long-tailed macaques A half-dozen members of the Canadian parliament are urging the government to immediately suspend imports of long-tailed macaques into the country over concerns the monkeys may be infected with tuberculosis and pose a biosecurity risk. In their Oct. 1 letter, the lawmakers cite…
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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+: Roche suffers setback as court allows generic version of its rare disease drug to be sold in India
STAT+: Roche suffers setback as court allows generic version of its rare disease drug to be sold in India In the latest tussle over access to medicines, an Indian court has upheld a ruling that found it would be in the public interest to allow a generic company to sell a lower-cost version of a…
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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+: 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+: 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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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+: 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+: Colorado board makes first-in-the-nation move by setting a payment limit on an Amgen drug
STAT+: Colorado board makes first-in-the-nation move by setting a payment limit on an Amgen drug In a first-in-the-nation move, a Colorado panel has voted to limit what health plans in the state will pay for a costly arthritis treatment, a step that may encourage other states to pursue similar strategies to contain spending on prescription…
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FDA approves another generic abortion pill, prompting outrage from conservatives
FDA approves another generic abortion pill, prompting outrage from conservatives WASHINGTON — Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with the Trump administration. Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form…
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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+: U.K. is urged to probe drugmakers for conspiring to scrap or halt investments amid pricing disputes
STAT+: U.K. is urged to probe drugmakers for conspiring to scrap or halt investments amid pricing disputes The U.K.’s antitrust regulator has been asked by patient advocacy groups to investigate several large drugmakers and their U.K. lobbying organization for “suspected” and “coordinated” efforts to drive up the prices of medicines. The backdrop to the complaint…
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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+: 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+: 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+: 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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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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STAT+: FDA approves ultra-rare disease drug that became a symbol of uncertainty over regulatory standards
STAT+: FDA approves ultra-rare disease drug that became a symbol of uncertainty over regulatory standards After months of uncertainty, the Food and Drug Administration offered accelerated approval for an ultra-rare disease drug that had become a symbol of the fraught balancing act between upholding regulatory standards and accommodating desperate patients and their families. The agency…
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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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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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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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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+: 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+: Scientists who revolutionized cystic fibrosis treatment win prestigious Lasker Award
STAT+: Scientists who revolutionized cystic fibrosis treatment win prestigious Lasker Award Three scientists who revolutionized the treatment of cystic fibrosis and prolonged the lifespan of patients with the deadly disease have won the Lasker Award, one of the most prestigious awards in medicine. Vertex Pharmaceuticals researcher Paul Negulescu, former Vertex researcher Jesús (Tito) González, and…
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Trump, Chinese biotech, and an industry career reshaped by illness
Trump, Chinese biotech, and an industry career reshaped by illness On this week’s episode of “The Readout LOUD”: a drug-industry career reshaped by illness, and the potential for political blowback against Chinese biotech. Listeners of this podcast probably know pharma consultant Mike Rea for his annual ranking of drug company R&D productivity. But this week,…
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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+: An API supplier in India wants you to know its metal detector is working just fine
STAT+: An API supplier in India wants you to know its metal detector is working just fine For those wondering about any metallic particles found in active pharmaceutical ingredients made by a supplier called Hikal, you can rest easy — the company says its metal detector is working again. Since 2020, nearly two dozen complaints…
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STAT+: Dozens of lawmakers urge HHS to abandon a pilot initiative for the controversial 340B program
STAT+: Dozens of lawmakers urge HHS to abandon a pilot initiative for the controversial 340B program More than 160 lawmakers have urged the Trump administration to abandon a newly announced pilot program that would allow pharmaceutical companies to offer rebates for a small number of therapies to hospitals that participate in a federal drug discount…
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STAT+: Summit Therapeutics hits possible snag on lung cancer drug seen as a blockbuster
STAT+: Summit Therapeutics hits possible snag on lung cancer drug seen as a blockbuster Summit Therapeutics may have a geography problem with its lung cancer drug ivonescimab. In a study update reported Sunday, patients from North America and Europe treated with the drug saw their lung cancer return and progress faster than patients from China…
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STAT+: Patient groups cheer as the WHO adds diabetes and cystic fibrosis drugs to its essential medicines list
STAT+: Patient groups cheer as the WHO adds diabetes and cystic fibrosis drugs to its essential medicines list For the first time, the World Health Organization has added various high-cost treatments for diabetes and cystic fibrosis to its list of essential medicines, a move that patient advocates hope will usher in a new era of…
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STAT+: Trump administration confirms plan for PEPFAR to distribute Gilead’s new HIV prevention drug
STAT+: Trump administration confirms plan for PEPFAR to distribute Gilead’s new HIV prevention drug After months of uncertainty, the Trump administration confirmed that it will work with Gilead Sciences and The Global Fund to Fight AIDS, Tuberculosis and Malaria to provide a groundbreaking HIV prevention drug to up to 2 million people in low- and…
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STAT+: Amneal Pharma is scolded by FDA for using contaminated bags for a sterile injectable drug
STAT+: Amneal Pharma is scolded by FDA for using contaminated bags for a sterile injectable drug In a startling failure of quality control, Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug even after identifying the risk and then lowered its standards so that the bags could continue to be used, according to…
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STAT+: Gilead wants state AIDS drug programs to pay significant price hikes for HIV meds
STAT+: Gilead wants state AIDS drug programs to pay significant price hikes for HIV meds Gilead Sciences, the largest maker of HIV medicines, is seeking to boost prices significantly for several treatments that are widely distributed by state AIDS Drug Assistance Programs. And the move is adding to financial uncertainty for the programs on top…
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STAT+: Alnylam’s hypertension treatment did not significantly lower blood pressure in mid-stage study
STAT+: Alnylam’s hypertension treatment did not significantly lower blood pressure in mid-stage study An investigational therapy from Alnylam Pharmaceuticals did not significantly lower blood pressure in a key Phase 2 trial, raising questions about the benefit of the twice-a-year treatment as it enters late-stage testing. Among high-risk patients already taking at least two common hypertension…
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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…