NIH’s Francis Collins: For Biden’s new research agency to succeed, it should prepare for some projects to fail
WASHINGTON — Francis Collins is ready for the National Institutes of Health to fail spectacularly….
Category: government agencies
STAT+: The ins and outs of the rare, controversial way Medicare might pay for Biogen’s new Alzheimer’s drug
WASHINGTON — The Food and Drug Administration last month foisted a nearly impossible decision on…
FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval
WASHINGTON — Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency…
STAT+: FDA scolds Amgen over a misleading ad that could deter use of biosimilar versions of its drug
In an embarrassing rebuke, the Food and Drug Administration has scolded Amgen (AMGN) over a…
When and how will we know if we need Covid-19 booster shots?
There’s a lot we don’t yet know about the data behind Pfizer and BioNTech’s renewed…
STAT+: Medicare starts process that could limit access to Biogen’s new Alzheimer’s drug
WASHINGTON — Federal officials on Monday announced the agency will start a process that could…
Powerful House Democrats demand documents from Biogen about coordination with FDA on new Alzheimer’s drug
WASHINGTON — Two powerful House Democrats on Monday demanded documents from Biogen about the approval…
Experts warn full Covid-19 vaccine approval is no quick fix for hesitancy
WASHINGTON — The Food and Drug Administration issuing full approval for two Covid-19 vaccines might…
Pfizer to discuss vaccine booster with U.S. officials Monday
WASHINGTON (AP) — Pfizer says it plans to meet with top U.S. health officials Monday…
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FDA calls for federal investigation into its controversial Alzheimer’s drug approval
The head of the Food and Drug Administration has called for a wide-ranging federal investigation…
STAT+: FDA extends shelf life for glaucoma drug discontinued by Pfizer, but patients remain concerned
In a bid to calm anxious patients, the Food and Drug Administration has extended the…
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STAT+: FDA’s expansive Alzheimer’s drug approval surprised even top agency officials
WASHINGTON — The Food and Drug Administration’s contentious decision to approve a new Alzheimer’s drug…
Listen: Aduhelm’s latest twist, how Covid variants are shaping the summer, & a digital health boom
How worrying is the Delta variant? Is there a digital health bubble? And what is…
STAT+: FDA, under fire from critics, revises prescribing information for Biogen’s Alzheimer’s drug
The Food and Drug Administration on Thursday changed the prescribing label for Biogen’s Alzheimer’s treatment…
STAT+: The failure of a cancer drug study leaves Cel-Sci on the brink of collapse
The failure of Cel-Sci’s immunotherapy treatment called Multikine to prolong the survival of patients with…
STAT+: Regulators in many European countries fail to ensure clinical trial data are available
Amid ongoing concerns over clinical trial transparency, a new report finds “notable gaps” in the…
STAT+: Supreme Court to take up hospitals’ challenge to Medicare drug pay cuts
WASHINGTON — In a win for safety-net hospitals, the Supreme Court decided to hear their…
Listen: A CRISPR milestone, Biogen’s FDA saga, & George Yancopoulos on biotech in 2021
How much can CRISPR really do? Has the FDA been totally honest? And is it…
Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug
WASHINGTON — Former health secretary Donna Shalala called for a federal investigation into the Food…
STAT+: Poll: Most neurologists and primary care doctors disagree with FDA’s approval of Alzheimer’s drug
A majority of U.S. physicians disagree with the decision by the Food and Drug Administration…
STAT+: Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug
It was perhaps the most contentious drug approval in decades, shocking drug company executives, insurance…
STAT+: In an about-face, Health Canada allows a controversial rare disease drug back on the market
In yet another twist in a complicated tale, Health Canada has reinstated approval of a…
STAT+: House leaders to investigate FDA approval and price of Biogen’s Alzheimer’s drug
WASHINGTON — The top House Democrats on two powerful committees on Friday announced an investigation…
STAT+: Will FDA quickly review a Lilly drug to alleviate cost concerns for Alzheimer’s drugs?
In an unexpected move, U.S regulators granted Eli Lilly (LLY) a breakthrough designation for its…
CDC advisory panel backs use of dengue vaccine in high-risk areas, despite delivery challenges
An expert panel voted Thursday to advise that the Centers for Disease Control and Prevention…
Listen: FDA inner workings, GSK’s foggy future, & the alarming rise in colorectal cancer
How does the FDA handle unprecedented decisions? What’s it like to go on “Good Morning…
STAT+: FDA’s Woodcock is just ‘not that concerned’ about the criticism over Biogen’s Alzheimer’s drug, Aduhelm
WASHINGTON — The Food and Drug Administration has been without a permanent commissioner for six…
A crucial, overlooked question on the new Alzheimer’s drug: When should patients stop taking it?
For families and physicians grappling with the historic approval this month of the controversial Alzheimer’s…
Key Democrats slam FDA for failing to crack down on Juul and other e-cigarette makers
WASHINGTON — Congressional Democrats openly pressured acting Food and Drug Administration Commissioner Janet Woodcock to…
STAT+: Key science officials detail their plans for a new research agency — and Congress is getting closer to funding it
WASHINGTON — Two key federal health officials are pitching a new branch of the National…
Opinion: FDA should lead the way on new ALS treatments, not Canada and Europe
Following the Food and Drug Administration’s recent decision to give the green light to aducanumab,…
STAT+: BIO’s chief on the FDA commissioner rumors, drug pricing, and IP rights
WASHINGTON — Everyone wants to know whether Michelle McMurry-Heath, the newly minted president of the…
STAT+: HHS withdraws 340B drug discount opinion amid lawsuits by pharma companies
After a defeat in federal court, the Department of Health and Human Services withdrew an…
Opinion: 3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying
Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack…
STAT+: Billions spent on prescription drug ads may have increased Medicare spending
The large sums of money spent on advertising prescription drugs directly to consumers may have…
Opinion: Why a controversial decision won’t stop me from serving on FDA advisory committees
Last week’s controversial decision by the FDA to give aducanumab, Biogen’s Alzheimer’s drug, accelerated approval…
STAT+: ‘A litany of flaws’: Advocacy group urges HHS to boot FDA officials over Alzheimer’s drug approval
Reacting to the controversial approval of the Biogen (BIIB) Alzheimer’s drug, a leading advocacy group…
STAT+: Former FDA chief Hahn defends his jump to Flagship Pioneering, the firm behind Moderna
When biotech investor Flagship Pioneering announced that it had hired former Food and Drug Administration…
STAT+: Biden administration moves to axe Trump 340B rule targeting community clinics
WASHINGTON — The Biden administration on Tuesday moved to axe a Trump-era policy that would…
STAT+: Advocates blast the FDA for not moving as fast on ALS as on Alzheimer’s
WASHINGTON — The Food and Drug Administration fast-tracked Biogen’s divisive Alzheimer’s drug Aduhelm, but it’s…
FDA accuses company of distributing unapproved Covid test and using falsified data
The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test,…
FDA accuses company of distributing unapproved Covid test and using falsified data
The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test,…
Listen: Every angle on the FDA’s polarizing approval of Biogen’s Alzheimer’s drug
Was the FDA right to approve Aduhelm? What’s a fair price for a debatable drug?…
NIH releases a plan to confront structural racism. Critics say it’s not enough
Saying structural racism is a chronic problem throughout biomedical research and within their own walls,…
Virtual Event: The ASCO Recap, Live!
After the biggest meeting in cancer research, sit down with cancer’s biggest decision-maker: the director…
STAT+: Despite its high price tag, the new Alzheimer’s drug isn’t reigniting the drug pricing debate
WASHINGTON — It has all the makings of a bombastic drug pricing debate: a highly…
An extra twist in the FDA’s Alzheimer’s decision: no limits on which patients can get the drug
As if the saga of aducanumab needed another twist, the Food and Drug Administration tossed…
STAT+: ‘The price is bewildering’:The price of Biogen’s Alzheimer’s drug may lead payers to erect roadblocks
The Food and Drug Administration’s approval on Monday of an Alzheimer’s drug developed by Biogen…
STAT+: By approving Biogen’s Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk
In order to approve a new Alzheimer’s treatment, the Food and Drug Administration is rewriting…
Listen: Fauci’s emails, FDA kremlinology, & covering the CRISPR babies scandal
Who is Anthony Fauci emailing at 3 a.m.? Does the FDA leave legible tea leaves?…