Category: biotechnology
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STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks
STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks NEW YORK — Vinay Prasad, the Food and Drug Administration’s top vaccines regulator, blamed “misleading media narratives” for the escalating criticism of his leadership amid turmoil and plummeting morale at the agency. Prasad’s remarks, delivered Thursday at a New York investor conference closed…
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A new top drug regulator and the future of psychedelics
A new top drug regulator and the future of psychedelics On this week’s episode of “The Readout Loud”: a look at an emerging class of psychedelic drugs that may treat depression, anxiety, and other psychiatric conditions without the hallucinogenic “trip.” Plus, a dash through the week’s biotech news. The turmoil at the Food and Drug…
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STAT+: Hair loss drug succeeds in Phase 3, but data underwhelms experts
STAT+: Hair loss drug succeeds in Phase 3, but data underwhelms experts A topical hair loss medication successfully built up hair in a Phase 3 trial, according to the results of two late-stage trials released Wednesday. Cosmo Pharmaceuticals, which is based in Dublin, ran the studies on men with a common form of hair loss…
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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+: A drug that was ‘engineered with AI’ enters Phase 3 testing
STAT+: A drug that was ‘engineered with AI’ enters Phase 3 testing Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. My colleagues will be in Orlando later this week for the American Society of Hematology meeting. Sign up for their newsletter…
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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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STAT+: Sarepta cleared to test new safety regimen for Duchenne drug
STAT+: Sarepta cleared to test new safety regimen for Duchenne drug Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We discuss some big news that the Trump administration dropped last night. And we’ll be taking a break this Thursday and Friday. We’ll…
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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+: Lilly hits trillion-dollar valuation as GLP-1 era peaks
STAT+: Lilly hits trillion-dollar valuation as GLP-1 era peaks Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! We’re closing in on CMS’s deadline for 2027 Medicare-negotiated drug prices. Plus, we see a break from precedent in how the FDA selects priority review…
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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+: Recursion seeks to deliver results, and a VC sees a wave of M&A coming
STAT+: Recursion seeks to deliver results, and a VC sees a wave of M&A coming Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got some spicy comments from Mark Cuban, and a pair of biotech Q&As. Let’s get to…
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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+: FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk
STAT+: FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk New warnings and restrictions placed on Sarepta Therapeutics’ gene therapy last week by the Food and Drug Administration have cast a spotlight on an important but overlooked heart-safety risk. “Acute, serious, and life-threatening” cases of heart inflammation called myocarditis and elevations…
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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+: Pfizer closes $10 billion Metsera deal
STAT+: Pfizer closes $10 billion Metsera deal Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! If you’re still wondering “What the heck happened with Moderna?” the latest episode of the video series STATus Report spells it out quite nicely. Also, a KFF…
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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+: Makary, Prasad outline pathway for bespoke gene therapy
STAT+: Makary, Prasad outline pathway for bespoke gene therapy Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we learn AbbVie has ended its partnership with Calico, the FDA outlines how bespoke gene-editing treatments can make it through the regulatory pipeline,…
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STAT+: Kura Oncology secures approval for leukemia drug, its first
STAT+: Kura Oncology secures approval for leukemia drug, its first The Food and Drug Administration on Thursday approved a drug made by Kura Oncology to treat patients with a certain type of genetically altered leukemia. The medicine will be sold under the brand name Komzifti. The FDA cleared the drug to treat patients with relapsed…
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Merck’s heart disease win and the FDA’s new drug regulator
Merck’s heart disease win and the FDA’s new drug regulator What does Rick Pazdur’s new role mean for the Food and Drug Administration? Has Merck solved the PCSK9 access issue? And how much credit can the president take for lowering GLP-1 drug prices? Dean Li, the head of R&D at Merck, joins us to discuss…
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STAT+: Why is Eli Lilly worth nearly $1 trillion?
STAT+: Why is Eli Lilly worth nearly $1 trillion? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got big FDA news to get into today — let’s get straight into it. FDA names Richard Pazdur as top drug regulator The…
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STAT+: AbbVie cuts ties with Google-backed longevity company, lays off scientists
STAT+: AbbVie cuts ties with Google-backed longevity company, lays off scientists AbbVie is ending a decade-long partnership with Calico Life Sciences, an Alphabet-funded biotech company focused on aging research, and laying off chemists working on discovering new drugs. The moves, detailed in internal emails sent Tuesday and viewed by STAT, come as the pharmaceutical giant…
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STAT+: Richard Pazdur, longtime cancer regulator, named drug center director at FDA
STAT+: Richard Pazdur, longtime cancer regulator, named drug center director at FDA WASHINGTON — The Food and Drug Administration on Tuesday named Richard Pazdur, its longtime overseer of cancer therapies, as its top drug regulator. Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who exited the agency earlier this month amid…
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STAT+: Chinese government’s support for biotech fuels huge rally
STAT+: Chinese government’s support for biotech fuels huge rally Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, we just had our first snow of the season in Chicago, I just ordered a pie for Thanksgiving, and I’m still in denial that…
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STAT+: 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+: 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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Melodrama at the FDA and the Pfizer-Novo bidding war
Melodrama at the FDA and the Pfizer-Novo bidding war On this week’s episode of “The Readout LOUD”: “Mean Girls” melodrama at the top of the FDA and the latest on the Pfizer-Novo Nordisk bidding war for Metsera. On a jam-packed show, your co-hosts, minus the vacationing Allison DeAngelis, chat with STAT’s D.C. correspondent Lizzy Lawrence…
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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+: Pfizer’s view on the Metsera bidding war
STAT+: Pfizer’s view on the Metsera bidding war Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’re hosting a virtual event tomorrow about the rise and unraveling of Moderna. My colleagues Jason Mast and Damian Garde will be there to talk about…
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STAT+: 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+: Scandal and controversy take toll on FDA credibility
STAT+: Scandal and controversy take toll on FDA credibility Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got another busy week of earnings — Pfizer reported this morning and Novo Nordisk will be reporting tomorrow. We’ll be watching for any…
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STAT+: Trump administration nears deals for cheaper weight loss drugs with Novo Nordisk, Eli Lilly
STAT+: Trump administration nears deals for cheaper weight loss drugs with Novo Nordisk, Eli Lilly WASHINGTON — The Trump administration is nearing deals with Eli Lilly and Novo Nordisk to lower the prices of their weight loss drugs and expand access to them, people familiar with the talks told STAT. The companies have been close to…
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STAT+: 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+: 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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BridgeBio’s great week and Moderna’s unraveling
BridgeBio’s great week and Moderna’s unraveling Has BridgeBio’s business model worked? How are executives at Moderna dealing with the company’s slump? And who will the hosts dress up as for Halloween? We discuss all that on this week’s episode of the “The Readout LOUD,” STAT’s biotech podcast. We bring on BridgeBio CEO Neil Kumar to…
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STAT+: Alnylam raises guidance as sales of heart drug match expectations
STAT+: Alnylam raises guidance as sales of heart drug match expectations Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! Today, we have a deep probe into Moderna’s travails from STAT’s tireless Jason Mast. Also, a pharma bidding war, thoughts on psychedelic regulation,…
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STAT+: Natera, known for spotting cancer recurrence, wades into early detection
STAT+: Natera, known for spotting cancer recurrence, wades into early detection Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. It seems everyone I know has been getting sick lately — hope you are all taking care of yourselves! Onto the news…
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STAT+: 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+: Ro wants to measure ‘food noise’ in obesity care
STAT+: Ro wants to measure ‘food noise’ in obesity care Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, you’ve made it Friday! We’ve got some more news to get through before heading into the weekend. FDA delivers split decision on…
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STAT+: 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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Startups push the FDA and biotech booms in North Carolina
Startups push the FDA and biotech booms in North Carolina Can Trump take credit for North Carolina’s booming biopharma industry? Which drugs could get a shortcut to the market? And who wore a tuxedo to the STAT Summit? We discuss all that and more in the latest episode of “The Readout LOUD.” Read the rest……
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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+: Effort to guide treatment of cancer with novel blood tests may get boost from new research
STAT+: Effort to guide treatment of cancer with novel blood tests may get boost from new research BERLIN — For years, scientists have held out hope that tests that look for the molecular fingerprints of a cancer’s presence could help clinicians determine which patients need further treatment after surgery, and which can be considered truly…
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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+: 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+: Grail says new data on multi-cancer screening test show improved performance
STAT+: Grail says new data on multi-cancer screening test show improved performance As part of its bid to transform the future of cancer screening and seize control of a potentially vast and increasingly competitive market, Grail announced fresh data on Friday from a large U.S. study of its flagship blood-based test for detecting dozens 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+: 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+: J&J reportedly in talks to buy Protagonist
STAT+: J&J reportedly in talks to buy Protagonist Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. My colleagues were hard at work throughout the weekend reporting on major firings across the CDC. We’ve also got a ton of biopharma news…
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STAT+: 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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Party in biotech land and AstraZeneca’s miscalculation
Party in biotech land and AstraZeneca’s miscalculation Where did former vaccine regulator Peter Marks find a new job? How did a math error cost AstraZeneca a rare disease candidate? And is biotech back? We discuss all that on this week’s episode of the “The Readout LOUD,” STAT’s biotech podcast. We bring on Mizuho health care…
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STAT+: Billionaire-backed VC firm launches, led by former Flagship associate
STAT+: Billionaire-backed VC firm launches, led by former Flagship associate Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. At the start of this week, my editor said the news flow was looking slow. He’s jinxed us yet again. Let’s get…
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STAT+: Orca submits T cell therapy for FDA approval
STAT+: Orca submits T cell therapy for FDA approval Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. We’ve got some exciting news of our own this morning: the return of Damian Garde, who once authored this very newsletter and who is coming…
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STAT+: TCGX closes $1.3 billion fund amid investor surge
STAT+: TCGX closes $1.3 billion fund amid investor surge Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Today, we talk about the big regulatory changes afoot in Europe, how telehealth upended the drug market, and more. The need-to-know this morning …
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STAT+: A second generic version of the abortion pill mifepristone approved by FDA
STAT+: A second generic version of the abortion pill mifepristone approved by FDA Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hullo! Today, we talk about Amgen’s positive new PCSK9 data, learn more about the new NIH office meant to reduce reliance…
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STAT+: 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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A pharma C-suite shakeup and Trump’s deal with Pfizer
A pharma C-suite shakeup and Trump’s deal with Pfizer How will we look back on Emma Walmsley’s tenure as GSK’s CEO? Why did one of the FDA’s top drug officials call out an obscure lupus drug on LinkedIn? And will we ever stop talking about the pharma patent cliff? We discuss all that and more…
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STAT+: Which biotechs are affected by the government shutdown?
STAT+: Which biotechs are affected by the government shutdown? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. I can’t believe it either, but we’re in the fourth quarter of the year. We’ve got a guide for you on the key…
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Visual Pollen Classification Using CNNs and Vision Transformers
Visual Pollen Classification Using CNNs and Vision Transformers Filling the data gap: A machine learning approach to pollen identification in ecology and biotechnology The post Visual Pollen Classification Using CNNs and Vision Transformers appeared first on Towards Data Science. Karol Struniawski Go to original source
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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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A gene therapy success in Huntington’s and Trump’s autism announcement
A gene therapy success in Huntington’s and Trump’s autism announcement Why were doctors and investors so excited about trial results of UniQure’s gene therapy for Huntington’s disease? Are autism rates actually rising? And what does the research tell us about Tylenol and autism? We discuss all that on this week’s episode of the “The Readout…
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STAT+: Crinetics wins FDA approval for acromegaly drug, faces competition with Novartis and Ipsen
STAT+: Crinetics wins FDA approval for acromegaly drug, faces competition with Novartis and Ipsen SAN DIEGO — Crinetics Pharmaceuticals won Food and Drug Administration approval on Thursday for a drug for a rare and debilitating hormonal disorder — the company’s first approved product. But the treatment faces competition from pharma giants with blockbuster medicines already…
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STAT+: Veru update shows FDA still values weight loss over body composition
STAT+: Veru update shows FDA still values weight loss over body composition Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got big news on a gene therapy for Huntington’s disease, so let’s get straight to it. Uniqure hails ‘groundbreaking’…
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STAT+: With Trump’s anti-vaccine comments, Kennedy’s influence grows
STAT+: With Trump’s anti-vaccine comments, Kennedy’s influence grows WASHINGTON — President Trump’s anti-vaccine comments on Monday signal health secretary Robert F. Kennedy Jr.’s growing influence — and raise new questions about how far the pair may go to upend vaccine policy. Standing with Kennedy beside him at the White House, Trump called the childhood vaccine…
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STAT+: Doctors are more tied to pharma as trust erodes
STAT+: Doctors are more tied to pharma as trust erodes Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we read about a big acquisition fueled by obesity, doctors shifting their views on biopharma marketing, see a rare disease drug win approval after…
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In a chaotic meeting, RFK Jr.’s handpicked advisers begin altering the childhood vaccine schedule
In a chaotic meeting, RFK Jr.’s handpicked advisers begin altering the childhood vaccine schedule ATLANTA — Health and Human Services Secretary Robert F. Kennedy Jr. has said he wants his handpicked panel of vaccine advisers to restore declining public trust in vaccines. What that looked like was on full display on Thursday and Friday: The…
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Winner of mRNA Nobel Prize says ACIP member’s claim that Covid vaccines persist is “absolutely impossible”
Winner of mRNA Nobel Prize says ACIP member’s claim that Covid vaccines persist is “absolutely impossible” On Thursday and Friday, the Centers for Disease Control and Prevention held a meeting of its Advisory Committee on Immunization Practices, a key panel that gives the CDC’s director guidance about what vaccines to recommend to the public. The…
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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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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 sours on the U.K., plus biotech M&A’s quiet roll
Pharma sours on the U.K., plus biotech M&A’s quiet roll Are pharmaceutical companies pulling their money out of the United Kingdom because of Trump? How is biotech M&A pacing this year? And what will vaccine advisors discuss at their closely watched meeting this week? We discuss all that and more on this week’s episode of…
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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+: Amid industry headwinds, Biogen breaks ground on new headquarters
STAT+: Amid industry headwinds, Biogen breaks ground on new headquarters CAMBRIDGE, Mass. — Biogen on Tuesday held a ceremonial groundbreaking of its 16-story headquarters in Kendall Square, ushering in the latest phase of the neighborhood’s transformation from “Nowhere Square” to what its backers like to call “the most innovative square mile on the planet.” Nobel laureates Walter…
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STAT+: Hill staff gets briefed on implications of Trump’s drug pricing plan
STAT+: Hill staff gets briefed on implications of Trump’s drug pricing plan WASHINGTON — Congress is again discussing the Trump administration’s plan to force drug companies to lower their U.S. prices, at least behind the scenes. Congressional staffers and health policy experts from major think tanks held a closed-door meeting to discuss policy options that…
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STAT+: U.S. pressures U.K. as pharma pauses investments there
STAT+: U.S. pressures U.K. as pharma pauses investments there Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we see moves to potentially dismantle FDA ad comms, see the U.S. pressuring the U.K. over its stringent drug-pricing policy, and more. The…
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FDA leaders moving to abandon advisory committee reviews of specific new drugs
FDA leaders moving to abandon advisory committee reviews of specific new drugs FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny. The agency “would like to get away” from assembling panels…
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STAT+: 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+: FDA pushing non-opioid path for chronic pain
STAT+: FDA pushing non-opioid path for chronic pain Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we note that psychedelics are suddenly a hot topic for larger pharmaceutical companies, dissect Patrick Soon-Shiong’s claims on his lung cancer drug, and more.…
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STAT+: Merck halts U.K. research operations and bails on new facility in London
STAT+: Merck halts U.K. research operations and bails on new facility in London LONDON — In a blow to the U.K., Merck said Wednesday it was halting research operations in the country and bailing on a major London research center, in part to protest how the U.K. pays for medicines. The U.K. has been trying…
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STAT+: House appropriators snub Kennedy, include mRNA vaccine funding in spending bill
STAT+: House appropriators snub Kennedy, include mRNA vaccine funding in spending bill WASHINGTON — House appropriators have snubbed Health and Human Services Secretary Robert F. Kennedy Jr. by including an amendment in their 2026 spending bill that specifically funds continued messenger RNA vaccine research, despite his effort to roll it back. In August, Kennedy announced…
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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+: Pig kidneys to enter FDA-backed human trial next year
STAT+: Pig kidneys to enter FDA-backed human trial next year Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello there. Today, we learn the FDA is advancing a trial for gene-edited pig organs in humans, see geographical discrepancies in lung cancer trial…