Category: Biotech
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STAT+: At ‘hush-hush’ MAHA summit, RFK Jr. and deputies to mix with biotech leaders
STAT+: At ‘hush-hush’ MAHA summit, RFK Jr. and deputies to mix with biotech leaders WASHINGTON — Health secretary Robert F. Kennedy Jr. and many top deputies are scheduled to speak alongside industry executives and health activists at a daylong MAHA event on Wednesday that has not been publicly disclosed by administration officials or event organizers.…
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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+: Merck’s pill to reduce cholesterol on top of statins matches results from injectables
STAT+: Merck’s pill to reduce cholesterol on top of statins matches results from injectables NEW ORLEANS — A pill designed to further lower cholesterol in people already on statins but at risk of a serious cardiovascular event — their first or a recurrence — reduced LDL cholesterol by up to 60%, a new late-stage trial…
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STAT+: Amgen’s cholesterol shot prevented first heart attacks and strokes, more detailed data affirm
STAT+: Amgen’s cholesterol shot prevented first heart attacks and strokes, more detailed data affirm NEW ORLEANS — A cholesterol-lowering injection that’s been on the market for nearly a decade has now shown its power to cut cardiovascular events in people considered at high risk but who haven’t yet suffered a heart attack or stroke. A…
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STAT+: CRISPR-based treatment cuts cholesterol and triglycerides in early study
STAT+: CRISPR-based treatment cuts cholesterol and triglycerides in early study A CRISPR-based gene editing therapy dramatically reduced levels of low-density lipoprotein, often called “bad cholesterol,” and triglycerides in patients with heart disease, a new study found. Some researchers said that the treatment, developed by the biotech CRISPR Therapeutics and so far tested in just 15…
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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+: 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+: 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+: 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+: 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+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs
STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs WASHINGTON — The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients. The framework will shorten the path…
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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+: Eli Lilly, NVIDIA team up to build pharma’s biggest AI supercomputer
STAT+: Eli Lilly, NVIDIA team up to build pharma’s biggest AI supercomputer Eli Lilly announced a partnership with chipmaker NVIDIA on Tuesday to build what it claims will be the “most powerful supercomputer owned and operated by a pharmaceutical company.” Lilly’s technology investment is meant to help the drugmaker tap into the potential of artificial…
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STAT+: Casey Means faces confirmation hearing for surgeon general
STAT+: Casey Means faces confirmation hearing for surgeon general 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. The wife and I went to the Rehoboth Beach Sea Witch Festival dressed as a…
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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+: 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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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+: 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+: 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+: 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+: 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+: 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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How to Classify Lung Cancer Subtype from DNA Copy Numbers Using PyTorch
How to Classify Lung Cancer Subtype from DNA Copy Numbers Using PyTorch A step-by-step introduction to understanding cancer from the perspective of a data scientist. The post How to Classify Lung Cancer Subtype from DNA Copy Numbers Using PyTorch appeared first on Towards Data Science. Adam Streck Go to original source
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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+: 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+: 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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Opinion: Drug developers shouldn’t shortchange the autoimmune community
Opinion: Drug developers shouldn’t shortchange the autoimmune community My teenage years were ravaged by severe autoimmune disease. In that era, the burdens of treatment for Crohn’s disease rivaled the misery of the affliction. My illness brought searing stomach pain, fatigue, and fistulas. The steroids my physician prescribed caused breakouts of cystic acne all over my…
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STAT+: Sarepta to seek approval for gene therapy in rare form of muscular dystrophy
STAT+: Sarepta to seek approval for gene therapy in rare form of muscular dystrophy An experimental gene therapy from Sarepta Therapeutics increased levels of the gene missing in an ultra-rare form of muscular dystrophy, according to data the company presented Friday. The company has said it plans to file for approval in the disease, known…
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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+: 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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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+: 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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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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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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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+: 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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STAT+: Fifty cancer types in one liquid biopsy test: Exact Sciences enters early-detection market
STAT+: Fifty cancer types in one liquid biopsy test: Exact Sciences enters early-detection market Consumers can now purchase Exact Sciences’ liquid biopsy early detection test, Cancerguard, and get an indication of whether they might have one of 50 different cancers included in the test’s analysis. The biotechnology company launched the test on Wednesday, and Tom…
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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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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+: 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…
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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+: Trump pressures drugmakers amid CDC turmoil
STAT+: Trump pressures drugmakers amid CDC turmoil Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Welcome back from the holiday weekend. Today we have some candor in ALL CAPS from Trump on Covid vaccines, glowy data from Ionis that could lead to…
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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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STAT+: Cytokinetics drug yielded benefits over common therapy in patients with heart condition, study shows
STAT+: Cytokinetics drug yielded benefits over common therapy in patients with heart condition, study shows An experimental medicine from Cytokinetics improved exercise capacity more than a widely prescribed beta blocker in patients newly diagnosed with a common, inherited heart condition, study results reported Saturday showed. The Cytokinetics drug, called aficamten, is currently being reviewed by…
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STAT+: Third Rock tops STAT’s annual VC ranking
STAT+: Third Rock tops STAT’s annual VC ranking 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 colleague Allison DeAngelis has been working for months on our annual VC rankings report. Read on for what she found. Third Rock tops…
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STAT+: New report details the state of the biotech industry in Mass. The results are grim
STAT+: New report details the state of the biotech industry in Mass. The results are grim The industry group MassBio has released its annual temperature check on the biotech industry in Massachusetts, and the results are grim. Both public and private funding have plummeted as federal policy changes have thrown the biotech sector into an…
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STAT+: Akeso says its closely watched drug improved patient survival in a lung cancer trial
STAT+: Akeso says its closely watched drug improved patient survival in a lung cancer trial Akeso, a Chinese biotech with a drug positioned to rival Merck’s megablockbuster Keytruda, has reported for the first time that the therapy can improve patient survival. The therapy, ivonescimab, showed a statistically significant survival benefit as a second-line treatment when…
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STAT+: AbbVie to buy Gilgamesh’s psychedelic drug for up to $1.2 billion
STAT+: AbbVie to buy Gilgamesh’s psychedelic drug for up to $1.2 billion AbbVie on Monday said it will buy Gilgamesh Pharmaceuticals’ investigational psychedelic drug to treat major depression, a sign that pharma companies are warming up more to the burgeoning field. The pharma giant will acquire the treatment, called bretisilocin, for up to $1.2 billion,…
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STAT+: Supreme Court lets Trump slash NIH research funds
STAT+: Supreme Court lets Trump slash NIH research funds 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. The Supreme Court is allowing the Trump administration to cut $783 million in research grants tied to DEI work. Also, STAT just unveiled…
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STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis
STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis WASHINGTON — The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting…
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STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds
STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s…
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STAT+: Was the reaction to Viking’s oral data overblown?
STAT+: Was the reaction to Viking’s oral data overblown? 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 learned yesterday that Walmart has recalled some of its frozen shrimp after the FDA warned that they may have been contaminated with…
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STAT+: FDA delays decision on Regenxbio gene therapy
STAT+: FDA delays decision on Regenxbio 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. Good morning. Today we look at what some people in the industry are calling a “pharm to table” trend. Read on to learn more about it.…
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STAT+: Who are the richest people in health care right now?
STAT+: Who are the richest people in health care right now? 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 examine the plush pay packages of health care’s top CEOs in 2024. Also, we discuss Stealth BioTherapeutics’ efforts to rally…
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STAT+: Eli Lilly says it will hike list prices for drugs abroad. Now what?
STAT+: Eli Lilly says it will hike list prices for drugs abroad. Now what? 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 march-in rights return to the headlines, ponder how Eli Lilly’s plan to hike list prices in Europe…
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STAT+: Eli Lilly says it will raise drug prices in Europe to ‘make them lower’ in U.S.
STAT+: Eli Lilly says it will raise drug prices in Europe to ‘make them lower’ in U.S. Eli Lilly said Thursday that it would increase the prices of medicines in Europe and other developed markets “in order to make them lower” in the U.S., an apparent response to the Trump administration’s calls to do so.…
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STAT+: Drugmakers form new group to lobby on impact of Medicare drug price negotiations
STAT+: Drugmakers form new group to lobby on impact of Medicare drug price negotiations WASHINGTON — A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records. The group is called the IRA Watchdog…
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STAT+: Stoke Therapeutics release new data on Dravet syndrome drug
STAT+: Stoke Therapeutics release new data on Dravet syndrome 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. As AI becomes more widely used in health care, could it actually lead doctors to lose some of their skills? One new…
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STAT+: Insmed’s lung disease drug approved in the U.S.
STAT+: Insmed’s lung disease drug approved in the U.S. Insmed on Tuesday received Food and Drug Administration clearance for the first treatment for a chronic lung disease, opening the biotech up to what could be a multibillion-dollar product. Insmed will sell the daily pill, brensocatib, under the brand name Brinsupri for bronchiectasis. The approval comes…
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STAT+: Vinay Prasad returns to the FDA, weeks after his ouster
STAT+: Vinay Prasad returns to the FDA, weeks after his ouster WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene therapy, and blood product regulation. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and…
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In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings
In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings WASHINGTON — Top drug regulator George Tidmarsh assured Food and Drug Administration staff this week that he and other leaders are trying to bring operations back to normal. “I know that I’m coming in here at a challenging time,” Tidmarsh said at…
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STAT+: Dewpoint Therapeutics, biotech startup in a once-buzzy field, cuts 70% of staff
STAT+: Dewpoint Therapeutics, biotech startup in a once-buzzy field, cuts 70% of staff Dewpoint Therapeutics, a startup working in the once-buzzy field of biomolecular condensates, laid off most of its staff Thursday. The biotech is cutting around 70% of its workforce, a source told STAT. Dewpoint declined to provide the number of employees who were…
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STAT+: Kennedy’s rejection of mRNA vaccines thwarts scientific progress — and threatens national security, experts say
STAT+: Kennedy’s rejection of mRNA vaccines thwarts scientific progress — and threatens national security, experts say Health secretary Robert F. Kennedy Jr.’s decision this week to discontinue funding of the development of messenger RNA vaccines has alarmed scientists, who have warned that it will leave the country far less prepared for future pandemics. But it is…
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STAT+: Unpacking Trump’s approach to health care oversight
STAT+: Unpacking Trump’s approach to health care oversight 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 was reminded recently of why I dig mass transit upon overhearing the train conductor and…
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STAT+: Exact Sciences acquires rights to rival Freenome’s blood-based colon cancer test
STAT+: Exact Sciences acquires rights to rival Freenome’s blood-based colon cancer test Exact Sciences announced on Wednesday that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome. Exact is paying Freenome $75 million for exclusive rights in the United States to current and future versions of the Bay Area…
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STAT+: Sarepta hired a Trump-connected firm to lobby on Duchenne treatment
STAT+: Sarepta hired a Trump-connected firm to lobby on Duchenne treatment WASHINGTON — Sarepta Therapeutics, which has come under regulatory pressure over its gene therapy for Duchenne muscular dystrophy, hired a Trump-connected lobbying firm after the death of a teenage boy treated with the drug, according to lobbying disclosure reports. Continue to STAT+ to read…
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STAT+: Vertex next-generation pain candidate fails Phase 2 trial
STAT+: Vertex next-generation pain candidate fails Phase 2 trial Vertex Pharmaceuticals said Monday afternoon that its next-generation non-opioid pain reliever failed to significantly outperform placebo in a Phase 2 trial. The experimental drug, codenamed VX-993, is similar to the company’s recently approved pill Journavx but could potentially be given at higher doses and formulated as…
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STAT+: Trump demands drugmakers slash U.S. price now
STAT+: Trump demands drugmakers slash U.S. price now 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, and happy birthday to me! Today, we see the Senate Appropriations Committee look to increase NIH funding, despite the Trump administration’s request to slash…
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Trump escalates demands that pharma companies lower their drug prices
Trump escalates demands that pharma companies lower their drug prices President Trump escalated his demands that pharma companies lower U.S. drug prices in line with what other countries pay, sending letters to 17 major drug companies Thursday that called on them to take actions by Sept. 29. He specifically asked the firms to: provide their…
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STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse
STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse Vinay Prasad’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But his forced departure is probably worse. It will likely be celebrated in many corners: by the many people who…
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STAT+: FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
STAT+: FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt In a sharp reversal, the Food and Drug Administration on Monday said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to some patients. The therapy, called Elevidys, will once…