Category: Biotech
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STAT+: FDA panel stirs backlash for SSRI use during pregnancy
STAT+: FDA panel stirs backlash for SSRI use during pregnancy 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 discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics’ gene therapy, see an FDA panel…
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STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak
STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak Jennifer Hill Blair recognized the Cincinnati number on her buzzing phone and slipped out of the school meeting, excited to finally learn when her son Cayse would receive a therapy she believed would change his life. Blair, a second-grade teacher in southern…
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STAT+: FDA opens applications for new voucher program
STAT+: FDA opens applications for new voucher program 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 more developments with Sarepta today. My colleagues got exclusive comments from a senior FDA official — read on for what the official said.…
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STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and…
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STAT+: The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear
STAT+: The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear In a matter of a few days last week, Sarepta Therapeutics announced major layoffs, acknowledged the death of another patient receiving one of its gene therapies, and was urged by the Food and Drug Administration to suspend shipments of a…
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Opinion: A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry
Opinion: A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry For decades, the Food and Drug Administration has partnered with clinicians and industry to deliver evidence-based medical innovations using a gold-standard framework for drug development and oversight. The agency has the authority to review any approved drug,…
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STAT+: Sarepta Therapeutics crisis is huge blow to Duchenne families, company
STAT+: Sarepta Therapeutics crisis is huge blow to Duchenne families, company Sarepta Therapeutics confronted one of the most serious crises in its history on Friday, as the Food and Drug Administration prepared to ask the company to halt all shipments of its gene therapy for Duchenne muscular dystrophy — a treatment that had been a…
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Opinion: We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress
Opinion: We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress They say death is one of life’s few certainties. For a boy or young man living with Duchenne muscular dystrophy, that certainty has a cruel twist: the anticipation of dying young. As mothers of children with this disease, we have…
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STAT+: Undruggable ‘disordered’ proteins become druggable with new AI techniques from David Baker
STAT+: Undruggable ‘disordered’ proteins become druggable with new AI techniques from David Baker For decades, structural biologists shoved what looked like shoddy data in the back of their closets, embarrassed. While attempting to gather the structures of proteins, they would sometimes find that all or at least a portion of the protein would just not…
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STAT+: Scientists show that mRNA therapy can be delivered as a capsule
STAT+: Scientists show that mRNA therapy can be delivered as a capsule An oral capsule can efficiently deliver liquid mRNA therapy directly to the gut, a possible new delivery mechanism for mRNA vaccines, a new study finds. In the study published in Science Translational Medicine on Wednesday, researchers said they successfully used RNACap, a capsule…
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STAT+: Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting move
STAT+: Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting move Sarepta Therapeutics laid off more than one-third of its workforce, or approximately 500 employees, the company announced Wednesday — a drastic cost-cutting move following the deaths of two teenagers that forced the company to restrict usage of its gene therapy for Duchenne muscular…
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STAT+: Kailera drug shows notable weight loss in China trial
STAT+: Kailera drug shows notable weight loss in China trial 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 have a short and sweet newsletter today. And if you are in any areas hit by the flash foods, I hope…
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STAT+: RFK Jr. gives vaccine skeptics plum HHS posts
STAT+: RFK Jr. gives vaccine skeptics plum HHS posts 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. Mr. Medicare Dr. Oz suggests 10 minutes of yoga straight out of bed, preferably with…
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STAT+: FDA declines to approve Ultragenyx gene therapy
STAT+: FDA declines to approve Ultragenyx 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! It’s Meghana today, writing about GLP-1s being deployed for addiction, weighing the FDA commissioner’s vision versus reality, and more. The need-to-know this morning AstraZeneca said its experimental…
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STAT+: Questions about the FDA’s ‘radical transparency’ efforts
STAT+: Questions about the FDA’s ‘radical transparency’ efforts Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of complete response letters. FDA…
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STAT+: Brawl over Eylea gets biosimilar industry’s attention
STAT+: Brawl over Eylea gets biosimilar industry’s attention Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Today, we talk about a cool experimental enzyme therapy, observe more patent maneuvers over Eylea, and see an ‘underdog’ startup get a huge seed round to…
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STAT+: FDA publishes rejection letters sent to drugmakers, with a big caveat
STAT+: FDA publishes rejection letters sent to drugmakers, with a big caveat The Food and Drug Administration on Thursday published more than 200 letters that it sent to companies when it rejected their medicines, focusing attention on what’s often an opaque part of the drug review process. The agency only highlighted letters that went to…
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STAT+: HHS backtracks on pledge to disclose new vaccine advisers’ conflicts of interest
STAT+: HHS backtracks on pledge to disclose new vaccine advisers’ conflicts of interest WASHINGTON — The Department of Health and Human Services is sitting on information about new vaccine advisers’ conflicts of interest, and seemingly backtracking on its vow to make key disclosure documents public. Agency officials previously said they would release ethics forms for…
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STAT+: Novartis wins approval for newborn malaria treatment
STAT+: Novartis wins approval for newborn malaria treatment 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 hope everyone had a great holiday weekend. Let’s get into the news today. The need-to-know this morning Foundering CAR-T therapy developer Cargo Therapeutics is being acquired and…
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STAT+: Fed-up and demoralized, FDA staff are leaving.
STAT+: Fed-up and demoralized, FDA staff are leaving. 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. Between innings of the July 4 Chesapeake Baysox game against the Richmond Flying Squirrels there was…
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STAT+: Survival rates for cancer patients on immunotherapy depend on insurance coverage, study finds
STAT+: Survival rates for cancer patients on immunotherapy depend on insurance coverage, study finds As a cancer patient, access to innovative drugs can help extend your life — that is if you have health insurance, a new study finds. In a JAMA Open Network study published Monday, researchers from the American Cancer Society found that…
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STAT+: Khosla Ventures sets sights on $4 billion in new funds
STAT+: Khosla Ventures sets sights on $4 billion in new funds Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, friends! We’re back. Hope you are having a delightful summer (or winter, I suppose, depending on your hemisphere). Today, we talk about morale…
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STAT+: Cogent Biosciences drug improves symptoms of chronic immune disorder, study results show
STAT+: Cogent Biosciences drug improves symptoms of chronic immune disorder, study results show Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint…
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STAT+: Memo said to describe biotech industry meeting calls RFK Jr. a ‘direct threat to public health’
STAT+: Memo said to describe biotech industry meeting calls RFK Jr. a ‘direct threat to public health’ A memo that purports to summarize a meeting held by members of a leading biotech trade group suggests deep concern about health secretary Robert F. Kennedy Jr.’s stance on vaccines, and describes him as a “direct threat to…
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STAT+: What’s on your 2025 health AI bingo card?
STAT+: What’s on your 2025 health AI bingo card? You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. I had a lot of fun putting together this week’s edition. There’s a lot to chew…
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STAT+: Sage Therapeutics cuts most of its workforce following acquisition
STAT+: Sage Therapeutics cuts most of its workforce following acquisition Sage Therapeutics is laying off most of its employees after announcing its planned acquisition earlier this month. The Cambridge, Mass.-based biotech firm will cut 338 jobs effective Aug. 22, according to state filings. In February, the company reported employing 353 full-time staff, including 122 working in research…
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STAT+: Vertex stem cell therapy spurs insulin independence
STAT+: Vertex stem cell therapy spurs insulin independence Good morning! Today, we get deeper into the ousting of Nicole Verdun at the FDA, see promise from Vertex’s cell therapy for diabetes, and unpack the story of developing the newly approved Gilead PrEP drug lenacapivir. The need-to-know this morning Novo Nordisk terminated its marketing relationship with…
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STAT+: GLP-1 drug helped type 1 diabetes patients keep healthy glucose levels and lose weight
STAT+: GLP-1 drug helped type 1 diabetes patients keep healthy glucose levels and lose weight Obesity drugs were first approved to treat type 2 diabetes, but there’s a growing movement to test them in type 1 diabetes, too. Research presented Monday at a large diabetes meeting showed some promise for this approach. Patients who took…
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STAT+: Amgen’s obesity drug led to high discontinuation rates in mid-stage trial, as company plans to adjust dosing
STAT+: Amgen’s obesity drug led to high discontinuation rates in mid-stage trial, as company plans to adjust dosing CHICAGO — Amgen’s monthly obesity candidate led to substantial weight loss but a high rate of side effects and discontinuations in a mid-stage trial, results that support the company’s decision to use a slower dosing schedule to…
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STAT+: Full data on Novo Nordisk’s new amylin drug raise dosing questions
STAT+: Full data on Novo Nordisk’s new amylin drug raise dosing questions CHICAGO — Novo Nordisk’s next-generation obesity injection targeting the amylin hormone showed substantial weight loss in an early study, but similar efficacy across different doses and high rates of side effects raise questions about which dose Novo will pursue going forward. In the…
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STAT+: Off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results
STAT+: Off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results Twelve people with type 1 diabetes who received an investigational off-the-shelf stem cell therapy were able to produce their own insulin and keep healthy blood glucose levels for at least one year, Vertex Pharmaceuticals said Friday. After three months, none of…
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STAT+: GLP-1 reduced migraine frequency by nearly half, in a pilot study
STAT+: GLP-1 reduced migraine frequency by nearly half, in a pilot study GLP-1 drugs could treat more than just diabetes and obesity. They may also reduce migraine frequency. That is according to the findings of a study presented on Friday at the European Academy of Neurology congress. The pilot study found that GLP-1 agonists reduced…
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STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official The ouster of the Food and Drug Administration’s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has…
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STAT+: Gilead’s CEO on the approval of a powerful new drug to prevent HIV
STAT+: Gilead’s CEO on the approval of a powerful new drug to prevent HIV On Wednesday, the Food and Drug Administration approved a new medicine, lenacapavir (brand name: Yeztugo) that could be the closest thing so far to an HIV vaccine: a long-acting antiviral that, given twice a year, can prevent people from contracting the…
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STAT+: Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout
STAT+: Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout This story is an excerpt from Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. Cogent Biosciences and Blueprint Medicines are direct competitors who hate each other. During a talk at the recent…
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STAT+: What’s next for Sarepta Therapeutics with gene therapy under fire?
STAT+: What’s next for Sarepta Therapeutics with gene therapy under fire? This story is an excerpt from Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. The Duchenne muscular dystrophy community is reeling following the second death of a patient from liver failure caused by Sarepta Therapeutics’…
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STAT+: U.K. decision blocks a pair of Alzheimer’s drugs from access through its national health service
STAT+: U.K. decision blocks a pair of Alzheimer’s drugs from access through its national health service LONDON — A U.K. health agency reiterated on Thursday that the limited benefits of a pair of new Alzheimer’s drugs do not justify their high prices, meaning the medicines won’t be made available through the National Health Service. The…
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Opinion: Following second patient death, Duchenne muscular dystrophy families deserve answers about Elevidys
Opinion: Following second patient death, Duchenne muscular dystrophy families deserve answers about Elevidys On Sunday at 1 a.m. Eastern time, an announcement went out from the first-generation gene therapy company for Duchenne muscular dystrophy: A second patient who had been treated with Elevidys has died. This second family said yes to hope, yes to science,…
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STAT+: What David Baker’s AI biotech unicorn Xaira has been up to
STAT+: What David Baker’s AI biotech unicorn Xaira has been up to You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. We’re almost at the 20th issue of AI Prognosis; can you believe it?…
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STAT+: More universities open to private equity deals, and emerging companies turn to new targets
STAT+: More universities open to private equity deals, and emerging companies turn to new targets This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here, and sign up for our morning biotech news roundup newsletter here. Hello all, I have a fresh double…
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STAT+: FDA announces a new priority review program in bid to further administration goals
STAT+: FDA announces a new priority review program in bid to further administration goals WASHINGTON — The Food and Drug Administration is launching a program to reward companies with accelerated drug review and speedy agency feedback, if their actions align with the agency’s national health priorities. Those priorities include addressing unmet public health needs or health…
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STAT+: George W. Bush drops by BIO, and so does the FDA commissioner
STAT+: George W. Bush drops by BIO, and so does the FDA commissioner This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here, and sign up for our morning biotech news roundup newsletter here. Happy Tuesday, folks! I have an exciting update for you: Friend…
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STAT+: What we’re hearing on Chinese NewCos, AI, and BIO’s executive ranks
STAT+: What we’re hearing on Chinese NewCos, AI, and BIO’s executive ranks This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here, and sign up for our morning biotech news roundup newsletter here. Hello everyone! Allison DeAngelis here, coming to you from Boston’s…
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STAT+: Sarepta reports second patient death after treatment with Duchenne gene therapy
STAT+: Sarepta reports second patient death after treatment with Duchenne gene therapy Sarepta Therapeutics said Sunday that it was halting shipments of its Duchenne muscular dystrophy gene therapy for patients who can no longer walk, following the death of a second person who received the treatment. Sarepta disclosed the first patient death — a 16-year-old…
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STAT+: Anne Wojcicki wins back 23andMe, this time as a nonprofit
STAT+: Anne Wojcicki wins back 23andMe, this time as a nonprofit A nonprofit led by Anne Wojcicki, the co-founder and long-time CEO of genetic data firm 23andMe, won a last-minute bidding war to buy most of the company’s assets for a price of $305 million, the company said in a press release. The news, reported…
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STAT+: HHS tries pushing pharma to the negotiating table
STAT+: HHS tries pushing pharma to the negotiating table 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’re hearing more about President Trump’s “most-favored nation” plan for drug pricing, Recursion’s case for why the company laid off 20% of…
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STAT+: Trump administration demands pharma companies begin drug price negotiations, a day after key deadline
STAT+: Trump administration demands pharma companies begin drug price negotiations, a day after key deadline WASHINGTON — The Trump administration is pushing pharmaceutical companies to begin negotiations to bring their drug prices in line with what other countries pay — usually far less than Americans. “Under President Trump’s direction, HHS is demanding that pharmaceutical companies…
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STAT+: Braced for details on Trump’s ‘most favored nation’ policy, pharma industry is still waiting
STAT+: Braced for details on Trump’s ‘most favored nation’ policy, pharma industry is still waiting WASHINGTON — Executives at pharmaceutical companies have been bracing for more information from the Trump administration this week about how it planned to lower drug prices. That information has not yet arrived, despite the administration’s self-imposed deadline to disclose by…
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STAT+: Cassidy is circulating a proposed law to push down U.S. drug prices, backing a key Trump ambition
STAT+: Cassidy is circulating a proposed law to push down U.S. drug prices, backing a key Trump ambition WASHINGTON — Senate health committee Chair Bill Cassidy (La.) is the latest Republican to take an interest in legislation that would tie U.S. brand drug prices to lower prices in other wealthy countries, according to seven people…
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Merck’s RSV antibody treatment for infants is approved by FDA
Merck’s RSV antibody treatment for infants is approved by FDA A third monoclonal antibody product to protect babies against respiratory syncytial virus was approved by the Food and Drug Administration on Monday, a development public health experts hope may eventually help to bring down the price of this effective but costly way of reducing the…
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STAT+: National Resilience, startup hoping to reinvent drug manufacturing, to ‘wind down’ many of its facilities
STAT+: National Resilience, startup hoping to reinvent drug manufacturing, to ‘wind down’ many of its facilities National Resilience, a startup that has raised over $2 billion by promising to transform drug manufacturing, said Monday that it would “wind down” many of its facilities. But what remains of the firm has raised an additional $250 million…
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STAT+: FDA reassures rare disease advocates that ‘being flexible’ is plan for gene therapy
STAT+: FDA reassures rare disease advocates that ‘being flexible’ is plan for gene therapy What will the Trump administration mean for gene therapy? Researchers, advocates, and executives got a glimpse of the answer Thursday, as the Food and Drug Administration convened a “Cell and Gene Therapy Roundtable.” It was an unusual event. Multiple panelists told…
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STAT+: Taurine, a darling of longevity seekers, is found to be unreliable biomarker for aging
STAT+: Taurine, a darling of longevity seekers, is found to be unreliable biomarker for aging Vijay Yadav warned people not to start downing taurine — an amino acid abundant in plants, animals and some energy drinks — just because his mice and monkey study suggested it might be an elixir for long life. But that…
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After groundbreaking CRISPR therapy, a homecoming
After groundbreaking CRISPR therapy, a homecoming Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Baby KJ is back home! Also, we discuss the questionable efficacy of ctDNA blood tests, see what Vinay Prasad has to say at NORD, and more. Read…
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Pluvicto pushes earlier in prostate cancer play
Pluvicto pushes earlier in prostate cancer play 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, STAT’s Matthew Herper chats with J&J’s R&D chief, we see the radiopharmaceutical Pluvicto being considered earlier for prostate cancer, and more. Read the rest… Meghana…
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STAT+: On ASCO Day 4, J&J bets on Rybrevant and airs ‘innovation ecosystem’ concerns
STAT+: On ASCO Day 4, J&J bets on Rybrevant and airs ‘innovation ecosystem’ concerns This is the web version of STAT’s special newsletter from the annual meeting of the American Society of Oncology. For more updates on the latest in cancer news, sign up for our Cancer Briefing newsletter here. ASCO ends tomorrow, but alas, dear readers,…
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STAT+: At ASCO Day 3, AstraZeneca dominates, Takeda reveals experimental drug data, Eli Lilly serves salad
STAT+: At ASCO Day 3, AstraZeneca dominates, Takeda reveals experimental drug data, Eli Lilly serves salad This is the web version of STAT’s special newsletter from the annual meeting of the American Society of Oncology. For more updates on the latest in cancer news, sign up for our Cancer Briefing newsletter here. We’re going to get to…
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STAT+: AstraZeneca’s CEO balances cancer-fighting opportunities with political uncertainty
STAT+: AstraZeneca’s CEO balances cancer-fighting opportunities with political uncertainty CHICAGO — Each year, 40,000 cancer researchers, doctors, and industry executives gather here for the biggest meeting in oncology. And for seven years, it has been almost assumed that the medicines generating the most buzz will come from AstraZeneca. Perhaps that’s why, in a wood-paneled conference…
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STAT+: Combination treatment reduces risk of tumor progression in aggressive form of breast cancer, study shows
STAT+: Combination treatment reduces risk of tumor progression in aggressive form of breast cancer, study shows CHICAGO — A treatment that combines two different types of cancer-fighting medicines — Gilead Sciences’ Trodelvy with Merck’s Keytruda — reduced the risk of tumor progression by more than one-third in women with an aggressive form of breast cancer. …
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STAT+: As Trump proposes NIH cuts, a top Merck executive sees fragility in a ‘super-highway for biomedicine’
STAT+: As Trump proposes NIH cuts, a top Merck executive sees fragility in a ‘super-highway for biomedicine’ CHICAGO — Amid ongoing uncertainty around funding for the National Institutes of Health, and what it could mean for U.S. innovation, a top Merck executive stressed that the agency is “an incredible super-highway for biomedicine,” and that it’s “a…
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FDA approves a next-generation Covid vaccine from Moderna, with restrictions
FDA approves a next-generation Covid vaccine from Moderna, with restrictions The Food and Drug Administration approved Moderna’s new Covid-19 vaccine late Friday, though it placed restrictions on its use that the company’s existing Covid shot, Spikevax, does not currently face. The new vaccine, which will be marketed under the name mNexspike, will not immediately replace…
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STAT+: ASCO day 2: A tragic paradox, Gilead updates, and lots of Pfizer news
STAT+: ASCO day 2: A tragic paradox, Gilead updates, and lots of Pfizer news This is the web version of STAT’s special newsletter from the annual meeting of the American Society of Oncology. For more updates on the latest in cancer news, sign up for our Cancer Briefing newsletter here. ASCO is usually sweltering, but it’s…
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Illumina’s PromoterAI unlocks rare disease clues in noncoding genome
Illumina’s PromoterAI unlocks rare disease clues in noncoding genome 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 discuss how one Brown contrarian and cancer researcher wants $50 billion for the NCI, we see a UniQure case study that…
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STAT+: RFK Jr.’s latest moves on vaccines
STAT+: RFK Jr.’s latest moves on vaccines 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. NIH is terminating research grants left and right, impeding early career paths and leading some young scientists…
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Post-TIGIT flop, iTeos Therapeutics is shuttering
Post-TIGIT flop, iTeos Therapeutics is shuttering 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 look at the implications of BARDA cutting a major vaccine contract with Moderna, hear why former FDA chief Scott Gottlieb thinks agency layoffs will impede…
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STAT+: HHS cancels nearly $600 million Moderna contract on vaccines for flu pandemics
STAT+: HHS cancels nearly $600 million Moderna contract on vaccines for flu pandemics This story will be updated The Department of Health and Human Services has notified Moderna that it is canceling a nearly $600 million contract with the company to develop, test, and license vaccines for flu strains that could trigger future pandemics, including…
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Lilly to acquire biotech developing pain drugs
Lilly to acquire biotech developing pain drugs 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 seeking nominations for our annual Wunderkinds list, which aims to honor some of the most promising early-career scientists out there. If you have someone in mind, submit…
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RFK Jr. rolls back Covid vaccine recommendations for healthy children, pregnant people
RFK Jr. rolls back Covid vaccine recommendations for healthy children, pregnant people Health secretary Robert F. Kennedy Jr. announced Tuesday that he has unilaterally struck the recommendation that healthy children and healthy pregnant people get Covid-19 booster shots — a move that experts say is unprecedented. Kennedy made the announcement on the social media site X,…
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STAT+: What Baby KJ means for the CRISPR gene editing industry
STAT+: What Baby KJ means for the CRISPR gene editing industry For the ailing gene editing industry, hope came earlier this month in the tiny, smiling, fuzzy-headed form of KJ Muldoon. At just 6 months old, KJ received a gene editing treatment custom-built to correct his unique mutation. He’s not cured, researchers explained at the…
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GSK drug’s new approval sets up competition with Dupixent
GSK drug’s new approval sets up competition with Dupixent 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. Apologies that this newsletter is coming late to you this morning — we had some technical difficulties. But we’ve still got the news…
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STAT+: Merus drug, with immunotherapy, shows preliminary survival boost for patients with head and neck cancer
STAT+: Merus drug, with immunotherapy, shows preliminary survival boost for patients with head and neck cancer Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis…
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STAT+: Five burning questions on the FDA’s new Covid-19 vaccine framework
STAT+: Five burning questions on the FDA’s new Covid-19 vaccine framework WASHINGTON — Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine framework would answer all of their questions. But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval…
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FDA clears first blood test for diagnosing Alzheimer’s
FDA clears first blood test for diagnosing Alzheimer’s The Food and Drug Administration approved on Friday the first blood test for diagnosing Alzheimer’s disease, opening up a quicker way for patients to get detected for the neurological condition and receive treatment. The test, developed by Japan-based Fujirebio Diagnostics, uses a blood sample to detect the…
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STAT+: At gene therapy meeting, no one wants to talk about the Vinay Prasad (not) in the room
STAT+: At gene therapy meeting, no one wants to talk about the Vinay Prasad (not) in the room NEW ORLEANS — Last year, hundreds of people poured in to see Peter Marks, the Food and Drug Administration’s head of biologics, speak at the American Society of Gene and Cell Therapy conference. The regulator was seen by…
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STAT+: Day 3 at ASGCT: Vinay Prasad speculation, screening newborns, promising data
STAT+: Day 3 at ASGCT: Vinay Prasad speculation, screening newborns, promising data NEW ORLEANS — Greetings from the home stretch of American Society of Gene and Cell Therapy conference, where everyone is still talking about Baby KJ and no one wants to talk about Vinay Prasad. The Vinay Prasad in the room Last year, hundreds…
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STAT+: Day 2 of ASGCT: Good news for Baby KJ and the dream of personalized gene editing
STAT+: Day 2 of ASGCT: Good news for Baby KJ and the dream of personalized gene editing NEW ORLEANS — Greetings from ASGCT, where the gene therapy field had some great news for once, about a highly photogenic infant. Baby KJ gets a custom CRISPR edit to his genome Kiran Musunuru, a researcher at the University of…
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STAT+: Eli Lilly and AstraZeneca top a consultancy’s ranking of drug company R&D
STAT+: Eli Lilly and AstraZeneca top a consultancy’s ranking of drug company R&D A consultancy’s new ranking of drug company R&D shows Eli Lilly has risen to the top of the drug development heap — but when it comes to invention, AstraZeneca, with its wealth of experimental cancer and rare disease therapies, ranks above its…
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STAT+: Our biggest burning questions on Trump’s order to bring down drug prices
STAT+: Our biggest burning questions on Trump’s order to bring down drug prices WASHINGTON — President Trump’s executive order to lower drug prices through sweeping, cross-agency action left leaders in the pharmaceutical industry scrambling Monday to make sense of what may be ahead — and how to respond. The announcement was long on messaging, but…
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STAT+: Trump’s drug-pricing order takes a hard line against pharma. Investors shrugged
STAT+: Trump’s drug-pricing order takes a hard line against pharma. Investors shrugged President Trump on Monday unveiled his plan to dramatically overhaul the way the U.S. pays for drugs by lowering what he calls “inflated” prices to those paid by other countries. Pharma investors didn’t seem to care. The XBI, a closely tracked index of…
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FDA approves Verastem’s ovarian cancer treatment
FDA approves Verastem’s ovarian cancer treatment Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today, we talk about the FDA’s new artificial intelligence effort in the wake of mass layoffs, see AI darling Insitro cut staff, and more. Read the rest… Meghana…
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STAT+: Here’s how Trump might approach his drug pricing plan
STAT+: Here’s how Trump might approach his drug pricing plan WASHINGTON — President Trump is widely expected to try to advance a “most-favored nation” policy next week in an effort to reduce U.S. drug prices — a move that is likely to significantly rattle the pharmaceutical industry, cheer his political base, and, possibly, leave open…
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STAT+: Insitro, an AI biotech founded by Daphne Koller, lays off staff
STAT+: Insitro, an AI biotech founded by Daphne Koller, lays off staff Insitro, the closely watched AI biotech founded by the Stanford professor and entrepreneur Daphne Koller, said Thursday it was laying off 22% of its staff, or around 60 people. It’s part of a series of cuts that have hit well-backed startups over the…
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STAT+: 5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review
STAT+: 5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review The Food and Drug Administration said it will rapidly roll out a generative artificial intelligence model to assist scientific reviews across the agency, setting up a high-stakes test of the technology’s use in vetting products used in the care of millions of…
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STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies
STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies WASHINGTON — Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply. Prasad, previously an epidemiology professor at…
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STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA
STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA People seeking roles in government are often careful about what they say in public, or at least somewhat hesitant to freely share their opinions. It’s difficult to know exactly what’s going on in their heads. Not Vinay Prasad. The new…
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STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial
STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial Vertex Pharmaceuticals on Monday reported disappointing first-quarter earnings impacted by weaker-than-expected sales of its drugs for cystic fibrosis, and little or no contributions from a gene therapy for sickle cell disease and a recently launched pain medicine. A “tolerability issue” caused a temporary…
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STAT+: At Stanford conference, typically guarded biotech leaders share their concerns about Trump policies
STAT+: At Stanford conference, typically guarded biotech leaders share their concerns about Trump policies PALO ALTO, Calif. — At an annual meeting usually focused on the industry’s future, life science leaders couldn’t help but grapple — 100 days into President Trump’s second term — with a present clouded by uncertainty. At Stanford’s Drug Discovery Symposium, biotech…
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STAT+: Sales of BridgeBio’s new heart drug blow past expectations
STAT+: Sales of BridgeBio’s new heart drug blow past expectations BridgeBio’s recently approved heart drug brought in $36.7 million in sales in the first quarter, blowing past expectations as the biotech continues to see a strong demand for its first major commercial product. Analysts had estimated that the treatment, called Attruby, would bring in sales…
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STAT+: HPV vaccine news ‘that will save millions of lives’ from cancer, and other AACR news
STAT+: HPV vaccine news ‘that will save millions of lives’ from cancer, and other AACR news You’re reading the web edition of AACR in 30 Seconds, STAT’s guide to the American Association for Cancer Research annual meeting. There’s one more day: sign up for email here. Despite the shadow cast over cancer research by recent…
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STAT+: Capricor Therapeutics forges ahead with FDA on Duchenne drug, despite political tumult
STAT+: Capricor Therapeutics forges ahead with FDA on Duchenne drug, despite political tumult The Food and Drug Administration is nearly halfway through a review of Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy. Even with the tumult inside the agency, interactions between the company and the agency staff have been unaffected, according to the company’s…
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Opinion: STAT readers on the animal wellness industry, drug price floors, and more
Opinion: STAT readers on the animal wellness industry, drug price floors, and more First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others. To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected…
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STAT+: Caribou delays readout, discontinues programs, betting on off-the-shelf CAR-T therapies
STAT+: Caribou delays readout, discontinues programs, betting on off-the-shelf CAR-T therapies Caribou Biosciences is delaying the readout of clinical trials involving its CRISPR T-cell therapies for blood cancer — hoping that longer follow-up will deliver enough positive data to keep the programs and the struggling biotech company alive. The company’s decision, announced Thursday, amounts to…
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STAT+: Bristol’s Cobenfy disappoints as supplemental antipsychotic drug
STAT+: Bristol’s Cobenfy disappoints as supplemental antipsychotic drug A landmark new treatment for schizophrenia didn’t provide additional benefits to patients when given on top of standard-of-care therapy, Bristol Myers Squibb announced Tuesday. The drug, Cobenfy, was approved last year based on data from three randomized studies comparing the drug to placebo. It was the first…
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STAT+: Biotech entrepreneur Sam Waksal accused of ‘reckless conduct’ in new lawsuit
STAT+: Biotech entrepreneur Sam Waksal accused of ‘reckless conduct’ in new lawsuit Sam Waksal is once again in legal trouble. The biotech entrepreneur, who was famously convicted of insider trading in 2003, allegedly breached his fiduciary duties and engaged in “grossly negligent and reckless conduct” as the chairman, CEO, and largest shareholder of Equilibre Biopharmaceuticals,…
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STAT+: Research grants as political ammo; Death to dyes?
STAT+: Research grants as political ammo; Death to dyes? 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. STAT won its first National Magazine Award for General Excellence. Not bad, huh? Help us…
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STAT+: GSK blood cancer therapy, once pulled from the market, is approved in the U.K.
STAT+: GSK blood cancer therapy, once pulled from the market, is approved in the U.K. GSK’s blood cancer drug Blenrep won regulatory approval in the U.K. on Thursday, marking the medicine’s return to the market after it was withdrawn several years ago. The drug, which treats multiple myeloma, will be used in combination with other…
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STAT+: RFK Jr. is back to criticizing vaccines, and Trump’s new drug-cost plan
STAT+: RFK Jr. is back to criticizing vaccines, and Trump’s new drug-cost plan 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 cast my leafy-green seeds already, and my mint, chives and…
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More proposed cuts to the NIH
More proposed cuts to the NIH 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 talk about Arkansas making a bold move to curb PBM power, analyze Trump’s executive order in regards to drug prices, and more. Read the rest… Meghana…
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STAT+: Trump’s plans to lower drug prices have echoes of past efforts
STAT+: Trump’s plans to lower drug prices have echoes of past efforts WASHINGTON — The Trump administration has an expansive view for how it can lower drug prices for Americans. It has been here before. The question is whether this time will be different. During his first term, President Trump tried to tie U.S. drug…