Category: biotechnology
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STAT+: Summit Therapeutics hits possible snag on lung cancer drug seen as a blockbuster
STAT+: Summit Therapeutics hits possible snag on lung cancer drug seen as a blockbuster Summit Therapeutics may have a geography problem with its lung cancer drug ivonescimab. In a study update reported Sunday, patients from North America and Europe treated with the drug saw their lung cancer return and progress faster than patients from China…
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STAT+: Patient groups cheer as the WHO adds diabetes and cystic fibrosis drugs to its essential medicines list
STAT+: Patient groups cheer as the WHO adds diabetes and cystic fibrosis drugs to its essential medicines list For the first time, the World Health Organization has added various high-cost treatments for diabetes and cystic fibrosis to its list of essential medicines, a move that patient advocates hope will usher in a new era of…
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STAT+: Trump administration confirms plan for PEPFAR to distribute Gilead’s new HIV prevention drug
STAT+: Trump administration confirms plan for PEPFAR to distribute Gilead’s new HIV prevention drug After months of uncertainty, the Trump administration confirmed that it will work with Gilead Sciences and The Global Fund to Fight AIDS, Tuberculosis and Malaria to provide a groundbreaking HIV prevention drug to up to 2 million people in low- and…
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New stakes in the vaccine dispute and a boost for biotech
New stakes in the vaccine dispute and a boost for biotech Does President Trump deserve a Nobel Peace Prize for Operation Warp Speed? What will health secretary Robert F. Kennedy Jr. tell Congress about the changes at the Centers for Disease Control and Prevention? And is biotech back? We discuss all that and more on…
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STAT+: Amneal Pharma is scolded by FDA for using contaminated bags for a sterile injectable drug
STAT+: Amneal Pharma is scolded by FDA for using contaminated bags for a sterile injectable drug In a startling failure of quality control, Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug even after identifying the risk and then lowered its standards so that the bags could continue to be used, according to…
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STAT+: 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+: 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+: 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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The ouster of CDC’s director, biotech venture firm rankings
The ouster of CDC’s director, biotech venture firm rankings What is happening to the leadership of the Centers for Disease Control and Prevention? Which biotech venture capital firm has generated the best returns for investors? And how did cat hair show up inside a major drug manufacturing plant? We discuss all that on this week’s…
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FDA issues narrower approvals for Covid boosters, revokes emergency authorizations
FDA issues narrower approvals for Covid boosters, revokes emergency authorizations WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations for the vaccines, in a set of moves that could make the shots more difficult to obtain for children under 5, in particular. The moves were announced…
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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+: 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+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: FDA 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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Viking’s obesity flop, ‘pharma to table’ drug sales
Viking’s obesity flop, ‘pharma to table’ drug sales On this week’s episode of “The Readout LOUD”: vikings. No, not the seafaring Norse people of the 10th century, or the Minnesota football team. The gang will discuss obesity drug developer Viking Therapeutics and the investor cult that embraces it, both of which performed a painful belly…
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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+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds
STAT+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds Conflicts of interest on federal government vaccine panels have declined to “historically low levels” in recent years according to a new study, findings that are likely to increase debate over a contentious issue pushed by Health and…
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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+: 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+: 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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Vinay Prasad’s return, animal testing alternatives, and mRNA upended
Vinay Prasad’s return, animal testing alternatives, and mRNA upended Have investors soured on mRNA biotechs? How will Vinay Prasad approach his role at the Food and Drug Administration the second time around? And how do you pronounce “bronchiectasis”? We address all that and more on this week’s episode of “The Readout LOUD.” We discuss the…
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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+: Dear Vinay: Please embrace dissent and fade into the background
STAT+: Dear Vinay: Please embrace dissent and fade into the background Dear Vinay: My editors asked me to explain your return to the Food and Drug Administration to readers. But I’m more interested, right now, in giving advice to you. Look, any claim I have to clairvoyance is void. I was surprised as anyone by…
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STAT+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals
STAT+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals Patient advocacy groups are urging the South African government to reopen an antitrust investigation into Vertex Pharmaceuticals over allegations the company misled authorities into closing a high-profile case last year over access to a cystic fibrosis treatment. Last December, the Competition Commission ruled…
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Closing a zombie biotech, and Lilly’s disappointing obesity readout
Closing a zombie biotech, and Lilly’s disappointing obesity readout How does a biotech company decide to shut itself down? Why does Eli Lilly have so much riding on its oral obesity candidate? And what’s the outlook for Vertex’s pain franchise? We discuss that and more on this on this week’s episode of “The Readout LOUD,”…
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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+: 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+: 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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Opinion: STAT readers debate involuntary commitment, Sarepta, and more
Opinion: STAT readers debate involuntary commitment, Sarepta, 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 Letters to the Editor…
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How Computers “See” Molecules
How Computers “See” Molecules Generative Molecular Design (Part 1): common molecular representations in data science. The post How Computers “See” Molecules appeared first on Towards Data Science. Tianyuan Zheng Go to original source
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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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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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What Vinay Prasad’s ouster means for biotech and the FDA
What Vinay Prasad’s ouster means for biotech and the FDA This week’s show is focused on a single topic — the ouster of Food and Drug Administration official Vinay Prasad from his job running the agency’s biologics division. This surprising development came after a series of controversial decisions he made on Sarepta’s gene therapy for…
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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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Opinion: Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine
Opinion: Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine A version of this piece first appeared in Sensible Medicine. Vinay Prasad, Marty Makary, and Adam Cifu, among others, were founding members of Sensible Medicine. After news came out that Vinay Prasad would be leaving the…
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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…
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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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A mother’s perspective on Sarepta’s gene therapy halt
A mother’s perspective on Sarepta’s gene therapy halt How are families of patients reacting to the removal of Sarepta’s gene therapy from the market? Why are investors excited about narcolpesy drugs? And why has there been less financing in oncology startups? We chat about all that and more on this on this week’s episode of…
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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+: AlphaFold developer Google DeepMind to fund CASP as NIH funding falls short
STAT+: AlphaFold developer Google DeepMind to fund CASP as NIH funding falls short CASP, the protein structure prediction contest that launched DeepMind’s AlphaFold to international fame and a Nobel Prize, has secured temporary funding to continue operations. The organization’s current funding — from the National Institutes of Health — is set to run out in…
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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+: 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+: 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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Inside an FDA drug rejection, and layoffs at Sarepta
Inside an FDA drug rejection, and layoffs at Sarepta Just how many employees is Sarepta Therapeutics laying off? And why did the Food and Drug Administration reject Ultragenyx’s rare disease drug over manufacturing qualms? We discuss all that and more on this week’s episode of “The Readout LOUD”. Read the rest… Allison DeAngelis, Adam Feuerstein,…
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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+: ViiV expands licensing deal for its HIV drug in low-income countries
STAT+: ViiV expands licensing deal for its HIV drug in low-income countries Once again, ViiV Healthcare has announced steps to widen access to a sought-after HIV medicine in low- and middle-income countries, reflecting ongoing pressure to respond to criticism. Under the latest arrangement, the company is expanding a licensing agreement reached three years ago 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+: 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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FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility Moderna’s Covid-19 vaccine for children has been given full Food and Drug Administration approval, making it the first Covid vaccine for kids in the United States that will no longer be administered under an emergency use authorization. But the approval comes with…
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NIH grant cuts, FDA transparency questions, and biotech M&A
NIH grant cuts, FDA transparency questions, and biotech M&A On this week’s episode of “The Readout LOUD”: a closer look at the NIH’s grant-cutting legal playbook, a not-so-transparent transparency push by the FDA commissioner, and another big biotech acquisition. Our colleague Anil Oza joins us to unravel a previously unseen memo he obtained from HHS…
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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+: 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+: 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+: 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+: 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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Opinion: Proposed cuts could have ‘catastrophic effect,’ 110 biomedical, health sciences industry leaders tell Congress
Opinion: Proposed cuts could have ‘catastrophic effect,’ 110 biomedical, health sciences industry leaders tell Congress As leaders of United States companies positioned in the biomedical/health sciences landscape, we are well aware that our companies are but one component of an expansive and interconnected scientific ecosystem requiring federal, industry, and academic partnership. Government funding of research…
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Vaccine policy frays, CDC nominee in the hot seat, & obesity drug side effects
Vaccine policy frays, CDC nominee in the hot seat, & obesity drug side effects What does the fracturing of vaccine advice and policy mean for the U.S. health care ecosystem? Will the potential head of the Centers for Disease Control and Prevention stand up to her boss? And can Amgen overcome its obesity drug’s side…
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STAT+: Regeneron seeks to revamp the controversial relationships between pharma and patient charities
STAT+: Regeneron seeks to revamp the controversial relationships between pharma and patient charities In a bid to rework the controversial relationship between drugmakers and patient charities, Regeneron Pharmaceuticals has announced a new program in which it will match up to $200 million in donations this year to a leading foundation called Good Days. The move…
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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+: 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+: 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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FDA’s gene therapy turmoil, and an alternative model for funding research
FDA’s gene therapy turmoil, and an alternative model for funding research Why did the Food and Drug Administration suddenly oust one of its top gene therapy regulators? Is the agency growing too political? And should private firms fund academic research? We chat about all that and more on this on this week’s episode of “The…
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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+: 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+: 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+: 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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Opinion: Bill Gates: I lost my father to Alzheimer’s. But I’m more optimistic than ever about fighting the disease
Opinion: Bill Gates: I lost my father to Alzheimer’s. But I’m more optimistic than ever about fighting the disease Father’s Day without my dad never gets easier. Although he is on my mind every day, I always find myself thinking about him even more often this time of year. My dad was a giant in…
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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+: 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+: 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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The upheaval of CDC’s vaccine panel, and drug pricing confusion
The upheaval of CDC’s vaccine panel, and drug pricing confusion Why did Robert F. Kennedy Jr. abruptly fire all members of the expert panel that advises the Centers for Disease Control and Prevention on vaccines? Who are the new members that Kennedy named? And what does that all mean for the future of public health?…
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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…