Category: drug development
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STAT+: Veru update shows FDA still values weight loss over body composition
STAT+: Veru update shows FDA still values weight loss over body composition Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got big news on a gene therapy for Huntington’s disease, so let’s get straight to it. Uniqure hails ‘groundbreaking’…
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STAT+: Doctors are more tied to pharma as trust erodes
STAT+: Doctors are more tied to pharma as trust erodes Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we read about a big acquisition fueled by obesity, doctors shifting their views on biopharma marketing, see a rare disease drug win approval after…
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STAT+: FDA approves ultra-rare disease drug that became a symbol of uncertainty over regulatory standards
STAT+: FDA approves ultra-rare disease drug that became a symbol of uncertainty over regulatory standards After months of uncertainty, the Food and Drug Administration offered accelerated approval for an ultra-rare disease drug that had become a symbol of the fraught balancing act between upholding regulatory standards and accommodating desperate patients and their families. The agency…
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STAT+: U.S. pressures U.K. as pharma pauses investments there
STAT+: U.S. pressures U.K. as pharma pauses investments there Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we see moves to potentially dismantle FDA ad comms, see the U.S. pressuring the U.K. over its stringent drug-pricing policy, and more. The…
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STAT+: FDA pushing non-opioid path for chronic pain
STAT+: FDA pushing non-opioid path for chronic pain Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we note that psychedelics are suddenly a hot topic for larger pharmaceutical companies, dissect Patrick Soon-Shiong’s claims on his lung cancer drug, and more.…
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STAT+: Pig kidneys to enter FDA-backed human trial next year
STAT+: Pig kidneys to enter FDA-backed human trial next year Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello there. Today, we learn the FDA is advancing a trial for gene-edited pig organs in humans, see geographical discrepancies in lung cancer trial…
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STAT+: Summit Therapeutics hits possible snag on lung cancer drug seen as a blockbuster
STAT+: Summit Therapeutics hits possible snag on lung cancer drug seen as a blockbuster Summit Therapeutics may have a geography problem with its lung cancer drug ivonescimab. In a study update reported Sunday, patients from North America and Europe treated with the drug saw their lung cancer return and progress faster than patients from China…
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STAT+: Trump pressures drugmakers amid CDC turmoil
STAT+: Trump pressures drugmakers amid CDC turmoil Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Welcome back from the holiday weekend. Today we have some candor in ALL CAPS from Trump on Covid vaccines, glowy data from Ionis that could lead to…
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STAT+: 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+: 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+: Was the reaction to Viking’s oral data overblown?
STAT+: Was the reaction to Viking’s oral data overblown? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We learned yesterday that Walmart has recalled some of its frozen shrimp after the FDA warned that they may have been contaminated with…
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STAT+: FDA delays decision on Regenxbio gene therapy
STAT+: FDA delays decision on Regenxbio gene therapy Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Today we look at what some people in the industry are calling a “pharm to table” trend. Read on to learn more about it.…
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STAT+: Who are the richest people in health care right now?
STAT+: Who are the richest people in health care right now? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we examine the plush pay packages of health care’s top CEOs in 2024. Also, we discuss Stealth BioTherapeutics’ efforts to rally…
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STAT+: Eli Lilly says it will hike list prices for drugs abroad. Now what?
STAT+: Eli Lilly says it will hike list prices for drugs abroad. Now what? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we see march-in rights return to the headlines, ponder how Eli Lilly’s plan to hike list prices in Europe…
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STAT+: 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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In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings
In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings WASHINGTON — Top drug regulator George Tidmarsh assured Food and Drug Administration staff this week that he and other leaders are trying to bring operations back to normal. “I know that I’m coming in here at a challenging time,” Tidmarsh said at…
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STAT+: Dewpoint Therapeutics, biotech startup in a once-buzzy field, cuts 70% of staff
STAT+: Dewpoint Therapeutics, biotech startup in a once-buzzy field, cuts 70% of staff Dewpoint Therapeutics, a startup working in the once-buzzy field of biomolecular condensates, laid off most of its staff Thursday. The biotech is cutting around 70% of its workforce, a source told STAT. Dewpoint declined to provide the number of employees who were…
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STAT+: Vertex next-generation pain candidate fails Phase 2 trial
STAT+: Vertex next-generation pain candidate fails Phase 2 trial Vertex Pharmaceuticals said Monday afternoon that its next-generation non-opioid pain reliever failed to significantly outperform placebo in a Phase 2 trial. The experimental drug, codenamed VX-993, is similar to the company’s recently approved pill Journavx but could potentially be given at higher doses and formulated as…
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STAT+: Trump demands drugmakers slash U.S. price now
STAT+: Trump demands drugmakers slash U.S. price now Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, and happy birthday to me! Today, we see the Senate Appropriations Committee look to increase NIH funding, despite the Trump administration’s request to slash…
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STAT+: Inside the fall of Vinay Prasad at the FDA
STAT+: Inside the fall of Vinay Prasad at the FDA Vinay Prasad had a problem. Several, actually. His staff at the Food and Drug Administration kept leaking to the press. He was under attack by President Trump’s allies after moving to pull a gene therapy off the market. Democrats were not happy with his Covid…
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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+: 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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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+: 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+: 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+: 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+: Novo Nordisk’s amylin obesity drug keeps performing like Zepbound
STAT+: Novo Nordisk’s amylin obesity drug keeps performing like Zepbound CHICAGO — Late-stage results of Novo Nordisk’s obesity candidate CagriSema suggest the drug is comparable to Eli Lilly’s Zepbound on safety and efficacy, further data indicating that CagriSema may not be the standout treatment that investors had hoped for. Novo previously reported that patients on…
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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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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+: 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+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda
STAT+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment. The dispute with Halozyme…
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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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At ASCO 2025, attendees see reason for hope, despite worries
At ASCO 2025, attendees see reason for hope, despite worries For more updates on the latest in cancer news, sign up for our Cancer Briefing newsletter here. The annual meeting of the American Society of Clinical Oncology is now in session. As always, STAT has your appetite for cancer news covered. Reporters Matt Herper, Adam…
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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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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+: 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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STAT+: Novavax wins narrowed approval for its Covid-19 shot after delay
STAT+: Novavax wins narrowed approval for its Covid-19 shot after delay The Food and Drug Administration has finally approved Novavax’s Covid-19 vaccine, but in doing so has placed restrictions on it that its two competitors in the U.S. market do not face. The long-awaited license limits use of the vaccine to people 65 and older…
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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+: 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+: The state of antibiotic development: ‘Deplorable comes to mind’
STAT+: The state of antibiotic development: ‘Deplorable comes to mind’ Four years ago, an ambitious pharmaceutical industry venture to tackle antibiotic resistance launched to invest in small companies that can develop two to four novel antibiotics by 2030 — and replenish the global supply chain with needed treatments. The effort began with $1 billion in backing…
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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+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices
STAT+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices 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. A horse named Journalism was favored to win the…
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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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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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Pfizer discontinues its experimental GLP-1 pill
Pfizer discontinues its experimental GLP-1 pill 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 interesting new gene-editing data from Verve, see the NIH starting to convene advisory councils again, and more. Read the rest… Meghana Keshavan Go to statnews
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STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’
STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’ In an unexpected move, the U.S. Food and Drug Administration announced plans this week to reduce — and possibly replace — animal testing with other methods for developing certain medicines in a bid to lower R&D costs and,…
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NIH hit with chaos, cuts, and contractor purge
NIH hit with chaos, cuts, and contractor purge Hello. Today, we dive into the implications of the ongoing cuts to various health and science agencies….It’s a doozy. Oh, and if you like talking about neuroscience and happen to be near San Diego this weekend, come hang with me and my colleagues at STAT@AAN: The Future…
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STAT+: Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease
STAT+: Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease WASHINGTON — Marty Makary’s first address to staff as FDA commissioner on Wednesday afternoon sounded a bit like an introduction to one of his books. It included sweeping declarations about the need to challenge scientific norms, and to identify the root…
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STAT+: FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs
STAT+: FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs WASHINGTON — Marty Makary’s first official day as commissioner of the Food and Drug Administration began with employees in tears, learning from security guards that they were losing their jobs. The news release announcing the start of his…
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Emotional whiplash for PTC Therapeutics
Emotional whiplash for PTC Therapeutics 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 process the shockwaves in biotech following the ouster of CBER chief Peter Marks, see a radiopharmaceutical expand its reach, and more. Read the rest… Meghana Keshavan…