Articles across AI, biotech, forecasting, and emerging tech.
Addiction clinics around the country are seeing a growing number of cases related to gas station products made from the kratom leaf and its derivatives. At the telehealth addiction clinic Boulder Care, for example, people who report using kratom products constituted 3% of all new patients in September 2025. By July 2026, that number was 8%, and in August, it jumped to 14%. Read the rest…
Montana passed a law called SB535. It builds on right-to-try (pre-approval access with informed consent, Phase 1 safety data etc.) but goes much further, fixing problems with those laws.Alex Tabarrok called it "the most important regulatory innovation in drug approval in my lifetime" (https://marginalrevolution.com/marginalrevolution/2026/06/mo...). Was posted here but died in /new (https://news.ycombinator.com/item?id=48559525). The mods suggested this post.I contributed ideas to the law and am now implementing it through my company. I invested in biotech for years and watched companies struggle. I built the biotech ecosystem in Prospera as an alternative, concluded it was too early, and now think Montana is the best place to prove this.Why this exists: When FDA approves a bad drug, heads roll. When it delays a good one, the deaths are statistical and nobody gets blamed ("invisible graveyard"). So the incentive is overcaution, which is why the cost per approved drug has roughly doubled every 9 years for decades ("Eroom's Law"). Founders are in the "Valley of Death" around Phase 1: grants are no longer available, and commercial money wants assurance the drug will pass the next trial. Only ~10% of post-Phase 1 drugs get approved, but 68% of failed trials don’t stop because they found lack of safety or efficacy but commercial reasons (Williams et al., PLOS ONE 2015). Federal Right to Try and Expanded Access haven't fixed this. Federal reform is super-hard.What Montana allows: A physician can give an experimental treatment outside a trial if: it completed FDA Phase 1 under an active IND; a state-registered private review board (ETRB) approved the protocol; it's delivered at a state-licensed clinic; consent exceeds the federal standard & adverse events need to be reported. The key is: sponsors and clinics can charge.Why this time it's different: The risk-reward ratio is what's broken. Right to Try and Expanded Access don't let sponsors charge, so treating a patient is risk plus expense. Montana is the first state law where sponsors of IND-stage drugs can price in that risk. Trial recruitment today is a price-control system: per-patient cost is around $50-100k, typically has a ceiling upward on what it can pay patients ("undue inducement") and a floor downward (no profit, only at cost in RTT / EA). Montana removes both (I know this will lead to lots of debate, let’s have it.)So this is not a free for all, the additional liberties come with tough oversight. An ETRB is Montana's version of an IRB: safety review, consent, mandatory outcome reporting, and you can't withhold safety information from patients. That’s the truth-funding mechanism.What companies can do now: If you have a Phase 1 asset stuck in the Valley of Death: treat patients, negotiate payment, get real-world data, use it to sharpen your Phase 2/3 design.Disclosure: my company formed the first ETRB. The model is review fees, like an IRB; no equity in applicants, no payment by outcome; COI policy and board bios public; decision letters published with applicant consent; annual outcome report required.Objections:- Someone gets hurt? Same as trials and ordinary care: US legal system, legal recourse.- FDA shuts it down? They haven't said they won't, but historically FDA goes after grey-market clinics, not state laws; we're asking for safe harbor, but some companies aren't waiting.- Snake oil? Bad actors want to fly under the radar, and Montana makes that hard.What's needed: Biotechs with Phase 1+ assets willing to move before full FDA assurance, to build the evidence that gets the agency on board - the point is not to skip FDA, but to reduce the cost of data. And ex-FDA reviewers, IND operators, IRB members telling us where this breaks.Happy to answer anything.
On September 9th, Apple announced it was revamping its Apple Watch Health Sensing System, rolling out a Readiness score (0 to 10), and increasing the frequency of heart rate variability (HRV) outputs 24-fold. This can be viewed as upping its competition with various other consumer wearable sensors. These “readiness scores” as a composite of multiple metrics, with heart rate variability (HRV) being front and center for most. The majority of Americans are now using wearable sensors, which equates ...
About a month ago, chemists made a synthetic cell capable of eating, growing, and dividing for at least five generations. They called it SpudCell, and the lead author, Kate Adamala of the University of Minnesota, thinks it might be able to reproduce perpetually by 2030; a feat that, she argues, would finally make SpudCell “alive.”I flew to Minnesota and interviewed Adamala for about three hours. First, I wanted to understand the bottlenecks with SpudCell. What engineering changes will they make ...
The Food and Drug Administration on Thursday approved a new gene therapy for Sanfilippo syndrome type A, an ultra-rare disease sometimes known as childhood Alzheimer’s. The therapy, called Fayuvi, was developed by Ultragenyx. It is the first drug specifically approved to treat Sanfilippo. Ultragenyx did not immediately release a price. “It’s hard to overstate what this approval would mean for everybody who is living with this really horrific disease and watching their children suffer and pass aw...
For years, researchers have known that, among people diagnosed with lung cancer, the prevalence of nonsmokers has been increasing. But they have been trying to determine what factors — whether genetic, environmental, or something else — might put these “never-smokers” at heightened risk. Now, researchers have identified a very rare genetic variant that is associated with 25-fold higher odds of lung cancer, they reported in the journal Science on Thursday. In the U.S., the variant is far more co...
For the last decade, scientists have been steadily getting better at growing “cerebral organoids,” miniature, three-dimensional brain-like structures, from human stem cells in the lab. Now, a group from Stanford University has found a way to advance their usefulness for studying brain development and disease — by instead growing them inside mice that have had large parts of their own brains genetically removed. Neuroscientists say these “neuro-chimeric” mice, whose brains are half-human — by v...
A Medicare experiment in paying for technology to help people manage chronic conditions has just barely gotten underway, and officials are already moving to expand it. Announced last year, the ACCESS model will pay approved companies to manage certain chronic conditions, including diabetes, high blood pressure, chronic musculoskeletal pain, depression, and anxiety. The model introduces outcome-aligned payments, in which providers are paid more if their patients’ conditions improve. Regulators on...
Vera Therapeutics said Tuesday that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease, according to final, two-year results from a Phase 3 clinical trial. In July, the Food and Drug Administration granted accelerated approval to Trutakna for the treatment of IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condit...
Spaceflight is a risky business. Keeping astronauts healthy, especially their hearts, has driven Benjamin Levine’s career as a top consulting cardiologist to NASA. Now that a Mars mission is on the horizon, his most recent research continues to test how well exercise maintains the heart’s structure and function during prolonged spaceflight. In their paper published Tuesday in Circulation, an international team reports results from 13 astronauts who performed onboard echocardiograms during thei...
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Studying brain scan data from individuals — not group averages — reveals key brain-function differences in children who struggle with goal-oriented tasks, a Stanford Medicine study found.
A nanoparticle ink that can print structural colour onto flat or 3D surfaces could be used to create anti-counterfeit images, smart windows and displays, and vibrant artworks
A male house sparrow. Photo by Edoddridge via Wikimedia Commons Most city dwellers have been woken up at some point by the chirping of birds outside their apartment window, but a new...
Researchers are developing a futuristic alternative to LASIK that reshapes the eye without lasers or incisions. Using mild electrical pulses and platinum contact lenses, they temporarily soften the cornea so it can be molded into a new shape. Early tests on rabbit eyes successfully corrected nearsightedness in about a minute while preserving the eye’s structure.
Exclusive: Researchers warn of ‘major crisis in male reproductive health’ partly driven by obesity and diabetes
Multiplexed in-vivo perturbations, interpreted by a foundation model that has only ever seen human tumors.
Scientists made 16 successful viruses that had their genetic code designed by artificial intelligence.
Intelligence quotient decline following frequent or dependent cannabis use in youth: a systematic review and meta-analysis of longitudinal studies - Volume 51 Issue 2
Learn how Biohub and UC Berkeley solved cryo-EM's contrast problem with a laser phase plate, opening a new window into the molecular machinery of living cells.
New research investigates the shifting patterns of odors as they travel through the air. The findings may help explain how animals navigate using smell and eventually inform development of odor-finding robots.
In recent weeks the results (announced by press release) of 2 major placebo-controlled randomized trials—ZEUS, testing an interleukin-6 (IL-6) blocker vs inflammation, and HORIZON, testing a drug to lower Lp(a), indicated failure to achieve their primary endpoint.Are we maxxed out for new treatments vs heart disease, as this article in the WSJ (←gift link) today asserts? “Cardiovascular drug development is starting to look a bit like the modern oil industry. The easy wells have been tapped. What...
Definium Therapeutics said Monday that its LSD therapy helped patients with anxiety in a second late-stage trial, setting up the company to seek the first approval of a psychedelic drug for anxiety. In the 12-week trial, patients taking a 100-microgram dose of the drug, called DT120, experienced a 9.8-point drop on a test called the Hamilton Anxiety Rating Scale, while those on placebo experienced a 4.7-point drop. The difference of 5.1 points is similar to what was seen in Definium’s first late...
Platinum-based chemotherapy — in particular cisplatin and carboplatin — are a lifeline for children with certain cancers. These treatments, for instance, transformed the prognosis of hepatoblastoma, a rare cancer of the liver that is the most commonly diagnosed in childhood, from a five-year survival rate of 20% to more than 80% for localized tumors. However, these medications work by damaging the DNA of cancer cells, and they are also known to cause mutations in the DNA of healthy cells, poten...
An ongoing shortage of cancer medications continues to force leading cancer centers around the U.S. to seek work-around strategies to treat patients and a majority also report that clinical trials have been disrupted, according to a new survey. All of the centers noted they are experiencing a shortage of at least one medicine, and more than 20% of the centers are currently reporting shortages of five or more different medications. The survey was conducted by the National Comprehensive Cancer Net...
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. Before the end of September, UniQure is expected to report four-year results from the closely tracked clinical trial of AMT-130, its gene therapy for Huntington’s disease. Three-year results were reported almost one year ago. The high dose of AMT-130, administered to 12 patients, slowed the progression of Huntington’s by 75% compared to match...
NEW YORK — The two measles-related deaths in Pennsylvania last month involved infants, and the virus itself caused one of the deaths, a Pennsylvania coroner confirmed Wednesday. Lancaster County’s coroner, Dr. Stephen Diamantoni, said he told the Centers for Disease Control and Prevention of his conclusions. CDC officials, however, have not said whether they will count either death as measles-associated, and the agency’s website still carries a disclaimer about them.Read the rest…
ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. ARPA-H on Wednesday announced the first batch of awards to health tech ...
SAN DIEGO — When Kura Oncology decided to take aim at a protein involved in cell division and signaling, researchers reported a bonus finding: Targeting the protein, menin, didn’t just control the growth of leukemia cells, it also helped control blood sugar levels in animal studies. The biotech on Wednesday announced that it is turning that insight into a new company. The new firm, Caspian Therapeutics, is launching with $50 million in financing to develop menin inhibitors for diabetes and other...
BOSTON — The building that houses the Brigham and Women’s Hospital emergency department opened in 2022. But by 2025, it was already too small. One early September evening, the emergency room had 59 patients — 152, if you counted everyone in the waiting room. “In terms of rooms for acute care, we have 61,” said Christopher Baugh, an emergency physician at the hospital. “You can’t see 152 patients in 61 rooms.” Patient beds lined every possible area, with a full circle of beds surrounding the sta...
In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dr...
Inhibrx said Tuesday that its experimental immunotherapy targeting a protein called OX40 showed responses in patients with head and neck cancer. But the most striking results were in a small subset of patients with HPV-positive tumors, which could significantly limit the drug’s use. The results are notable as a legion of drugmakers — including Pfizer, Genentech, GSK, and AstraZeneca — previously tried and failed to use OX40 as a weapon against tumors over the past 15 years. “It’s just really gr...
Roivant said Tuesday an experimental drug for a type of pulmonary hypertension achieved the goals of a mid-stage study — positive results that could open up a new way to treat the serious lung disease and bolster the biotech company’s financial health with a second blockbuster medicine. In the 16-week Phase 2 study, Roivant said, its drug mosliciguat achieved a statistically significant 56% reduction compared to placebo in pulmonary vascular resistance — a measure of blood pressure and flow wit...
A closely watched cardiovascular drug from Novartis failed in a pivotal study, the company said Friday, a major blow to the firm and to efforts to target a common heart disease risk factor. The drug, called pelacarsen, had shown in earlier trials that it could drastically lower levels of what’s called Lp(a), a little blob of lipids and proteins that at elevated concentrations increases the likelihood of severe heart problems. But Novartis said that in the Phase 3 HORIZON trial, pelacarsen faile...
When doctors think about sticking an organ from another animal into a person, one of their many questions is about what might happen after they take that organ out. Would the patient produce antibodies that would complicate a human-to-human transplant later on? The scientists at eGenesis didn’t think so, based on what they saw in primate studies. But now they have confirmation. On Thursday evening, the biotech company — one of a handful racing to develop xenografts, as these interspecies transpl...
Ionis Pharmaceuticals on Thursday received Food and Drug Administration approval for the first disease modifying therapy for Alexander disease, a rare and deadly neurological condition. The FDA approved the drug, Zanvastro, for use in children and adults after a pivotal trial showed that walking speed, a common measure of motor function in neurologic disease, stayed stable in treated patients while those in the control group saw a 33% decline. The study also contained hints that treating young ...
From 2021 to 2023, more than 105,000 people in the U.S. died from a drug overdose each year — tens of thousands more than the already high rates seen in the lead-up to the Covid pandemic. Then, suddenly, the death rates dropped. In 2024, U.S. overdose deaths decreased 27%. Preliminary data from 2025 show another meaningful drop, though overdose mortality is still quite high. Other countries with major overdose problems also saw fewer deaths: In Scotland, there was a 13% decrease in 2024, and in ...
Under the Trump administration, competition for government funding for biomedical research has reached new heights. In June, the National Institutes of Health proposed one solution: limiting the number of grants each individual scientist can have at a given moment. The agency recently released the anonymized 3,307 responses to its call for feedback, and it appears the proposal has drawn more mixed reactions than earlier such proposals. The NIH estimates that 40% of the responses opposed the pro...
AstraZeneca on Friday detailed the surprise failure of a closely watched heart disease clinical trial, laying out how its experimental drug offered no additional benefits for patients who were largely already on another type of medicine — the latest twist in a multibillion-dollar market. The study indicated that patients with a progressive condition known as ATTR-CM who received AstraZeneca’s drug — what’s called a silencer — saw no improvements if they were already taking another type of drug ...
The Food and Drug Administration on Thursday approved a new medicine from Roivant and its subsidiary Priovant for the treatment of dermatomyositis, a rare autoimmune disease characterized by muscle weakness and a painful skin rash. The drug, called brepocitinib, will be marketed under the brand name Lisraya. It’s a pill taken once daily. High doses of steroids and other immune-suppressing drugs are the current standard of care for patients with dermatomyositis, which affects between 40,000 and...
A personalized cancer vaccine developed by Moderna and Merck has generated widespread enthusiasm since the companies announced last week that it had succeeded in a late-stage trial. If regulators ultimately approve it, the treatment will be a triumph of immunology and cancer biology. But it may also be a triumph of the algorithm. The vaccine, intismeran autogene, would be the first approved medicine whose genetic instructions — that is, the individual letters of its mRNA — is determined by a com...
The newer shingles vaccine has been turning heads since its link to lower dementia rates was reported two years ago. Now the same research team behind that observation has found an association between receiving the Shingrix shot and a reduced risk of heart disease. There have been signals before of cardiovascular benefits in people who got the newer, recombinant vaccine to prevent shingles, a painful, often serious flare-up in older people of the chickenpox virus from childhood. Those who got Sh...
In late September 2024, patients noticed a nurse at Adventist Health in Bakersfield, Calif., was acting strangely. The nurse was walking barefoot through the intensive care unit, talking to herself and acting abrasively toward others. Family members of patients noticed the nurse sloppily taking out IV needles but were afraid to confront her. “I know she was on something because you can tell,” one family member told federal investigators after the incident. Another patient in the post-anesthesiol...
At an off-site leadership meeting held by Moderna in March 2023 — after mid-stage results of the biotech company’s cancer vaccine showed promise — CEO Stéphane Bancel had the floor. He asked if any of the 100 or so executives present had expected the experimental treatment to succeed. If they did, he said, please stand up. Stephen Hoge, Moderna’s president, was standing on stage. He sat down. Then, Hoge recalled in an interview with STAT, Bancel sat down, too. “None of us believed it,” Hoge said...
The Food and Drug Administration has again paused trials for Regenxbio’s gene therapy for a rare childhood brain disorder, after small masses were found on the spines of five patients, the company said Monday. Regenxbio said the patients, who have mucopolysaccharidosis (MPS) type II or Hunter syndrome, did not have any symptoms related to the masses. The announcement comes seven months after Regenxbio announced that one boy who received a very similar therapy the company developed for MPS type I...
For most localized solid tumors, it’s common for surgeons to try to preserve as much of the diseased organ as possible, removing only the cancer along with some healthy tissue surrounding it to avoid further spread. But for prostate cancer, treatment is usually all or nothing. Except for patients with low-grade disease that’s unlikely to turn deadly, the whole gland gets removed, or irradiated. The long-term consequences can be serious, notably incontinence and erectile dysfunction. A less aggr...
The pathologists were stumped. Six people had tried to identify a patient’s cancer based on a recent lymph node biopsy. They’d stained the cells 70 times to try to draw out more distinguishing features — but still, nobody had an answer. At Stanford, a physician called onto the case was trying out a new tool called ChatEHR, one of several large language model-powered tools being deployed by health systems to summarize patients’ often-extensive medical records. It got a question: Did the patient h...