Normal Science

STAT+: Closely watched Pfizer lung cancer drug falls short in clinical trial

Pfizer said Monday that an experimental drug it hoped could replace a widely used chemotherapy in one of the most common forms of lung cancer fell short in a clinical trial. Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year, Pfizer’s CEO, Albert Bourla, said on an earnings call the drug “could be a driver of growth later this decade.” In a note to investors in May, Leerink analyst David Risinger called the ...

The US moves to reclaim the therapeutic pipeline

Today, the Department of Health and Human Services (HHS) announced new plans aimed at restoring American leadership in clinical research by removing unnecessary barriers to clinical trials — in other words, properly doing Clinical Trial Abundance.In a call with journalists, Acting FDA Commissioner Kyle Diamantas and NIH Director Jay Bhattacharya outlined a series of reforms designed to hasten Phase I trials and encourage companies to conduct studies in the US. The FDA's efforts are intended to r...

STAT+: FDA to launch pilot program to speed up early-stage clinical trials

WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they say will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the field. The pilot comes as the Food and Drug Administration, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. That proposal was champione...

STAT+: Definium LSD therapy helped patients with major depression in late-stage trial

Definium Therapeutics said Monday that its LSD therapy significantly helped patients with major depression in its first Phase 3 trial, bringing the psychedelic drug closer to a potential approval. Six weeks after a single dose, patients on the pill, called DT120, experienced a 13.3-point drop on a depression test called the Montgomery-Åsberg Depression Rating Scale (MADRS), compared with a 5.2-point drop among patients taking placebo. By 12 weeks, the effect waned a bit but was largely maintaine...

STAT+: Pharma goes on a spending spree, snapping up biotechs in a hurry

Pharmaceutical companies are hungry to make deals, and they’re making more than they have in years.  In the past six months, there have been 33 biotech acquisitions valued at $1 billion or more, capped by AbbVie’s acquisition of Apogee Therapeutics on Monday. Pharmaceutical companies and even some large biotech companies have spent around $134 billion on these deals. They’ve blown past last year’s totals in roughly half the amount of time. Pharma companies struck 26 blockbuster M&A deals in 2025...

BioByte 164: TARIO-2 Tracks Patient Responses to ICI Therapies, Decoding Human Interferon for Antiviral Discovery, and Cortical Layering in Tetrapods

Reminder to apply to attend our fourth annual AI x Bio Summit at the NYSE on July 23rd! Spots are filling up quickly, apply here to attend.Subscribe nowGustav Klimt, The Tree of Life, Stoclet Frieze, 1909, mosaicWhat we readPapersFoundation AI Models for the Prediction of Therapeutic Response to Next Generation Immune Checkpoint Inhibitors [Dalton et al., preprint, June 2026]Why it matters: TARIO-2 aims to address patient response prediction in the drug development cycle by leveraging widely-ava...

NIH diversity programs doubled undergraduates’ odds of getting a Ph.D., 20-year study finds

The path to becoming a scientist is long and twisting, making it difficult to assess whether programs intended to help those careers along are successful.  But on Wednesday, the results of one such study are being published after 20 years of research. The paper in the journal Science Advances found that two diversity-oriented programs supported by the National Institutes of Health doubled the odds that an undergraduate student would earn a Ph.D. Read the rest…

Agentic AI Comes to Medicine

It was just a matter of time. Agentic autonomous AI has already been applied to life science and many other domains, and today there were 2 notable publications in Nature that move this concept forward for healthcare. One is called MIRA from Jacob Kather and colleagues from Germany, and the other is called AMIE, from Mike Schaekermann and colleagues at Google (acronyms defined below). This work is getting well beyond AI support for narrow applications, such as help in making diagnoses, to full m...

STAT+: FDA appears open to Moderna’s flu vaccine ahead of adcomm

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, one venture capitalist weighs in on the China biotech debate. Let me know if you agree with her or not. UniQure will submit Huntington’s therapy for approval The FDA has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker, the biotech company UniQure, to file for U.S. approval, the ...

STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval

The Food and Drug Administration has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker, the biotech company UniQure, to file for U.S. approval, the company said Wednesday.  UniQure will submit a marketing application in the third quarter seeking accelerated approval for the treatment, called AMT-130. The decision comes after a recent meeting with FDA officials during which the agency agreed that a three-year analysis of an...

Does Employment Slow Cognitive Decline? Evidence from Labor Market Shocks

Founded in 1920, the NBER is a private, non-profit, non-partisan organization dedicated to conducting economic research and to disseminating research findings among academics, public policy makers, and business professionals.

Group averages obscure how an individual's brain controls behavior: study

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.

Underwater robot tracks sperm whale conversations in real time

Researchers print structural colour with an inkjet printer

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

Urban Birds Are Rising Earlier Because of Traffic Noise (2013)

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...

Forget LASIK: Safer, cheaper vision correction without lasers or surgery

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.

Perturb-MARS: Reading mouse experiments through a human lens

Multiplexed in-vivo perturbations, interpreted by a foundation model that has only ever seen human tumors.

Laser Phase Plate Cryo-Electron Microscopy

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.

Nocturnal migratory birds follow rhythm of the moon

STAT+: Human Cell Atlas leader’s tie to 10x Genomics raises conflict-of-interest questions

A decade since its founding, the International Human Cell Atlas Consortium is hosting a high-profile meeting in Boston this week, with panels featuring more than two dozen prominent academics and biotech industry leaders, including Genentech’s Aviv Regev, David Altshuler of Vertex Pharmaceuticals, and Eric Lander from the Broad Institute. The event, which is expected to draw hundreds of scientists from across the globe, comes at an inflection point in the HCA’s ambitious aim to build a comprehen...

STAT+: Amid confusion over Pfizer’s emergency penicillin program, newborn is diagnosed with preventable syphilis

The request was an emergency. In late March, a woman in Gila County, Arizona, was diagnosed with syphilis, and she was pregnant. She needed an injection of penicillin — if possible, 30 days before delivery — but the bacteria corkscrewing through her body increased her risk of delivering early. Without timely treatment, her pregnancy could end in miscarriage, stillbirth, or infant death, and if the infant survived, the child might live with bone deformities, brain damage, blindness, and deafness,...

Nonprofit buys experimental cancer drug to maintain patient access

In a rare move, nonprofit organization Blood Cancer United announced Thursday it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last.Read the ...

Drinking during pregnancy rose after 2020, new CDC data suggest

New data released Thursday suggest the prevalence of drinking during pregnancy increased in recent years.  National survey data published in a Centers for Disease Control and Prevention report show about 15% of adult pregnant women reported current drinking (use in the prior 30 days) between 2021 and 2024. About 13.5% of women reported the same between 2018 and 2020.Read the rest…

BioByte 163: CRISPR Targets Cancer, Tahoe's Rhaister Model Challenges the Need for the Virtual Cell and the Bio Bottleneck is Agentic

Welcome to Decoding Bio’s BioByte: each week our writing collective highlight notable news—from the latest scientific papers to the latest funding rounds—and everything in between. All in one place.Subscribe nowAamir Ahmed, Jane Pendjiky and Michael Millar, Detecting cancer in human tissues, LM, fluorescence immunohistochemistry & confocal microscopy️溺️ Reminder to apply to attend our fourth annual AI x Bio Summit at the NYSE on July 23rd! Spots are filling up quickly, apply here to attend. ️...

Manufacturing requirements are killing cell and gene therapy

Yesterday, ultra-rare disease company Grace Therapeutics announced it may be forced to shut down after the FDA requested a second manufacturing run before it can submit its new application for approval. This is a requirement the company says it simply cannot survive, as it would require another twenty million or so in funding. I explained in a tweet why the requirements the FDA has regarding this are absurd.What I really want to bring home though is that the story of Grace Therapeutics is not un...

FDA OKs first new sunscreen ingredient in more than 25 years

WASHINGTON — Federal health regulators on Tuesday signed off on the first new sunscreen ingredient for the U.S. market in more than 25 years, giving Americans access to a skin-protecting chemical long used in Europe and other parts of the world. The Food and Drug Administration says the ingredient, bemotrizinol, met the agency’s standards for protecting from dangerous ultraviolet rays while causing little irritation or absorption into the skin. The ingredient is safe for adults and children 6 mo...

STAT+: AstraZeneca’s GLP-1 pill shows promise in obesity, diabetes trials

AstraZeneca’s investigational GLP-1 pill showed promise in mid-stage obesity and diabetes studies, but it may still be too early to determine how it stacks up against oral treatments already on the market. In one Phase 2 trial of people with obesity, called VISTA, those on the highest dose of the drug, called elecoglipron, lost 11.2% of their weight after 36 weeks, when looking at all patients regardless of discontinuations, according to data presented Monday at the annual meeting of the America...

STAT+: Lilly shares safety, tolerability data on its next-gen obesity drug

Eli Lilly has already established that its next-generation obesity drug can lead to highly rapid weight loss. Researchers disclosed new data Saturday that provide more details on the safety and tolerability of the closely watched therapy. Lilly previously said that in one late-stage study, called TRANSCEND-T2D-1, retatrutide helped people with diabetes lower blood sugar and lose a significant amount of weight, which is notable since those who have diabetes tend to lose less weight on treatment t...

HHS confirms Americans with high-risk Ebola exposures will have access to experimental therapy

Americans who have high-risk exposures to Ebola in the current outbreak in Central Africa will have access to an antibody treatment that has shown great promise in animal testing but hasn’t yet undergone a clinical trial to show whether it is efficacious in people, the Department of Health and Human Services confirmed Thursday. The antibody treatment, known as MBP-134, is made by San Diego-based Mapp Biopharmaceuticals, with funding from the Biomedical Advanced Research and Development Authority...

STAT+: Supreme Court backs generic drugmaker in ‘skinny labeling’ case

The Supreme Court unanimously ruled that Hikma Pharmaceuticals did not infringe patents held by Amarin in a decision that makes generic drugmakers less vulnerable to lawsuits over so-called skinny labels. The ruling overturned a lower court decision that sided with Amarin. Generic drugmakers had argued that, if the Supreme Court also ruled in favor of Amarin, they would be discouraged from making and selling lower-cost versions of brand-name medicines, which would maintain higher prices for pres...

STAT+: After hospitals, patients get a turn to bring AI into the doctor’s office

Patients are getting used to being recorded in the doctor’s office. More than a quarter of U.S. practices now use AI-based listening tools called ambient scribes, which capture visits in real time and draft clinical notes for clinicians to enter into patients’ medical records.  But what happens when it’s the patient doing the recording? Nearly every patient now has a recording device in their pocket, and commercial large language models have made it easier than ever for them to transcribe and in...

Male puberty is understudied — but when it starts may predict long-term health risks

Puberty is an inevitable part of human maturation, and it increasingly appears to hold a key to understanding individuals’ risk for developing poor health outcomes later in life. Research in girls has established a significant relationship between disease risk and the timing of puberty onset. Early puberty has been connected to a higher risk for illnesses including endometriosis, type 2 diabetes, heart disease, breast cancer, depression, eating disorders, uterine fibroids, and osteoarthritis, as...

STAT+: Alnylam to partner with Inceptive Nucleics for AI foundation models for RNAi therapeutics

Jakob Uszkoreit went from inventing the “T” in ChatGPT to putting the “AI” in Alnylam’s RNAi therapeutics. After over a dozen years at Google, where he’d co-authored the seminal “Attention is all you need” paper that laid the foundations for artificial intelligence models like GPT, Uszkoreit in 2021 left a job at Google Brain to start Inceptive Nucleics. The company is building “AI foundation models of life” — models that will hopefully learn so much about how biology operates that they will be ...

The hidden history of BPC-157, a favorite MAHA peptide

STAT is co-publishing this with Undark. This story was supported by the Pulitzer Center. In 1975, in a medical school classroom in what was then the Socialist Federal Republic of Yugoslavia, Predrag Sikiric had an idea that he has pursued for more than 50 years. Read the rest…

Ultra-low doses could bring costly cancer treatments to more patients in poorer countries

CHICAGO — What if the trick to getting cancer immunotherapy to parts of the world that can’t access it is simply lowering the dose? A lower-cost immunotherapy approach could extend survival for patients with advanced head and neck squamous cell carcinoma in resource-limited countries, according to results presented Sunday at the annual meeting of the American Society of Clinical Oncology.Read the rest…

STAT+: For prostate cancer patients set on surgery, new hormone regimen may improve outcomes, study finds

CHICAGO — Patients with high-risk prostate cancer that hasn’t spread typically have two standard treatment paths before them. Remove the prostate surgically or do a combination of radiation therapy and hormone therapy. Now, with the results of a new Phase 3 clinical trial, some oncologists believe a third option may soon be laid on the table: surgery with hormone therapy both before and after the operation. The study, called the PROTEUS trial, found that combining two hormone therapies both befo...

Searching for X-Lab-Shaped Bottlenecks in Quantum Interconnect and Integrated Photonics

This is a preliminary post on the NSF X-Labs Quantum Interconnect and Integrated Photonics topic. We’re writing this as a provocation directed towards expert researchers, PMs and others in this field - we’d like your help to continue this very early investigation or spin up your own. In particular, we want to get this in the hands of people who can find the FRO-shaped bottlenecks here (and especially those who want to start new organizations to work on them), and start a conversation with them t...

BioByte 161: CellCage Enclosures Allow Monitoring of Dynamic Transitions Across Cell States, New Breakthroughs in Targeting GPCRs, and a Modular View of Aging

Welcome to Decoding Bio’s BioByte: each week our writing collective highlight notable news—from the latest scientific papers to the latest funding rounds—and everything in between. All in one place.Subscribe nowWassily Kandinsky, Circles in a Circle, 1923, oil on canvasWhat we readPapersScalable longitudinal imaging and transcriptomics of cells in dynamic enclosures [Khurana et al., bioRxiv, May 2026]Why it matters: Single-cell transcriptomics defines cell states by clustering RNA, but a sequenc...

STAT+: Experimental hepatitis B treatment was a ‘functional cure’ for nearly 1 in 5, new data show

An experimental medicine helped vanquish hepatitis B in clinical trials in nearly 1 in 5 people with chronic infections caused by the virus, far outperforming available treatment options in an illness that kills 1 million people every year.  Some 250 million to 300 million people globally have chronic hepatitis B infections, which can cause serious issues including cirrhosis and liver cancer. Current treatments, known as nucleoside analogues, lead to so-called functional cures in only 1% to 3% o...

STAT+: Heart patch engineered from stem cells revved up weakened hearts

Hearts can’t heal themselves.  After a heart attack or other cardiovascular insult, hearts can’t regenerate weakened muscles, leaving them less able to pump blood throughout the body. While medications to manage symptoms of heart failure — including newer obesity drugs — have been improving outcomes, many people ultimately face only two solutions: a heart transplant or heart device implant. Now a small new study reports progress with a novel method. After people received patches of heart muscle ...

STAT+: Eli Lilly says Verve’s gene editor lowers cholesterol levels in early study

Eli Lilly said Monday that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol. Lilly acquired the therapy, VERVE-102, in its $1 billion buyout of Verve Therapeutics last year. Executives tout it as a potential treatment to broadly prevent heart disease, the world’s leading killer, as many patients strug...

STAT+: Lilly’s ‘triple-G’ drug leads to bariatric-surgery levels of weight loss in trial

Eli Lilly reported Thursday that in a late-stage trial, its next-generation obesity drug led to levels of weight loss approaching the effectiveness seen with bariatric surgery, but that there were high rates of side effects and discontinuations, raising questions about how appealing the treatment would be.  In the Phase 3 study, which enrolled obese and overweight people who didn’t have diabetes, those who took the highest dose and stayed on the treatment, called retatrutide, lost on average 28....

STAT+: Pioneering trial for treating genetic disease before birth nears reality

SAN FRANCISCO — While Tippi MacKenzie was a postdoctoral fellow in the early 2000s, she and her lab mates experimented with using the then-new technology of gene replacement therapy to try to treat inherited disorders in mice before they were born. Over and over it worked. They cured mice with hemophilia and mice with tyrosinemia. And the whole time, people kept telling her that gene therapy in human fetuses was just around the corner, just five years away.  It’s now been 25 years, and such a re...

NSF Just Did Something Important

Last week, NSF announced $1.5 billion for the NSF X-Labs initiative — independent, mission-driven research teams pursuing platform technologies that traditional institutions aren’t built to tackle. The first two topics are Scientific Instrumentation for Sensing and Imaging, and Quantum Systems: Interconnects and Integrated Photonics.A few years ago, Caleb Watney at IFP published a high-level proposal for exactly this kind of program. He called them X-Labs and described four basic award types. Th...

BioByte 159: the Release of OpenBind, uPAR CAR-T Breaks Down Tumor Defenses, Triplet Tumbling Microscopy Improves Detection of PPIs, and the Potential Role of Autoantibodies in Schizophrenia

Welcome to Decoding Bio’s BioByte: each week our writing collective highlight notable news—from the latest scientific papers to the latest funding rounds—and everything in between. All in one place.Subscribe nowProf. Bill Harris, Neuronal migration is an artwork depicting many very young neurons that have been produced in the neuroepithelium migrating to their appropriate destinations in the brain. This image highlights the future of neuroscience showing different classes of cells colour coded. ...

STAT+: A new kind of liver crisis is emerging in the U.S. The American diet is to blame

The United States is hardly the only country where heavy and binge drinking is a problem. But Americans face a unique crisis: This country’s obesity and diabetes epidemics, combined with heavy alcohol use, are causing more people to get sick from a liver disease that, until recently, didn’t even have a name.  Metabolic dysfunction and alcohol-associated liver disease, or MetALD, is now a leading concern among doctors in the U.S. as more young people and women face serious illness and die from th...

The ‘velocity of obesity’ aims to show which nations are slowing an epidemic

Don’t call it the “obesity pandemic.” That one-size-fits-all label no longer captures the diverse trajectories of weight gain around the world, a new report argues. In some countries rising obesity rates are slowing or even sliding downward, trajectories largely linked to the wealth of nations.  Looking instead at velocity to see not how far, but how fast obesity is rising — or not — revealed rates that continue to climb in most low- and middle-income countries, but are flattening in most high-i...

PCOS’s new name is PMOS, a small letter change that required a big scientific process

PCOS is dead. Long live PMOS.  Revealed Tuesday, the one-letter change in nomenclature for a common metabolic condition in women may seem unremarkable, but it follows more than a decade of vigorous debate over the need for a name that more precisely and completely describes what until now was known as polycystic ovary syndrome (PCOS). Read the rest…

STAT+: In the battle of sepsis algorithms, performance alone doesn’t predict victory

Five years ago, the bottom fell out of sepsis prediction software. Hundreds of hospitals had adopted an algorithm from electronic health record company Epic that promised to alert physicians to predicted cases of sepsis, a life-threatening reaction to infection that kills more than 350,000 people in the United States every year.  The AI was a technical flop. Despite its results on paper, the technology failed to perform in the real world, and sent so many alerts that doctors tuned them out or ho...

STAT+: Capsida says it still doesn’t know what caused gene therapy death 

Capsida Biotherapeutics said Tuesday that it still had no answers in its investigation into the death of a child in a gene therapy trial last September. Its scientists’ efforts, it said, have been stymied because the hospital where the study was conducted has declined to share tissue samples from an autopsy.  The therapy, known as CAP-002, was the first of a wave of new gene therapies designed to deliver genes deep into the brain. Scientists around the world engineered viruses that could slide t...