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  • Scientists discover a powerful new antivenom hidden in rattlesnake blood

    Scientists discover a powerful new antivenom hidden in rattlesnake blood

    University of Maryland researchers have identified a promising new way to treat venomous snakebites by borrowing from snakes’ own natural defenses. Their approach uses toxin-blocking proteins that western diamondback rattlesnakes evolved to protect themselves from venom.

    By combining specific proteins found in rattlesnake blood, the researchers achieved unusually strong protection against venom from several dangerous snake species.

    The study was led by Distinguished University Professor of BiologySean B. Carroll and published in the Proceedings of the National Academy of Sciences. The findings could help researchers develop more powerful antivenoms for deadly snakebites, which remain a major health threat in some regions of the world.

    “This is one of those great stories when nature has already solved a problem we’ve been grappling with for decades,” said Carroll, who also holds the Andrew and Mary Balo and Nicholas and Susan Simon Endowed Chair at UMD.

    The Global Challenge of Snakebites

    Snakebite is considered one of the world’s most neglected tropical diseases. According to the World Health Organization, venomous snakes kill an estimated 80,000 to 140,000 people annually, while hundreds of thousands of survivors are left with permanent disabilities. Many of those affected live in rural areas where effective antivenom can be difficult to obtain.

    Existing antivenoms save lives, but they also have major drawbacks. They are typically produced by exposing large animals to snake venom and then collecting the antibodies those animals generate. Manufacturing these treatments can be costly, their quality and effectiveness can vary, and they may not work equally well against the many different toxins found in venom from different snake species. They can also cause serious immune reactions.

    Those limitations have pushed scientists to search for better options. In this case, the researchers turned to snakes themselves for clues.

    “We’ve known from anecdotes for 100 years that vipers tend to be resistant to their own venom,” Carroll said. “But for a long time, nobody knew what exactly was circulating in their blood that protected them.”

    A Natural Defense Hidden in Rattlesnake Blood

    In 2022, Carroll’s laboratory found part of the answer: a protein called FETUA-3. The researchers discovered that it could block the activity of many metalloproteinase toxins found in western diamondback rattlesnake venom. It could also bind to and inhibit toxins from the venoms of several other rattlesnake species.

    “Here was evolution’s way for snakes to protect themselves from accidental self-envenomation,” he said, which prompted a follow-up question. “Why rely on horse antibodies when nature has packaged an effective antidote right there in the snake?”

    For the new research, co-authors including Elda Sánchez, director of the National Natural Toxins Research Center at Texas A&M University-Kingsville, examined what each FETUA protein contributes to venom resistance.

    The team found that individual proteins could counter certain effects of venom. One might reduce bleeding, for example, while another could interfere with enzyme activity. However, none of the FETUA proteins on its own was able to completely prevent death from a venomous bite.

    Protein Combinations Dramatically Boost Protection

    The results changed when researchers combined several FETUA proteins. These mixtures were far more effective at blocking the harmful effects of venom than the individual proteins alone.

    Finding the best combinations is complicated because snake venom is extraordinarily complex. A single venom can contain around 100 toxin proteins belonging to multiple protein families, and venom composition differs from one snake species to another.

    “The ingredients are there,” Carroll said. “We just have to keep testing various mixtures.”

    In laboratory experiments, optimized combinations of the proteins were about 10 times more potent than the current sheep-derived rattlesnake antivenom. The mixtures completely neutralized the lethal effects of rattlesnake venom and also provided broad protection against venom from multiple viper species, including species separated by millions of years of evolution.

    “The fact that parts of these inhibitors have been perfectly conserved over 50 million years of snake evolution tells you just how real a risk this is for these animals,” Carroll said, noting that how snakes envenomate themselves, whether through mouth tissue during a bite, by eating envenomated prey, through cannibalism or all of the above, isn’t well understood.

    Toward a New Generation of Antivenoms

    The present study concentrated on metalloproteinases, one important family of venom toxins. The researchers are now using the same general strategy to target other toxin families.

    “We’re getting remarkably close to having effective solutions for the three major toxin families in vipers,” Carroll said. “What we’ve learned here, together with research we’re doing now, gives us real confidence that nature-based recombinant [lab-produced] antivenoms are within reach.”

    Carroll expects that the first commercial applications of “nature’s antivenom” could be in veterinary medicine, with treatments for human snakebites potentially following later.

    He envisions future antivenoms that protect against a wider range of venoms while also being safer, less expensive and easier to manufacture on a large scale than many current treatments.

    “We could make train cars-worth of this stuff and help solve a massive global health problem,” Carroll said. “Many of our most important medicines have come from nature. I’m delighted that the components for a better-than-commercial antivenom were in these snakes all along.”

    Along with Carroll, the UMD co-authors included Department of Biology visiting faculty specialists Fiona Ukken and Yetunde Ayinuola.

    The research was funded by the Howard Hughes Medical Institute and the Viper Resource Center (Grant #P40OD01960-22). This article does not necessarily reflect the views of these organizations.

  • Early statin use linked to 15% lower dementia risk

    Early statin use linked to 15% lower dementia risk

    Starting statin treatment soon after a type 2 diabetes diagnosis was associated with a reduced risk of developing dementia, according to research presented at ESC Congress 2026 and published in The Lancet Regional Health – Europe.

    As populations age, the number of people living with dementia is expected to increase substantially. Because there are currently no effective treatments capable of preventing or reversing most forms of dementia, researchers are increasingly focused on identifying factors that could reduce the likelihood of developing the condition.

    According to the Lancet Commission, nearly half of dementia cases could theoretically be prevented by addressing 14 modifiable risk factors. One of those factors involves managing cholesterol beginning in midlife.

    “Detecting and treating high levels of low-density lipoprotein cholesterol (LDL-C) from midlife is one such highlighted risk factor,” explained presenter, Doctor Tummas Ternhamar from Copenhagen University Hospital, Denmark.

    This issue may be especially relevant for people with type 2 diabetes. High LDL-C is common among these patients, while diabetes itself is recognized as a risk factor for cognitive decline and dementia.

    “We hypothesized that early initiation of LDL-C-lowering statins following type 2 diabetes diagnosis could be associated with a lower risk of dementia,” said Doctor Ternhamar. “And we tested this in a large nationwide study using analysis methods to emulate a randomized trial and reduce some of the bias associated with observational studies,” he noted.

    Tracking More Than 132,000 People

    Using Danish national registers, researchers identified 132,585 people who had not previously taken statins and who developed type 2 diabetes between 2006 and 2019. Participants were followed through the end of 2021, and medical records were examined for diagnoses of all-cause dementia.

    The researchers used a clone-censor-weight design to compare dementia rates according to when statin therapy began. One group did not start statins within five years of receiving a diabetes diagnosis. A second group began statins early, within one year of diagnosis, while a third began treatment later, between one and five years after diagnosis.

    During a median follow-up period of 7.1 years, 2.7% of participants developed dementia.

    Earlier Statin Use Linked to Lower Risk

    Compared with people who did not begin statin therapy, those who started statins within the first year after being diagnosed with type 2 diabetes had a 15% lower relative risk of dementia over 10 years.

    Starting treatment later was also associated with a benefit, although the association was smaller. People who began statins between one and five years after diagnosis had a 10% lower relative risk of dementia over 10 years. Similar results were observed in women and men.

    Doctor Ternhamar concluded: “In individuals developing type 2 diabetes, statins were associated with a lower risk of dementia, most pronounced in those with early initiation. Statins seem to be underused in patients with type 2 diabetes, despite their protective effects against cardiovascular disease. Our findings suggest another potentially important reason to ensure that patients with type 2 diabetes and high LDL-C receive timely statin treatment.”

    Findings Cannot Prove Statins Prevent Dementia

    The results suggest that beginning statin therapy sooner after a type 2 diabetes diagnosis may have potential benefits beyond the drugs’ established role in protecting cardiovascular health. However, because the research was observational, it cannot establish that taking statins directly prevents dementia.

    Commenting on the findings, Professor Isabel Goncalves, Member of the ESC Communication Committee, said: “People with type 2 diabetes already have a higher risk of dementia and are advised to lower cholesterol to reduce their risk of heart attack and stroke. This study suggests that starting statins soon after a type 2 diabetes diagnosis may also be linked to a modest reduction in dementia risk, with greater benefit than delaying treatment. Because statins are widely available and inexpensive, the findings are potentially important. However, this was an observational study, so it cannot prove that statins prevent dementia. The results should therefore support further research and help inform discussions between patients and clinicians.”

    This work was supported by grants from the Danish Cardiovascular Academy, which is funded by the Novo Nordisk Foundation and The Danish Heart Foundation, Herlev and Gentofte Hospital, Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond, Beckett fonden, Overlæge Johan Boserup og Lise Boserups legat and Direktør Jakob Madsens og Hustru Olga Madsens fond.

  • Cialis linked to higher glaucoma risk in large study

    Cialis linked to higher glaucoma risk in large study

    A widely used erectile dysfunction medication may be associated with a greater risk of glaucoma when taken long-term to relieve urinary symptoms caused by an enlarged prostate, according to a large comparative study published online in the British Journal of Ophthalmology.

    The findings suggest that men who use tadalafil (Cialis) over extended periods for these symptoms may benefit from closer monitoring of their eye health. Researchers say this may be especially important for people who already have glaucoma risk factors, including a family history of the disease or elevated pressure within the eye (ocular hypertension).

    Tadalafil and Eye Health

    Tadalafil belongs to a group of medications known as phosphodiesterase type 5 inhibitors (PDE5i), the same drug class that includes sildenafil (Viagra). These medications are widely used for erectile dysfunction, while tadalafil is also prescribed for urinary problems associated with an enlarged prostate.

    Previous research has connected PDE5i medications with several types of eye problems, including disorders involving the optic nerve and the macula, which is the area of the retina responsible for detailed central vision.

    However, researchers say the evidence surrounding glaucoma has remained inconsistent. In particular, relatively little is known about glaucoma risk when tadalafil is used for lower urinary tract symptoms, a treatment that commonly involves taking the medication every day over a long period.

    To investigate this question more closely, the researchers examined whether tadalafil, a long-acting PDE5i, was associated with an increased risk of glaucoma when prescribed for urinary tract symptoms related to an enlarged prostate (benign prostatic hyperplasia).

    Nearly 74,000 Men Included in the Study

    The team analyzed anonymized health information from 73,854 men aged 40 or older in the TriNetX Analytics Network (Global Collaborative Network). Half had been prescribed tadalafil or another PDE5i for up to 5 years (between January 2012 and December 2022) to manage their symptoms, while the other half had not received these medications.

    Researchers then compared the two groups to determine how often participants developed glaucoma or ocular hypertension and how frequently they began treatment for glaucoma after 5 years.

    To make the comparison more meaningful, men in the two groups were matched according to a range of factors that could potentially influence the results. These included age, ethnicity, smoking, alcohol related disorders, prescribed medications, and underlying health conditions such as cardiovascular disease, diabetes, cancer, high cholesterol, kidney function, obesity, and chronic obstructive pulmonary disease (COPD).

    Glaucoma Risk Was 22% Higher

    The analysis found that men prescribed tadalafil were significantly (22%) more likely to develop glaucoma than men who had not received the medication.

    They were also more likely to develop several related conditions. Ocular hypertension was 32% more common, while primary open-angle glaucoma, the most common form of glaucoma, was 33% more likely. Men prescribed tadalafil were also 33% more likely to begin glaucoma treatment.

    Additional analyses showed that the associations remained among men who developed glaucoma within 1, 3, or 6 months after beginning tadalafil treatment.

    The same pattern was consistently seen among patients aged 50+, White participants, and people with several of the underlying medical conditions considered in the analysis.

    Study Cannot Prove Cialis Causes Glaucoma

    The researchers caution that the findings do not establish that tadalafil directly causes glaucoma. Because this was an observational study, it can identify associations but cannot determine cause and effect.

    There were also several limitations. For example, the researchers could not account for changes in medication prescriptions or actual medication use over time, nor could they fully track the development of additional underlying health conditions during the study period.

    Most participants were White, which means the findings may not necessarily apply to men from other ethnic backgrounds.

    Even so, the researchers say the results warrant further investigation into how long-term PDE5i use might affect the eyes.

    They write: “These findings suggest that chronic PDE5 inhibition may influence ocular physiology, warranting further mechanistic investigation.”

    Researchers Recommend Eye Monitoring for Higher Risk Patients

    Importantly, the researchers are not advising patients to stop using tadalafil. Instead, they suggest that people taking the medication for extended periods may need appropriate eye screening and follow-up, particularly when other glaucoma risk factors are already present.

    They emphasize: “These findings do not contraindicate tadalafil use but highlight the importance of baseline ophthalmic assessment and regular follow-up, particularly in patients with pre-existing glaucoma, ocular hypertension, a family history of glaucoma, high myopia [short-sightedness], or those requiring long-term therapy.”

  • FDA raises bar for foreign site inspections as China trials surge

    FDA raises bar for foreign site inspections as China trials surge

    In the wake of three deaths reported in separate gene therapy trials conducted in China, U.S. lawmakers called on the FDA to reject clinical data from China unless the trial site has recently undergone an FDA audit. On Wednesday, four agency officials published an op-ed outlining steps the FDA plans to take toward strengthening oversight of foreign trial sites.

    The number of clinical trials being conducted in China has risen dramatically over the last 15-plus years. In 2010, fewer than 8% of global clinical trials were run in China, according to an April report from the National Bureau of Economic Research. By 2020, the Asian country had overtaken the U.S. in annual registered trials.

    “Accepting Chinese clinical data poses real risks for patients,” Reps. John Moolenaar (R-MI) and Ben Cline (R-VA) wrote in a letter to Acting FDA Commissioner Kyle Diamantas last month.

    The FDA will add resources to expand oversight at foreign clinical trial sites, aim to improve communication with drug sponsors and strengthen internal reviewer training to help identify clinical trial sites of possible concern, according to the agency’s editorial, which was published in FDA Voices on Wednesday afternoon. Notably, the article does not refer to any specific geographical region.

    “This is not protectionism, and it is not a geopolitical statement about any particular country’s scientific capacity,” the authors wrote. “Many foreign research institutions produce clinical data of the highest quality, and the FDA actively welcomes and relies on such data.”

    The piece was penned by Michael Davis, acting director of the Center for Drug Evaluation and Research (CDER); Karim Mikhail, acting director of the Center for Biologics Evaluation and Research (CBER); Michelle Tarver, director of the Center for Devices and Radiological Health; and R. Angelo de Claro, director of the Oncology Center of Excellence.

    Three fatalities occurring recently in Chinese clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients.

    August 21, 2026

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    Nevertheless, the op-ed comes at a time when the FDA is working to reshore early-stage clinical research. A first step to doing this, a senior FDA representative told BioSpace in a pre-publication interview, is to “modernize and improve the U.S. system”—something the Department of Health and Human Services (HHS) has begun to tackle with the rollout of Operation TrialBlazer. Announced in June, the initiative seeks to reduce the time from drug identification to Phase 1 trials and expedite early clinical development timelines by as much as a year.

    Another important step, the FDA representative continued, “is how do we make sure we have a level playing field, so there’s not sort of perception or reality that by moving outside the U.S., you are able to potentially cut corners.” That’s the focus of Wednesday’s editorial, they said, which is the first public step forward to bringing clinical sites in other countries in line with the FDA’s standard in terms of good clinical practice regulations or human subjects protections.

    A particular area of concern for the FDA is early feasibility and Phase 1 studies conducted at sites “in countries or regions where geopolitical conditions make informed consent difficult to ensure, or where documented human rights concerns create a heightened risk that consent was not freely and voluntarily given,” the authors wrote.

    The senior agency representative pointed to a situation where American biospecimens are sent to China: “Are people informed about that?”

    The authors also touched on a key theme of the Department of Health and Human Services (HHS) under Secretary Robert F. Kennedy Jr.: transparency. When the FDA identifies concerns related to human subject protection or data integrity in sites outside the U.S., the agency “will make more information from inspections publicly available, as appropriate, so that sponsors, patients, and the public can understand where deficiencies have been identified and take that into account in development plans,” according to the editorial.

    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.

    July 20, 2026

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    The FDA will also strive for active engagement with sponsors at the pre-submission stage, the authors wrote, including discussing the provenance and investigational new drug (IND) or investigational device exemption (IDE) status of foreign clinical data with sponsors early in development. This “will better position both parties to identify and address data integrity, human subject protection, and related issues prior to application review,” according to the editorial.

    The agency is devoting additional resources to help solve these challenges. “We’ve definitely increased the number of BIMO [Bioresearch Monitoring] inspectors both at our China office and . . . throughout some other global offices,” the senior representative said, adding that the FDA is also looking into other tools to expand oversight, including remote assessments and information collection requests.

    In parallel to efforts to tighten and reshore clinical research, the Trump administration has been laser-focused on bringing manufacturing back to the U.S. In an executive order in May, President Donald Trump ordered the FDA to cut down the time it takes to approve pharmaceutical manufacturing plants in the U.S., and set the groundwork for the agency to implement surprise inspections on foreign plants, instead of planned visits as is the current process.

    Increasing foreign plant inspections has “definitely been an increased area of priority,” the FDA representative said on Wednesday.

    The editorial’s tone appeared to be directed at putting drug developers on notice.

    “Sponsors should treat the inability to inspect or access all relevant data as a material factor in their regulatory strategy, not an administrative footnote,” the FDA officials wrote.

    The authors concluded their editorial with the following message to drug sponsors: “If you are building a regulatory strategy around clinical data from sites where the FDA has been unable to inspect, or from circumstances where the conditions for ethical research are in serious question, think again.”

    The U.S. is scrambling to compete with a strategically positioned China on the biotech stage as the Asian country surpasses America in biomedical research and clinical trials. So far, China is winning.

    August 31, 2026

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  • Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing

    Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing

    The U.K. has stopped allowing the use of rare autoimmune disease therapy Tavneos in new patients, becoming the latest major health regulator to act on concerns about the drug’s benefit-risk profile.

    Tavneos is sold as Avacopan Vifor in the U.K. and is marketed there by CSL Vifor. The drug was originally developed by ChemoCentryx and won FDA approval in 2021 for ANCA-associated vasculitis, a systemic disease that can lead to organ damage and failure. Amgen acquired ChemoCentryx for $3.7 billion in 2022, and the pharma remains Tavneos’ owner in the U.S.

    In a media release on Tuesday, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) said that the decision to suspend Avacopan Vifor was driven by an assessment of all available evidence for the drug, as well as concerns raised by patients and healthcare professionals regarding “the integrity and reliability of data from the pivotal clinical study underpinning the medicine’s authorization.”

    Amgen expressed disappointment with the MHRA’s decision. “We disagree with the MHRA’s decision to withdraw Tavneos from the U.K. market and are deeply concerned about the impact this decision may have on rare disease patients,” a company spokesperson told BioSpace in an email.

    “We are disappointed that the MHRA’s interpretation of the data fails to appropriately recognize the totality of evidence supporting the effectiveness and favorable benefit-risk profile of Tavneos,” the spokesperson added, pointing to real-world studies and secondary-endpoint data.

    While supply and sale to new patients is no longer allowed, CSL Vifor can still provide the drug to those who are already on Avacopan Vifor as these patients are “safely transitioned” to alternative products. The MHRA has allowed a six-month “managed withdrawal period” after which it will completely revoke the drug’s marketing authorization in the U.K.

    Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.

    July 10, 2026

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    The deadline for that withdrawal is currently set for March 1, 2027.

    Tavneos’ troubles started in January this year, when the FDA first asked Amgen to voluntarily take the drug off the market, pointing to uncertainties with how ChemoCentryx re-adjudicated the pivotal data that led to Tavneos’ approval. Amgen refused.

    The standoff has continued between the pharma and the regulator, and in recent months escalated to involve other territories and parties. Last month, the European Medicines Agency, the main health regulatory body for the European Union, pulled marketing authorization for Tavneos, likewise pointing to “serious breaches” in how the pivotal trial had been conducted. Japan earlier this year also instructed Kissei Pharmaceutical, which markets Tavneos in the country, to add new warnings to the drug alerting prescribers of risks such as liver complications and death.

    In June, The New England Journal of Medicine retracted a paper for that same study at the request of two authors. “Without the knowledge of these two authors, the primary end-point assessments in nine patients were readjudicated after database lock and trial unblinding,” the journal wrote at the time.

    Amgen has requested a hearing with the FDA over the Tavneos row. The pharma is building its defense of the drug with an independent analysis of pivotal data, supplemented by patient testimonials.

  • 9 midsize drugmakers climb aboard Trump’s MFN train

    9 midsize drugmakers climb aboard Trump’s MFN train

    Nine midsize biopharma companies have agreed to voluntarily participate in the Trump administration’s drug affordability push, pledging to bring down the prices of their products to the same level as in similarly developed countries.

    These new participants are Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals and UCB, according to a White House release on Monday. They join the 17 Big Pharmas that had previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program, for a total of 26 companies representing some 89% of the branded drug market, the White House said.

    Monday’s agreements will lower prices for medicines for chronic and rare diseases such as hemophilia, Parkinson’s, glaucoma and several forms of cancer, among other conditions.

    Aside from cutting drug costs, those nine companies have collectively committed at least $19.6 billion in near-term manufacturing investments in the U.S., the White House said. UCB, Sun Pharma, Astellas and Teva have additionally promised to contribute to the Strategic Active Pharmaceutical Ingredients Reserve, a government stockpile to protect the domestic supply of essential medicines.

    “We see a net benefit for [companies],” Truist Securities wrote in an investor note on Monday, explaining that joining President Donald Trump’s pricing programs could provide “relief from tariffs” and “exemption from liability under the mandatory GLOBE and GUARD MFN demonstrations in Medicare.”

    GLOBE and GUARD are mandatory models requiring rebates from manufacturers for certain medicines under Medicare Part B and Part D, respectively, if the prices for these drugs go above those in economically comparable countries, according to the U.S. Centers for Medicare and Medicaid Services (CMS). GLOBE is slated to start Oct. 1, while GUARD launches Jan. 1, 2027.

    Separately from these nine companies, Incyte on Monday also announced that it has entered into an agreement with CMS to improve access to the company’s Jakafi and Jakafi XR. In particular, the company has agreed to provide these products at prices “aligned” with costs in similar industrialized countries.

    In exchange, Incyte similarly expects that it will be exempt from certain pricing mandates in the future, as per an SEC filing.

    Truist doesn’t expect these pricing agreements to heavily impact the drug manufacturers that chose to participate. “For the sector, we continue to believe MFN has migrated from existential threat to a negotiated and manageable ‘cost of doing business,” the firm said. “We continue to anticipate business as usual.”

    Indeed, many of the industry’s largest companies reached similar drug pricing agreements with the government months ago and have not reported significant impacts of MFN to their businesses. These include Eli Lilly, Novo Nordisk, Amgen, Sanofi, Novartis and Bristol Myers Squibb, among others.

    Of note, Jefferies on Tuesday morning noted that Takeda, arguably the largest Japanese drugmaker, has yet to reach a drug pricing deal with the Trump administration, though negotiations are reportedly underway.

    Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.

    January 6, 2026

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  • A “quantum bath” puts quantum entanglement on autopilot

    A “quantum bath” puts quantum entanglement on autopilot

    Future quantum computers may depend on the ability to connect widely separated modules through distributed entanglement. Until now, creating this kind of connection has generally required active control and repeated measurements. Physicists at the Institute of Science and Technology Austria (ISTA) have now demonstrated a fully autonomous alternative based on a “quantum bath” made from correlated particles of light.

    Published in Physical Review X, the experiment provides the first demonstration of a prediction proposed more than 20 years ago. The approach could eventually offer a new foundation for practical quantum technologies.

    Connecting Distant Quantum Bits

    Entanglement is one of the defining phenomena of quantum physics. It allows particles or systems to share correlations that cannot be explained by classical physics. Creating distributed entanglement between physically separated qubits (quantum bits) could be important for building larger quantum computers and future quantum networks.

    Previous attempts to entangle distant qubits have generally followed one of two strategies. One method sends a single, actively controlled photon from one qubit to another. Another has each qubit emit a photon, with the two photons then matched in an effort to generate entanglement.

    The second approach was recognized by the 2022 Nobel Prize in Physics. However, it still depends on repeated measurements and post-selection, and even then, the process does not always successfully produce entanglement.

    PhD student Alejandro Andrés-Juanes and professor Johannes Fink at the Institute of Science and Technology Austria (ISTA) worked with international collaborators to develop a different solution. Their system uses a quantum bath that automatically brings distant qubits into synchronization. In a prototype device, the researchers used a shared source of correlated light particles to entangle two separated qubits, experimentally realizing an idea that had remained theoretical for more than two decades.

    Fully Autonomous Quantum Entanglement

    Quantum entanglement can take several forms. Continuous-variable entangled states can be produced efficiently and are therefore relatively accessible. They can be compared with a pendulum, whose position and momentum change continuously.

    Many useful quantum technologies, however, depend on “discrete-variable” systems. These involve ‘all-or-nothing’ forms of entanglement that stationary qubits can use. The challenge for the ISTA team was finding a way to connect these readily available continuous forms of entanglement with the discrete forms needed for practical applications.

    “In this work, we aimed to overcome this mismatch between the readily available and the practically useful forms of entanglement,” says Andrés-Juanes. “By stabilizing the entangled states remotely, our approach is fully autonomous and requires no active control or measurement.”

    A Quantum Bath Powered by Correlated Light

    Maintaining both entanglement and quantum coherence is one of the major difficulties facing quantum computing.

    The researchers addressed that problem by making the qubits’ surrounding environment itself responsible for producing and stabilizing entanglement.

    “In our method, the quantum bath — meaning the qubits’ environment — is the source of entanglement. It creates a new ground state through a continuous stream of correlated photons,” says Fink. “This way, the entangled qubit state is stabilized, even beyond the qubits’ own ‘lifetime’, and remains always available as a resource for further quantum processing. This makes the approach conceptually significant.”

    Because the entangled state remains available, researchers can access it whenever it is needed. That differs from temporary entanglement, which has to be used during the brief period when it exists.

    Microwave Photons Keep Qubits Connected

    To couple the qubits with the entangled photon source, the researchers relied on microwave photons. These low-energy light particles are especially useful for manipulating quantum information and are already central to leading superconducting-qubit technology.

    Optical photons serve a different role and are commonly used in optics and atomic physics. They may also become important for carrying quantum information between distant quantum computers through fiber optics, an area that the Fink group at ISTA is also investigating.

    Measuring the Hidden Quantum State

    The researchers needed to confirm that the two qubits were actually synchronized inside the quantum bath. To do that, they used quantum tomography, a technique that reconstructs a quantum system by examining many different ‘slices’ of its behavior.

    “Qubits can be in a superposition of states, but all these states collapse when we measure them, leaving us with a 0 or 1 state,” says Andrés-Juanes.

    Quantum tomography allowed the researchers to perform measurements lasting only 20-80 nanoseconds and use those observations to investigate the qubits’ underlying states. A nanosecond is one billionth of a second.

    A 20-Year Prediction Becomes an Experiment

    By successfully entangling two isolated qubits through a quantum bath, the ISTA researchers created a proof-of-concept laboratory prototype for the long-standing theoretical proposal.

    “We present a relatively simple method that could be scaled up to synchronize multiple distant qubits,” says Andrés-Juanes.

    The new approach is promising, but it is not yet as efficient as methods that actively control qubit states. “Our method currently transfers about 10% of the bath’s available entanglement.”

    The researchers suggest that one reason the idea took more than two decades to demonstrate is that the original theory was developed under idealized conditions that are difficult to reproduce experimentally.

    “Our experiments helped us reveal several factors that may have prevented scientists from designing a functional quantum bath using a single source of correlated photons for distributed entanglement,” says Fink.

    The prototype developed at ISTA could provide new opportunities for quantum-optics experiments. It may also contribute to efforts to expand quantum processors and ultimately move them closer to fault-tolerant operation.

  • China poses increasing security risk as US biotech innovation edge erodes

    China poses increasing security risk as US biotech innovation edge erodes

    When China surpassed the U.S. six years ago in terms of the number of clinical trials and in natural science publications soon thereafter, the surges were shots across the bow for the American research-industrial complex, according to some observers. Since then, the U.S. has also fallen behind the Asian nation in R&D funding and translational science—potentially putting the country at risk in the event of a geopolitical crisis.

    “China’s approach has been to steal, scale and strangle American competitors in this space,” Caitlin Frazer, executive director of the National Security Commission on Emerging Biotechnology (NSCEB), told BioSpace. “We have to start thinking about what it means if we so erode our innovation base here in the U.S. that we are dependent on a potential adversary for life-sustaining medications.”

    The NSCEB is a short-term task force that was created by Congress in 2022 to review where national security could be threatened by China’s newfound dominance and recommend potential remedies that could put the U.S. back on top.

    The battle between the U.S. and China for global superpower supremacy has spilled over in recent years to the biotech industry. Chief among those concerns is genetic data transfer, or the possibility that Americans’ genetic information and clinical data could be accessible by the Chinese government, according to a recent publication in The Economy. Further, running early clinical trials in China means a hit to the U.S. economy, and the potential for Chinese patients to secure access to novel medicines before Americans.

    “The U.S. has long been the leader in biotechnology innovation in many ways,” Frazer said. “Modern biotechnology is an American invention, and many of the platforms and tools that biotechnologists across the world rely on were innovated in labs here.”

    But China has taken advantage of a U.S. system that has increasingly become less likely to reward biotech innovators, Frazer warned, and “we have struggled to scale and commercialize those innovations coming out of American labs.

    “The result of that,” she continued, “is that China principally, but other countries more broadly, have built the manufacturing capacity to scale the inventions created there.”

    And now, she added, China is also threatening to overtake the U.S. in basic science research, where canceled grants and budget cuts have crippled dozens of programs. “What’s changing now is that in addition to being out-manufactured, we are at risk of being out-innovated,” Frazer said.

    China’s ascendance in early-stage biotech is “a call to action” for the U.S. to retain its position as a global leader, Seema Kumar, CEO of healthcare innovation coalition Cure, told BioSpace.

    “It’s not just academia, and it’s not just biotech—everybody has skin in the game,” she said.

    Frazer pointed to other tech sectors in which the Chinese government wields supply chain power, such as critical minerals, that help foster geopolitical leverage for the Asian nation.

    When it comes to life sciences, Frazer described the risk bluntly: “The actual discovery of a blockbuster cancer drug, a no-kidding cure for cancer, to be innovated and manufactured in China and therefore to be under the control of the [Chinese Communist Party].”

    NSCEB’s findings

    China has taken advantage of U.S. stagnation in fundamental science research to build a thriving biotech infrastructure that makes it difficult for the U.S. to compete, Frazer said. She specifically pointed to “a 20-year strategy by the Chinese government to dominate in biotechnology,” using regulatory reforms to streamline and bring its system in alignment with international standards. The NSCEB report calls China’s approach “economic warfare.”

    To respond and foster a thriving U.S. biotech environment, NSCEB in its April 2025 report recommended streamlining regulation to more quickly move products from lab to market; treating biological data as a strategic national resource; and building physical manufacturing infrastructure for fledgling companies to cross the so-called valley of death of drug development. On the funding side, the commission advised empowering the government to invest in the private sector through taxpayer-backed, VC-like entities alongside market commitment agreements that would make the government a first consumer of biotech products.

    It’s a “run-faster agenda,” Frazer said, designed to reestablish U.S. leadership in the space through regulation, data, infrastructure and investment.

    The NSCEB is also exploring ways in which the U.S. can actively push back against China’s advantage, Frazer said. The commission, which will wrap up operations by the end of the year, is currently conducting an investigation into Chinese subsidization and pricing practices that undercut American competitors.

    The group is also seeking out points of failure in the supply chain that make U.S. companies reliant on a Chinese supplier or service provider without an alternative. One piece of legislation already in place to combat such reliance is the BIOSECURE Act, signed into law in December 2025. Though the final bill did not name specific firms as previous iterations had, it did blacklist “companies of concern” in China that lawmakers deemed to pose national security risks.

    In terms of the U.S. regulatory environment, Frazer said the FDA needs to move more efficiently through risk assessment of products where the science is familiar and devote more agency time and resources to creating clear, durable pathways for the regulation of novel products where the science is not yet as well understood, such as rare diseases with smaller patient populations.

    This comes down to predictability and transparency, she said, with an emphasis on the FDA sticking to timelines and communicating questions and concerns with drug sponsors in a timely manner. She pointed to Phase 1 trial initiation as a particular sticking point for the FDA, resulting in a competitive edge for countries like China and Australia, and the agency is now taking steps to address this concern. This summer, the FDA launched a handful of initiatives under the Department of Health and Human Services’ broader Operation Trialblazer Initiative aimed at streamlining investigational new drug applications and first-in-human trials.

    The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.

    August 3, 2026

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    9 min read

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    On a grander scale, though, Frazer emphasized the need for a master plan—something she said has so far been missing. “There has not been a durable national strategy that persists from administration to administration” to support the U.S. biotech industry and protect it from dependence on China.

    China, on the other hand, “runs the country as a company,” said Insilico Medicine CEO Alex Zhavoronkov. He describes five-year plans that detail “which areas are going to get funding and with which performance indicators.” In the U.S., meanwhile, diversifying priorities are diluting the country’s biotechnology dominance, he said.

    Also part of the challenge is that the biotech industry’s long timelines don’t jibe well with the U.S. political system, Frazer noted. “It can take 10 years to bring a product to market, and that’s five election cycles in the House of Representatives, or two and a half presidencies.”

    Since the NSCEB report came out last year, however, 36 of the commission’s numerous recommendations have seen bipartisan legislative action, according to Frazer. Some of this action has come through Congress, she added, while nine of the commission’s recommendations have been included in White House executive orders.

    “Congress is now seizing the opportunity to legislate on these issues in a bipartisan way, which is something we have historically not seen here in the U.S.,” Frazer said.

    But the U.S. still lacks that critical national biotech strategy to combat China’s rise, she added—and corralling the industry to join in that effort could be another challenge altogether.

    An industry torn

    Most life science professionals project that China will continue to outpace the U.S. In a recent survey conducted by Cure, 72% of senior U.S. industry and academic leaders said China’s biomedical sector is improving at a faster pace than that of the U.S., and 85% said the U.S. will lose its lead within 10 years.

    Biotech leaders have expressed to the NSCEB that the ability to run a clinical trial more quickly and cheaply in China, resulting in quicker access to first-in-human data, is attractive, according to Frazer. While the same leaders are also concerned about the erosion of U.S. clinical trials and what that means for long-term competitiveness, China is increasingly viewed as a place to innovate, not just to manufacture, she said.

    It’s something the Chinese system has been hammering away at for decades, BDO Life Sciences National Leader Brad Stewart told BioSpace.

    “In China, they work very quickly with access to capital and lower costs, and what they’re paying for workers, for land, for power, for everything, is lower—plus they’ve got great access to talent,” Stewart said. In contrast, the regulatory system in the U.S. is “very slow-moving,” he said, “so you can see why companies are able to get into clinical work quickly and just move at a faster pace in China, and time is money.”

    While Operation Trialblazer aims to expedite early-stage trials, the regulatory bodies involved in clinical research are just one pinch point. The medical sites that administer trials are also a part of the bureaucracy.

    The U.S. remains the largest healthcare market in the entire world “without question,” Stewart said, but that long history of legacy systems and bureaucracy has made it a relatively slow-moving machine. “The Chinese system seems more built for purpose as opposed to one built on many decades of regulation.”

    The biopharma industry therefore often sees China as an arena worth exploring. Several deals have been struck between U.S. and Chinese drugmakers since the beginning of 2025, including recent ones between Pfizer and China’s Innovent Biologics, and Bristol Myers Squibb and Hengrui Pharmaceuticals, each with more than $10 billion on the line.

    From a global perspective, China’s rise is “great for biotech,” said Alex Zhavoronkov, CEO of Insilico Medicine, whose AI-based drug discovery company has conducted extensive business in the country.

    Zhavoronkov looks to companies like SpaceX and Tesla as exemplars for the global biotech sector making inroads in China. “We are not a China-based company, but we want to fiercely compete there and also use China as a platform—Elon [Musk] provided us with a great playbook for doing that,” Zhavoronkov told BioSpace.

    This month, Insilico re-upped with China Medical System Holdings to develop neuroscience and autoimmune candidates. Insilico listed on the Hong Kong stock exchange late last year.

    I think it’s immoral to restrict collaboration in biotech. If the U.S. wants to compete, the best way to do that is to deregulate.

    Alex Zhavoronkov, CEO of Insilico

    Zhavoronkov thus vehemently disagrees with efforts to restrict U.S. companies from working with Chinese firms. “The objective of the biotechnology industry is to make drugs cheaper, faster, better and with a high probability of success to serve patients,” he said. “I think it’s immoral to restrict collaboration in biotech. If the U.S. wants to compete, the best way to do that is to deregulate.”

    Norstella, a company that builds AI to facilitate clinical trial planning, similarly sees China’s biotech rise as an opportunity and advises clients to go wherever they can to build a program that will move as quickly as possible.

    “We’re agnostic in terms of whether that’s in the U.S. or China, and certainly if you’re looking at where Phase 1 clinical trials have been able to start up and enroll and give preliminary data quickly, that’s in China,” said Daniel Chancellor, Norstella’s VP of Thought Leadership. “China is now running three times as many Phase 1 clinical trials as the U.S., and that’s with good reason.”

    Daniel Hanley, founder and director of the BIOS Clinical Trial Coordinating Center at the Johns Hopkins School of Medicine, pointed out the security risk for the U.S. in this scenario, however. “We should be worried that a parallel system may exist that could be co-opted in a time of stressed competition,” he said.

    Frazer was more stern in her warning. “With the trajectory that we are on, we believe the U.S. is at risk of falling behind in the next couple of years, and we may never recover from that.”

  • Common supplements rival antibiotics for severe gum disease

    Common supplements rival antibiotics for severe gum disease

    A combination of omega-3 and low-dose acetylsalicylic acid (ASA) performed about as well as antibiotics in a yearlong study of people with severe periodontitis, raising the possibility of an alternative treatment for some patients.

    The research was conducted by scientists affiliated with Albert Einstein Israelite Hospital, Guarulhos University (UNG), the University of Taubaté (UNITAU), and the Ribeirão Preto School of Dentistry at USP (FORP-USP) in Brazil, along with Harvard University in the United States. The findings were published in the Journal of Periodontology.

    Researchers say the results could eventually help reduce antibiotic use in selected patients, an important consideration as bacterial resistance becomes an increasingly serious global health problem.

    Severe Periodontitis Can Damage Bone and Teeth

    Supported by FAPESP (projects 20/05874-2 and 20/05875-9), the clinical study included 109 people with advanced periodontitis who were followed for one year.

    Periodontitis is a chronic inflammatory disease that develops when bacteria accumulate below the gumline and damage the tissues that hold teeth in place. In advanced cases, the disease can destroy supporting bone, loosen teeth, and eventually cause tooth loss.

    “Patients with severe disease have very deep pockets, which act as reservoirs for bacteria associated with the disease. It’s a very challenging condition to treat,” says dental surgeon Nídia Cristina Castro dos Santos, the first author of the study and a professor and researcher at Einstein.

    Researchers Compared Four Treatment Strategies

    The participants were randomly divided into four groups. Everyone received subgingival instrumentation, popularly known as scaling, which is a standard treatment for periodontitis. The procedure removes bacterial deposits and other material from below the gums.

    What differed among the groups was the additional treatment they received.

    Participants in the control group were given placebo versions of the antibiotics, omega-3, and ASA, packaged in capsules that looked like the active treatments.

    A second group received the antibiotics metronidazole and amoxicillin. This combination has some of the strongest scientific evidence supporting its use in severe periodontitis. Patients took the antibiotics three times per day for 14 days.

    A third group received three grams of omega-3 each day along with a daily dose of aspirin for six months.

    The fourth group received both approaches, taking antibiotics for two weeks while also following the omega-3 and ASA regimen for six months.

    Researchers assessed the participants again after three, six, and twelve months.

    Omega-3 and Aspirin Nearly Matched Antibiotics

    After one year, about 58% of patients treated with antibiotics had reached the clinical target established by the researchers. That goal was defined as having no more than four remaining deep periodontal pockets.

    The omega-3 and ASA group achieved a nearly identical result, with 57.7% of participants reaching the same target.

    The difference compared with standard treatment alone was substantial. Among patients who received scaling plus placebo, only 23.1% met the clinical goal.

    Surprisingly, using antibiotics together with omega-3 and ASA did not produce any additional benefit over either strategy alone.

    “The use of antibiotics isn’t considered the gold standard of treatment. Although metronidazole and amoxicillin yield good results in the most severe cases, their use should be evaluated on a case-by-case basis due to risks related to bacterial resistance and possible adverse effects,” says Castro dos Santos.

    Earlier Research Pointed to Omega-3’s Potential

    The findings build on previous work examining omega-3 and inflammation in periodontal disease.

    In an earlier FAPESP-supported study published in Scientific Reports, researchers found that omega-3 supplementation reduced inflammation and bone loss associated with periodontal disease in rats. The effect was particularly noticeable when supplementation was combined with physical exercise.

    Because that research used an animal model, it could not establish whether the same effects would occur in people. However, it provided evidence that omega-3 might influence inflammatory processes involved in oral disease.

    Helping the Body Resolve Inflammation

    According to Castro, omega-3 works differently from conventional anti-inflammatory medications.

    Rather than simply blocking particular inflammatory pathways, omega-3 can contribute to the production of molecules that help the body naturally bring inflammation to an end and promote tissue repair.

    Low-dose ASA was included because it can enhance the production of these inflammation-resolving molecules. Researchers therefore suspected that combining omega-3 with ASA might help the body gain better control over the persistent inflammation associated with periodontitis.

    “We imagined that the combination of antibiotics and omega-3 would be most effective in controlling periodontitis in these patients. We also believed that the results for the group that used omega-3 with ASA would be slightly lower than those for the antibiotic group. The result was surprising because the two therapies performed very similarly, paving the way for it to become a treatment option for these patients,” says Castro.

    Benefits Continued After Treatment Ended

    The researchers were also struck by how long the apparent benefits lasted.

    Participants who had taken omega-3 and ASA continued to show results similar to those seen at the end of treatment even six months after supplementation had stopped.

    According to Castro, the persistence of the effect raises the possibility that changing the way the body responds to inflammation could produce longer-lasting benefits. Researchers are still investigating exactly how this might happen.

    For dental surgeon Magda Feres, the lead author of the study and a full professor at the Harvard School of Dental Medicine and the Graduate Program in Dentistry at UNG, the results suggest that targeting the inflammatory response could provide another option for certain patients.

    “The combination of omega-3 and low-dose aspirin achieved clinical benefits comparable to those of the metronidazole and amoxicillin protocol, opening up a real alternative for those who can’t take antibiotics, especially patients with allergies or intolerance to these medications,” she says.

    A Possible Way to Reduce Antibiotic Use

    The potential to treat some cases without antibiotics is particularly relevant because antibiotic resistance is considered one of the major threats to global public health.

    When bacteria are repeatedly exposed to antibiotics, strains that can survive the drugs may spread, making infections more difficult to treat. Reducing unnecessary antibiotic use is therefore an important public health goal.

    “Demonstrating that it’s possible to treat severe periodontitis by modulating the body’s own response is new and relevant information that helps preserve antibiotics for when they are truly indispensable,” says Feres.

    More Evidence Is Needed

    Despite the promising results, the researchers stress that omega-3 and aspirin should not yet be viewed as a routine replacement for antibiotics in severe periodontitis.

    The clinical trial included patients who did not have significant systemic or oral diseases. Additional studies will be needed to determine whether the findings hold true in broader and more diverse populations, and to establish which patients are most likely to benefit from each treatment strategy.

    Researchers are also conducting microbiological analyses to understand what happens to bacteria inside periodontal pockets during treatment.

    Preliminary findings suggest that the therapies may reduce bacterial species associated with periodontal disease while increasing microorganisms linked to healthier gums.

    “It’s an important step forward, but not the end of the story. Therefore, the message is one of cautious optimism: we have a promising, scientifically plausible alternative to antibiotics in select cases. Routine replacement will require more evidence,” she concludes.

  • IBM quantum computer solves classically intractable problem in 15 minutes

    IBM quantum computer solves classically intractable problem in 15 minutes

    Scientists used a new error correction strategy to encode 70 logical qubits and tackle a problem considered classically intractable.

    The quantum computation was completed in about 15 minutes, while leading classical computing methods would require an impractical amount of time to perform the same task.

    IBM and researchers at the University of Chicago have announced a quantum computing demonstration that meets key criteria for quantum advantage. The experiment performed a calculation beyond the practical reach of leading classical simulation techniques while also providing evidence that the quantum computer produced a reliable result.

    In a new paper, “Sampling hard circuits with verifiably high fidelity,” the researchers describe how they achieved both goals using a newly designed form of encoded quantum circuit. The work represents one of the largest demonstrations of logical quantum computing reported so far.

    The circuits and experimental results have also been made publicly available through the Quantum Advantage Tracker.

    Why Quantum Results Are So Difficult to Verify

    Researchers have long used a benchmark called random circuit sampling (RCS) to explore whether quantum computers can outperform conventional machines.

    In simplified terms, RCS challenges a quantum computer to generate patterns that become so complicated that a classical computer cannot efficiently reproduce them. That makes the benchmark useful for testing the limits of classical simulation.

    But it also creates a major problem. Once the quantum calculation becomes too difficult for a classical computer to reproduce, verifying that the quantum machine actually produced the correct result becomes increasingly difficult as well. Eventually, checking the answer can itself become infeasible unless researchers make strong assumptions about how the quantum computer behaves internally.

    The IBM and University of Chicago team approached this verification problem by developing a more structured alternative to RCS.

    The researchers showed that their method preserves the same computational hardness criteria associated with RCS, meaning the problem remains extremely difficult for classical computers. At the same time, the added structure allows errors to be detected during the quantum computation.

    “Verification remains one of the biggest challenges in firmly establishing experimental quantum advantage,” said Bill Fefferman, Associate Professor at the University of Chicago. “This experiment develops techniques to better characterize the fidelity of hard quantum states under noise, increasing confidence that the quantum computer is solving a computationally hard problem.”

    Soumik Ghosh, PhD student in Fefferman’s group at the University of Chicago, added, “Beyond strengthening experimental validation, advances in verification have the potential to unlock practical applications for the next generation of quantum computers.”

    70 Logical Qubits With Lower Error Rates

    The experiment also included one of the world’s largest-known demonstrations of quantum error correction.

    The researchers operated 70 logical qubits. Unlike individual physical qubits, logical qubits are encoded in a way that helps protect quantum information from errors and noise.

    Using those logical qubits, the team carried out 2,415 logical two-qubit operations and 468 logical “T gates,” two measures that reflect the complexity of the quantum circuit.

    The encoded design significantly improved reliability. Effective logical error rates were 10 times lower than the underlying physical error rates, allowing the circuit to maintain unusually high fidelity even while performing a large number of quantum operations.

    IBM Says Quantum Advantage Has Entered a New Stage

    “We are now firmly in the quantum advantage era,” said Jay Gambetta, Director of IBM Research and IBM Fellow. “We have demonstrated a quantum computation beyond the practical reach of classical computers that establishes, with statistical confidence, a lower bound on how faithfully it was executed. This milestone gives scientists, developers, and businesses a new foundation for trusting quantum computers as they scale to problems far beyond what we can achieve classically.”

    The researchers found that many leading classical simulation methods would face prohibitive runtimes when attempting the same task.

    The IBM quantum computer, by comparison, completed the computation in approximately 15 minutes.

    A Step Toward Larger, More Trustworthy Quantum Computers

    Speed alone is not enough for quantum computing to become useful at larger scales. Researchers also need ways to suppress errors and establish confidence that a quantum system produced a valid result.

    This experiment advances both goals at once by combining large-scale logical quantum computing with a method for evaluating the reliability of a calculation that is already beyond practical classical simulation.

    Error correction and trustworthy verification are considered essential for scaling quantum computers toward more difficult problems, making the new demonstration an important step toward that goal.