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Paper Mills and the Fight Against Scientific Fraud

Scientific publishing is facing a growing challenge from fabricated research produced by industrial-scale paper mills. But researchers and publishers are fighting back through technology and collaboration to protect the integrity of the scientific record.

Scientific publishing is based on the trust that the data are real and that peer review ensures quality. But that trust is being eroded by commercial enterprises known as paper mills—coordinated commercial operations that sell authorship slots in fraudulent or manipulated manuscripts, then submit those manuscripts to journals.

Unlike traditional misconduct, these are not lone researchers cutting corners but businesses producing research at scale, often tailored to meet the demands of specific fields, journals, and career incentives.

A recent analysis of almost 19,000 online adverts for paper mills revealed authorship slots being sold for between $36 to $5,600 depending on the position of the slot, highlighting how commercialized the market is. The average for a first author position was $1,030 and, although the study did not examine which adverts resulted in published papers, another investigation traced approximately 1,000 authorship adverts to more than 400 published papers.

The magnitude of the problem is difficult to estimate. A 2022 report by the Committee on Publication Ethics (COPE) and the International Association of Scientific, Technical & Medical Publishers (STM) found that the percentage of suspect papers submitted to journals was around two percent overall but increased sharply to as high as 46% in journals targeted by paper mills.

The pressure to publish

Adrian Barnett
Adrian Barnett, PhD
Professor
Queensland University of Technology

For honest researchers, it might be difficult to understand why paper mills even exist. At the heart of the issue is what Adrian Barnett, PhD, a professor in the Australian Centre for Health Services and Innovation at Queensland University of Technology, described as the “publish or perish” phenomenon.

“If I could do one simple thing tomorrow, I would ban all the university league tables,” said Barnett. “They’re just encouraging corruption.” Ranking systems that prioritize publication volume can push researchers toward quantity over quality, making paper mills an easy way to meet expectations.

Furthermore, publication is often not just a measure of success but a requirement for career progression. “For the clients, it’s believed that they need publications that they can’t achieve through their own efforts, either because they don’t have the time, the facilities, the training, or the money to do research and yet, for whatever reason, their employers expect them to,” explained Jennifer Byrne, PhD, a professor of molecular oncology and lead of the Publication and Research Integrity in Medical Research group at the University of Sydney.

Jennifer Byrne
Jennifer Byrne, PhD
Professor
University of Sydne

Byrne has published extensively about paper mills and publication integrity; she got into the field accidentally when she came across some papers about a gene that her team discovered many years earlier. “In 2014–2015, we realized that five or six different groups suddenly published very similar papers about this gene in different journals,” she said. “And I just thought, that doesn’t really make a lot of sense.”

Upon investigation, Byrne found that the papers, and a further 48 similar publications, showed features consistent with mass production. She has since proposed that human gene research in general is highly vulnerable to paper mills. “You can hide fake research quite effectively in experimental fields, because it’s very difficult and time-consuming to reproduce experimental studies,” she said.

Why paper mills matter

Aside from the obvious fraud, paper mills are problematic for several reasons. Byrne describes them as “a billion-dollar problem” with few resources devoted to tackling it. And although she and others have advocated for scaled investments, progress so far has been slow.

The publishing system can also reinforce the problem. Paper mills are profit-driven, but journals also benefit through article processing charges and citations, creating what Byrne describes as a “circle” in which “everyone gets what they want.”

The consequences of paper mill papers being published can influence real research. The papers are cited, reused, and built upon, wasting both time and money for all involved.

More broadly, the erosion of trust can drive researchers away from entire fields. In Byrne’s case, she stopped doing preclinical cancer research. “I left because there were a lot of papers that I couldn’t trust. When you get to the point where you can’t trust most of the recent literature, it’s very difficult to continue,” she said.

There are also more sinister risks. Barnett recalled reports of paper mills exploiting their clients, including instances of potential blackmail. “If you’ve been a regular customer and then you suddenly stop, they might try and squeeze more money,” he said. “They’ve got absolutely no scruples.”

Despite these impacts, deterrents are limited. “There are almost none,” said Byrne.

Retractions are often slow, meaning damage is done before action is taken, and retraction rates are far below where they should be.

In an April 2026 report to a U.S. Congress hearing on the state of scientific publishing, Kate Travis, managing editor of Retraction Watch, showed that the retraction rate was around 0.2% in 2025, up from 0.02% in 2016. Yet, the report states that Retraction Watch “are confident that the rate […] should be about two percent—10 times what it is today.”

How to tackle the problem

Concerns about problematic papers are often raised by individual researchers or so-called science sleuths on platforms such as PubPeer. Although they have become skilled at spotting telltale signs of a paper mill, like manipulated images, distinct layouts, author affiliations that might not match the topic of the paper, unusual patterns of coauthors, and fake peer reviews, it is difficult for the untrained eye to detect problems from a single paper.

This is why there have been calls for increased awareness. “Awareness is always the first step,” said Byrne, who is working with The Lancet–World Conferences on Research Integrity Foundation commission to address critical issues related to research integrity.

Efforts to extend awareness are also being coordinated through initiatives such as United2Act, which brings together stakeholders from research institutions, publishers, sleuths, and universities to develop shared guidance and educational resources.

But even with greater coordination, human detection has limits. As paper mills scale, automated tools are becoming essential.

Earlier this year, Barnett, Byrne, and colleagues published a paper in the BMJ showing that their large language model (LLM) could flag papers suspected of being from paper mills by analyzing sentence-level patterns. The model identified 9.9% of more than 2.6 million cancer research papers for further review. Many of the papers were linked to regions with strong publication incentives, including China.

However, Barnett emphasized that the model “is not a 100% proof, it’s a quick and simple flag that should encourage reviewers to look at those papers and look for other signs of paper mill activity.”

Other paper mill detection technologies are also available. Platforms such as Clear Skies, which is used by the STM Integrity Hub, use machine learning to detect patterns across large bodies of literature, while image-forensics tools and cross-publisher data sharing help identify duplicated figures and submissions.

Alongside these tools, Barnett suggested that researchers may increasingly need to provide a “breadcrumb trail,” through preregistration of hypotheses and transparent workflows to demonstrate the authenticity of their work.

Platforms such as PubPeer and Retraction Watch also play a role, enabling researchers to flag concerns and share evidence about suspect papers after publication. These flags then prompt journal retractions and investigations, making it a critical component in the fight against paper mill activity.

A call for tighter regulation

Aside from technology, Byrne would like to see tighter regulation for the commercial publishing industry, akin to something like the ISO 9001 quality management standards that have been widely adopted across industries like manufacturing, engineering, and healthcare.

“We need a regulatory framework that rewards journals that do the right thing and that care about publishing quality,” she said. “And we need to disincentivize the current commercial drive towards publishing anything for money.”

Byrne believes that funders and researchers should be demanding these standards. “They pay for the research, the journal subscriptions, the article processing charges, and give their research for free,” she said. “They don’t ask anything in return, in terms of quality standards, and that’s unacceptable.”

Marie Soulière
Marie Soulière, PhD
Elected Trustee
COPE

Marie Soulière, PhD, an elected trustee of COPE and chair of the COPE Paper mill Working Group, acknowledged that “a standard such as ISO 9001 could help with process consistency, documentation, and accountability.” But she said, “it would not be a direct solution to publication fraud or paper mills” and “would need to sit alongside integrity-specific controls, not replace them.”

How publishers are responding

Publishers are increasingly shifting from isolated responses to coordinated action. Initiatives like the STM Integrity Hub and United2Act are driving cross-industry collaboration and shared detection approaches.

Soulière said that several recommendations from the COPE/STM 2022 “have been put into practice, particularly around cross-publisher collaboration, shared screening approaches, and investment in integrity infrastructure.”

A central strategy, highlighted in a publication from the United2Act working groups, uses the “Swiss Cheese Model,” a move toward layered screening that combines tools such as plagiarism screening, image forensics, citation analysis, and author verification. “Each safeguard has limitations, but multiple checks together make it harder for fraudulent papers to pass through,” said Soulière.

Adya Misra
Adya Misra, PhD
Associate Director
Sage

Publishers are also strengthening internal processes. As Adya Misra, PhD, associate director of research integrity at Sage, described: “Our research integrity team acts centrally to support editors and internal journal teams with both prevention of suspicious or problematic research and the correction of the scholarly record … in line with COPE guidance.”

A spokesperson for Taylor & Francis highlighted their work on external collaborations designed to address the root causes of integrity issues. They are partnering with the National Science Library at the Chinese Academy of Sciences to develop research integrity and publishing ethics training programs, designed to ensure that students and researchers at all levels receive adequate support and to help them avoid exploitation by unethical third-party services such as paper mills.

AI changes the game

Even as safeguards improve, artificial intelligence (AI) is moving the goalposts. Many current detection strategies were developed to target structured forms of fraud; template-driven papers, recycled images, and repeated patterns across manuscripts. But these signals are beginning to disappear. “Our system worked because the paper mills would have a template, but now with AI, there is no template,” said Barnett. “It’s going to absolutely change everything.”

Barnett and his colleague Matt Spick, PhD, a lecturer in health and biomedical data analytics at the University of Surrey, recently demonstrated this by generating a complete scientific paper in just under 30 minutes using publicly available data and the OpenAI platform PRISM.

“All we did was give it the dataset and said write a paper for an Elsevier journal,” Barnett explained. “If an honors student had given me this paper, I would have been pretty pleased.”

Health engineer working at a 3D printing laboratory
Credit: Hispanolistic / Getty Images

Paradoxically, AI could also be bad news for paper mills as people realize they can create the papers themselves at little to no cost.

Reasons for cautious optimism

With AI adding to the challenges that publishers and researchers already face, the future could appear bleak. Barnett recalled an analogy describing the AI problem as an oil spill in a digital ocean, “We don’t know how deep it is, can’t get to the bottom of it, and it’s very difficult to clean up.”

Even removing a single problematic paper can require significant time and effort, while thousands more remain undetected. But Byrne remains positive that the work being done can have an impact.

“I’m actually really positive, because I think the biggest thing is awareness,” she said, noting that when she gives talks, she asks if the audience has heard of paper mills. “In 2023, that might have been five percent of people, and yet by 2025 it had increased to 30%–50%,” she said.

Soulière added that increased collaboration and transparency within scholarly publishing is another positive takeaway.

“Publishers, editors, institutions, and other stakeholders are no longer treating these issues as isolated problems,” she said. “They are investing in stronger screening systems, clearer policies, and better cross-sector coordination. In that sense, this moment is also driving progress and innovation.

“While the risks are serious, the response from the sector shows that trust can be reinforced, and that the system is becoming better equipped to detect problems earlier and protect the scholarly record more effectively,” Soulière concluded.

 

Laura Cowen is a freelance medical journalist who has been covering healthcare news for over 10 years. Her main specialties are oncology and diabetes, but she has written about subjects ranging from cardiology to ophthalmology and is particularly interested in infectious diseases and public health.

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StockWatch: Abivax Survives a Roller Coaster Week

More acutely than most companies, Abivax (Euronext Paris and Nasdaq: ABVX) felt firsthand the ups and downs of the proverbial stock market roller coaster this past week as investor fears over safety signals associated with the French biotech’s late-stage ulcerative colitis (UC) drug candidate briefly overshadowed its positive Phase III clinical results.

Shares of Abivax skidded on June 2, the first trading day after the company announced positive topline results from the Phase III ABTECT maintenance trial (NCT05535946), which is assessing obefazimod in adults with moderately to severely active UC.

Abivax’s stock plummeted after analysts from Jefferies, Morgan Stanley, Truist Securities, and Wedbush Securities raised as a safety concern a portion of data showing malignancies in nine patients among the 580 enrolled in the study. Jefferies reacted the strongest among the firms, downgrading Abivax’s stock rating from “Buy” to “Hold” and lowering its 12-month price target on the company’s shares 44%, from $160 to $90.

“Cancer signal complicates matters,” Faisal Khurshid, a managing director and equity research analyst with Jefferies, wrote in a research note. “Promise of the drug is to deliver strong efficacy w/ oral convenience and w/out JAK safety baggage. However, cancer cases seen in maintenance break our thesis. Even if proven to be not drug-related or v[ery] low incidence, we expect an overhang to investor interest, strategic optionality, and commercial uptake.”

Wedbush analyst David Nierengarten upgraded Abivax on the overall ABTECT data, from “Underperform” to “Neutral,” though he lowered the firm’s target price 18%, from $110 to $90. But he also cautioned, according to published reports, that the data increase the risk of obefazimod being approved with a black box warning on its label.

The other two firms lowered their price targets as well:

  • Morgan Stanley (Judah Frommer)—Down 9% from $145 to $132, maintaining its “Overweight” rating.
  • Truist (Greg Renza)—Down 4% from $140 to $135, maintaining its “Buy” rating.

Of the nine patients diagnosed with malignancies, seven received the higher 50 mg dosage of obefazimod, one the lower 25 mg dose, and one placebo. Squamous cell carcinoma cases were seen in three of the patients—one dosed at 25 mg, the others 50 mg. Basal cell carcinoma cases emerged in two 50 mg patients and one placebo patient, while cases of prostate cancer, breast cancer, and colonic dysplasia were seen in one patient each, all dosed at 50 mg.

In its announcement of the ABTECT data, Abivax stated that the prostate, breast, and colon cancer cases “were considered unrelated to treatment by investigators.” Among the squamous cell and basal cell cases, two of the four 50 mg patients were deemed “not/unlikely related to drug,” while of the remaining two cases, one had a medical history of skin cancer, the company added.

Swinging negative, then positive

Yet the cancer and pre-cancerous cell cases nevertheless led investors to sell off their Abivax shares on June 2. Abivax’s ordinary shares traded on Euronext Paris plummeted 44% from €111.80 ($128.81) to €63.10 ($72.70), while the company’s American depositary shares (ADSs) traded on the Nasdaq Global Market also plunged 44% from $129.69 to $72.50.

No sooner did Abivax shares start to free-fall, however, than a more positive narrative emerged among another set of analysts. They cited the ABTECT maintenance study’s overall positive findings, which showed that both doses of the first-in-class miR-124 enhancer met the study’s primary endpoint by showing positive absolute clinical remission rates of 50.8% for the 25 mg dose and 51.3% for the 50 mg dose. Both results blew away the 10.4% absolute clinical remission rate of placebo.

When adjusted for placebo, obefazimod showed placebo-adjusted clinical remission rates of ∆39.3% for the 25 mg dose and ∆40.3% for the 50 mg (both p<0.0001).

Obefazimod also met all of ABTECT’s key secondary endpoints, including endoscopic improvement, endoscopic remission, histologic-endoscopic mucosal improvement  (HEMI), corticosteroid free clinical remission, and sustained clinical remission.

In endoscopic remission, Abivax showed in an investor presentation, obefazimod showed placebo-adjusted endoscopic remission rates of 38% (50 mg) and 31% (25 mg), outperforming nine marketed drugs that carry indications in UC—which ranged from 8% by both Omvoh® (mirikizumab-mrkz) marketed by Eli Lilly (NYSE: LLY) and  Skyrizi® (risankizumab-rzaa) marketed by AbbVie (NYSE: ABBV), to 20% shown by AbbVie’s Rinvoq® (upadacitinib), Tremfya® (guselkumab) marketed by Johnson & Johnson (NYSE: JNJ), and Velsipity® (etrasimod) marketed by Pfizer (NYSE: PFE).

“While most therapies cluster in the 8% to 20% range, obefazimod stands alone at 31% and 38%, demonstrating a level of efficacy that is well beyond the range achieved by other treatment classes. This finding is particularly important because achieving endoscopic remission has been consistently associated with lower relapse rates and better long-term patient outcomes,” Abivax CEO Marc de Garidel said June 1, addressing analysts during a conference call held to discuss the ABTECT study results.

He also cited Abivax’s Phase IIa/IIb open-label extension study (NCT05177835), designed to assess the long-term safety and the efficacy profile of 25 mg obefazimod given once daily in subjects previously enrolled in two earlier Phase II trials, ABX464-102 (NCT03368118) or ABX464-104 (NCT04023396). Data from the extension study announced in May showed that patients receiving 50 mg of obefazimod for two to four years and then transitioned to 25 mg for up to an additional three years maintained durable clinical remission and a favorable safety profile for up to seven years of treatment exposure.

Abivax said it plans to submit a New Drug Application (NDA) submission to the FDA for obefazimod late in the fourth quarter.

“Transformational potential”

“Taken together, we believe these results validate the transformational potential of obefazimod and position us well as we advance toward our planned NDA submission in late 2026,” de Garidel said, declaring: “Today’s results firmly establish obefazimod as a potential new standard of care for the treatment of ulcerative colitis.”

Thomas J. Smith, senior managing director, immunology and metabolism, and a senior research analyst with Leerink Partners, appeared to agree with de Garidel in a research note.

“We believe obe[fazimod]’s results suggest a best-in-disease maintenance profile, especially among oral therapeutics in UC,” Smith wrote in his initial research note on Abivax’s ABTECT data. “We continue to believe that obe features the most compelling late-stage clinical profile for a novel oral agent in IBD [inflammatory bowel disease] amid heightened M&A/BD [business development] activity that underscores large pharma’s interest in the space.”

Several big-money merger-and-acquisition (M&A) deals in recent years have centered around pharma giants buying developers of drugs for UC, Crohn’s disease, and other forms of IBD. The biggest of these was Merck & Co. (NYSE: MRK) acquiring Prometheus Biosciences for $10.8 billion in 2023, while Lilly bought out Morphic Therapeutic for about $3.2 billion in 2024; Roche Holding (SIX Swiss Exchange: ROP and RO; OTCQX: RHHBY) snapped up Telavant Holdings for up-to-$7.25 billion in 2023; and Pfizer acquired Arena Pharmaceuticals for $6.7 billion in a deal completed in 2022.

Abivax itself has found itself rumored as a potential candidate for being acquired—it made GEN’s A-List of Top 10 Takeover Targets of 2026—since last summer, when the company reported dazzling data from two Phase III trials, ABTECT-1 (ABX464-105; NCT05507203) and ABTECT-2 (ABX464-106; NCT05507216).

As for the reported malignancies, Smith commented in a follow-up research note: “We do not view the reported malignancies as an outsized or approvability-limiting safety risk, particularly given the absolute low event counts, investigator assessment that the non-NMSC malignancies were unrelated to treatment, IDMC [independent data monitoring commission] adjudication supporting the safety profile, lack of organ-specific clustering, and mitigating circumstances noted across each case.”

Obefazimod is a small molecule upregulator of miR-124, an anti-inflammatory microRNA. It enhances the selective splicing of a single long noncoding RNA to generate miR-124, which downregulates cytokines and chemokines shown to promote inflammation, including tumor necrosis factor (TNF) alpha, IL-6, monocyte chemoattractant protein-1 (MCP-1), and IL-17, as well as Th17+ cells.

Under its former name ABX464, obefazimod was initially developed against HIV but was repurposed to fight inflammatory conditions based on its anti-inflammatory effect.

“Best in indication”

Also bullish on Abivax is Citizens JMP Securities, where Jason Butler, managing director, biotechnology equity research, raised his firm’s price target 43%, from $131 to $187, based on ABTECT’s positive data exceeding expectations. Butler maintained Citizens JMP’s “Market Outperform” rating on Abivax shares.

“We view efficacy (~40% placebo-adjusted clinical remission rate) as best in indication, easily surpassing drugs across all approved classes of UC therapies,” Butler wrote. “We believe the Phase [III] efficacy and safety results, together with its oral once-daily profile, support that obefazimod can be transformational to the UC treatment landscape, benefiting both earlier-stage and more severe/refractory patients.”

“Importantly, we also view the safety profile as compelling and are comfortable that the drug is not associated with a clear malignancy risk (which is the primary debate driving stock volatility post-market),” Butler added.

The more positive feedback from analysts apparently swayed investors, as Abivax’s stock price rebounded roughly 40% on both exchanges since the initial nosedive. The Nasdaq shares vaulted 24% to $90.15 on Wednesday, then rose another 16% to $104.93 Thursday before dipping 3% Friday, finishing the week at $101.53 and with a 23.5% five-day decline.

On Euronext Paris, Abivax shares bounced back 13% to €71.25 ($82.09) on Wednesday, jumped another 18% Thursday to €83.95 ($96.72), then finished Friday up 5% to €87.85 ($101.21) and a 22.5% five-day decline.

Butler said the maintenance study’s data suggested that Abivax could potentially generate more positive clinical results for obefazimod in its ongoing Phase IIb ENHANCE-CD induction trial in Crohn’s disease (NCT06456593), which is expected to read out in mid-2027. He added that ABTECT’s results were strong enough to support approval of both the 25 mg and 50 mg doses: “While we anticipate malignancies to be included in the label, we continue to believe in the differentiated profile of obefazimod.”

Speaking with analysts, de Garidel agreed with pursuing approvals for obefazimod at both 25 mg and 50 mg: “Our thinking is that both doses will be very helpful for patients, and we plan to file at year-end with those two doses for maintenance.”

Leaders and laggards

  • Absci (Nasdaq: ABSI) shares climbed 24% from $5.94 to $7.34 Thursday after Leerink Partners initiated coverage of the generative AI-based drug developer with an “Outperform” rating and a 12-month price target of $12. Mani Foroohar, MD, senior managing director, genetic medicines, and a senior research analyst with Leerink, lauded the company’s drug mechanism of blocking prolactin (PRL)–prolactin receptor (PRLR) signaling as seen in its lead pipeline candidate ABS-201, an anti-prolactin receptor antibody in Phase I/II studies for androgenetic alopecia that advanced into the clinic last year, with a Phase II study in endometriosis expected to start in the fourth quarter: “We see a totality of evidence supporting PRLR blockade in these indications, and see even partial/early clinical validation opening a clear path to valuation >double the current market cap (~$1.1B fully diluted),” Foroohar wrote in a research note.
  • Fulcrum Therapeutics (Nasdaq: FULC) shares jumped 9.5% from $3.37 to $3.69 Friday after the developer of small molecule drugs for rare blood disorders disclosed in a regulatory filing that it will slash its workforce approximately 85%—from 57 to nine full-time employees—in a cost-cutting move expected to be substantially completed during the second quarter. Fulcrum said it expects to incur approximately $4.2 million in charges related to the layoffs, consisting primarily of employee severance, employee benefits, and related costs. Fulcrum vowed to “significantly” reduce its operating expenses and launched a strategic review after scrapping its lead pipeline program to develop pociredir as a treatment for sickle cell disease (SCD). The development followed the FDA expressing heightened concerns about pociredir’s risks and benefits in fighting SCD due to an unexpectedly high rate of secondary blood cancers seen with another PRC2 inhibitor, Tazverik®(tazemetostat), marketed by Ipsen (Euronext Paris: IPN).
  • Oculis Holding (Nasdaq: OCS) shares tumbled 36% from $22.70 to $14.51 June 1, after the Swiss neuroophthalmology and ophthalmology drug developer said it did not plan to pursue an FDA filing seeking approval for its OCS-01 eye drops in diabetic macular edema (DME). Oculis acknowledged that OCS-01 failed two Phase III trials, DIAMOND-1 (NCT05066997) and DIAMOND-2 (NCT06172257), by missing their primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52. The key secondary endpoint of the proportion of patients with ≥15-letter gain in BCVA was not met in both trials, though another secondary endpoint, retinal thickness as measured by OCT, showed a “substantial and persistent” reduction with OCS-01 vs vehicle at all visits in DIAMOND-2, and at all visits except Week 52 in DIAMOND-1.

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Researchers say microrobots can deliver stem cells to treat spinal cord injuries

Researchers in Zurich say they have developed a method to use microrobots delivering stem cell therapies to treat spinal cord injuries. According to ETH Zurich and the University of Zurich (UZH), modern therapies for spinal cord injuries attempt to influence implanted stem cells using electrical stimulation, promoting the growth of new nerve cells. However, researchers…

The post Researchers say microrobots can deliver stem cells to treat spinal cord injuries appeared first on Medical Design and Outsourcing.

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Triple Play: Lilly Acquires Three Developers of Infectious Disease Vaccines for Up-to-$3.8B

Eli Lilly has agreed to acquire three privately-held developers of vaccines for infectious diseases for a combined up to $3.83 billion cash, the companies said today, in deals intended to expand the acquisitive pharma giant’s R&D efforts into infectious disease—and which represent Lilly’s eighth, ninth, and 10th planned buyouts of smaller biotechs this year alone.

Lilly announced planned acquisitions of Vaccine Company for up to $1.55 billion, Curevo for up to $1.5 billion, and LimmaTech Biologics for up to $780 million. The planned triple play of buyouts, Lilly said, will enable it to apply differentiated technology platforms toward attacking infectious diseases, focusing on viral pathogens linked to long-term neurological and oncological risk, plus bacterial pathogens long considered difficult to prevent or treat.

“These acquisitions reflect a deliberate strategy to prevent disease at its source rather than treat its consequences,” Daniel M. Skovronsky, MD, PhD, chief scientific and product officer, and president, Lilly Research Laboratories, said in a statement.

“Decades of evidence now link common infections to diseases that potentially emerge years later, including neurological disease, cancer and infertility. And as antimicrobial resistance erodes our ability to treat bacterial infections, vaccines are increasingly the only path to prevention,” Skovronsky added. “Combining these companies’ platforms and teams with Lilly’s global scale positions us to change that trajectory.”

Investors appeared to support the triple play, sending Lilly shares up 1.36% to $1,079.19 as of 11:56 a.m. ET, from $1,065 at Friday’s close of trading.

Capitalizing on tirzepatide billions

The deal spree reflects Lilly’s desire to capitalize on the billions of dollars it is generating from sales of its obesity and diabetes drugs based on glucagon-like peptide 1 (GLP-1) receptor analysts alone or in tandem with a glucose-dependent insulinotropic polypeptide (GIP).

Those drugs account for 58% or $49.329 billion of the $84.978 billion in revenues reported by Lilly in 2025 and the first quarter of 2026. Lilly markets tirzepatide, a GLP-1/GIP dual agonist, in obesity as Zepbound® ($13.542 billion in 2025, $4.16 billion in first quarter 2026) and in diabetes as Mounjaro® ($22.965 billion, $8.662 billion in Q1 ‘26).

Lilly executives did not mention infectious diseases as a potential area of future growth during the company’s most recent earnings call last month with analysts following Q1 results, even as it cited three other therapeutic areas: I&I (immunology and inflammation), neuroscience, and oncology.

“We’re proud of what we’re doing in those three areas, and I think each of them has very significant unmet medical needs that we can scale into as our medicines are successful. We like what we got, and we like the direction we’re going. Of course, in each of those areas, we also see opportunities to get a lot bigger, and we’ve highlighted some of the themes already in those areas,” Skovronsky said on the April 30 call.

“Even without the obesity and metabolic business, Lilly would be the fastest or surely one of the fastest-growing pharmaceutical companies in the industry,” Skovronsky added.

Parade of purchases

Lilly’s long parade of purchases began January 7 when it inked a $1.2 billion acquisition of Ventyx Biosciences, an NLRP3-targeting oral drug developer focused on inflammatory diseases. A month earlier, Lilly announced plans to buy out circular RNA cell therapy developer Orna Therapeutics for up to $2.4 billion, targeting advancements in cell therapy. And in March, Lilly committed up to $7.8 billion to acquire Centessa Therapeutics, a developer of sleep disorder drugs.

Last month, Lilly agreed to acquire three cancer drug companies—in vivo chimeric antigen receptor T-cell (CAR T) developer Kelonia Therapeutics for up to $7 billion; JAK inhibitor developer Ajax Therapeutics for up to $2.3 billion; and next-generation dual-payload antibody-drug conjugate (ADC) developer CrossBridge Bio for up to $300 million.

Just last week on May 20, non-viral DNA delivery-focused drug developer Engage Biologics announced it had been acquired by Lilly for up to $202 million cash, including an upfront payment and payments upon achieving specified development milestones.

As for the latest planned acquisitions:

South San Francisco, CA-based Vaccine Company is developing in vivo nanoparticle (IVN) technologies designed to enable the antigen display known to elicit durable immune responses associated with virus-like particle vaccines, while avoiding the manufacturing burden of traditional VLP production. The company is advancing a preclinical pipeline spanning multiple viral pathogens; the lead program applies this technology to Epstein-Barr Virus (EBV) with a five-antigen Phase I-ready candidate.

Preventing mono and consequences

Lilly and Vaccine Company reason that a prophylactic vaccine could prevent not only acute infectious mononucleosis but also long-term neurological and oncological consequences that may follow infection, given what it said was growing evidence linking EBV to multiple sclerosis and several malignancies,

Under the acquisition deal, Lilly agreed to give Vaccine Company shareholders up to $1.55 billion, which would include an undisclosed upfront payment and additional payments tied to achieving specified clinical and commercial milestones.

LimmaTech Biologics, based near Zurich in Schlieren, Switzerland, is a developer of vaccines targeting bacterial pathogens for which rising antimicrobial resistance is steadily closing therapeutic options, including Staphylococcus aureus, Neisseria gonorrhoeae, and Chlamydia trachomatis. LimmaTech’s platform is designed to generate broad, durable immune responses against complex bacterial targets by targeting the toxins and superantigens that drive disease.

LimmaTech’s lead program, LTB-SA7, is in Phase I development as a vaccine against S. aureus, the leading cause of surgical-site infection. The company has also developed a preclinical pipeline of candidates targeting additional bacterial pathogens, including those that drive infertility and other long-term consequences of infection that fall disproportionately on women.

Lilly has agreed to acquire LimmaTech for up to $780 million, which will include an undisclosed upfront payment and additional potential payments also tied to achieving specified clinical and regulatory milestones.

Seeking greater tolerability

Bothell, WA-based Curevo has an infectious disease vaccine pipeline led by amezosvatein, an adjuvanted subunit vaccine being developed for the prevention of shingles in adults. Curevo acknowledges that the current standard of care for shingles prevention, GlaxoSmithKline (GSK)’s Shingrix® (Zoster Vaccine Recombinant, Adjuvanted) is effective, but says tolerability challenges can limit overall vaccination rates and contribute to second-dose hesitancy, leaving a meaningful portion of patients with reduced or no protection against shingles and its long-term consequences.

To prevent that problem, amezosvatein has been engineered with a next-generation synthetic adjuvant. In a Phase II trial head-to-head against Shingrix, amezosvatein matched immune response across all primary endpoints and reduced side effects such as activity-limiting fatigue, chills, and pain at the injection site by more than half. Lilly and Curevo reason that in light of growing evidence linking shingles to elevated risk of stroke and tying shingles vaccination to lower risk of dementia, a better-tolerated vaccine could reduce these long-term risks, thus expanding the reach of shingles prevention.

Lilly’s up to $1.5 billion deal price for Curevo includes another upfront payment and an additional payment hinging upon achievement of a certain milestone, all unspecified.

All three deals are subject to customary closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Lilly said it will determine the accounting treatment of the transactions upon closing, in accordance with Generally Accepted Accounting Principles (GAAP). The transactions will be reflected in Lilly’s future financial results and financial guidance to investors.

That guidance was raised last month after Lilly reported stellar first quarter earnings tied to booming sale of its blockbuster tirzepatide-based drugs. Lilly raised its full-year 2026 revenue guidance to between $82 billion and $85 billion, and non-GAAP earnings per share (EPS) guidance to be in the range of $35.50 to $37.00.

In February, Lilly guided investors to between $80 billion and $83 billion in revenue, and non-GAAP EPS ranging from of $33.50 to $35.00.

The post Triple Play: Lilly Acquires Three Developers of Infectious Disease Vaccines for Up-to-$3.8B appeared first on GEN – Genetic Engineering and Biotechnology News.

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Ultra-Short Radiotherapy Schedule for Prostate Cancer Supported by HERMES Trial

U.K. research has shown that condensing prostate cancer radiotherapy into two sessions, but with a higher dose per session, rather than the traditional five sessions does not lead to increased side effects when treatment is delivered using state-of-the-art magnetic resonance imaging (MRI)-guided technology.

Lead researcher Sian Cooper, clinical research fellow at The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research in London, told Inside Precision Medicine that the results of the HERMES trial “point toward a future where prostate radiotherapy is tailored to the disease, to the individual’s anatomy and symptom profile, whilst being mindful of the impact of treatment time on patients’ lives.”

Presenting at the 2026 Congress of the European Society for Radiotherapy and Oncology (ESTRO), Cooper said that the number of people diagnosed with prostate cancer is projected to double by 2040, meaning the demand for effective and efficient treatment has never been greater.

At present, localized prostate cancer is typically treated with stereotactic body radiotherapy over five sessions, but there has been increasing interest delivering the treatment in fewer sessions, with a larger dose each session.

“For patients, a two-session treatment course would be far less disruptive than the weeks of daily hospital visits that radiotherapy has traditionally required. This convenience comes with clear benefits for work, leisure, family life and travel. For clinicians and health systems, fewer fractions mean faster workflow throughput, and getting patients the right treatment, quicker,” said Cooper.

“We wanted to find out whether giving the equivalent dose in just two treatment sessions could be feasible and safe for patients, and to understand how it might affect the potential side effects patients can experience, such as problems with urinary and bowel function.”

The move toward giving higher radiotherapy doses in fewer sessions has been made possible by improvements in radiotherapy delivery technology over recent years.

“It has allowed us to harness the power of modern computing and discoveries in clinical physics, to create radiotherapy doses which conform very tightly to the edge of the prostate,” Cooper explained. “This results in vastly less dose to the normal, healthy tissues around the cancer.”

The HERMES trial used a Unity MR-Linac (Elekta AB, Sweden) machine, which Cooper describes as “the ultimate evolution of this progress,” to deliver radiotherapy to participants.

The device combines real-time MR scanning with a linear accelerator and is known as MRI-guided adaptive radiotherapy. It allows adaptation of the radiotherapy beam design to changes in patient anatomy on the treatment day as well as moment by moment motion management, meaning that if there are any changes in the target or healthy bystander organs, the radiation beam can be switched off.

“This level of precision was needed to safely deliver the high dose of radiation necessary to maintain the biologically equivalent dose in just two fractions,” Cooper noted.

In all, 46 participants (median age 74 years) with intermediate or lower high-risk prostate cancer were randomly assigned to receive radiotherapy at a dose of 24 Gy in two fractions over 8 days, with a 27 Gy integrated boost to the MRI defined tumor (n=22), or 36.25 Gy in five fractions over two weeks to the planning target volume, with 40 Gy to the prostate and proximal one cm seminal vesicles (n=24). All participants had androgen deprivation treatment for at least six months.

Cooper reported that, at two years, four (18%) participants in the two-fraction arm and six (25%) in the five-fraction arm experienced moderate (grade 2) urinary adverse events (AEs) such as increased frequency or urgency. Grade 2 gastrointestinal AEs occurred in one participant in each arm (5% and 4%, respectively).

There were no grade 3 or worse genitourinary or gastrointestinal events in either group.

The team also showed that quality of life, measured by the International Prostate Symptom Score and the International Index of Erectile Function, showed minimal change up to two years but will continue to be monitored up to five years.

Cooper said that the investigators will present efficacy data, a secondary endpoint, when it matures but she pointed out that as “the cancer control rate for prostate cancer is so high, it often takes many years for failures to appear, whereas trial data for ultra hypofractionation show that the genitourinary adverse event rate is the primary concern after treatment.”

ESTRO president, Matthias Guckenberger, MD, from University Hospital Zurich, Switzerland, who was not involved in the research said: “While the technology used in this trial is currently available in only a limited number of specialist centers worldwide, they are growing rapidly. These results can help guide how they are used and help us understand whether two-session radiotherapy should become a new standard of care.”

The post Ultra-Short Radiotherapy Schedule for Prostate Cancer Supported by HERMES Trial appeared first on Inside Precision Medicine.

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Determinants of antipsychotic prescription in women detainees admitted to an acute forensic psychiatric unit

BackgroundWomen represent a small proportion of the global prison population but carry a disproportionate burden of mental illness. Evidence indicates high rates of psychotropic medication use among women in prison, often independently of the clinical diagnosis. Antipsychotics, particularly second-generation (SGAs) are widely prescribed in forensic settings. Data focusing on the prescription of these agents to women detainees are still scarce.ObjectivesThis study aimed to investigate whether socio-demographic, clinical and forensic characteristics determine SGA prescription to women admitted in an acute forensic psychiatric ward located in prison.MethodsWe conducted a retrospective study of 166 women admitted between 2014 and 2023 to the sole acute forensic psychiatric unit for detainees in French-speaking Switzerland. Among them, 128 cases received second generation antipsychotic medication during their hospital stay. Sociodemographic data included age, nationality, educational attainment and primary spoken language. Criminological variables included types of offense and detention. Clinical variables included psychiatric outpatient and inpatient history prior to conviction, total number of stays during the study period, main diagnosis, presence of substance use disorder and personality disorders. Psychotropic prescriptions were analyzed with conversion of antipsychotic doses into chlorpromazine equivalents. Regression analyses, including LASSO models were used to identify variables associated with antipsychotic dosage.ResultsPsychotropic use was very high with more than two-thirds receiving two or more psychotropic agents. SGAs were prescribed in 77.1% of cases (128 out of 166 cases), while psychotic disorders were diagnosed in only 28.3% indicating frequent off-label use. Regression analyses showed that higher antipsychotic doses were associated with previous psychiatric history, more inpatient stays and court-ordered treatments. Cluster A personality disorders were associated with lower antipsychotic doses.ConclusionsOur findings reveal an extremely high rate of psychotropic use with very frequent off-label prescription for antipsychotics in acute forensic psychiatry wards. Moreover, they show that clinical variables and not demographic and criminological factors determine the use of antipsychotics in this setting.
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Antibody Promotes Nerve Regeneration in Spinal Cord Injury Patients

Swiss research shows treatment with an antibody known as NG101 promotes regeneration of damaged spinal cord tissue in some people with spinal cord injury by blocking a protein called Nogo-A that normally suppresses nerve regrowth in the central nervous system.

Compared to placebo, participants treated with the antibody showed faster lesion volume shrinkage and a significantly slower loss of spinal cord tissue, both in terms of size and myelin content, above the injury site.

This study, published in Nature Communications, is an additional analysis of a subset of 106 patients of a Phase IIb study published last year in The Lancet Neurology and carried out by Swiss and German academic researchers as well as the Swiss biotech NovaGo Therapeutics, which is developing the antibody. The original trial population included 126 people.  It did not robustly meet its primary endpoint across the full patient population but showed promising signals in some motor-incomplete patients.

The current study specifically looked at people for whom magnetic resonance imaging (MRI) data were available. It investigated whether NG101 produced measurable structural changes in the spinal cord over time, whether MRI could detect those changes even in patients without obvious clinical improvement, also whether combining imaging with electrophysiology could better identify likely responders to inform more efficient future trial designs.

In the Phase IIb study the antibody was delivered directly into the spinal canal to 106 participants with acute cervical spinal cord injury within weeks of injury. Over a six month follow up period, the team measured lesion volume, spinal cord cross-sectional area, and myelin integrity.

The patients treated with NG101 showed a slowing of damage and faster injury improvement than those in the placebo group. The researchers believe this suggests the drug either slows post-injury neurodegeneration or actively promotes nerve fiber sprouting.

“Our data suggest that NG101 antibody treatment demonstrates both focal and remote structural preservation following cervical spinal cord injury, consistent with regenerative mechanisms seen in preclinical models,” write lead author Patrick Freund, MD, PhD, a professor and researcher at the University of Zurich and Balgrist University Hospital, and colleagues.

“These changes are detectable even in participants without overt functional improvement, underscoring the value of quantitative MRI in revealing treatment effects that may be missed by clinical scores alone.”

The post Antibody Promotes Nerve Regeneration in Spinal Cord Injury Patients appeared first on Inside Precision Medicine.

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STAT+: Roche to buy PathAI for $750 million

Roche has signed a deal to pay $750 million upfront for Boston-based PathAI, an acquisition by the Swiss pharmaceutical giant to speed up its use of artificial intelligence to help pathologists diagnose disease.

The agreement, which is expected to close in the second half of the year, could generate an additional $300 million for PathAI if it leads to the achievement of certain milestones.

“Joining forces with Roche marks a new era for PathAI, enabling us to realize our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed,” said Andy Beck, chief executive and cofounder of PathAI, in a statement. “Roche’s global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide.”

Continue to STAT+ to read the full story…

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Here’s what you need to know about the cruise ship hantavirus outbreak

MIT Technology Review Explains: Let our writers untangle the complex, messy world of technology to help you understand what’s coming next. You can read more from the series here.

Eight passengers aboard a Dutch-flagged cruise ship have contracted a type of hantavirus, a rare virus transmitted by rats. Three of them have died. As the ship prepares to dock in the Canary Islands, plans are being finalized to let the remaining passengers and crew disembark safely.

The virus in question appears to have a high fatality rate. Read on for answers to the big questions surrounding the outbreak—and to hear why health experts don’t expect a rerun of the covid-19 pandemic.

What is hantavirus?

Hantaviruses are a group of viruses that typically infect rodents but can be transmitted to humans through exposure to the animals or their droppings, urine, or saliva. The viruses don’t seem to cause illness in rodents, but they can make people very unwell. The symptoms can depend on the type of hantavirus a person has been exposed to. Varieties found in the Americas can cause hantavirus cardiopulmonary syndrome, which affects the lungs and heart and has a fatality rate of up to 50%.

That condition made headlines last year when it caused the death of pianist Betsy Arakawa, the wife of actor Gene Hackman. 

How many cases have there been so far?

On April 6, a man aboard the MV Hondius developed respiratory symptoms. He became very unwell and died just five days later. His wife, who left the ship at the island of Saint Helena, also developed symptoms. Her health deteriorated during a flight to Johannesburg, South Africa, and she died the following day, on April 26. South Africa’s National Institute of Communicable Diseases tested samples taken from the woman and confirmed that she had hantavirus.

A third person aboard the ship, who developed symptoms on April 28, died on May 2. Four other passengers who became ill were evacuated—one to South Africa and three to the Netherlands.

An eighth person had disembarked in Saint Helena and reported similar symptoms once he was in Zurich, Switzerland. A team at Geneva University Hospitals confirmed that he had become ill from the Andes virus—a form of hantavirus that can be spread between people.

Could this be the start of the next pandemic?

Health experts don’t believe so. They stress that the situation is nothing like the one the coronavirus that causes covid-19 presented in 2020. For a start, the Andes virus is not a mysterious new virus—scientists already have an understanding of it, and Argentina is sharing diagnostic kits it has already developed.

The virus also doesn’t spread in the same way. Officials at the World Health Organization emphasized that the spread of hantavirus requires close contact—the kind a person might have with a partner, household member, or medical caregiver.

The cruise ship outbreak represents “a specific confined setting where people are interacting in a prolonged close contact,” Abdirahman Mahamud, the alert and response director for the WHO’s health emergency program, said at a press event on Thursday. “With the experience our member states have, and the actions they have taken, we believe that this will not lead to a subsequent chain of transmission.”

What about the rest of the people onboard the ship?

All the remaining passengers have been asked to stay in their cabins, which the WHO says are being disinfected. Doctors and health professionals from the WHO and the European Center for Disease Prevention and Control have boarded the ship and are assessing everyone on board.

So far, no one else on board has developed symptoms, Maria Van Kerkhove, WHO acting director for epidemic and pandemic management, said at the press event. That’s “a good sign,” she said, but she added that the Andes virus has a long incubation period (around six weeks). Passengers are being advised to wear a medical mask when they leave their rooms.

At the same event, WHO director general Tedros Adhanom Ghebreyesus said he was in regular contact with the ship’s captain, who was reporting that “morale had increased significantly” since the ship started its journey to the Canary Islands.

What do we know about the Andes virus?

The Andes virus is the only hantavirus that is known to be transmitted between people. That transmission seems to rely on prolonged, intimate contact.

There was an Andes virus outbreak in Argentina around eight years ago. Between November 2018 and February 2019, there were 34 confirmed cases of infection, and 11 deaths. That outbreak was triggered when a person with symptoms attended a social gathering, said Tedros. “We are in a similar situation right now,” he said. “A cluster in a confined space with close contact.”

The fact that the 2018 outbreak was limited to 34 cases should be somewhat reassuring, he implied. “We believe this will be a limited outbreak if the public health measures are implemented and solidarity is shown across all countries,” he said.

How is hantavirus treated?

Unfortunately, we don’t have any specific antiviral treatments or vaccines for hantavirus. The WHO recommends early intensive care for people who develop symptoms. “This can save lives,” Anaïs Legand, WHO technical lead on viral hemorrhagic fevers, said on Thursday.

How did people get infected in the first place?

We don’t yet have an answer to that. But we do know that the couple who died had traveled through Argentina, Chile, and Uruguay on a birdwatching trip before they boarded the ship. That trip included visits to areas where species of rats that carry the Andes virus are known to live. The WHO is working with authorities in Argentina to try to retrace the couple’s movements on that trip.

Has the virus spread beyond the ship?

We don’t yet know for sure. The WHO is receiving reports of “potential suspect cases,” Van Kerkhove said at the Thursday briefing. Some of them have links to the ship or its passengers. Each “alert” will be followed up by health authorities in the relevant country, she said.

Has the US withdrawal from WHO affected anything?

Five US states have said they are monitoring US nationals who have disembarked from the ship. WHO officials are stressing that they are still sharing technical information with the US Centers for Disease Control and Prevention. “Things are … as they used to be,” Tedros said. “WHO’s mission is to help the world to be safe … and we want the American people to be safe as well.”

But it’s worth noting that cuts made by the Trump administration aren’t exactly putting the US in a good position for events like these. Last year, all full-time employees in the CDC’s Vessel Sanitation Program—which helps prevent and control illness outbreaks on cruise ships—were laid off. Further cuts to the CDC have left public health experts worried about how ill prepared the US is to deal with future disease outbreaks.

What will happen next?

Any suspected cases will be monitored by health authorities. Passengers are due to disembark in Tenerife in the Canary Islands on Sunday, May 10, and the WHO has said it will work with the Spanish government to ensure that the risk to residents remains low and that the passengers are treated with dignity and respect.

In the meantime, scientists are working to fully sequence the genome of the virus from patient samples. They want to find out if it is different from the viruses involved in the previous cases. “So far, we haven’t seen anything unusual,” said Van Kerkhove.