Category: cancer

  • Merck and Moderna have ‘lot of exploring to do’ after initial cancer vaccine success

    Merck and Moderna have ‘lot of exploring to do’ after initial cancer vaccine success

    By Jason Mast

    Oct. 15, 2026

    General Assignment Reporter

    After public school teacher Gary Keblish was diagnosed with melanoma in 2019, a surgeon cut out the tumor. But he wasn’t out of the woods. In some patients, melanoma aggressively recurs after surgery, so his doctors referred him to a new trial: for Merck and Moderna’s personalized mRNA cancer vaccine. 

    Speaking by video at the STAT Summit on Thursday, Keblish compared the journey — in all its physical and emotional turbulence — to a trip on Ms. Frizzle’s Magic School Bus. “Seatbelts, everyone!” he said, quoting the iconic line.

    He’s glad he went. Today, he is still teaching, and Merck and Moderna are preparing to file the vaccine for approval, after announcing in August that it significantly delayed both cancer recurrence and the development of metastatic disease in melanoma patients like Keblish, in a large Phase 3 trial.  

    It’s a landmark moment for a cancer vaccine field that has long struggled to live up to its hype. But the two companies’ work is far from complete. They are now looking to prove the vaccine isn’t just a powerful tool for certain melanoma patients but that it can also transform a sea of other tumors, as an early generation of immunotherapies did. 

    It is careful and costly work.

    “We have a lot of exploring to do and need to prioritize where we explore,” Moderna President Stephen Hoge said on stage at the summit.

    Beside Hoge, Merck R&D chief Dean Li outlined an exploration strategy. The vaccine, known chemically as intismeran autogene, works in combination with Merck’s blockbuster immunotherapy Keytruda, which has been tested in thousands of trials over the last 15 years. Keytruda works better in some tumors — so-called hot tumors, which often have lots of mutations — than other so-called cold tumors.

    “We know exactly where I-O [immuno-oncology] works, where a checkpoint inhibitor works, where it doesn’t, where it almost worked and didn’t make it,” said Li.

    Gary Keblish participated in an early trial of the Merck-Moderna cancer vaccine.Courtesy Gary Keblish

    The pair has largely focused to date on settings where Keytruda has worked best, such as an  adjuvant — add-on — therapy for melanoma patients whose visible tumors have already been removed by a surgeon. They are already running trials in adjuvant lung, kidney, and bladder cancer. 

    Li and Hoge suggested other settings they may explore or where trials are just beginning, including in tumors where Keytruda failed but another kind of immunotherapy worked, or as a standalone therapy in very early-stage tumors. “There’s an incredible opportunity to think about how we bring immunotherapy into earlier interventions and really intercept cancer so that we don’t present with stage 3, stage 4 disease later,” said Hoge. 

    Li contrasted their approach with “other people” who “may not have the advantage” of their expertise and have chosen to go after cold or metastatic tumors — an apparent nod at Moderna’s mRNA rival BioNTech, which has some early promising early data but also notable failures.

    “We have chosen not to do this,” Li said. “But I can tell you: Anyone has positive data and it’s out there, you will never see Moderna and Merck pivot [so] fast.”

    Small tests in adjuvant pancreatic and gastric cancer are underway, to test the possibility. Li also floated the possibility of using the vaccine in patients whose metastatic tumors have already been shrunk by other treatments.

    In the meantime, they continue to try to improve the technology. The vaccine is made by looking at individual tumors and using an algorithm to select up to 34 mutant proteins, in hope that you can then flash those as a “wanted sign” to the immune system.

    The algorithm is imperfect. But by closely analyzing the immune systems of patients in their trials, Moderna and Merck could in theory build even better software. 

    “It’s a real privilege to have all that information across the now several thousand people in our Phase 3 program,” Hoge said. “I’m looking forward to digging into it.”

  • STAT+: Verastem’s KRAS inhibitor shows promise in pancreatic cancer

    STAT+: Verastem’s KRAS inhibitor shows promise in pancreatic cancer

    Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

    I, too, wanted to express how devastated I am over losing our colleague Helen Branswell.  She was kind, scrupulous, brilliant, and truly inspiring in action. Thank you, Helen. 

    The need-to-know this morning

    • Privately held U.K. biotech OMass Therapeutics raised $310 million to support the clinical development of a drug to treat congenital adrenal hyperplasia, an inherited endocrine disorder. 
    • The investment firm Orbimed raised nearly $3 billion for two, new private equity funds that will invest in U.S, European and Asian health care companies. 

    Investor: China’s biotech boom threatens U.S. venture capital

    From STAT’s Allison DeAngelis: The rise of Chinese biotech isn’t just impacting U.S. companies, one investor is warning. It’s threatening VC firms.

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  • Cancer drug worth over Rs 9 lakh missing from Delhi hospital; probe ordered

    Cancer drug worth over Rs 9 lakh missing from Delhi hospital; probe ordered

    • Published On Oct 14, 2026 at 02:36 PM IST

    New Delhi: Four boxes containing injections of a cancer drug went missing from the Delhi State Cancer Institute in east Delhi’s Dilshad Garden, prompting the registration of an FIR, police said on Tuesday.

    The estimated retail value of the missing medicines is between Rs 9 lakh and Rs 10.8 lakh, according to experts.

    The complaint, filed by Dr Pankaj Tyagi, associate professor of gastroenterology at the institute, stated that four boxes containing nimotuzumab 200 mg injections, with each box containing four vials of 50 mg each, were found missing from a designated refrigerator in the chemotherapy day care department on the second floor.

    Nimotuzumab is a monoclonal antibody used in targeted cancer treatment. It works by targeting the epidermal growth factor receptor (EGFR), a protein involved in the growth of cancer cells. It is used in the treatment of certain cancers, including head and neck cancer and glioma.

    According to the complaint, the injections were placed in the refrigerator on October 3 between 5.30 pm and 6 pm, after the completion of chemotherapy procedures.

    When the refrigerator was opened on October 5 to issue the medicines for use, the four boxes were found missing, the complaint stated.

    The institute constituted a committee to conduct an internal inquiry into the reported shortage and examine the relevant stock and medicine records, according to the complaint.

    An immediate response on the matter was not available from the hospital.

    The matter was subsequently brought to the notice of the police for verification and investigation.

    An FIR was registered on October 12 at the G T B Enclave police station under Section 305(a) of the Bharatiya Nyaya Sanhita. The accused has been listed as unknown in the FIR.

    The police said that they have initiated an investigation into the matter. The official further said the hospital had reported similar incidents in the past, adding that the possibility of an organised network dealing would also be examined as part of the investigation.

    • Published On Oct 14, 2026 at 02:36 PM IST

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  • The Sometimes-Awkward Art of Asking for a Second Opinion

    The Sometimes-Awkward Art of Asking for a Second Opinion

    When Carol Daniel, a veteran broadcast journalist who lives near St. Louis, was diagnosed with thyroid cancer in 2022, her husband encouraged her to seek a second opinion. She was worried that consulting another doctor might seem like a betrayal.

    Daniel said she wondered: “Am I cheating on him? Am I going behind his back? Am I acting like I don’t trust him by seeking a second opinion?”

    Many patients find themselves in this position, but family medicine physician Jen Caudle said patients shouldn’t feel awkward about asking for a second opinion. In fact, in her practice in New Jersey, she encourages people to have open conversations with their care team.

    “We shouldn’t be offended,” Caudle said. “We should support you.”

    Patients can also think of their primary care provider as the quarterback of their care team, Caudle said, and ask that doctor for help navigating opinions or diagnoses from specialists.

    Cara Anthony and Blake Farmer, hosts of the HealthQ series, spoke with Caudle about the sometimes-awkward art of asking for a second opinion.

    The QTip:

    Your primary care provider can help you navigate first and second opinions from specialists.


    Katherine Ruppelt and Emily Siner at Nashville Public Radio contributed to this report.


    HealthQ is a health series from reporters Cara Anthony and Blake Farmer, approachable guides to an unapproachable healthcare system. It’s a collaboration between Nashville Public Radio and KFF Health News.

  • STAT+: Roche goes beyond licensing in deal with Chinese biotech

    STAT+: Roche goes beyond licensing in deal with Chinese biotech

    DOJ signals it will start scrutinizing drugmakers, PhrMA sues Trump administration, and more biotech news

    gantenerumab Alzheimer's disease Roche
    Sebastien Bozon/AFP via Getty Images

    Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

    Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

    Good morning. Let’s get straight to the news.

    The need-to-know this morning

    Roche goes beyond licensing in deal with Chinese biotech

    Over the past few years, pharma companies have flocked to China to license existing drug candidates. Roche is taking a new approach, partnering with Chinese startup Defand Therapeutics to discover new medicines.

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    1. National Biotech Reporter

      Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

  • STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines

    STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines

    Allison covers what hot startups are getting up to, and who’s financing them. She is also co-host of the weekly biotech podcast, “The Readout Loud.” You can reach Allison on Signal at AllisonDeAngelis.01.

    Roche is digging deeper into the biotech industry in China, striking a new partnership with a drug startup there. But rather than licensing the startup’s clinical-stage medicines, Roche is enlisting it to discover new ones, signaling a potential shift in global drug development. 

    Chinese startup Defand Therapeutics said Thursday that it had signed a collaboration deal with Roche to develop molecular glue medicines. Under the deal, Defand will discover and develop multiple drugs for cancer and immune-driven diseases. The financial terms were not disclosed, but a source with knowledge of the agreement said it could be worth close to $1 billion between the upfront fee and payments Defand could get if it meets various preclinical, clinical, and regulatory goals. 

    Molecular glue therapies are a buzzy new area of drug development, designed to create a sticky, more effective connection onto problematic proteins to destroy them. Development of these drugs has just begun to accelerate, thanks in large part to the data from Revolution Medicines, showing its molecular glue treatment Rasonque nearly doubled the survival rate of patients with pancreatic cancer. 

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  • Breast cancer can behave differently in older women. This physician is making more tailored treatments a reality

    Breast cancer can behave differently in older women. This physician is making more tailored treatments a reality

    Of all the factors that can increase a person’s risk of breast cancer, age is among the most significant. Almost half of people diagnosed with breast cancer are at least 65, and about 20% are 75 or older. Despite these rates, older women are frequently excluded from clinical trials; one study of breast cancer trials found that only 9% of participants were 65 or older, leaving physicians with a poorer understanding of how drugs behave in older adults and fewer guidelines with which to treat them.

    There’s increasing evidence that these patients could benefit from more tailored treatments. Neil Carleton, a cancer biologist and first-year resident physician at Brigham and Women’s Hospital, said that breast tumors can develop and grow differently in older patients than in younger ones because of hormone levels and inflammation. 

    “It can be a very heterogeneous disease,” Carleton said. But “historically, we’ve kind of treated all breast cancer the same,” he added — in a way that’s “age-agnostic.” 

    Carleton, who was recently named a STAT Wunderkind, wants to change that. After an M.D.-Ph.D. spent studying how clinicians can better treat tumors in older adults, he is now working to ensure that these patients receive care that is right for them, whether that means dialing back treatment or increasing it.

    “We typically think an older adult may be a little bit more frail” or less able to tolerate standard surgeries and therapies, he said. “But I don’t even think it’s about that. I think it’s more about appropriately treating.”

    Crafting the ‘nudge’

    As an undergraduate at Carnegie Mellon University, Carleton spent two summers working in a Johns Hopkins prostate cancer lab and was surprised to see surgeons making a point to attend the department’s journal club. On Wednesday mornings, as the urology group — basic scientists and physicians alike, in all stages of their careers — filed into the conference room to discuss scientific papers in the field, Carleton began to see how medicine and research were intertwined. 

    He’d been thinking about medical school since high school in Pittsburgh, when a formative biology teacher veered his lessons away from photosynthesis and toward anatomy, physiology, and new biotechnology — the kind of science that explained how human health really worked. The idea of a physician-scientist was completely new, and it felt like the right fit.

    “I knew you could be a doctor, and I knew you could do research. I had no idea that you could kind of do both,” Carleton said.

    When he started his M.D.-Ph.D. at the University of Pittsburgh in 2018, Carleton began working in the lab of Adrian Lee and Steffi Oesterreich, a husband-and-wife team of breast cancer biologists who were enthusiastic about new ideas and had a robust track record of translational research. Lee remembers the intensity with which Carleton wanted to be involved in that kind of work. “We can go on doing basic research forever, but we would like to eventually impact patient care,” Lee said. “And you could tell that he wanted to do that.” 

    At the time, there were reports from surgeons and in the scientific literature that older women with breast cancer were being overtreated. The three started talking about the patients that would come to launch Carleton’s career and a body of work in Lee and Oesterreich’s lab. In 2020, under the guidance of Lee, Oesterreich, and surgeon Priscilla McAuliffe, Carleton set out to quantify how many patients were receiving a surgery called a sentinel lymph node biopsy. 

    When removing a tumor from a patient’s breast, surgeons sometimes make an incision in the armpit and take a small amount of lymph node tissue to see if the cancer has spread there. Though professional society guidelines recommended against performing this biopsy on women 70 or older with early-stage cancer, other groups had reported that it was still being done.

    In data from the university medical center, Carleton found that about 65% of patients were still receiving biopsies. Rates actually continued to increase after the Society of Surgical Oncology adopted the guidelines in 2016, even though patients who received the biopsy were not more likely to survive or avoid recurrence. But “it can be very hard for surgeons to stop doing a surgery that’s kind of been ingrained in the paradigm for a while,” Carleton said.

    How, then, could he and his colleagues convince surgeons to reconsider? They designed a “nudge” within the electronic health record — a pop-up that would appear in a provider’s schedule for a qualifying patient that would remind them to consider omitting the biopsy. They implemented the nudge in eight clinics across the community and, in a clinical trial, tracked biopsy rates. The year after the nudge, they decreased by almost half.

    McAuliffe, now a breast cancer surgeon and clinical investigator at Emory University, said that surgeons encounter a lot of extraneous information in the electronic health record — but the nudge was simple. “I think that it reminded them without being a burden to them,” she said.

    One surgeon, when surveyed, said that the nudge “did exactly what its job was,” urging physicians to think about biology rather than reflexively recommending the biopsy. “I had to keep in mind that complete care doesn’t always equate with better care,” they said.

    The science behind a paradox

    While in the clinic, Carleton began studying a years-old question in the lab. Most breast cancer cases in older women are estrogen-receptor positive (ER+), meaning that tumor cells have receptors that bind to estrogen and trigger cancer growth. By 85, 91% of women with breast cancer have ER+ disease, even though postmenopausal women have lower levels of circulating estrogen. Carleton wanted to know how those tumors managed, seemingly paradoxically, to thrive.

    Looking at the gene expression in tissue from patients and healthy controls, Carleton and his colleagues found that the patients produced more of an enzyme involved in converting estrone — a form of estrogen that circulates in the bloodstream in postmenopausal women — to estradiol, its more potent version, within the tumor’s environment. 

    Scientists had known for 20 years that tumors made their own estrogen but didn’t know how it was done, Lee said. The enzyme Carleton identified was more than a mechanistic insight — it created a druggable target. In 3D models the lab made from patient cells, inhibiting the enzyme blocked estrogen conversion.

    Currently, doctors often treat postmenopausal women with ER+ tumors with inhibitors of a different enzyme. The drugs cause side effects like fatigue and joint pain, which lead many patients to stop treatment prematurely. Though the work is still early, Carleton hopes that drugs targeting the process they identified, administered through a gel or patch, could treat or even prevent breast cancer with fewer side effects. “I think it opens up possible therapeutic interventions,” he said.

    ‘Refining what we do’

    When looking through patient data early in his degree, Carleton noticed that some women ages 70 and older were forgoing surgery — not only the biopsy, but also a procedure to remove the main tumor in the breast. In this group, only 3% died of breast cancer after six years, and about 91% had their tumors controlled with primary endocrine therapy, which blocks estrogen receptors on ER+ breast cancer to prevent its growth. 

    If you could identify those patients for whom endocrine therapy might be enough treatment and monitor them, both the patient and their surgeon might be more comfortable with scaling back surgery, Lee said. “Precision medicine doesn’t mean doing more,” he said. “It means refining what we do, and sometimes refining what we mean we do means doing less.”

    While others might have missed the dozens of patients that hadn’t had any surgery among the thousands that did, Lee said, Carleton has a knack for noticing small details. And in September 2021, he uncovered a way to potentially track disease in patients who might not need surgery.

    Sitting in a talk at a local conference, Carleton learned about circulating tumor DNA (ctDNA), which cancer cells release into the bloodstream and can be measured to survey tumor growth. Natera, a molecular diagnostics company, had designed an assay that seemed perfect for older patients who’d declined surgery in favor of endocrine therapy: It required only a blood sample and could be done through a mobile blood-drawing service that came to their homes. Carleton and Lee approached Natera and, in the months afterward, designed a clinical trial to test whether they could use ctDNA to watch and identify patients at risk of progression.

    “It’s not an easy trial to recruit to — to say to someone, ‘Hey, you have breast cancer, but we’re not going to cut it out,’” Lee said. 

    But Carleton “has an amazing ability to kind of get the message across and encourage people,” Lee said, and put in hours with patients and physicians to earn their trust. Carleton was surprised by how many older adults were thrilled to join a trial that would guide not only their care, but the treatment of others going forward. “I think it was kind of one of the first times they were even approached to join a study,” he said.

    Over the next few years, the team studied patients who decided against surgery with Natera’s assay and ultrasound imaging. Patients with detectable ctDNA at six months were 30 times more likely to progress in their disease during the study, suggesting ctDNA was a marker of potential progression. And indeed, no patients with undetectable ctDNA before endocrine therapy progressed.

    The ‘closer’

    Today, as a first-year resident in Boston, Carleton spends most of his time treating patients. But he stays engaged with research: with the students in Lee and Oesterreich’s lab continuing to study the estrogen-converting enzyme, and with projects like designing a larger ctDNA trial. Lee and Oesterreich, with whom he still has regular check-ins, call him a “closer” — someone who takes on projects and sees them through to completion, synthesizing complex data from basic science and clinical practice into an understandable whole. “He has the complete package,” Lee said.

    Ultimately, Carleton hopes this work can help patients receive care without frequent trips to the clinic — turning breast cancer “into more of a chronic disease,” he said, where a patient might just take a daily pill and have regular imaging or ctDNA tests.

    Of course, Carleton said, not every patient will want that, and people with aggressive disease may need every intense treatment, test, and appointment. But better tools can help doctors identify: Who can be the patient they send home?

  • STAT+: Why this startup is taking its AI to predict breast cancer risk directly to patients

    STAT+: Why this startup is taking its AI to predict breast cancer risk directly to patients

    Waiting on doctors and insurers to get on board would have taken too long, Clairity says

    Adobe

    Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer telehealth. Confidential tips can be sent on Signal at palmer.01.

    You’re reading Part 5 of Paying for AI, a series examining how new clinical artificial intelligence tools influence the affordability of health care and patients’ long-term health. Here’s Part 1, Part 2, Part 3, and Part 4.

    “Don’t wait. Choose to be informed.” 

    That’s the call to action that patients will find on the site for digital health company Everlywell, which has offered at-home lab tests directly to consumers for a decade. But last week, it wasn’t marketing a prick to measure blood glucose or screen for celiac disease: It was launching one of a new generation of AI-based risk prediction algorithms for medical images. 

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    1. Health Tech Correspondent

      Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer telehealth. Confidential tips can be sent on Signal at palmer.01.

  • Caribou Bio’s Journey With Off-the-Shelf Cell Therapy Reaches the End of the Road

    Caribou Bio’s Journey With Off-the-Shelf Cell Therapy Reaches the End of the Road

    Caribou Biosciences has an off-the-shelf cell therapy with encouraging clinical data to date and agreement with the FDA on the design of a pivotal study in advanced cases of a difficult-to-treat blood cancer. What the company doesn’t have is the capital for that Phase 3 clinical trial.

    Given the financial challenges, Caribou is stopping work on that program and a second one — its only remaining therapeutic candidates. The discontinuations announced after Tuesday’s market close will lead to job and spending cuts as the Berkeley, California-based biotech explores “strategic alternatives” that it said could include a merger, acquisition, or sale of its assets.

    “The Board took these actions in view of the current financing environment for allogeneic CAR-T cell therapies, which has made it increasingly challenging to secure the capital necessary to responsibly advance the Company’s allogeneic CAR-T cell therapy programs,” the company said in a Tuesday regulatory filing.

    Caribou’s allogeneic cell therapies are made by engineering immune cells sourced from healthy donors. The engineering is done with CRISPR technology; Caribou was co-founded by Jennifer Doudna, the scientist who won a Nobel Prize in Chemistry for her CRISPR discoveries. The off-the-shelf approach of allogeneic CAR-T cell therapies was intended to offer manufacturing and therapeutic advantages over first-generation CAR-T drugs, autologous therapies made by harvesting and engineering a patient’s own T cells.

    Caribou’s Phase 3-ready therapeutic candidate, vispacabtagene regedleucel (vispa-cel), is an allogeneic CAR-T cell therapy developed to treat relapsed or refractory cases of B cell non-Hodgkin lymphoma. It’s engineered in a way that enhances its activity and limits exhaustion of the cell therapy, which is a problem for autologous CAR-T therapies. The second discontinued Caribou program is CB-011, which is designed to target the protein BCMA to treat relapsed or refractory multiple myeloma.

    Autologous therapies use a patient’s own T cells, but these cells have diminished fitness and function from fighting cancer and enduring earlier lines of treatment that damages them. By contrast, allogeneic therapies start with healthy immune cells from healthy donors, which could lead to better outcomes. But one of the key challenges facing all allogeneic cell therapy developers is achieving the same or better durability as autologous cell therapies. Caribou’s discontinuations mean the company won’t have the opportunity to show its therapies can offer these advantages.

    In a research note, Leerink Partners analyst Daina Graybosch noted that Caribou’s announcement came on the heels of AbbVie reporting its T cell engager (TCE), Epkinly, succeeded in a Phase 3 test as a first-line treatment for diffuse large B-cell lymphoma, an aggressive type of non-Hodgkin lymphoma. Graybosch said that in a world where TCEs are becoming entrenched as first-line treatments for these cancers, there’s still a place for allogeneic cell therapies for patients who need it after a TCE.

    “This view is grounded in the real-world observation that autologous CAR-T efficacy can become compromised in patients who received prior TCE, potentially due to reduced fitness of the patient-derived starting cell product material,” she said. “By delivering an allo-CAR-T derived from a healthy donor cell source, the modality can sidestep this mechanistic liability.”

    Graybosch said investors who appreciate Caribou’s approach might be interested in the clinical-stage allogeneic CAR-T programs of Fate Therapeutics and AvenCell Therapeutics.

    Caribou was founded in 2011 and went public a decade later, raising $304 million in an upsized IPO. At the time, vispa-cel (then known as CB-010) and CB-011 were in early clinical development. Despite the strong investor interest in the IPO, the company has since weathered financial and competitive challenges. While allogeneic cell therapies would offer manufacturing advantages compared to autologous therapies, biopharma companies and investors are increasingly turning their focus to in vivo cell therapies with much less manufacturing cost and complexity.

    Caribou is now implementing its third restructuring in the past three years. In 2024, the company discontinued a preclinical natural killer cell therapy program in order to extend its cash runway. Last year, Caribou cut deeper by discontinuing a program for lupus and another one for acute myeloid leukemia, both in Phase 1 development. The company also cut its preclinical research, leaving only vispa-cell and CB-011 in the pipeline.

    As of February, Caribou’s headcount was 97, according to the company’s annual report. In its second quarter 2026 financial report, Caribou said its cash position was $113.8 million.

    Caribou’s board of directors approved the current restructuring last Friday, the company said in the regulatory filing. The “substantial reduction” of the workforce will take place in the current quarter, leaving a limited number of employees to complete the strategic alternatives process and wind down the business. Expenses related to the restructuring will be between $15 million and $19 million.

    Photo by Flickr user Thomas via a Creative Commons license

  • STAT+: Merck suffers a setback in Europe over its new Keytruda formulation

    STAT+: Merck suffers a setback in Europe over its new Keytruda formulation

    By Ed Silverman

    Oct. 7, 2026

    Pharmalot Columnist, Senior Writer

    Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

    In a setback for Merck, a Dutch court ruled that the company infringed on a patent pertaining to a subcutaneous formulation of its Keytruda cancer treatment and was ordered to halt manufacturing and marketing of the medication in several European countries, including France, Italy, Sweden, Switzerland, and the Netherlands.

    The ruling came as part of a widening patent infringement dispute with Halozyme Therapeutics over the best-selling cancer treatment. Patients requiring Keytruda will still have access to the existing intravenous version, which is not affected by the patent dispute or court order.

    In a statement, Merck said it “strongly” disagreed with the court’s decision.

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