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  • Sacituzumab Govitecan-hziy Led to Similar Progression-free Survival as Standard of Care for Certain Endocrine Therapy-refractory Advanced Breast Cancers

    SAN ANTONIO – Patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancers had similar progression-free survival (PFS) whether they were treated with sacituzumab govitecan-hziy (Trodelvy) or standard-of-care chemotherapy as the first treatment after endocrine therapy, according to results from the phase III ASCENT-07 clinical trial presented at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12, 2025.

    “HR-positive, HER2-negative breast cancers are typically treated with first-line endocrine therapy, but treatment resistance is common,” said Komal Jhaveri, MD, the Patricia and James Cayne chair for junior faculty; associate attending, Breast Medicine and Early Drug Development Services; and section head of the Endocrine Therapy Research Program at Memorial Sloan Kettering Cancer Center.

    “In cases where HR-positive, HER2-negative, metastatic breast cancer has become refractory to endocrine therapy, chemotherapy remains a common standard,” she explained. “Chemotherapy agents have shown marginal survival benefit but are associated with numerous toxicities that can be severe and long-lasting. Therefore, there remains a high unmet need in this setting for additional effective treatments.”

    Sacituzumab govitecan-hziy is an antibody-drug conjugate that targets the TROP-2 protein found on the surface of most breast cancer cells to deliver a cytotoxic agent to these cells, as well as to neighboring cells within the tumor microenvironment. One of the therapeutic’s approved indications is for patients with HR-positive, HER2-negative advanced breast cancers that have progressed on or after endocrine therapy and chemotherapy. The approval was based on statistically significant and clinically meaningful PFS and overall survival (OS) data from the phase III TROPiCS-02 clinical trial, said Jhaveri. In that study, patients treated with sacituzumab govitecan-hziy after two or more lines of chemotherapy had a 34% lower risk of disease progression or death and a 3.2-month improvement in OS compared with those treated with another line of chemotherapy.

    Those results led Jhaveri and colleagues to ask whether sacituzumab govitecan-hziy would also be beneficial earlier in the treatment course—for patients who had received endocrine therapy but who had not yet been treated with chemotherapy.

    To test this, they conducted the ASCENT-07 trial, which enrolled 690 patients with HR-positive, HER2-negative advanced breast cancers who had received prior endocrine therapy and who were candidates for first chemotherapy. Patients were randomly assigned (2:1) to receive either sacituzumab govitecan-hziy or standard-of-care chemotherapy.

    The ASCENT-07 trial did not meet its primary endpoint of improved PFS by blinded independent central review. After a median follow-up of 15.4 months, the median PFS was 8.3 months in both arms with a hazard ratio of 0.85.

    While data on OS were not mature at the time of this primary analysis, Jhaveri noted that preliminary results suggest a potentially lower risk of death among patients treated with sacituzumab govitecan-hziy. “It will be critical that we continue to follow patients for overall survival to better understand the potential long-term impact of sacituzumab govitecan-hziy in this treatment setting,” she added.

    The rates of treatment response were similar between the arms, but numerically higher for patients treated with sacituzumab govitecan-hziy, with 37% of patients experiencing responses to sacituzumab govitecan-hziy and 33% to chemotherapy. The median duration of response was numerically longer with sacituzumab govitecan-hziy than with chemotherapy (12.1 months vs. 9.3 months).  

    According to Jhaveri, the toxicities associated with sacituzumab govitecan-hziy in this trial were consistent with those observed in previous breast cancer studies. In both arms, the most common grade 3 or higher treatment-related adverse events were neutropenia and leukopenia, with both of these occurring at higher rates among patients treated with sacituzumab govitecan-hziy. Treatment-related adverse events that led to treatment discontinuation were observed in approximately 3% of patients in the sacituzumab govitecan-hziy and 7% in the chemotherapy arm.

    “While our study did not meet its primary endpoint of PFS for patients who have not yet received chemotherapy, sacituzumab govitecan-hziy remains a standard of care for HR-positive, HER2-negative metastatic breast cancers after prior endocrine therapy and chemotherapy based on the PFS and overall survival results seen in the TROPiCS-02 study,” said Jhaveri.

    “HR-positive, HER2-negative metastatic breast cancer is a highly heterogeneous disease, and this complexity makes it particularly challenging to manage, especially in patients whose disease has already progressed on multiple lines of endocrine therapy,” she added.

    The study did not compare the efficacy of sacituzumab govitecan-hziy with trastuzumab deruxtecan (T-DXd; Enhertu), a HER2-targeted antibody-drug conjugate that is now approved for some HR-positive, HER2-negative breast cancers that express enough HER2 to be considered “HER2-low” or “HER2-ultralow.” T-DXd was not approved to treat HER2-low and -ultralow breast cancers in the chemotherapy naïve setting until after enrollment for the ASCENT-07 trial had closed.

    “The ASCENT-07 study design and choice of comparator was aligned with treatment guidelines for this line of treatment and disease setting at the time of study planning and conduct,” Jhaveri noted.

    The study was sponsored by Gilead Sciences. Jhaveri reports consulting and/or advisory board roles with Novartis, Pfizer, Genentech, Eisai Co., AstraZeneca, Blueprint Medicines, Daiichi Sankyo, Menarini/Stemline Therapeutics, Gilead Sciences, Scorpion Therapeutics/Lilly, Bicycle Therapeutics, Olema Pharmaceuticals, Lilly/Loxo Oncology, Merck, Zymeworks, Halda Therapeutics, Arvinas, and RayzeBio. Jhaveri reports research funding to her institution from Novartis, Genentech, AstraZeneca, Pfizer, Lilly/Loxo Oncology, Zymeworks, Gilead Sciences, Puma Biotechnology, Merck, Scorpion Therapeutics, RayzeBio, Eisai Co., Bicycle Therapeutics, BridgeBio Oncology Therapeutics, and Blueprint Medicines.

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  • Adding Tucatinib to First-line Maintenance Therapy Delayed Disease Progression in HER2-positive Metastatic Breast Cancer in HER2CLIMB-05 Trial | AACR

    SAN ANTONIO – Adding tucatinib (Tukysa) to first-line maintenance therapy with trastuzumab (Herceptin) and pertuzumab (Perjeta) delayed disease progression in patients with HER2-positive metastatic breast cancer, potentially extending time off chemotherapy, according to results from the phase III clinical trial HER2CLIMB-05 presented at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12, 2025.

    The results of this study were simultaneously published in the Journal of Clinical Oncology.

    HER2-positive breast cancer accounts for approximately 17% of all breast cancer cases and is associated with a five-year survival rate of less than 50% for patients with metastatic disease. Since 2012, the first-line treatment for HER2-positive metastatic breast cancer has remained largely unchanged, consisting of chemotherapy followed by maintenance therapy with dual anti-HER2 monoclonal antibodies, said Erika Hamilton, MD, director of Breast Cancer Research at Sarah Cannon Research Institute (SCRI) in Nashville. Currently, most patients experience disease progression within two years of starting treatment and often have to transition to chemotherapy. “The results of our study show that the addition of tucatinib to the standard of care represents an enhanced first-line maintenance therapy option for patients with HER2-positive metastatic breast cancer, providing an opportunity to prolong time to disease progression and time off chemotherapy,” said Hamilton, who presented this study.

    Tucatinib, a selective inhibitor of HER2, has previously shown efficacy in later lines of therapy, including in patients with brain metastases, according to the results from the HER2CLIMB study, Hamilton said. Based on this, the U.S. Food and Drug Administration approved this drug in 2020 for treatment of unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least one prior therapy. “The HER2CLIMB-05 trial was initiated to investigate the efficacy of tucatinib in a first-line maintenance setting in patients with HER2-positive metastatic breast cancer who completed chemotherapy-based induction therapy without disease progression,” she said. “We also wanted to assess whether targeting HER2 both intracellularly, with tucatinib, and extracellularly, with dual blockade with monoclonal antibodies, may potentially improve patient outcomes,” she added.

    The trial enrolled 654 patients with HER2-positive advanced breast cancer who had completed four to eight cycles of induction chemotherapy plus trastuzumab and pertuzumab, without disease progression. The patients were randomly assigned to receive either tucatinib or a placebo alongside continued trastuzumab and pertuzumab.

    At a median follow-up of 23 months, the patients who received tucatinib had a progression-free survival (PFS) of over two years—an improvement of 8.6 months compared with the patients in the control arm.

    Patients with hormone receptor (HR)-negative disease experienced a 44.6% reduction in risk of progression or death, with a 12.3-month improvement in median PFS. Those with HR-positive disease saw a 27.5% reduction in risk of progression or death and a 6.9-month improvement in median PFS.

    Among the 12.2% of patients with brain metastases at baseline, tucatinib nearly doubled the median central nervous system-PFS, which is the time taken for the cancer to progress to the brain or death from any cause—from 4.3 months to 8.5 months. “Central nervous system-PFS was a secondary endpoint and this finding is preliminary,” cautioned Hamilton, adding that 54% of the patients in the tucatinib arm remained on study treatment at the data cutoff of this analysis.

    These findings suggest that tucatinib may offer broad benefits across diverse patient subgroups, Hamilton said. She emphasized the importance of enhancing HER2 targeting during the maintenance phase, rather than waiting for disease progression. “Prolonging the maintenance phase allows patients to maintain disease control, while extending their time off chemotherapy,” she said. She noted that the results of the HER2CLIMB-05 trial, alongside recent data from the PATINA trial—where incorporating palbociclib (Ibrance) into the treatment regimen for HR-positive, HER2-positive metastatic breast cancer showed a 15-month improvement in PFS—support a shift toward more personalized first-line maintenance strategies for this patient population.

    A limitation of this study is the exclusive enrollment of patients who had not progressed after induction therapy, potentially introducing selection bias, Hamilton explained. Another limitation is that the differences in brain imaging frequency and the cessation of routine imaging after systemic progression may have affected the accuracy of central nervous system-PFS assessments.

    The study was funded by Seagen, which was acquired by Pfizer in December 2023. Hamilton holds consulting and advisory roles with Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis GmbH, Verascity Science, Theratechnologies, Accutar Biotech, Entos, Fosun Pharma, Gilead Sciences, Jaxx Pharmaceuticals, MphaR, Zentalis, Jefferies, and Tempus. She has received research funding from AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, StemcentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix/Inspirna, Novartis, Mersana, Millennium, TapImmune Inc./Marker Therapeutics, Lilly, Pfizer Inc., Tesaro, Boehringer Ingelheim, H3 Biomedicine/Eisai, Radius Health, Acerta Pharma, MacroGenics, AbbVie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, NuCana, Regeneron, Leap Therapeutics, Taiho Pharmaceutical, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Sutro Biopharma, Zenith Epigenetics, Arvinas, Harpoon Therapeutics, Black Diamond Therapeutics, Orinove, Molecular Templates, Seagen, Compugen, G1 Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Institute, Onconova Therapeutics, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, ImmunoGen, Plexxikon, Amgen, Akeso Biopharma, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pionyr Immunotherapeutics, Repertoire Immune Medicines, Treadwell Therapeutics, Jacobio Pharma, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque Therapeutics, BeiGene/BeOne Medicines, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology/Lilly, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, ProfoundBio, Cullinan Oncology/Cullinan Therapeutics, Bristol Myers Squibb, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, and Stemline Therapeutics.

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  • ‘What to buy Dad for Christmas’: is retail ready for the AI shopping shift? | Retail industry

    ‘What to buy Dad for Christmas’: is retail ready for the AI shopping shift? | Retail industry

    Christmas shopping – some love it, to others it’s a chore and this year for the first time many of us will outsource the annual task of coming up with gift ideas to artificial intelligence.

    While traditional internet search, social media – especially TikTok and Instagram – and simply wandering a local high street will still be the main routes to presents for most this year, about a quarter of people in the UK are already using AI to find the right products, according to PricewaterhouseCoopers.

    For brands appealing to younger people, the revolution is well under way: the rival advisory firm KPMG says as many as 30% of shoppers aged 25-34 are using AI to find products, compared with 1% of those aged over 65.

    Asking a large language model (LLM) such as ChatGPT or Gemini what you should get your father-in-law – rather than typing “whisky” or “socks” into Google or DuckDuckGo – may seem a small change in habits. However, it marks a sea change for retailers accustomed to paying search engines to promote their listings.

    LLMs allow users to ask questions in conversational language, perhaps by speaking into their computer or phone. Instead of just providing a list of links, they offer specific suggestions with the potential for big sales for items that are regularly recommended.

    The chatbots produce their responses by scraping the internet and inbuilt datasets for relevant information, with some sources given more trusted status than others.

    Companies large and small are scrambling to adapt to this new world where the keywords and advertising deals previously central to web marketing hold less importance than the reviewers’ opinions, accurate availability information and product details read by LLMs such as OpenAI’s ChatGPT, Google’s Gemini and Meta’s Llama.

    The shake-up may create an opening for independent businesses to cut through online, but some big brands are concerned they will be lost in a wild west where it is unclear how to reach the consumer. Marketers must now appeal not only to shoppers directly but also to their AI bots.

    “Retailers can’t buy their way into the search – they have to earn it,” says Emma Ford, the director of digital transformation for PwC UK. “The experience, expertise, authenticity and trustworthiness [of a brand online] help. Sentiment across the internet is really important.”

    Several large UK retailers have told the Guardian they already have teams on the case looking at a wide variety of tactics, from making sure they appear in Reddit forums – a key source for some platforms – to responding to reviews on Google or Trustpilot, and ensuring AI models can access the correct product data.

    While some say they are being cautious with resources, amid signs certain individual LLMs could disappear as rapidly as they have sprung up, the belief is that this new way of interacting online is here to stay.

    Nickyl Raithatha, the chief executive of the online card and gift seller Moonpig, says AI search’s relevance for companies this year is relatively low but his company is well-prepared for rapid change.

    He says Moonpig is ensuring its products are picked up in AI search by using generative engine optimisation (GEO) techniques such as “online content with people discussing the best way to make someone happy on Mothers Day” in its own content or on discussions boards and in YouTube videos. He adds: “There is a growing science around this and we are all learning.”

    Ford says businesses are still feeling their way into the nuances of how the technology will find and respond to their online presence. Online reviews, for example, are clearly a factor in AI decision-making, but it is not clear how much importance is placed on particular platforms or how they rank against other factors such as reliable availability data, longevity of a brand or secure payment options.

    It may be that suppliers that have been around longer and have a broader profile are foregrounded, but their long history of ups and downs could also play against them.

    “I do think AI will change retail for the next 20 years,” says Peter Ruis, the managing director of John Lewis. He contends that established brands such as his will benefit from having a strong reputation with the technology in place to sell online, while shoppers could discover they stock items previously assumed to have been available only at a specialist.

    In future, industry watchers believe, ChatGPT, Amazon and Google are likely to try to monetise their AI platforms with some form of paid search or featured ads.

    More sophisticated “AI agent” models are also being developed – bots that can autonomously perform complex multistage tasks such as seeking out the best deals, placing orders and organising delivery.

    For example, it could be possible for these digital secretaries to negotiate offers tailored to particular customers, such as bundling together a number of furniture purchases from various outlets during a move, which have been customised to fit budget, style and delivery preferences, according to the advisory firm McKinsey.

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    That could lead retailers into allowing their systems to flex product prices to attract particular searchers.

    Organising the return of an unwanted item could also be taken on by AI agents, with one acting on behalf of the shoppers and the other for the retailer.

    However, such technology is fraught with potential pitfalls. Retailers will need systems that can cope with a potential flurry of queries and to have clear rules on who might be responsible for glitches such as unwanted purchases made by a bot.

    In the US, the online marketplace Etsy was the first to team up with ChatGPT to make it possible to pay for goods via the LLM’s instant checkout service. The e-commerce platform Shopify and the retailers Walmart and Target swiftly followed. While the deals do not appear to prioritise their products in searches, the inclusion of a “buy” button for their goods could put them ahead of the pack.

    Anna Bancroft, a partner in PwC’s digital transformation team, points out that under current UK rules it is not possible for an AI bot to make a purchase on behalf of a human, and regulation would need to change for such systems to run without human oversight. She says retailers and shoppers are cautious about giving the robots access to customer data and handling payment.

    There are also concerns about agents being susceptible to manipulation, as Microsoft has found in research simulations. Meanwhile, tech retail players are becoming territorial about who gets to crawl whose data.

    Last month, Amazon sued the AI company Perplexity over its shopping feature that automates placing orders for users. Amazon accused the startup of covertly accessing customer accounts and disguising AI activity as human browsing. Perplexity hit back, defending users’ right to delegate their shopping to AI agents and calling the suit “a bully tactic to suppress competition”.

    In this rapidly shifting landscape, Ford suggests independent retailers may have a chance to shine. “Independents have potential to go faster,” she says, with the ability to respond nimbly without having to sign off large budgets.

    Michelle Ovens, the founder of Small Business Britain, which advises independent retailers on how to survive on the changing high street, agrees. “[Independent businesses] don’t necessarily need to spend a lot of money. You don’t necessarily need a big team,” she says.

    Ovens advises local shopkeepers to ask AI platforms themselves how best to make sure they can appear. “Be clear about who you are,” she says, with a description making clear that you are an independent specialist, up-to-date pictures and “encourage customers who have got experience of the brand to give a good review”.

    However, all of this should not stand ahead of making a website engaging and easy to shop on, Ovens adds. “There will not be a dramatic shift this Christmas. We’ll see change over time and operators will rise to the challenge.”

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  • FTI Consulting Expands Healthcare Risk Management & Advisory Practice with Appointment of Mitch Harris as Senior Managing Director

    FTI Consulting Expands Healthcare Risk Management & Advisory Practice with Appointment of Mitch Harris as Senior Managing Director

    WASHINGTON, Dec. 10, 2025 (GLOBE NEWSWIRE) — FTI Consulting, Inc. (NYSE: FCN) today announced the appointment of Mitch Harris as a Senior Managing Director in the Healthcare Risk Management & Advisory practice within the firm’s Forensic and Litigation Consulting segment.

    Mr. Harris, who is based in Los Angeles, has more than three decades of experience driving healthcare strategy for major health plans, health systems and pharmacy benefit managers across the United States. His expertise includes leveraging data and AI to improve performance and support clients with operational and regulatory challenges.

    In his role at FTI Consulting, he will support clients with regulatory strategy and government programs compliance, as well as operational optimization and turnaround initiatives.

    “The healthcare industry is experiencing rising costs, increased regulatory complexity and intensified oversight, creating operational and financial volatility and continuing to increase our clients’ need for expert support and advice,” said Wayne Gibson, Leader of the Healthcare Risk Management & Advisory practice at FTI Consulting. “Mitch brings diverse capabilities to our deep bench of experts, working with clients to address regulatory, operational and financial risk and support innovative digital transformation, ultimately unlocking value.”

    Earlier in his career, Mr. Harris held roles at PwC’s Health Industries Advisory practice, where he led business development and operational strategy for the national health plan compliance and regulatory practice. He has also served in management roles at Caremore Medical Management Company (now Carelon) and Blue Shield of California.

    Commenting on his appointment, Mr. Harris said, “FTI Consulting is a global, expert-driven firm with a reputation for supporting high-stakes, high-profile projects. Our experts can predict and remediate risk and proactively mitigate issues while implementing process improvement to optimize costs. I look forward to joining my colleagues as we work to solve our clients’ biggest challenges.”

    About FTI Consulting 
    FTI Consulting, Inc. is a leading global expert firm for organizations facing crisis and transformation, with more than 8,100 employees located in 32 countries and territories as of September 30, 2025. In certain jurisdictions, FTI Consulting’s services are provided through distinct legal entities that are separately capitalized and independently managed. The Company generated $3.70 billion in revenues during fiscal year 2024. More information can be found at www.fticonsulting.com. 

    FTI Consulting, Inc.  
    555 12th Street NW  
    Washington, DC 20004  
    +1.202.312.9100 

    Investor Contact:  
    Mollie Hawkes 
    +1.617.747.1791 
    mollie.hawkes@fticonsulting.com 

    Media Contact:  
    Sam Ford 
    +1.617.480.7402 
    samantha.ford@fticonsulting.com

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    Source: FTI Consulting, Inc.

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  • Travel firm Tui says it is using AI to create ‘inspirational’ videos | Tui Travel

    Travel firm Tui says it is using AI to create ‘inspirational’ videos | Tui Travel

    Tui, Europe’s biggest travel operator, has said it is investing heavily in AI as more people turn to ChatGPT to help book their holidays, including using the technology to create “inspirational” videos and content.

    The chief executive, Sebastian Ebel, said the company was investing in generative engine optimisation (GEO), the latest incarnation of search engine optimisation (SEO), to help push Tui to the top of results from AI chatbots including ChatGPT and Gemini.

    While traditional SEO relied on links and keywords to increase visibility in search engine results, GEO tries to increase recommendations via chatbots by ensuring a product is mentioned in the message boards, videos and other online datasets that the AI agents crunch to produce their answers.

    Ebel said connecting to large language models and social media companies would help Tui to grow. “By being part of their ecosystem, not depending on Google alone any more, [we are] going into the space where our customer is,” he said. “We are building a partnership where we can optimise search, where we can broaden distribution and proximity to ChatGPT and TikTok.”

    It comes as people increasingly use AI agents – autonomous digital secretaries – to help with their online shopping. This year OpenAI, Perplexity, Google and Microsoft all launched AI features that allow users to search for products through their chatbots, with agents that can complete orders on behalf of consumers.

    Tui said it was using AI to help create “inspirational videos, content and translations to improve trip planning”, as well as AI-powered voice and chat agents for customer services.

    It is the latest effort by the German travel operator to incorporate AI technology into its customer experience, after it started using ChatGPT in its app to provide holiday recommendations in 2023. Its first launch had some hiccups, with the Guardian finding at the time that the bot struggled with basic conversation.

    Tui reported annual pre-tax profits up 20% to just over €1bn (£904m), close to a record high. Revenue rose 4% to €24.2bn but is expected to grow at a slower rate next year, between 2% and 4%, reflecting “prevailing macroeconomic and geopolitical uncertainties”, Tui said.

    The company, which has been struggling in its core German market, also laid out plans to cut costs by €250m by 2028, though Ebel insisted “there is a big difference in having less jobs versus cutting jobs”.

    He said: “Our workforce is changing and we are getting more efficient. We will not get less people in total. We want to grow and we want to be more efficient.”

    The company, which is headquartered in Hanover, employs about 67,000 people around the world. Its shares fell by 2.8% in early trading on Tuesday and are down by about 34% over the past five years.

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    Ebel said he was “very unsatisfied” with the share price, though the chief financial officer, Mathias Kiep, said a new dividend policy of €0.10 a share could help revive the stock.

    The company signalled that some of the price pressure on travellers could ease, with Ebel saying the market was “over the high inflation times”.

    Holiday bookings for next summer have been positive so far, Tui said, with popular destinations for 2026 including Greece, the Balearic Islands and Turkey.

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  • McDonald’s pulls AI-generated Christmas advert following backlash

    McDonald’s pulls AI-generated Christmas advert following backlash

    McDonald’s has taken down a Christmas advert made with Artificial Intelligence (AI) following online backlash.

    The 45-second advert was produced with generative AI clips and released publicly on McDonald’s Netherlands YouTube channel on 6 December.

    Viewers on social media denounced the use of AI in the film, with one commenter calling it “the most god-awful ad I’ve seen this year”.

    On 9 December McDonald’s Netherlands removed the video, adding in a statement to BBC News that the moment served as “an important learning” as the company explored “the effective use of AI”.

    The advert was created for McDonald’s by Dutch company TBWANeboko and US production company The Sweetshop.

    Adverts which include generative AI have become a growing trend among major brands, such as Coca-Cola, particularly for the Christmas season.

    The McDonald’s advert depicted things that can go wrong during the Christmas break, using the slogan “the most terrible time of the year”, and suggesting the time was better spent in the company of the fast food giant.

    Following its release, viewers criticised the film’s uncanny-looking characters and large number of stitched together clips, calling it “creepy” and “poorly edited”.

    As clips made using generative AI are more likely to distort the longer they run for – most clips made using the process tend to be roughly six to 10 seconds long – even a 45-second advert would likely consist of many videos edited together.

    The video also provoked concerns for job displacement in the industry, with one Instagram comment noting: “No actors, no camera team..welcome to the future of filmmaking. And it sucks.”

    Following the video being made private on the McDonald’s Netherlands YouTube channel, The Sweetshop’s chief executive Melanie Bridge defended the advert.

    As quoted in Futurism, she said the production process took “seven weeks” where the team “hardly slept” and created “thousands of takes – then shaped them in the edit just as we would on any high-craft production”.

    “This wasn’t an AI trick,” she said. “It was a film.”

    In a statement to BBC News, McDonald’s Netherlands said the video was meant to “reflect the stressful moments that can occur during the holidays” but had decided to remove the advert.

    “This moment serves as an important learning as we explore the effective use of AI,” it said.

    Where normally a high-publicity Christmas campaign could take up to a year to pull off, companies have begun to look to firms which can produce films in a much shorter time span, using prompts from generative AI tools to create new video content.

    Coca-Cola seems to have been able to sway at least some of the general public with its second AI-generated Christmas ad in a row.

    While the use of AI to create the advert has been divisive, a report from analytics company Social Sprout found it had a 61% “positive sentiment rating” from commenters online.

    But several other businesses such as the Italian luxury fashion house Valentino have come under fire for using the technique in their campaigns, with critics calling Valentino’s advert “cheap” and “lazy”.

    BBC News has contacted The Sweetshop and TBWANeboko for comment.


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  • Fervo nabs $462M to complete massive next-gen…

    Fervo nabs $462M to complete massive next-gen…

    The startup Fervo Energy just raised another $462 million to build America’s next generation of geothermal power plants.

    On Wednesday, the Houston-based company said it closed a Series E funding round led by a new investor, B Capital, a global venture capital firm started by Facebook cofounder Eduardo Saverin. With the latest announcement, Fervo says it’s raised about $1.5 billion overall since 2017 as it develops what could become the world’s largest ​“enhanced geothermal system” in Utah.

    “Fervo is setting the pace for the next era of clean, affordable, and reliable power in the U.S.,” Jeff Johnson, general partner at B Capital, said in a news release.

    The Series E funding comes as Fervo reportedly prepares to become a publicly traded company, which would let it raise even more capital for its ambitious projects. When asked about a potential IPO, Fervo said only that the company is ​“focused on executing our development plan” in an email to Canary Media. ​“We have a lot of capital needs going forward to fuel our planned growth and will be tapping a lot of different opportunities to make that happen.”

    The carbon-free energy from deep underground is available around the clock, but it represents only about 0.4% of total U.S. electricity generation — largely because the existing technology is constrained by geography. Today’s geothermal plants rely on naturally occurring reservoirs of hot water and steam to spin their turbines and generate power, which are available in a limited number of places.

    Fervo’s approach involves creating its own reservoirs by fracturing hot rocks and pumping them full of water. The company uses the same horizontal drilling techniques and fiber-optic sensing tools as the oil and gas industry in an effort to reach deeper wells and hotter sources than is possible with conventional geothermal technology.

    Its flagship development, Cape Station, is well underway in Beaver County, Utah. The project’s initial 100-megawatt installation is on track to start delivering power to the grid in October 2026, which will make it the first commercial-scale enhanced geothermal project to hit such a milestone worldwide, according to Fervo. An additional 400 MW is slated to come online in 2028.

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  • US health officials re-examine RSV shots despite documented safety and efficacy | Trump administration

    US health officials re-examine RSV shots despite documented safety and efficacy | Trump administration

    US regulatory officials are re-examining the safety of RSV shots despite no published reports of safety issues – a move that could lead to the removal or limitation of shots that have dramatically lowered hospitalizations among babies.

    It’s the latest move from US health officials under Robert F Kennedy Jr, the secretary of the US Department of Health and Human Services (HHS) and a longtime anti-vaccine activist, to limit access to shots and to undermine public trust in the safe and effective products.

    Officials at the US Food and Drug Administration (FDA) told three manufacturers of RSV preventative treatments for babies last week their products are being reviewed because of safety concerns raised by anti-vaccine activists, Reuters reported on Tuesday.

    When asked by the Guardian if the FDA was reviewing the preventative shots and maternal RSV shots, a spokesperson confirmed the news.

    The FDA routinely evaluates safety information about approved drugs, HHS press secretary Emily Hilliard said. A team at the FDA’s Center for Drug Evaluation and Research “is rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science and in the best interest of patients”, Hilliard said.

    The spokesperson did not respond to questions about whether the review was prompted by safety signals or anti-vaccine activists, and did not respond by press time to a question clarifying whether the review applies to shots for both babies and pregnant people.

    “The RSV shots were the first time we had any kind of tools to prevent these complications,” said Elias Kass, a naturopathic physician specializing in pediatrics in Seattle, Washington.

    RSV was the most common cause of hospitalization among US infants, he added: “To have a tool to prevent that is incredible.”

    There were two working groups assessing evidence on RSV for the Advisory Committee on Immunization Practices (ACIP) to the US Centers for Disease Control and Prevention (CDC). One group focused on the vaccines given during pregnancy and the other on the preventative shots given to babies.

    Neither group appears to have met since Kennedy fired all 17 previous advisers and replaced them with his own hand-picked advisers.

    Kevin Ault, a former ACIP adviser and an obstetrician/gynecologist who has remained a liaison for the committee, was on the RSV working group for maternal vaccination until it stopped meeting. No new safety information about RSV shots has been released, Ault said.

    In fact, news from the group was positive.

    “There were concerns about pre-term delivery as a safety signal in the original maternal trials, but there have been subsequent safety data that shows that’s not an increased risk,” Ault said. That evidence was publicly discussed by the previous ACIP advisers.

    “The efficacy and the safety signals have both been very reassuring,” Ault said.

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    Even so, the new vaccine advisers in their meeting last week made several comments about re-evaluating the vaccines given during pregnancy, saying they have “a new way of looking at pregnancy and vaccines,” Ault said. But no information about this new approach has been given to the public.

    The shots to prevent RSV are one of the greatest public health breakthroughs in recent years, with dramatic declines in hospitalization, Ault said.

    Vaccinating during pregnancy was 55% to 68% effective in keeping newborns from being hospitalized in the first six months of their lives, according to a survey of studies published in the New England Journal of Medicine in October.

    Babies who were given the preventative antibody shots were 79% to 83% less likely to be hospitalized, the study found.

    Decisions from the FDA could limit access to the shots, and public health experts worry that the announcements, without evidence, undermining the shots could affect public trust and confidence in vaccine safety.

    Before the shots were widely available, 2% to 3% of all infants in the US were hospitalized for RSV. The respiratory illness has also been associated with developing asthma.

    “Almost every parent has some experience with RSV,” Ault said. “So I think it’s going to be a lot easier to talk about the risk and benefits of these interventions to parents, just because they realize what a devastating disease it is.”

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  • IMF urges China to address economic imbalances as trade surplus hits $1 trillion

    IMF urges China to address economic imbalances as trade surplus hits $1 trillion

    HONG KONG — The head of the International Monetary Fund has urged China to fix its economic imbalances, saying the country of 1.4 billion people is too big to rely on exports for its growth.

    China’s global exports have been rising while shipments to the United States have contracted after President Donald Trump hiked taxes on imports from China and many other countries. Earlier this week, Beijing reported its trade surplus for 2025 had already exceeded a record $1 trillion.

    IMF Managing Director Kristalina Georgieva said the heavy reliance on exports risks provoking more moves by its trading partners to curb imports from China.

    “(China’s) continuing to depend on export-led growth risks furthering global trade tensions,” Georgieva told a press conference on Wednesday. “China is now too big to rely on exports as a source for growth… and (it has) a large domestic market that can be a big aspiration for growth in the years to come.”

    At a high-level meeting in October aimed at drawing up plans for the next five years, China’s leaders highlighted the need to boost domestic consumption. The ruling Communist Party has long sought to rebalance the economy away from heavy dependence both on exports and on massive investment in infrastructure.

    But the COVID-19 pandemic intervened, along with a prolonged downturn in the real estate market that has slowed activity for that once powerful engine for growth. Meanwhile, Beijing has pushed hard to expand manufacturing in high-tech industries, struggling to rein in excessive capacity in some areas such as automaking.

    Morgan Stanley recently predicted that by 2030, China’s market share in global exports could reach 16.5%, up from about 15% currently, supported by its advanced manufacturing and high-growth segments like robotics, electric vehicles and batteries.

    Georgieva was visiting Beijing for an annual economic forum involving the heads of major international organizations. The IMF also was concluding its annual review of China.

    Softening domestic consumption and demand in China has contributed to a weakened yuan versus the dollar and other currencies. That has made China’s exports cheaper compared with those of other countries, reinforcing trade imbalances.

    The IMF said comprehensive policies are needed to encourage Chinese people to spend more.

    While China’s market is huge and still growing at a nearly 5% annual pace, domestic demand has weakened as consumers cut back on spending due to job and income losses during and after the pandemic.

    The years-long property downturn also has hit household wealth, crimping shoppers’ appetites for spending and sapping demand for imports, amplifying the trade imbalance.

    Helping to offset the decline in exports to the U.S., China is selling more in other countries in Africa, Latin America, Southeast Asia and Europe. That has led to complaints from China’s trading partners as its imports have failed to keep pace.

    Wednesday, the EU Chamber of Commerce in China also warned its substantial trade surplus is raising worries.

    The IMF’s remarks followed Chinese Premier Li Qiang’s comments to the international group of financial experts Tuesday that higher tariffs have “dealt a severe blow” to the global economy.

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