Category: 3. Business

  • Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

    Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

    • Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and previously-treated nusinersen patients with SMA1
    • Biogen is dedicated to partnering with the SMA community to advance care through scientific innovation and a commitment to enhancing outcomes for people living with SMA

    CAMBRIDGE, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5 mL doses for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95% of all SMA cases.2 The SPINRAZA European Union marketing authorization has been updated to include the high dose regimen. The new high dose regimen comprises a more rapid loading phase, two 50 mg loading doses administered 14 days apart and 28 mg maintenance dose injections every four months thereafter. Individuals transitioning from the 12 mg dose will receive one 50 mg dose in place of their next 12 mg dose, followed by 28 mg maintenance doses every four months thereafter. SPINRAZA is for intrathecal use by lumbar puncture by health care professionals experienced in performing lumbar punctures.

    “Since its approval in the European Union in 2017, SPINRAZA has helped set a new standard in patient care and treated more than then 10,000 infants, children, teens and adults worldwide,” Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “We are proud to introduce the high dose regimen of SPINRAZA, which we have developed to address the evolving needs of individuals living with SMA, and are deeply committed to bringing it to the European SMA community as quickly as possible. We are grateful for all of the contributions of the SMA community who made today’s approval possible.”

    The EC approval is based on data from the three-part, Phase 2/3 DEVOTE study and its ongoing long-term extension. Results from the pivotal cohort of the study showed treatment-naïve, symptomatic infants who received the high dose regimen of SPINRAZA experienced statistically significant improvements in motor function as measured by the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND), when compared to a prespecified matched sham (untreated) group from the ENDEAR study* (mean difference: 26.19 points; +15.1 vs. -11.1, p<0.0001). Improvements in motor function were also observed in the open label cohort of individuals across a broad range of ages and SMA types who transitioned from the low dose regimen. These participants experienced a mean improvement on the Hammersmith Functional Motor Scale – Expanded of 1.8 points [SD 3.99] from baseline to Day 302.1

    “The DEVOTE results provide encouraging evidence that this new dosing option could deliver meaningful treatment outcomes with a safety profile generally consistent with the 12 mg dosing regimen,” said Eugenio Mercuri, M.D., Ph.D., Professor of Pediatric Neurology at the Catholic University, Rome, Italy. “I have witnessed the remarkable strides that have been made in treating SMA, but it is clear challenges remain. The European Commission approval of the high dose regimen of SPINRAZA is an important step toward addressing those challenges and advancing how we care for people living with SMA.”

    Throughout the study, high dose regimen was generally well tolerated, with reported adverse events consistent with SMA and the known safety profile of nusinersen. No new safety concerns were observed with continued use of high dose nusinersen in the long-term-extension study. In the DEVOTE study, the most common adverse events that occurred in at least 10% of participants treated with the high dose regimen and occurred at least 5% more frequently than the matched sham group were pneumonia, COVID-19, pneumonia aspiration, and malnutrition.1

    Special warnings and precautions for use of nusinersen include adverse reactions as a part of the lumbar puncture procedure, low platelet counts and blood clotting abnormalities, renal toxicity and hydrocephalus (excessive buildup of cerebrospinal fluid in the brain).3

    “As a community, we welcome advances that expand options for people living with SMA and reinforce continued innovation in SMA care,” said Nicole Gusset, CEO of SMA Europe. “This approval highlights the importance of sustained research and investment, contributing to a wider range of possibilities that may enable more tailored approaches to SMA care over time.”

    The updated Summary of Product Characteristics will be available on the European Medicines Agency website at www.ema.europa.eu. 

    The high dose regimen of SPINRAZA is also approved in Japan and is under review with the U.S. Food and Drug Administration (FDA) with a decision expected by April 3, 2026. Biogen is working with regulatory authorities around the world to progress this additional dosing option for people living with SMA. 

    *ENDEAR is one of the two pivotal studies that formed the basis of regulatory approvals for SPINRAZA 12 mg.

    About the DEVOTE Study1
    DEVOTE was a Phase 2/3 randomized, controlled, dose-escalating study designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of SPINRAZA when administered at a higher dose (50/28 mg). The study enrolled 145 participants across ages and SMA types at approximately 42 sites around the world. DEVOTE included an open-label safety evaluation cohort (Part A), a double-blind, active control randomized treatment cohort (Part B), followed by an open-label treatment cohort (Part C) to assess the safety and tolerability of transitioning participants from the currently approved dose of SPINRAZA 12 mg to the higher dose regimen being tested in the study.

    Part B was comprised of a pivotal cohort in treatment-naïve patients with infantile-onset SMA (n=75), and a supportive cohort in treatment-naïve patients with later-onset SMA (n=24). The primary endpoint of Part B measured the change from baseline on CHOP-INTEND at six months, comparing the high dose regimen of nusinersen to a matched, untreated sham control group from the Phase 3 ENDEAR study. ENDEAR is one of the two pivotal studies that formed the basis of regulatory approval for SPINRAZA 12 mg.

    Part C was an open-label evaluation of the higher dose regimen in children and adults who transitioned from SPINRAZA 12 mg to the 50/28 mg regimen (n=40).

    About SPINRAZA
    The high dose regimen of SPINRAZA (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5mL injections are approved in the European Union and Japan to treat infants, children and adults with spinal muscular atrophy (SMA). The high dose regimen of nusinersen is currently under review with the U.S. Food and Drug Administration (FDA) with a decision expected by April 3, 2026. SPINRAZA 12 mg/5 mL injection is approved for SMA in more than 71 countries.4

    The low dose regimen of SPINRAZA has shown efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years,5,6 combined with unsurpassed real-world experience. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs. 

    Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS). For more information, visit your respective country’s product website. For the U.S., please click here for Important Safety Information and full Prescribing Information .

    About Biogen
    Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.

    Biogen Safe Harbor
    This news release contains forward-looking statements, including, among others, relating to: the potential benefits, efficacy and safety of higher doses of nusinersen (marketed as SPINRAZA); the potential to improve outcomes for, and address unmet needs of, patients with SMA; potential regulatory discussions, submissions, decisions and approvals and the timing thereof; the anticipated benefits, risks and potential of our collaboration arrangements; the potential of our commercial business and pipeline programs, including nusinersen; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

    These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

    These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

    Digital Media Disclosure
    From time to time we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and this social media channel in addition to our press releases, SEC filings, public conference calls and webcasts, as the information posted on them could be material to investors.

    References:

    1. Crawford TO, et al. Exploring Higher Doses of Nusinersen in Spinal Muscular Atrophy: Final Results From Parts B and C of the 3-Part DEVOTE Study. Presented at: World Muscle Society (WMS) Congress; 2024; Prague, Czechia.
    2. Farrar MA, Kiernan MC. The Genetics of Spinal Muscular Atrophy: Progress and Challenges. Neurotherapeutics; 2015; 12:290–302.
    3. European Medicines Agency. SPINRAZA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/spinraza-epar-product-information_en.pdf. Last accessed: December 2025.
    4. Based on commercial patients, early access patients, and clinical trial participants through December 31, 2022. 
    5. Core Data sheet, Version 13, October 2021. SPINRAZA. Biogen Inc, Cambridge, MA.
    6. Finkel RS, et al. Final Safety and Efficacy Data From the SHINE Study in Participants With Infantile-Onset and Later-Onset SMA. Presented at: Cure SMA Conference; 2024; Austin, Texas.

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  • Linking complex microbial interactions and dysbiosis through a disordered Lotka–Volterra model

    Linking complex microbial interactions and dysbiosis through a disordered Lotka–Volterra model

    We thus collect all the parameters estimated from the data in a vector π=(h,qd,q0,K). As we will better detail in the Methods, we develop a moment matching inference algorithm to infer the model parameters θ, as depicted in Figure 1. The idea of the method is to introduce a cost function C(θ|π), representing a total relative error for some self-consistent equations. If the parameters θ are such that the right part of the self-consistent equation equals the left part, the problem is considered solved. Because the landscape associated with this cost function presents several minima, we perform multiple optimization procedures to collect an ensemble of possible solutions, from which we retain the top 30. First, we find that different solutions θ of the optimization problem provide ecological insights into the underlying microbiome populations.

    As originally predicted in Altieri et al., 2021, among all the parameters that define Equation 1, the only ones relevant for reproducing the theoretical phase diagram are the amplitude of demographic noise and the heterogeneity of interactions. The mean interaction strength, provided it is sufficiently positive, does not play a significant role. This prediction is fully confirmed by the inference procedure applied to the two microbiome datasets, allowing us to identify a universal signature that distinguishes healthy from unhealthy states. Figure 3a shows, indeed, that inferred noise (T) and interaction heterogeneity strength (σ) for healthy and diseased microbiomes are clustered in the two-dimensional plane.

    Distinct ecological organization in healthy vs diseased microbiomes.

    (a) Inferred T (demographic noise strength) and σ (interactions heterogeneity) for healthy (blue) and diseased (red) microbiomes are clustered. Darker dots correspond to better solutions (i.e., solutions with a lower value of the cost function C), while the two points with hexagonal markers correspond to the best two (healthy and diseased, respectively) solutions. In the first panel inset, we also show (in log–log scale) the species abundance distributions (SADs) corresponding to each solution. To have a more concise representation, we present each SAD fixing the disorder to its average ζ¯=Kμh. (b) The probability density function of the inferred interactions αi,j for healthy (blue) and diseased (red) microbiomes. Dysbiosis reduces the heterogeneity of the interaction strengths. The quantities reported in the legend are the average and standard deviation of αi,j. They are calculated as μXα=μX/SX and σXα=σX/SX, where SX is the species pool size, estimated as the set of all observed species in a dataset, X can denote healthy (H) or diseased (D) individuals.

    In particular, the SAD for the healthy cohort is robust among the different solutions of the inference procedure, as depicted by the superposition of the different curves in the inset of Figure 3a. On the other hand, SADs inferred from unhealthy patients have high sensitivity to different solutions. In particular, some of them display a mode for high-abundance species (light red lines in Figure 3a), a signature of dominant strain in the gut. Consistently, the distribution of the interactions P(αi,j) generated through the inferred parameters μ and σ is different between healthy and diseased cohorts, giving a distinct pattern of interactions (see Figure 3b), a result that is compatible with that found by Bashan et al., 2016. Remarkably, we find that dysbiosis reduces the heterogeneity of interaction strengths, a result also observed when taking correlations as a proxy for interactions (Seppi et al., 2023).

    We then assess how close the inferred σ and β=1/T (a.k.a. inverse temperature in a statistical physics approach) are to the critical RSB line of the dgLV (R=0), evaluated by keeping all the other parameters constant (see Methods). We find again that the replicon values R corresponding to each solution of our optimization protocol are significantly different for the two investigated microbiome phenotypes (see Figure 4a). In particular, diseased microbiomes are closer to marginal stability within the RS ansatz (Altieri et al., 2021; Mézard et al., 1987; de Almeida and Thouless, 1978). Furthermore, by investigating the shape of the SAD given by Equation 2, we can estimate the ratio between niche (represented by species interaction) and neutral (represented by birth/death and immigration) ecological forces, which can be captured by the quantity ψ (Wu et al., 2021). It detects the emergence of peaks in the SAD as a hallmark of niche processes (see Appendix 2).


    Stability of healthy vs diseased microbiomes.

    (a) The replicon eigenvalue corresponding to each solution of our optimization procedure (shaded dots). The solid hexagon represents the replicon corresponding to the best solutions that minimize the error in predicting the order parameters of the theory (minimum C). The two investigated microbiome phenotypes (healthy in blue, diseased in red) are significantly different. In particular, diseased microbiomes are closer to the marginal stability of replica-symmetric ansatz (gray horizontal line). (b) Solutions of the moment-matching objective function are shown as a function of ψ and m, which in turn depend on the species abundance distribution (SAD) parameters (see main text). Healthy (blue) and diseased (red) microbiomes appear to be clustered. Therefore, distinct ecological organization scenarios (strong neutrality/emergent neutrality) take place. Darker dots correspond to solutions with lower values of the cost function, while hexagonal markers correspond to the two best solutions.

    Inspired by field-theory arguments (see Methods and Appendix, Section S2), we can call the mass of the theory the m parameter, as defined above in Equation 2. In classical and quantum field theory, the particle–particle interaction embedded in the quadratic term is typically referred to as a mass source. In our context, m=1βσ2(qdq0) captures quadratic fluctuations of species abundances, as also appearing in the expression of the leading eigenvalue of the stability matrix. When m0, the analytical order parameters diverge and the system enters the unphysical regime of unbounded growth. As such, the mass term can be considered a complementary stability measure, capable of capturing the transition to the unbounded growth regime.

    In the model, two kinds of effects compete to shape the community structure. On the one hand, we have niche effects, encoded in disordered interactions and thus tracked by the parameters μ, σ, and K. Their overall effect is selective and tends to concentrate the SAD around the typical abundance value. On the other hand, we have neutral effects encoded in the stochastic dynamics and immigration, governing the low-abundance regime of the SAD. When the demographic noise amplitude is stronger than immigration (ν<1, as in our case), the SAD exhibits a low-abundance integrable divergence. In the opposite scenario, for ν>1, there is no divergence, and the SAD is modal. Since interactions are random, the probability of observing an internal mode can be estimated as the fraction of SADs realizations having non-trivial solutions to the stationary point equation. Such a quantity, dubbed as the niche–neutral ratio, can be analytically evaluated:

    (5)

    ψ=12Erfc(ζ+ζ¯2σζ)+12Erfc(ζζ¯2σζ) ,

    where ζ=4(1ν)mβ and ζ¯=Kμh. When ψ1, niche and neutral forces give comparable contributions to the dynamics, as both low-abundance divergence and a finite abundance mode coexist in the SAD. Finally, if the typical abundance diverges, we enter the unbounded growth phase, which means that the mass m and the niche–neutral ratio ψ are not independent, as suggested by the analytical expression for ψ. For an exhaustive derivation of this result, see Appendix 2. With the obtained model parameters, we are able to evaluate m and ψ for healthy and diseased microbiomes. Also, in this case, healthy and diseased microbiomes are visibly clustered, as shown in Figure 4. Unhealthy microbiomes turn out to be closer to the unbounded growth phase, and the niche–neutral ratio is larger by five orders of magnitude than the healthy case ψD105ψH. This leads us to argue that selective pressure is way larger in diseased states, while in the healthy one, birth and death effects are the key drivers of the dynamics. These results are also confirmed by the SAD shapes in the inset of Figure 3 (panel a).

    In summary, in the Results section, we show that (i) the inference pipeline robustly recovers demographic noise and interaction heterogeneity by calculating h, q0, and qd from the data; and (ii) these parameters cluster according to health status, with diseased microbiomes lying closer to the replica-symmetry-breaking threshold, indicating reduced ecological resilience.

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  • Multi-Criteria Decision Making for Decommissioning Projects

    Multi-Criteria Decision Making for Decommissioning Projects

    Multi-Criteria Decision Making

    Over 60 participants from 30 countries and three international organizations discussed how their countries have used multi-criteria decision making (MCDM) to plan decommissioning activities in line with national regulatory requirements, sustainability goals and long-term site objectives. Also used in spent fuel management, environmental remediation and advanced reactor technology assessment, MCDM assigns numerical weights to criteria based on input from regulators, industry representatives, operators and other stakeholders. Stakeholder groups may have differing views on the relative importance of these criteria, highlighting the need for constructive dialogue throughout the decision-making process.

    “MCDM can help us make good decisions by structuring complex decisions, balancing competing criteria, managing quantitative and qualitative factors and providing a shared understanding of both the problem and the preferred options,” said Simon Boniface, Decommissioning Strategy Manager at the UK’s Nuclear Decommissioning Authority. “It’s important to build confidence in the decision-making process, and so the views of all stakeholders need to be considered.”  

    Throughout the five-day meeting, participants presented decommissioning success stories as well as challenges and compared their approaches to decision making. They also collaborated on  hypothetical decommissioning planning scenarios using MCDM tools.

    “In the past, decisions often relied on experience rather than systematic evaluation,” said Inhye Hahm, a Senior Researcher in the Decommissioning Technology Research Division at the Korea Atomic Energy Research Institute. “Cost is typically the dominant factor in technology selection, however in some national or facility-specific contexts where disposal capacity is constrained, waste volume reduction may become a higher priority than cost.” 

    MCDM provides a structured and transparent way to integrate these competing factors, reducing reliance on experience-based or intuitive decision making, she added. The Kori-1 nuclear power reactor, which entered permanent shutdown in 2017, is set to become the Republic of Korea’s first decommissioned reactor after approval to begin this process was obtained last June.

    “Amelioration factors, or technical solutions that were not available when the initial decision was made, are important to consider as part of a holistic approach to decommissioning,” said Alexia Mercier, a nuclear chemist and project lead at the Organisation for Economic Cooperation and Development’s Nuclear Energy Agency. “These can include developments in the maturity  of a particular technique, new reuse or recycle options for material and new proposals for site repurposing.”

    Meeting recommendations included developing a publication on an adaptive MCDM framework for decommissioning; identifying additional case studies; and evaluating the demand for an IAEA Coordinated Research Project on the subject. Participants also called for workshops and other exercises to support capacity building in this area. 

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  • Alphabet hits $4tn valuation on AI hopes

    Alphabet hits $4tn valuation on AI hopes

    Unlock the Editor’s Digest for free

    Google’s parent company Alphabet has become the fourth Big Tech group to hit a $4tn market value, fuelled by investor optimism that its artificial intelligence models can compete with rivals such as OpenAI.

    Alphabet shares rose 0.2 per cent in early trading in New York on Monday, capping a more than 6 per cent rise in the past month and catapulting the company over a threshold already surpassed by Nvidia, Apple and Microsoft.

    At the start of last year, Alphabet’s shares had been lagging behind the broader AI-driven rally in Big Tech stocks, amid fears that its cash-cow search engine would be overshadowed by new apps such as ChatGPT and Perplexity.

    Investors were also concerned that US regulators were seeking to break up the Silicon Valley-based company.

    But the stock has more than doubled since April, as Demis Hassabis, co-founder of DeepMind, Google’s AI arm, led the group’s effort to make inroads on ChatGPT.

    Last month, OpenAI chief Sam Altman declared a “code red” over the need to improve its products, after Google released its Gemini 3 model, which is considered to have leapfrogged rivals on industry benchmarks.

    At the time, Koray Kavukcuoglu, Google’s AI architect and DeepMind’s chief technology officer, said the Big Tech group had “pushed our performance quite significantly” by training its AI models using Google’s own bespoke chips. The company also said it was integrating its latest AI models into products immediately.

    Alphabet also showed investors that its advertising revenues were still growing strongly despite the threat from chatbot rivals.

    The company’s quarterly revenues grew 16 per cent in the third quarter to surpass $100bn for the first time, it said in October, boosted by its booming cloud computing business and YouTube ads. Its Gemini app has grown rapidly to 650mn monthly users.

    Investors have also become more bullish on the company’s prospects after US courts signalled that they were unwilling to break up the Big Tech group.

    Last year, a US federal judge said that the Department of Justice’s request for Alphabet to spin off elements of its advertising business would not be “easily enforceable”, despite the court finding in April that the company had an illegal monopoly in digital ads.

    Analysts at HSBC have said that Alphabet’s “full stack AI strategy [is] paying dividends”, thanks to Google developing and operating its own chips, data centres and consumer and workplace apps, in addition to the world’s most popular search engine.

    By contrast, OpenAI and Anthropic are largely dependent on third parties for computing infrastructure and distribution.

    Alphabet’s stock-price momentum has also allowed Google co-founder Larry Page to leapfrog Oracle’s executive chair Larry Ellison as the world’s second-richest person after Elon Musk.

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  • Trade Trends to Watch in 2026

    Trade Trends to Watch in 2026

    Affordability, Agreements, and Action by Congress

    Inu Manak is senior fellow for trade policy.

    Despite the flurry of trade policy activity in 2025, President Donald Trump’s on-again, off-again tariff threats left the trade landscape largely intact. Tariffs are not nearly as high as anticipated, and firms took proactive measures to massively front-load the economy, delaying some tariff impacts. The year ahead is likely to be another roller coaster, but there are three trends in trade to keep a close eye on: the erosion of trade agreements, the effects of tariffs on affordability, and the potential limits of executive power in trade.

    More on:

    Greenberg Center for Geoeconomic Studies

    Trade and Investment

    The United States is charting a new course on trade, but it is casting aside fundamental rules that have underpinned the global trading system in the process. That is pushing some of its closest allies away and could further fragment trade rules. The Trump administration has signed a handful of new trade deals and is likely to increase pressure on trading partners next year to make those deals deliver (or walk away from them if they do not). Closer to home, if Trump rips up the deal with Canada and Mexico that he negotiated in his first term, it will send shock waves throughout the U.S. economy.

    That said, Trump was willing to test the limits of what markets would accept on tariffs this year; the effects of tariffs on affordability could continue to nag at him. The administration has exempted a range of household goods from tariffs, including bananas, beef, and coffee. If everyday items feel unaffordable, the administration could be pushed to respond with additional tariff relief.

    Throughout U.S. history, every major tariff increase was legislated by Congress. Today, Congress has virtually no role. This is a precarious state of affairs, because it means that trade policy is now beholden to whoever holds the White House—and in this case, trade policy is being made by one person. With the Supreme Court set to rule on Trump’s use of emergency tariffs early this year, we will soon find out if there are any limits to the president’s trade powers.

    Following the Money From Oil to Tech

    Edward Alden is senior fellow at CFR, specializing in U.S. economic competitiveness, trade, and immigration policy.

    Here is a rule for anticipating U.S. trade actions in 2026: follow the money. Despite promising tariff protections to revitalize American manufacturing, the Trump administration has selectively spared the wealthiest industries in the United States, from big tech to big oil.

    More on:

    Greenberg Center for Geoeconomic Studies

    Trade and Investment

    Tech companies avoided the worst tariffs—semiconductors and smart phones were exempted—and even benefited as the administration eased export controls on China and knocked down Canada’s digital services tax. Europe will be the main target in 2026: the Trump administration wants a rollback of the European Union’s Digital Services Act and artificial intelligence regulations.

    Conventional energy has also remained largely tariff-free, and new trade deals have included purchase commitments for U.S. natural gas and oil. More is likely, especially if Venezuelan oil is reopened to U.S. producers.

    None of that bodes well for the biggest trade negotiation of 2026: the review of the United States-Mexico-Canada Agreement. The sectors at stake, especially autos and agriculture, have been the most harmed by the Trump actions to date. This year could be the death knell for three decades of free trade in North America.

    Will Trade Policies Drop Drug Prices?

    Thomas Bollyky is senior fellow for international economics, law, and development and director of the Global Health Program. Elena Every is research associate for Global Health, Economics, and Development. Chloe Searchinger is former research associate for Global Health, Economics, and Development.

    In 2025, President Trump broke new ground by using trade tools in an effort to lower prescription drug prices at home, raise them abroad, and return drug manufacturing to the United States.

    The tactic resulted in deals with foreign governments and pledges from drug manufacturers and alike, but the details and text of most of those commitments have not been released. The agreements with manufacturers are voluntary.

    In 2026, we will be watching whether those trade deals generate real returns by lowering the sky-high costs that Americans pay for medicines and by reversing the U.S. pharmaceutical trade deficit, which has grown 9 percent annually over the last two decades—hitting record highs in 2025.

    It may take a while. In exchange for a three-year reprieve from U.S. tariffs, fourteen drugmakers agreed to lower their Medicaid drug prices, launch future drugs at prices comparable to those in other countries, and invest over $480 billion in U.S. manufacturing. Yet, our analysis of earning statements of companies that produce specialized pharmaceutical manufacturing equipment suggests that those drugmakers have not begun acquiring the means yet to launch new production facilities in the United States.

    In December, the United Kingdom agreed in principle to raise by 25 percent its cost-effectiveness threshold for medicines procurement that the UK’s National Health Service uses, although it is unclear whether that will result in the UK spending more and U.S. patients paying less for prescription drugs. The UK government reported that the cost allocations for the change had already been made earlier in 2025 and would not affect “frontline services.”

    Is the United States Still Committed to Slowing China’s AI Progress? 

    Chris McGuire is senior fellow for China and emerging technologies.

    The United States’ approach to export controls on technology to China in 2026 could dictate whether the United States maintains its lead over China in artificial intelligence (AI) or whether China approaches parity.

    Until 2025, export controls were the most important and most heavily used policy tool for slowing China’s technological progress in advanced technologies, particularly chip-making and AI. China has achieved real progress in those areas, but substantially less than if U.S. export controls had not been in place. Restrictions on the export of semiconductor manufacturing equipment (SME) have caused China’s advanced chip-making capabilities to significantly lag those of U.S. allies and partners in both quantity and quality, and restrictions on the export of AI chips have caused China’s AI models to lag U.S. models by at least seven months. Those controls have been imperfect, but effective.

    The Trump administration has not effected a single regulation tightening export controls on China, however. It has done nothing to tighten controls on SME exports, which were strengthened annually by the Biden administration, and has substantially loosened restrictions on AI chip exports to China. Meanwhile, China’s circumvention efforts grow by the day.

    If the U.S. export control regime on advanced technologies is not actively maintained, it will atrophy. That would risk allowing China to catch up at the worst possible moment: just as those advanced technologies are emerging as major drivers of U.S. economic growth and military modernization. 

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  • CrowdStrike and Nord Security Announce Strategic Partnership to Redefine SMB Cybersecurity

    CrowdStrike and Nord Security Announce Strategic Partnership to Redefine SMB Cybersecurity

    The partnership combines Nord Security’s secure access and credential management solutions with the CrowdStrike Falcon platform, delivering enterprise-grade protection that’s simple, accessible, and built for every business

    AUSTIN, Texas – January 12, 2026 – CrowdStrike (NASDAQ: CRWD) and Nord Security today announced a strategic partnership to redefine SMB cybersecurity. The collaboration combines CrowdStrike’s AI-native Falcon® platform with Nord Security’s secure access and credential management solutions to deliver enterprise-grade protection that’s simple, accessible, and built for every business. 

    Challenged by limited budgets and cyber security expertise, CrowdStrike’s State of SMB Cybersecurity Survey shows just 36% of small and midsize businesses are investing in new tools, and only 11% have adopted AI-powered defenses. At the same time, adversaries are increasingly targeting smaller organizations with enterprise-level attacks. This partnership directly addresses that gap, seamlessly giving SMBs access to the AI-powered protection, intelligence, and speed trusted by the world’s largest enterprises.

    The partnership introduces two key innovations:

    • Simplified e-commerce access: Nord Security will offer Falcon® Go, CrowdStrike’s AI-powered solution purpose-built for SMBs, and Falcon® Enterprise directly through NordLayer, a toggle-ready network security platform for business, pairing the power of the Falcon platform with NordLayer’s secure access to make enterprise-grade protection easy to buy and deploy. 
    • Expanded MSP offerings through Pax8: CrowdStrike, Nord Security, and Pax8 will launch an add-on for Falcon® Next-Gen SIEM that combines speed, detection and accuracy of the Falcon platform with Nord Security’s secure access and network solutions, including 90 days of free access for qualifying customers.


    “This partnership transforms how SMBs secure their business,” said Daniel Bernard, Chief Business Officer at CrowdStrike. “Together with Nord Security, we’re redefining cybersecurity for SMBs – combining the power of the Falcon platform with Nord Security’s SMB go-to-market prowess and secure access technology to deliver enterprise-grade protection that’s fast to deploy, simple to manage, and built to stop breaches.”

    “Every growing business faces the same challenge: their attack surface is expanding faster than their ability to secure it,” said Mantas Ulozas, Chief Business Development Officer at B2B Commercial at Nord Security. “By combining our secure access and credential management solutions with CrowdStrike’s Falcon platform, we’re removing barriers of cost and complexity that have long limited SMBs’ access to enterprise-grade protection – giving them the visibility and confidence to defend against modern threats.”

    For more information on the CrowdStrike-Nord Security partnership, visit here. 

    About CrowdStrike

    CrowdStrike (NASDAQ: CRWD), a global cybersecurity leader, has redefined modern security with the world’s most advanced cloud-native platform for protecting critical areas of enterprise risk – endpoints and cloud workloads, identity and data.

    Powered by the CrowdStrike Security Cloud and world-class AI, the CrowdStrike Falcon® platform leverages real-time indicators of attack, threat intelligence, evolving adversary tradecraft and enriched telemetry from across the enterprise to deliver hyper-accurate detections, automated protection and remediation, elite threat hunting and prioritized observability of vulnerabilities.

    Purpose-built in the cloud with a single lightweight-agent architecture, the Falcon platform delivers rapid and scalable deployment, superior protection and performance, reduced complexity and immediate time-to-value.

    CrowdStrike: We stop breaches.

    Learn more: https://www.crowdstrike.com/

    Follow us: Blog | X | LinkedIn | Instagram

    Start a free trial today: https://www.crowdstrike.com/trial

    © 2026 CrowdStrike, Inc. All rights reserved. CrowdStrike and CrowdStrike Falcon are marks owned by CrowdStrike, Inc. and are registered in the United States and other countries. CrowdStrike owns other trademarks and service marks and may use the brands of third parties to identify their products and services.

    About Nord Security 

    Nord Security is home to advanced cybersecurity solutions that share the Nord brand and values, including the world’s most advanced VPN service NordVPN, the next-generation password manager NordPass, the file encryption tool NordLocker, threat exposure management platform NordStellar, the toggle-ready network security platform for business NordLayer, an all-around identity theft protection service NordProtect, and Saily, an eSIM service. Established in 2012, Nord Security’s products are now acknowledged by the most influential tech sites and IT security specialists. More information: nordsecurity.com.

    Press Contacts


     



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  • Trump plan to cap credit card costs hits bank shares

    Trump plan to cap credit card costs hits bank shares

    Shares in banks and credit card firms have fallen after US President Donald Trump called for credit card costs to be capped.

    On Friday, Trump wrote on Truth Social that interest rates on cards should be limited to 10% for one year from 20 January. He did not specify how such a cap might be introduced or whether such a move would be legally enforceable.

    UK bank Barclays, which has a sizeable US card business, saw its shares fall 3.5%, while US firms such as American Express, Visa and Mastercard were also lower in early trading.

    US banking associations say capping rates will make it harder for people to access credit and be “devastating” for millions of families and small businesses.

    The average interest rate for credit cards in the US is roughly 20%.

    In his statement on social media, Trump called for limiting it to 10%, reviving an idea he had put forward during his 2024 presidential campaign.

    “Effective January 20, 2026, I, as President of the United States, am calling for a one year cap on Credit Card Interest Rates of 10%,” he wrote. “Please be informed that we will no longer let the American Public be ‘ripped off’ by Credit Card Companies.”

    On Sunday, speaking to reporters on Air Force One, Trump said credit card companies would be “in violation of the law” if they did not comply with his demands.

    American Express’s share price fell by 4% while Visa and Mastercard’s stock dropped more than 2%. Other US lenders including JPMorgan Chase and Bank of America also saw their shares open more than 1% lower.

    Forcing companies to lower their lending rates rate would “upend the basic economics of the industry,” said Matt Britzman, senior equity analyst at Hargreaves Lansdown.

    “Most banks would respond by cutting credit limits, closing riskier accounts, and scaling back rewards programmes, because they simply couldn’t cover losses at that price point.”

    Nearly half of US households in 2022 carried credit card debt, according to the most recent survey of consumer finances by the Federal Reserve.

    It found that those with a balance owed more than $6,000 (£4,454) on average – which, with interest rates around 20%, translated into roughly $100 in monthly charges.

    The idea of capping credit card rates has won support from an unlikely coalition of lawmakers, uniting those on the far-left, such as Bernie Sanders, with populists that back Trump’s MAGA agenda.

    But the path to bringing the proposal into force is unclear.

    Similar plans have languished in Congress. The administration has also pushed to reduce the role of agencies that have regulated such issues in the past.

    “Begging credit card companies to play nice is a joke,” Democrat Senator Elizabeth Warren said on X.

    “I said a year ago if Trump was serious I’d work to pass a bill to cap rates. Since then, he’s done nothing but try to shut down the CFPB [Consumer Financial Protection Bureau]”.

    Analysts said executive action by the White House would likely meet with legal challenge from the industry, which has had success in the past fighting regulation in the courts.

    A joint statement from five US banking bodies said they shared the president’s goal “of helping Americans access more affordable credit”.

    However, they added that the proposed cap would “reduce credit availability and be devastating for millions of American families and small businesses who rely on and value their credit cards, the very consumers this proposal intends to help”.

    “If enacted, this cap would only drive consumers toward less regulated, more costly alternatives.”

    Early last year, Sanders and fellow US senator Josh Hawley had introduced bipartisan legislation which aimed to cap interest rates on credit cards at 10% for five years, but it has yet to make it into law.

    In April 2025, the Trump administration moved to throw out a regulation capping credit card late fees at $8. The rule had been brought in by President Joe Biden’s administration as part of a crackdown on “junk fees”.

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  • Gold And Silver Hit New High Prices As Justice Department Investigates Fed – Forbes

    1. Gold And Silver Hit New High Prices As Justice Department Investigates Fed  Forbes
    2. Gold cracks $4,600/oz as Fed uncertainty fans safe-haven rush  Reuters
    3. Power price rallies push gold, silver to record highs on safe-haven demand  KITCO
    4. Gold Price Forecast: XAU/USD resumes record-setting run amid geopolitical and Fed concerns  FXStreet
    5. Valued metals hit record highs amid global unrest, Trump-Fed conflict  TRT World

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  • NVIDIA and Lilly Announce Co-Innovation AI Lab to Reinvent Drug Discovery in the Age of AI

    NVIDIA and Lilly Announce Co-Innovation AI Lab to Reinvent Drug Discovery in the Age of AI

    Companies to Jointly Invest up to $1 Billion Over Five Years in Infrastructure and Research

    News Summary:

    • NVIDIA and Lilly bring together a world-leading, multidisciplinary team of scientists, AI researchers and engineers to address the hardest problems in drug discovery.
    • The co-innovation lab infrastructure will be built on the NVIDIA BioNeMo platform and the NVIDIA Vera Rubin architecture.
    • NVIDIA and Lilly will pioneer robotics and physical AI to accelerate and scale medicine discovery and production.

    J.P. Morgan Healthcare Conference—NVIDIA and Eli Lilly and Company today announced a first-of-its-kind AI co-innovation lab focused on applying AI to tackle some of the most enduring challenges in the pharmaceutical industry.

    The lab brings together Lilly’s world-leading expertise in discovering, developing and manufacturing medicines with NVIDIA’s leadership in AI, accelerated computing and AI infrastructure. The two companies will invest up to $1 billion in talent, infrastructure and compute over five years to support the new AI co-innovation lab.

    Based in the San Francisco Bay Area, the lab will co-locate Lilly domain experts in biology, science and medicine with top AI model builders and engineers from NVIDIA, allowing them to work side by side to generate large-scale data and build powerful AI models that can accelerate medicine development, using NVIDIA BioNeMo™ as the critical platform.

    “AI is transforming every industry, and its most profound impact will be in life sciences,” said Jensen Huang, founder and CEO of NVIDIA. “NVIDIA and Lilly are bringing together the best of our industries to invent a new blueprint for drug discovery — one where scientists can explore vast biological and chemical spaces in silico before a single molecule is made.”

    “For nearly 150 years, we’ve been working to bring life-changing medicines to patients,” said David A. Ricks, chair and CEO of Lilly. “Combining our volumes of data and scientific knowledge with NVIDIA’s computational power and model-building expertise could reinvent drug discovery as we know it. By bringing together world-class talent in a startup environment, we’re creating the conditions for breakthroughs that neither company could achieve alone.”

    Building a Continuous Learning System for Drug Discovery

    The collaboration will initially focus on creating a continuous learning system that tightly connects Lilly’s agentic wet labs with computational dry labs, enabling 24/7 AI-assisted experimentation to support biologists and chemists. This scientist-in-the-loop framework aims to enable experiments, data generation and AI model development to continuously inform and improve one another.

    Harnessing access to unprecedented compute for the industry, massive, high-quality data generation and NVIDIA BioNeMo as the platform to accelerate drug discovery, the teams will focus on building next-generation foundation and frontier models for biology and chemistry.

    The new initiative expands on Lilly’s previously announced AI supercomputer and intends to harness investments in next-generation NVIDIA architectures, including NVIDIA Vera Rubin.

    The AI factory Lilly announced last fall, which is the most powerful in the pharmaceutical industry, will train large biomedical foundation and frontier models for identifying, optimizing and validating new molecules with exceptional speed and accuracy. It will also support new and advanced applications in manufacturing, medical imaging and scientific AI agents.

    Beyond drug discovery, NVIDIA and Lilly will explore opportunities to apply AI across clinical development, manufacturing and commercial operations to integrate multimodal models, agentic AI, robotics and digital twins.

    The use of physical AI and robotics in the AI factory will also help Lilly enhance its capacity to manufacture high-demand medications and strengthen supply chain reliability. With NVIDIA Omniverse™ libraries and NVIDIA RTX PRO™ Servers, Lilly can create digital twins of its manufacturing lines to model, stress test and optimize entire supply chains before making physical changes in the real world.

    Supporting Global Leadership in Biomedical Discovery

    NVIDIA leads in open-source AI, empowering companies with the models, data and tools needed to develop real-world AI systems. In addition, the NVIDIA Inception program provides startups with access to technical mentorship, as well as NVIDIA software and compute.

    Lilly TuneLab, an AI and machine learning platform, provides biotech companies with access to select Lilly models for drug discovery built on decades of Lilly’s proprietary data. TuneLab will include NVIDIA Clara™ open foundation models for life sciences as part of a future workflow offering.

    The co-innovation lab will provide NVIDIA and Lilly’s startup ecosystems and researchers with deep expertise and scale of computing resources.

    The lab’s work is expected to begin in South San Francisco early this year.

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  • Apple leads smartphone market in 2025 with biggest share as global shipments rose 2%

    Apple leads smartphone market in 2025 with biggest share as global shipments rose 2%

    Apple leads smartphone market in 2025 with biggest share as global shipments rose 2%

    Like 2024 when the it shipped the most smartphones globally, Apple has maintained its streak of shipping the most smartphones in 2025 as global smartphone shipments rose by 2% year-on-year in 2025.

    The slight uptick in phone sales are largely driven by stronger demand and economic growth in emerging markets, Reuters reported, citing data issued by Counterpoint Research.

    The iPhone maker maintained its position as the market leader with a 20% share in 2025, the highest among the top five brands.

    This landmark feat is courtesy of robust demand in major and mid-sized mobile phone markets and strong sales of the iPhone 17 series, as noted by analyst Varun Mishra.

    Manufacturers advanced shipments early in the year to avoid tariffs, but the impact remained negligilbe as 2025 came to a close, leaving volumes in the second half largely unaffected.

    Samsung managed at the second position with a 19% share after seeing modest growth in shipments, while Xiaomi came third with a 13% share, backed by consistent demand in emerging markets.

    But the upward trend seems to have run its course as the global smartphone market is projected to collapse in 2026 due to chip shortages and rising component costs.

    Counterpoint’s Research Director Tarun Pathak suggested that chipmakers are increasingly prioritising AI data centres over smartphone production, a move believed to adversely affect smartphone availability in 2026.

    As the market is aligning strategies with challenges at hand, smartphone makers might need to reassess their approaches to maintain growth and meet consumer demands. 


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