Category: 3. Business

  • Ruxolitinib Cream Improves Repigmentation, QOL in Vitiligo, but Better Patient Education, Guidance Are Needed – AJMC

    1. Ruxolitinib Cream Improves Repigmentation, QOL in Vitiligo, but Better Patient Education, Guidance Are Needed  AJMC
    2. TRuE-V Data Suggest 2 Years Is the True Benchmark for Ruxolitinib Response  Dermatology Times
    3. Prolonged Ruxolitinib Cream Shows Repigmentation in Vitiligo Despite Early Minimal Response: Study  Medical Dialogues

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  • Caveats to national security block on telecoms components, says CJEU Advocate General

    Caveats to national security block on telecoms components, says CJEU Advocate General

    Experts in telecoms and cybersecurity law Dr. Marc Salevic and David McIlwaine of Pinsent Masons said the recent opinion issued by Advocate General Tamara Ćapeta in the Elisa Eesti case marks an important point of reference for the treatment under EU law of national 5G security measures. The opinion is non-binding. A formal judgment of the Court of Justice of the EU (CJEU) in the case is expected later this year.

    At the core of the case is the question of how far member states can go, on grounds of national security, in restricting so‑called “high‑risk” telecommunications equipment – and where the limits of EU law lie.

    The case originates from an Estonian authorisation regime requiring telecommunications companies to obtain prior administrative approval for the use of certain hardware and software in their mobile networks. In the specific case, Elisa Eesti AS – a subsidiary of the Finnish telecommunications group Elisa Oyj – was granted only a time‑limited authorisation to use components from Chinese supplier Huawei in its mobile access network (2G–5G). The Estonian authorities classified Huawei as a “high‑risk supplier” and relied, among other things, on “joint risk assessments both at EU level and at the level of the Member States”.

    The Estonian administrative court hearing the case referred several questions to the CJEU for a preliminary ruling, in particular concerning the relationship between national security and the European Electronic Communications Code (EECC).

    The advocate general first said that measures to ensure the security of telecommunications networks generally fall within the scope of the EECC. Articles 40 and 41 EECC expressly require EU member states to ensure the security of electronic communications networks and services. This also includes hardware and software components of mobile networks.

    She further said that the risk assessment is primarily a matter of national security, under Article 4(2) of the Treaty on the EU, and therefore must be carried out by the competent national authorities and, in the event of a dispute, reviewed by the national courts. However, she said restrictions such as the time‑limited authorisation at issue must also comply with EU law requirements, including the freedom to provide services, the right to property and the principle of proportionality.

    The advocate general said the Estonian authorisation regime constituted a restriction on the freedom to provide electronic communications networks and services within the meaning of Article 12(1) EECC. She said the need to obtain advice authorisation makes market access more difficult and renders the provision of services less attractive.Dr. Salevic and McIlwaine said the advocate general’s classification of the Estonian restriction is legally significant, as it means that such measures are subject to a mandatory justification and proportionality review under Article 52(1) TFEU.

    The Advocate General formulated standards relevant for the justification of such restrictions.

    She said national authorities may not rely on abstract or blanket security concerns. Instead, she said a specific, case‑by‑case risk assessment needs to be undertaken. This risk assessment needs to examine: whether risks associated with the supplier actually affect the specific hardware or software concerned; the function, network position and importance of the components in question; and whether and to what extent risks attributable to a third country can be imputed to the supplier.

    McIlwaine said: “In other words: high‑risk classifications must not be applied schematically. The mere fact that a supplier originates from a third country is not sufficient.”

    Should the CJEU follow the advocate general’s opinion, it would be for the national authorities to carry out the decisive risk assessment in a legally sound manner in the specific case, and for the national courts to ensure effective judicial protection in this respect.

    Dr. Salevic added: “Since these fundamental requirements derive from EU primary law, they will also have to be observed in the context of the European Commission’s current proposals to amend the EU Cybersecurity Act with regard to the ICT supply chain.”

    He said the Elisa Eesti case is therefore likely to have significance far beyond Estonia for the further development of European 5G security architecture.

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  • CMA examines energy price hikes during Middle East conflict

    CMA examines energy price hikes during Middle East conflict

    The CMA is using its wide-ranging competition law and consumer protection powers – which were strengthened last year by the Digital Markets, Competition and Consumers Act 2024 (DMCCA) – to gather information from heating oil distributors and intermediaries to investigate concerns that companies are profiteering from the current crisis at the expense of UK consumers.

    Just weeks into the conflict, the agency announced it was taking urgent action amid reports that some heating oil suppliers in the UK had abruptly cancelled pre-existing orders only to offer new contracts at significantly higher prices, and that automatic top-up deliveries – which are triggered by low tank levels – were suddenly being charged at steep mark-ups. The regulator said it has written to a number of firms, both direct suppliers and intermediaries, to “seek further information about their practices”.

    On 20 March, the CMA also launched a formal heating oil market study to examine urgently how the retail supply of heating oil is operating across UK and whether “additional measures are needed to protect consumers”. The CMA estimates there are 150 suppliers of heating oil in the UK and the study invites industry stakeholders to submit comments by 8 April.

    The CMA proposes to focus its market study on the retail supply of heating oil for domestic use, examining how recent global oil price shocks have affected retail prices; margins and profits; the role of supply constraints and shortages; the extent to which competition restrains price rises; levels of price transparency; and whether any poor conduct or market characterises may have harmed consumers, including during periods of volatile input costs. The study will cover the UK as a whole, while recognising that the heating oil market operates differently in Northern Ireland, where energy policy is a devolved matter.

    The CMA is aiming to complete the statutory market study in just three months – a much shorter timeframe than the statutory requirement of 12 months – given “the acute nature of the challenges faced by consumers at this time”.

    Sarah Cardell, the CMA’s chief executive, said in a statement that global conflict typically drives up wholesale oil prices, meaning some retail price increases are inevitable. However, she stressed that such rises should not be opportunistic hikes and “should reflect genuine cost pressures” and described “troubling reports” of heating oil customers facing sharp price jumps. In light of the seriousness of these concerns, she said the CMA had taken steps to launch an investigation “as a matter of urgency” to ensure that customers are not being taken advantage of and are being “treated fairly”.

    The CMA is also closely monitoring petrol and diesel prices and has put petrol and diesel retailers on notice that it is intensifying oversight of fuel pump prices. In a recent statement, the regulator unveiled plans to accelerate collection of pricing data from thousands of UK fuel stations, enabling a rapid analysis of retailers’ profit margins since the crisis began. This includes examining how swiftly forecourt prices respond to changes in wholesale costs.

    The CMA has warned that fuel stations must not exploit the current geopolitical volatility, indicating that evidence of exploitation or unjustified price increases will be noted in an upcoming pricing report. The CMA’s enhanced monitoring in the fuel sector is supported by a new statutory “Fuel Finder” information scheme, which was introduced to improve price transparency and competition among petrol retailers in the long term. Last year, the CMA also gained new information-gathering and fining powers under the DMCCA to support its enforcement of the scheme. For clarity, the agency has highlighted that it does not regulate or set fuel prices: its role is to monitor and enforce competition law and consumer protection rules, not price control.

    While the CMA’s examination of price surges during the Middle East conflict are at an early stage with no assumption of wrongdoing, the CMA has indicated in its correspondence with the UK Chancellor that enforcement action will follow “without hesitation” if evidence shows consumer protection law has been breached.

    Commenting on the CMA’s recent announcements, Giles Warrington, a competition law expert at Pinsent Masons, said: “Competition and consumer regulators will understandably wish to act swiftly to address suspected non-compliance with competition law or consumer protection rules, however, no assumptions should be drawn about the reasons underlying such price increases or the legality of such practices. Businesses may themselves be experiencing unanticipated cost increases and may be unable to absorb these without increasing prices for consumers.”

    Warrington added that the compressed three-month timeframe set by the CMA for completing its heating oil market study may also put “significant time and administrative pressures” on businesses. “Companies will need to engage promptly and appropriately with CMA mandatory information-gathering requests or risk substantial fines for non-compliance,” he said.

    Tadeusz Gielas, a competition and consumer law expert at Pinsent Masons, said the CMA’s vigilance over crisis-driven pricing mirrors its earlier approach during the Covid-19 pandemic when it took a firm stance against suspected ‘price gouging’ and other exploitative practices. “During that period, the CMA – together with major retail trade bodies – issued warnings to businesses not to unjustifiably hike prices of essential goods,” he said. “It also launched multiple competition law investigations into retailers suspected of charging excessive prices for hand sanitiser under abuse of dominance rules, although those investigations were ultimately closed without penalties or findings of illegal behaviour.”

    The CMA also used its consumer protection powers throughout the pandemic to curb suspected harmful conduct and secured refunds and remedies for consumers, and may seek do to so again in appropriate cases, said Gielas.

    Paul Williams, a competition law expert with Pinsent Mason, said the CMA’s actions are a timely warning that businesses suspected of exploiting the conflict for financial gain may attract scrutiny by the authority: “The CMA’s approach during previous crises – such as during the Covid-19 pandemic – and now indicates that it will actively examine business practices to ensure firms are not behaving unlawfully,” he said. “Ensuring fair prices for consumers, especially on essential products, remains a top priority for the UK’s lead competition and consumer protection enforcer. The CMA’s current examination of heating oil, and petrol and diesel pricing – backed by its strategic focus and recently expanded enforcement powers – demonstrates a continuation of the CMA’s pro-consumer enforcement stance.”

    The CMA can use its full range of powers – from competition law to its recently-strengthened consumer law tools – to examine whether certain pricing practices might be unlawful and take redressive action against businesses and individuals.

    These interventions align closely with the CMA’s strategic priorities. In its Annual Plan for 2026–27 –which was recently finalised following public consultation – the CMA highlighted “championing consumers” and tackling practices that harm household budgets as core objectives. The annual plan references the CMA’s recent work on road fuel prices as part of its continued efforts to ease cost of living pressures for UK consumers. By examining pricing practices in heating oil and petrol and diesel, the CMA aims to visibly act on these commitments to shield UK consumers from unfair costs.

    The CMA’s moves come as the chancellor Rachel Reeves has also announced UK government plans to launch a new anti-profiteering framework “to protect working people to deal with businesses unfairly putting up prices to profiteer during this crisis.” As part of this initiative, the government says it “will not hesitate to introduce time-limited, targeted powers if needed to ensure the CMA and other regulators can clamp down on price gouging if it takes place.”

    Warrington noted that the CMA is generally unable to intervene in unilateral pricing behaviour unless a company is dominant and engages in excessive pricing that may breach competition law, or uses unfair commercial practices or contract terms that may breach consumer protection laws. He said that one route the CMA might explore under current powers would be to find certain companies to be dominant on a temporary basis only, which might open up consideration of excessive pricing as an abuse of dominance. 

    However, he added that this would not be an easy route for the CMA as there is very limited support, if any, for dominance to be established on this basis. He noted that many other jurisdictions have concepts of abuse of an unequal bargaining position or similar, which would be more useful to a regulator in the current context, but the UK does not have an equivalent regime.

    Warrington also said that powers for the CMA to deal with allegations of price gouging more generally would seek to address this enforcement gap, albeit on a temporary basis.  He noted that the government was generally sending a message to businesses around pricing during the crisis.

    Competition and consumer protection authorities in other jurisdictions are also monitoring whether traders may be exploiting the current conflict in the Middle East to unlawfully increase consumer prices in breach.

    In Ireland, the Competition and Consumer Protection Commission (CCPC) has reported receiving multiple consumer queries about the legality of price increases in home heating oil and alleged ‘price gouging’.  Relevant authorities in Germany, France, and Poland are also understood to be scrutinising similar consumer price increase concerns, while the European Commission is working with EU countries on measures to help mitigate the impact of high oil and gas prices on energy markets. In a recent speech Teresa Ribera, who heads EU competition law enforcement at the Commission, noted that competition policy can help address global crises and challenges.

    Given the increased vigilance by the CMA and other regulators on price increases during the Middle East conflict, businesses are advised to ensure they fully comply with relevant competition and consumer protection laws, including by verifying and updating their internal procedures around pricing and ensuring that relevant personnel receive targeted and up-to-date compliance training, Gielas said.

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  • Turn Sales Teams Into Video Stars

    Today’s automotive buyer doesn’t follow a linear path to purchase. They browse online at night, submit lead forms during work breaks, respond to text messages after dinner, and expect quick answers wherever they are. While many dealerships still rely heavily on contacting customers via email or phone during the sales process, consumers expect a more personalized approach. 

    That’s where video messaging comes in.

    The CDK 2026 Friction Points Study found that 72% of Sales teams use video in some form to engage, inform and communicate with shoppers. This data tells us that video is no longer experimental. It’s mainstream. However, execution varies widely. There’s a big gap between generic videos that fall flat and videos that help salespeople personally connect with customers and draw them into the dealership. 

    Personalized and Social Media Videos Lead the Way

    Video has already taken over the Service department with the advent of video multipoint inspections (MPI). But those videos are by and large formulaic. They need to explain a problem if one exists and show the service customer rather than tell them. The video builds trust and breaks down barriers when it comes to selling additional services. Sales teams have far more heavy lifting to do to translate a video into a tool that can convert a lead to a closed deal. But the effort pays off. 

    Nearly half of dealerships (49%) report that Sales staff create personalized videos and send them directly to customers. But that’s far below what shoppers actually expect. Nearly three out of four shoppers expect a personalized video interaction according to CoVideo. Dealers who utilize video in the sales process not only see 81% in lead-to-contact rate but they also sell twice as many cars.

    When customers see a real person addressing them by name and referencing a specific vehicle (even the VIN), it creates a sense of transparency, a human connection in a digital process, and increased trust before that first in-store interaction. In an industry where trust is often fragile, a personal connection really resonates. 

    And 42% of salespeople are taking it further by creating personalized content for social media platforms. A consistent social presence helps Sales staff build a following within their community, position themselves as product experts, and stay top of mind for repeat and referral business. In many markets, customers are choosing salespeople — not just dealerships.

    Video Use by Dealership Size 

    While video adoption overall is strong, how and how often, Sales teams use video differs significantly by dealership size. 

    Larger Dealer Groups (Six+ Rooftops) 

    Across many streams of CDK research, larger dealer groups are often the first to leverage new technology in their stores. That proves to be true in the Friction Points study with:

    • Sixty-four percent send personalized videos directly. 
    • Forty percent+ create videos for social media.
    • Eighty percent+ of Sales staff engage in video marketing.

    As one dealer explained, “We have a company that comes to the store and does professional videos twice a week and then sends them out to the customer, Facebook, TikTok and Instagram.”

    Small Dealer Groups (One to Two Rooftops)

    Smaller groups show energy around personalization but have room for growth.

    • Forty percent send videos directly to customers. 
    • Thirty-six percent of staff don’t use video at all — the highest of any group. 

    Midsize Dealer Groups (Three to Five Rooftops)

    These groups fall, predictably, in the middle. 

    • Fifty-two percent of their Sales staff send personalized videos directly.
    • Thirty-nine percent create videos for social media. 
    • Twenty-three percent don’t use video at all.

    Importantly, some of these differences may have more to do with dealership systems than with sales or willingness. As one dealer respondent put it, “Video used for vehicle ads but that is it. Nothing personalized. Our CRM has the capability, but it is very cumbersome.”

    Ease the Path to Video Stardom

    Having video as part of your sales process is one thing but having a video solution that’s directly embedded into your CRM workflow is the only way for it to become effective at scale. When your CRM allows Sales reps to:

    • Record and send video directly from the customer record
    • Automatically log video interactions
    • Track engagement analytics
    • Incorporate video into templates and campaigns

    Video becomes part of a structured, repeatable sales process instead of a nice-to-have. The CRM becomes the central hub that coordinates every communication channel, ensuring consistency, accountability and performance visibility. A CRM that supports and tracks all these touchpoints in one unified system becomes critical. Without it, conversations get fragmented, follow-ups get missed, and opportunities fall through the cracks.

    Video builds trust faster, drives engagement higher, and differentiates your brand. Learn how CDK CRM can transform your sales process one video at a time. 

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  • UNM study challenges “motherhood penalty,” finding workplace advantages for moms

    UNM study challenges “motherhood penalty,” finding workplace advantages for moms

    For decades, working mothers have been judged by a quiet assumption: that caregiving makes them less committed employees. In many workplaces, unconscious bias continues to shape how working parents—particularly mothers—are perceived.

    However, new research at The University of New Mexico suggests the opposite. This research found that mothers often integrate their family and children into their professional identity, leading to positive outcomes —a dynamic described as a “motherhood advantage.”

    The study, “Uncovering a motherhood advantage: How parenthood impacts perceptions of the meaning of work and work outcomes,” published in the Journal of Applied Psychology, was designed to test competing narratives about parenthood and workplace commitment.

    Assistant Professor of Human Resource Management I-Heng (Ray) Wu

    Assistant Professor of Human Resource Management I-Heng (Ray) Wu coauthored this academic article with researchers from The Chinese University of Hong Kong, University of South Florida, Shandong University, and Providence College. The authors conducted three survey-based analyses—two with Chinese samples and one with a U.S. sample. The researchers examined how employees view their work as a way to serve as role models for their families by demonstrating diligence, responsibility, and morality.

    This concept, known as Family-Centered Symbolic Meaning of Work (FCSMW), reflects how people construct meaning from their work through the lens of family influence.

    “While people derive diverse meanings from work—such as a calling, a path to self-actualization, or a means of financial gain—the family-centered symbolic meaning of work represents a distinct dimension,” said Wu. “It refers to employees’ perception of their work as an opportunity to model diligence, responsibility and morality for their family members.”

    The authors then assessed workplace outcomes to determine whether parenthood was associated with this type of work meaning and whether it translated into measurable benefits. They also examined whether the effects differed by gender.

    In broader workplace discourse, this conversation is often framed as a “fatherhood bonus,” where men are perceived as more committed providers, and a “motherhood penalty,” where women are viewed as less dedicated due to caregiving responsibilities.

    The findings directly challenge that assumption. Not only did parenthood show no negative impact on women’s commitment to work, but it was also associated with stronger motivation and improved workplace behaviors.

    “We are living in a time that is more inclusive, but there are still untested assumptions about working parents, especially working mothers,” Wu said.

    These assumptions carry real consequences. The motherhood penalty is often cited as a major factor in the gender pay gap, particularly as it widens mid-career.

     

    “Our research helps invalidate assumptions underlying the motherhood penalty by demonstrating the advantage that working mothers possess. We also found that women are more likely to speak up about ethical issues after they become mothers, more so than men when they become fathers, which is increasingly important in today’s business environment.”


    — Assistant Professor I-Heng (Ray) Wu





    When employees view their work as a platform to model integrity, responsibility and diligence for their children, they become intrinsically motivated to embody those values. This often translates into stronger work effort and organizational citizenship behaviors—such as helping colleagues, demonstrating loyalty and going beyond formal job expectations.

    Expecting mother working on her laptop

    Expecting mother working on a laptop.

    “We found that working women actually increase their work efforts and ethical behaviors after they become mothers because they want to set a good example for their family,” Wu said.

    Despite these findings, bias remains deeply embedded. Wu noted that many mothers still feel pressure to hide pregnancies or downplay family responsibilities due to fear of professional stigma.

    The authors suggest organizations should instead recognize and leverage the “motherhood advantage” by creating environments that support and normalize work-life integration.

    “Organizations should foster a culture that values rather than stigmatizes family commitments,” Wu said. “One simple step is encouraging employees to share that part of their lives openly.”

    Working mom on a zoom call

    Working mom on a Zoom call

    Initiatives like “take your child to work day” can also reinforce this shift by signaling that families are a source of pride rather than a professional liability. Such efforts may even strengthen employees’ sense of purpose and connection to their work.

    Wu also emphasized the need for companies to rethink how performance is evaluated.

    “Workplaces that overvalue face time, late-night availability or uninterrupted career paths may inadvertently penalize parents,” they said. “Emphasizing results and substantive contributions, rather than outdated ‘ideal worker’ norms, would ensure that highly effective employees can advance based on merit.”

    Even when presented with evidence, however, changing perceptions can be difficult. Wu recalled sharing the findings with company managers who remained skeptical, citing concerns about work-life conflict and commitment.

    “This shows how deep-seated the bias is,” Wu said. “Even with consistent evidence, it can be difficult to shift perspectives. That’s why we need more research to build a stronger foundation for change and foster a more accurate understanding of working parents’ contributions.”

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  • Ireland looks to raise turnover thresholds for mergers

    Ireland looks to raise turnover thresholds for mergers

    The Irish government has launched a public consultation on the proposal to increase the turnover thresholds that would trigger mandatory reporting – with an increase for individual turnover thresholds from €10 million to €15m, and an aggregated threshold rise from €60m to €100m.

    The new proposal is expected to save Irish firms around €1.8million a year in reduced costs and fees, with Irish enterprise minister Peter Burke claiming the proposed increase would allow the Competition and Consumer Protection Commission (CCPC) to place greater focus on mergers with potential to have a distortive effect on competition within the state.

    However Paul Williams, a mergers expert with Pinsent Masons, said that against the backdrop of the CCPC’s call‑in power – which enables the authority to require notification of transactions that fall below the financial thresholds – the proposed increase in those thresholds, while welcome, may in practice lead to more deals being called in for review, creating additional challenges for businesses.

    “The proposed increases to the merger notification thresholds are a welcome development in removing small transactions from the mandatory filing requirement,” he said.

    “However, this could also lead to a higher number of ‘call ins’ by the CCPC for below-threshold transactions which might raise competition concerns.”

    The turnover thresholds were last raised by the Irish government in 2019, although Ireland’s Competition Act, 2002 (as amended) gives the enterprise minister the power to do so once per year.

    Raising the financial thresholds would account for the effects of inflation since the last rise, and would align Ireland closer to other European economies.

    Ciarán Campbell, a competition expert with Pinsent Masons, explained: “Of the European countries considered by the CCPC during its threshold comparison exercise, the mean aggregate and individual turnover thresholds are around €88 million and €15 million respectively – so, the proposed increase does bring Ireland in line with its European counterparts. 

    “Given that the CCPC has, as part of its enforcement toolkit, a call‑in power – most recently exercised in the Uniphar/TouchStore transaction – one might have expected the individual target‑specific threshold to be set somewhat higher – for example, around €20 million – to ensure that only targets with a substantial nexus to Ireland fall within the scope of merger control.

    “However, the increase is nonetheless a welcome development.”

    The consultation will close on 1 May 2026.

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  • ESAs spring risk update highlights geopolitical pressures and rising private finance risks

    The European Supervisory Authorities (EBA, EIOPA and ESMA – the ESAs) today published their spring 2026 Joint Committee update on risks and vulnerabilities in the EU financial system. The update focuses on the challenges arising from ongoing geopolitical tensions and developments in private finance.

    Geopolitical tensions continue to pose significant risks

    The ESAs warn that ongoing geopolitical tensions, namely the war in the Middle East, pose significant risks to the global financial landscape through higher energy prices, potential inflationary pressures and weaker economic growth. The ESAs had previously warned about the risks of sudden repricing and liquidity reductions at times of elevated equity market valuations and compressed spreads in bond markets. Such developments can exacerbate market vulnerabilities, triggering volatility and revaluations.

    Higher interest rates may further tighten funding conditions and affect asset quality. Tensions around the Strait of Hormuz and airspace closures raise multi-line risk, although war exclusions are expected to limit net losses for insurers. More broadly, geopolitical events and cyber-attacks could generate shocks and disruptions to critical infrastructures.  –

    Risks linked to private finance

    The update also highlights emerging risks in private finance driven by limited data, low transparency, prolonged growth and complex, opaque interconnections with the broader financial system. These factors increase the potential for sudden market shifts in investor liquidity and spillovers to other parts of the financial system. 

    Recent developments in certain US private credit funds, linked to AI replacing more traditional software businesses, illustrate potential vulnerabilities related to changes in investor sentiment. 

    EU financial sector remains resilient overall

    Despite the challenging geopolitical environment, European financial markets have continued to demonstrate resilience. The insurance and Institutions for Occupational Retirement Provision (IORP) sectors maintain robust capital and funding positions.  In the banking sector, capital ratios remain high, while liquidity positions and asset quality are solid. Direct exposures to countries most affected by the war remain limited.

    Supervisors and market participants to maintain vigilance

    Given the ongoing geopolitical tensions, the Joint Committee of the ESAs calls on supervisors and market participants to maintain a high level of readiness. This includes proactive risk assessments with appropriate tools, the prudent management of sovereign exposures and the inclusion of geopolitical context in risk management. Possible indirect effects stemming from energy prices and exposures to highly affected sectors should also be closely monitored.  

    Financial institutions, authorities and investors are also encouraged to closely monitor and manage risks associated with private markets, considering limited transparency, rising exposures, and potential shifts in risk profiles, linked to the upcoming Solvency II 2027 changes.

     

    Further information:

    Tayfun Yilmaz

    Communications Officer
    press@esma.europa.eu

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  • Results from the Phase 2 POLAR Trial: Pembrolizumab and Olaparib in HRD Metastatic Pancreatic Cancer

    Results from the Phase 2 POLAR Trial: Pembrolizumab and Olaparib in HRD Metastatic Pancreatic Cancer

    Pancreatic cancer remains one of the most challenging malignancies to treat, particularly in the metastatic setting, where immunotherapy has historically shown minimal activity. However, a biologically defined subset of patients with homologous recombination deficiency (HRD), especially those harboring BRCA1, BRCA2, or PALB2 mutations, may be more sensitive to DNA-damaging agents and potentially to immunotherapy-based strategies.

    In this context, the POLAR trial explored whether combining PARP inhibition with PD-1 blockade could provide durable disease control in patients who had already benefited from platinum-based chemotherapy.

    The study was published in Nature Medicine on March 25, 2026.

    Title: Pembrolizumab and olaparib in homologous-recombination-deficient metastatic pancreatic cancer: the phase 2 POLAR trial

    Authors: Wungki Park, Catherine A. O’Connor, Joanne F. Chou, Marc Hilmi, Zeynep Tarcan, Carly Schwartz, Mary Larsen, Ramzi Homsi, Karthigayini Sivaprakasam, Shigeaki Umeda, Maria A. Perry, Anna M. Varghese, Kenneth H. Yu, Fiyinfolu Balogun, Alice Zervoudakis, Seth S. Katz, Tae-Hyung Kim, Ken Zhao, Allison L. Richards, Nicolas Lecomte, Daniel Martin Muldoon, Elias Karnoub, Walid Chatila, Jessica Yang, Imane El-Dika, Devika Rao, Smita Joshi, Michael B. Foote, Ryan Sugarman, James J. Harding, Andrew S. Epstein, David Kelsen, Sree Chalassani, Fergus Keane, Joshua D. Schoenfeld, Anupriya Singhal, Erin Diguglielmo, Chaitanya Bandlamudi, Junmin Song, Hulya Sahin

    Ozkan, Junguei Hong, Haochen Zhang, Agustin III Cardenas, Maria Lao, Jerry Melchor, Ronak Shah, Wenfei Kang, Francesca Mazzoni, Kevin Soares, Mark TA Donoghue, Ernesto Santos, Vineet Rolston, Marsha Reyngold, Alice Chia-chi Wei, Murray Tipping, Olca Basturk, Michael Berger, Richard Kihn Do, Mark Schattner, William R. Jarnagin, Nadeem Riaz, Vinod Balachandran, Dana Pe’er, Marinela Capanu, Christine Iacobuzio-Donahue, and Eileen M. O’Reilly

    Methods

    POLAR is a phase 2, single-center, non-randomized basket trial evaluating maintenance pembrolizumab in combination with olaparib in patients with metastatic pancreatic cancer who had achieved at least stable disease after platinum-based chemotherapy.

    A total of 63 patients were enrolled and prospectively assigned to three biomarker-defined cohorts. Cohort A included patients with core HRD mutations (BRCA1, BRCA2, or PALB2), cohort B included patients with non-core HRD mutations (such as ATM, CHEK2, and others), and cohort C included patients without HRD alterations but with platinum-sensitive disease.

    All patients received olaparib 300 mg twice daily and pembrolizumab administered intravenously every 3 weeks for 6 months, followed by every 6 weeks until disease progression or unacceptable toxicity.

    The co-primary endpoints in cohort A were an objective response rate of at least 43% and a 6-month progression-free survival rate of at least 77%.

    Schema of the POLAR

    Results

    At the time of analysis, 63 patients had been treated, and 46 were evaluable by RECIST criteria. Among RECIST-evaluable patients in cohort A (n=20), the objective response rate was 35% (95% CI: 15–59%), and the 6-month progression-free survival rate was 64% (95% CI: 49–82%), compared with 47% in cohort B and 13% in cohort C. These results did not meet the predefined primary endpoints. At a median follow-up of 37 months (95% CI: 27–47), outcomes were durable in cohort A.

    Despite this, clinically meaningful activity was observed. Median progression-free survival in cohort A was 8.3 months (95% CI: 5.3–not reached), and median overall survival reached 28 months (95% CI: 12–not reached). Long-term outcomes were notable, with 2-year and 3-year overall survival rates of 56% and 44%, respectively.

    Importantly, a subgroup of patients demonstrated particularly durable benefit, with 7.9% of patients achieving progression-free survival beyond 36 months. When including patients with non-measurable disease at baseline—many of whom had already experienced deep responses to platinum chemotherapy— the exploratory response rate increased to 52% (95% CI: 34–69%), and prolonged disease control was observed in several patients.

    Across cohorts, outcomes followed a clear biomarker gradient. In cohort B, the objective response rate was 8%, with a median progression-free survival of 4.8 months and median overall survival of 18 months. In cohort C, which included HRD-negative patients, outcomes were more limited, with an objective response rate of 14%, median progression-free survival of 3.3 months, and median overall survival of 10 months. Baseline CA19-9 was independently associated with progression-free survival, with a hazard ratio of 1.02 (95% CI: 1.02–1.03).

    Polar trial results

    Disease control was achieved in the majority of patients, particularly in cohort A, where the disease control rate reached 80%, compared with 75% in cohort B and 50% in cohort C. Among responders in cohort A, the median duration of response was 6.8 months, while the median duration of disease control reached 32 months when including patients with non-measurable disease.

    Subgroup analyses within cohort A revealed heterogeneity according to mutation type. Patients with BRCA2 and PALB2 mutations demonstrated longer progression-free and overall survival compared with those harboring BRCA1 mutations. Median progression-free survival was 9.9 months for BRCA2, 12.0 months for PALB2, and 6.1 months for BRCA1. Median overall survival was 28.0, 27.0, and 18.0 months, respectively.

    Translational insights

    The study incorporated an extensive translational program that provided important biological insights. Circulating tumor DNA analyses showed that patients with durable benefit often had very low or undetectable variant allele frequencies, whereas increases in ctDNA were associated with shorter progression-free survival.

    Tumors in cohort A exhibited a more immunogenic profile, including higher frameshift indel burden, increased tumor mutational burden, and higher genomic instability scores. These features were associated with increased tumor-infiltrating lymphocytes, particularly CD8+ T cells, which correlated with improved clinical outcomes.

    Together, these findings support the hypothesis that HRD tumors may be inherently more immunogenic and therefore more susceptible to combined PARP inhibition and immune checkpoint blockade.

    Results from the Phase 2 POLAR Trial: Pembrolizumab and Olaparib in HRD Metastatic Pancreatic Cancer

    Safety

    The combination was generally well tolerated, with no new safety signals. No grade 4 or 5 treatment-related adverse events were reported.

    The most common grade 3 treatment-related adverse event was anemia, occurring in 15% of patients, along with rare abdominal infection (1.6%). Immune-related adverse events included pneumonitis, colitis, hyperthyroidism, and hyperglycemia, with grade 3 immune toxicities observed in a small number of patients.

    Expert Highlights

    The POLAR trial contributes to a growing shift in how pancreatic cancer is conceptualized, moving away from the idea of a uniformly immunotherapy-resistant disease toward a more nuanced, biology-driven approach.

    Wungki Park, a clinician-scientist at Memorial Sloan Kettering Cancer Center and the Gerstner Sloan Kettering Graduate School of Biomedical Sciences, focusing on next-generation therapies in GI cancers, including KRAS-directed strategies and immune reprogramming, highlights:

    “The POLAR study was designed around the idea that pancreatic cancer should not be approached as a uniformly immunotherapy-resistant disease. Instead, we focused on whether a biologically defined subset, specifically homologous recombination-deficient tumors, may have increased susceptibility when treated in the right clinical context, particularly in the maintenance setting after platinum response. In that sense, I see POLAR as contributing to a shift toward more biomarker-driven and context-specific strategies in metastatic pancreatic cancer.”

    Wungki Park

    Beyond the clinical outcomes, the study also provides an important conceptual framework for future treatment strategies, emphasizing the role of tumor biology in guiding therapeutic decisions rather than broadly applying immunotherapy across all patients.

    “From a practice and field perspective, the key insight is not just the clinical signal itself, but the framework it supports. The data suggest that genomic features such as HRD may be linked to underlying tumor immunogenicity, which opens the door to more rational combinations and sequencing strategies, not broadly applying immunotherapy across all patients. It reinforces the importance of aligning treatment with tumor biology and continuing to refine patient selection.”

    Conclusion

    Although the POLAR trial did not meet its prespecified primary endpoints, it demonstrated meaningful and durable clinical activity in a subset of patients with HRD metastatic pancreatic cancer.

    The results suggest that combining PARP inhibition with PD-1 blockade may extend disease control beyond chemotherapy in biologically selected patients, particularly those with BRCA2 and PALB2 mutations.

    These findings reinforce the importance of biomarker-driven strategies and support further investigation of precision immunotherapy approaches in pancreatic cancer.

    The full article is available in Nature Medicine.

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  • Cellnex strengthens its corporate governance with annual director re-election and two new independent appointments

    Cellnex strengthens its corporate governance with annual director re-election and two new independent appointments

    Madrid, 27th March 2026.- Cellnex will submit to its General Shareholders’ Meeting, convened for 30th April, a set of corporate governance proposals that mark a significant step in the evolution of the Board’s oversight model.

    The most significant measure is the transition to annual director re-election, replacing the current three-year term. This model — standard in leading international markets — reinforces accountability to shareholders, enables a more dynamic evaluation of Board performance, and facilitates orderly Board refreshment when circumstances require it.

    The Meeting will also vote on the appointment of Cynthia Gordon and Kais Ben Hamida as new independent directors, together with the re-election of Marco Patuano (CEO), Christian Coco and Jonathan Amouyal (proprietary directors), and Óscar Fanjul (Chairman), Marieta del Rivero, Ana García Fau, Maite Ballester and Dominique D’Hinnin (independent directors).

    If the full set of proposals is approved, the Board would comprise 12 members, with a reinforced non-executive majority: 11 out of 12, of whom 8 are independent (67%) and 5 are women (42%).

    Executive continuity

    Marco Patuano’s re-election as executive director underscores a deliberate alignment: a Board renewing itself in governance standards and composition, partnering with executive leadership that has already begun deploying Cellnex’s operational and strategic priorities.

    Two profiles aligned with the Company’s strategic priorities

    Cynthia Gordon brings over three decades of executive experience in the telecommunications sector, with direct expertise in strategy, operations and M&A across multiple geographies. She has held senior leadership roles at Millicom, Ooredoo and Orange, and currently serves on the board of Airtel Africa. Her appointment broadens the Board’s operational and sectoral perspective at a time when Cellnex is deepening the optimisation of its business model.

    Kais Ben Hamida brings strong financial and transactional expertise, combining CFO roles — currently at Emirates Integrated Telecommunications Company (du), and previously at Mobily and Orange Egypt — with senior positions in M&A and investment, including at Orange Group and Valiance Capital. His profile strengthens the Board’s capacity to accompany capital allocation decisions and balance sheet evolution.

    Statement from the Chairman

    Óscar Fanjul, Chairman of Cellnex, stated: “Corporate governance is ultimately about trust — the trust of shareholders that the people overseeing this company have both the independence to challenge and the expertise to guide. The proposals before our shareholders reflect that conviction: a Board that is more accountable, more independent, and better equipped — technically and professionally — to support the execution of a strategy built around their expectations.”

     

    Cynthia Gordon

    Ms. Cynthia Gordon has over 30 years of experience in the telecommunications sector across multiple geographies, with extensive expertise in strategy development, operational execution and mergers and acquisitions. With significant board experience in leading telecoms companies, including Airtel Africa, Tele2 and Eutelsat, she brings a strong and diverse international perspective to the Company’s Board of Directors.

    Ms. Gordon currently serves as Non‑Executive Chair of Global Fashion Group and as a non‑executive director of Severfield plc and Airtel Africa plc. She also sits on various board committees across these organisations.

    Since 2019, she has served as Senior Advisor to Tillman Global Holdings, where she has evaluated and supported investments in digital and physical infrastructure, including towers, data centres, in‑building connectivity and energy solutions.

    Previously, Ms. Gordon served as Chief Executive Officer of Millicom Africa (2015–2017), leading a transformation of the company’s strategy, leadership and financial performance across six countries. Prior to that, she was Group Chief Commercial Officer at Ooredoo (2012–2015) and held several senior leadership roles at Orange – France Telecom, including Vice President of Partnerships & Emerging Markets and Vice President of Business Marketing.

    Earlier in her career, she held senior positions at BT, One to One (T‑Mobile), AT&T International, Scottish Telecom and Unilever.

    Ms. Cynthia Gordon holds a degree in Business Studies from the University of Brighton.

     

    Kais Ben Hamida

    Mr. Kais Ben Hamida currently serves as Chief Financial Officer of Emirates Integrated Telecommunications Company (du), listed on the Dubai Stock Exchange, and as a Board Member of du’s fintech subsidiary.

    Previously, Mr. Ben Hamida served as Chief Financial Officer of Mobily (Etisalat Group), listed on the Riyadh Stock Exchange, and as Chief Financial Officer of Orange Egypt (formerly Mobinil), listed on the Cairo Stock Exchange.

    He was also a Partner at Valiance Capital, a €1.5 billion infrastructure fund sponsored by Generali. Earlier in his career at Orange Group, he held the positions of Director of the Group CFO Office and Senior Vice President of the Mergers and Acquisitions Department, where he structured and executed cross‑border transactions with a total value exceeding €30 billion.

    Mr. Ben Hamida began his professional career at the World Bank, Société Générale, and France Telecom Mobiles International.

    He holds a degree from INSEAD’s International Directors Programme, a Master’s degree in Engineering from École Nationale des Ponts et Chaussées, a Master’s degree in Economics from Sorbonne University, and a Bachelor’s degree in Financial Engineering from École Polytechnique.

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