Category: 3. Business

  • FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial

    July 2, 2025 6:45 am ET


    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Oct. 25, 2025.

    The sBLA is based on data from the Phase 3 ZENITH trial. The ZENITH trial was the first PAH Phase 3 outcome study to use a primary endpoint comprised entirely of major morbidity and mortality events. It was also the first PAH Phase 3 study stopped early by an independent data monitoring committee for overwhelming efficacy. In ZENITH, WINREVAIR demonstrated a 76% reduction in the risk of a composite of all-cause death, lung transplantation, and hospitalization for PAH ≥24 hours compared to placebo. Improvement was observed early in treatment with increasing benefit throughout the study. The safety profile of WINREVAIR in ZENITH was generally consistent with that observed in previous studies. These results were published in the New England Journal of Medicine.

    “We are pleased that the FDA has accepted our sBLA for WINREVAIR and granted a priority review to consider an update to labeling for WINREVAIR to include the impressive results of ZENITH. There remains a significant unmet medical need for patients living with PAH who, despite being on background therapy, remain at higher risk of morbidity and mortality,” said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “The FDA’s Priority Review designation acceptance of our sBLA reinforces our confidence in WINREVAIR for a broad range of patients and represents a critical step toward advancing the treatment of PAH.”

    WINREVAIR is currently approved in more than 45 countries based on the results from the STELLAR trial.

    *World Health Organization

    About ZENITH

    The ZENITH study (NCT04896008) is a global, double-blind, placebo-controlled clinical trial to evaluate WINREVAIR when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in adult participants with WHO functional class III or IV PAH at high risk of mortality. ZENITH study inclusion criteria required Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 risk score of ≥9.

    The study enrolled 172 participants, who were randomized in a 1:1 ratio to either WINREVAIR plus background PAH therapy or placebo plus background PAH therapy. The primary composite outcome measure was time to first confirmed major morbidity or mortality event. Events were defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours. Secondary outcome measures included overall survival, transplant-free survival and several additional measures. The study excluded patients with PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension as well as diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement.

    Participants who completed the ZENITH trial were offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA (NCT04796337), consistent with that study’s eligibility criteria.

    About WINREVAIR (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg

    WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

    WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

    Selected Safety Information for WINREVAIR in the U.S.

    WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.

    WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required.

    In clinical studies, serious bleeding (eg, gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding.

    WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.

    Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility.

    The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%).

    Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.

    About PAH

    Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%.

    About Merck

    At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

    This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

    Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_pi.pdf, Patient Information for WINREVAIR at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ppi.pdf, and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at https://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ifu_1-vial_2-vial_kits.pdf.


    Source: Merck & Co., Inc.


    Continue Reading

  • The UK DUA Act’s Reform Pillars: Divergence from the EU GDPR – Age Appropriate Design Code (The Children's Code) – Kennedys Law LLP

    1. The UK DUA Act’s Reform Pillars: Divergence from the EU GDPR – Age Appropriate Design Code (The Children’s Code)  Kennedys Law LLP
    2. Fines for cookie contraventions more likely as a result of law change  Mishcon de Reya LLP
    3. UK businesses to benefit from new data protection laws  NI Business Info
    4. A soft touch  independentschoolmanagement.co.uk
    5. The UK DUA Act’s Reform Pillars: Divergence from the EU GDPR – Codified convergences with EU Law  Kennedys Law LLP

    Continue Reading

  • WFW Madrid Partner María Pilar García Guijarro named WIBLA EMEA Energy, Natural Resources & Mining Lawyer of the Year

    WFW Madrid Partner María Pilar García Guijarro named WIBLA EMEA Energy, Natural Resources & Mining Lawyer of the Year

    Watson Farley & Williams (“WFW”) is proud to announce that Partner María Pilar García Guijarro – WFW’s Energy Sector Head for Europe & Americas and Madrid Office Head – has been named ‘Lawyer of the Year – Energy, Natural Resources & Mining’ at the Women in Business Law Awards (“WIBLA”) EMEA 2025.

    The WIBLA awards celebrate the achievements of leading women lawyers across the EMEA region based on a robust research and client feedback process. Held in London on 26 June, the awards ceremony brought together leading lawyers from across the EMEA region, with WFW also shortlisted for Best Firm in Spain, reflecting the strength and reputation for excellence of the firm’s Spanish offering.

    María Pilar’s win recognises her prominent role advising on the most complex and high-value energy transactions, as well as her longstanding commitment to client service and fostering talent within her team. She is the first WFW partner based in Europe to receive a WIBLA award in the energy, natural resources and mining category, setting a new benchmark for excellence and marking a milestone in the growth and recognition of the firm’s EMEA energy offering.

    WFW Managing Partner Lindsey Keeble, WIBLA’s EMEA Shipping and Maritime Lawyer of the Year 2021, commented: “I’m delighted by this well-deserved recognition of María Pilar’s deep sector expertise, strategic insights and consistent dedication to both our clients and the firm. She plays a key role in the ongoing growth of our energy practice and we are thrilled to see her achievements acknowledged by a leading organisation such as WIBLA”.

    María Pilar said: “It is a real honour to receive this award, which reflects not only the quality of the work we do, but also the strength of the relationships we have built with our clients and colleagues across the industry. I’m especially grateful to my fantastic team at WFW, this recognition is as much theirs as mine. My thanks to WIBLA for this and my sincerest congratulations to all winners and nominees for their outstanding work across the profession”.

    Continue Reading

  • Commission continues action to lower energy bills with new guidance on renewables, grids infrastructure and network tariffs

    Commission continues action to lower energy bills with new guidance on renewables, grids infrastructure and network tariffs

    As part of its efforts to bring down the cost of electricity supply and make electricity bills more affordable for Europeans, the Commission has today provided new guidance to EU countries. It will facilitate the uptake of innovative renewable energy sources and forms of deployment, accelerate the rollout of grids and storage infrastructure and design future-proof electricity network charges. 

    The recommendation and 3 guidance documents will support the implementation of the revised Renewable Energy Directive and Electricity Market Design, as well as the Action Plan for Affordable Energy set out earlier this year to lower energy costs by accelerating the clean energy transition

    EU countries and the national energy regulators are invited to consider these support documents when designing national frameworks on these matters. The Commission stands ready to assist them in their efforts.

    Accelerated deployment of new types of renewable energy and forms of deployment

    Innovative renewable energy technologies such as ocean energy and floating offshore wind, as well as innovative forms of deployment of renewable energy such as agrisolar, floating solar and vehicle-integrated PV, have important potential, which is currently not being sufficiently tapped into. To support their roll-out, EU countries should develop clear regulatory frameworks. This will help provide legal certainty and facilitate their uptake. EU countries should design a financial framework for the support of renewable energies which is adapted to the specific needs of these technologies and forms of deployment. If applied, this will reduce the gap between the costs of these new types of renewable energy and those of conventional forms of deployment, fostering their development. EU countries should also encourage continued research and innovation to explore their potential benefits and clarify their environmental impacts. 

    Faster procedures for grids and storage roll-out

    The expected development of the electricity system in terms of growth in renewable energy generation, electricity demand and grid constraints requires the urgent expansion and reinforcement of the grids, combined with the accelerated deployment of storage solutions. EU countries are encouraged to facilitate this by means of designating areas for grid and storage infrastructure. Grids and storage projects located in these areas may then be exempted from certain types of environmental assessments.

    Future-proof electricity network charges to reduce energy system costs

    The necessary investments in renewable energy sources, grids and storage solutions require more flexibility and efficiency in the way the electricity grids are used and managed, to ensure their cost-effective operation. Energy regulators should design tariffs that reflect the needs of the electricity system and make the best use of the existing infrastructure by incentivising flexibility and encouraging consumers to use electricity when it is cheap to do so. 

    Background

    Europe’s high energy costs are heavily influenced by its dependence on imported fossil fuels. Expanding the amount and range of renewable energy sources would help reduce the costs of energy supply and energy prices for industry and citizens. To make this a reality, it is necessary to significantly accelerate the roll out of renewable energy projects, including innovative forms of deployment and innovative renewable energy technologies. Moreover, there is an urgent need to develop energy infrastructure enabling the uptake of the renewables, security of supply and market integration.

    Earlier this year, the Commission put forward an Action Plan for Affordable Energy to lower energy costs, complete the Energy Union, attract investments and be better prepared for potential energy crises. As a key component of the Clean Industrial Deal, this Plan will not only bring relief to households facing high energy bills, but also to industries that struggle with high production costs, with  estimated overall savings of €45 billion in 2025, that will progressively increase until €130 billion in annual savings by 2030 and €260 billion by 2040. 

    Dan Jørgensen, Commissioner for Energy and Housing, said:

    ‘The clean energy transition is not just a moral obligation towards our planet: it is a matter of security and independence for Europe. Lower energy prices and a secure energy system with a high share of renewables are the backbone of a sustainable and competitive economy. With this new guidance to our Member States, we are showing the way towards a cleaner, cheaper and more efficient energy system.’

    Related links

     

    Continue Reading

  • Entain completes full rollout of Group BetStation across all UK and Ireland retail locations

    Entain, the global sports betting and gaming group, has successfully and fully deployed its proprietary Group BetStation (GBS) platform across all Ladbrokes and Coral shops in the United Kingdom and Ireland.

    This marks a major milestone in Entain’s digital retail transformation concluding a journey that began with the launch of the first GBS terminal in Feltham in November 2020 and culminated with the final installation in Swansea. In total, over 2,400 shops were upgraded across the UK and Ireland.

    GBS by numbers:

    1. Over 2,400 shops upgraded across the UK and Ireland
    2. 12,000 betting terminals converted
    3. Strong growth in ‘Other sports’ betting
    4. Grand National bets placed via GBS up by more than half year-on-year
    5. Football bet builder activity has doubled in the last six months.

    GBS is a fully in-house developed, self-service betting solution that delivers a market-leading digital type experience to retail customers. Built entirely from the ground up, the project has converted 12,000 terminals and is now the primary sports betting channel across Entain’s retail estate. The deployment is the result of thousands of hours of development and testing, reflecting significant investment in technology and innovation.

    Fiona Wallace, Head of Self-Service Betting Terminals at Entain says,

    “Five years ago, Entain set out to deliver a best-in-class betting experience for our UK and Ireland retail customers, through our BetStation terminals. Our software, which tech teams have worked tirelessly on over that period, is market leading, offering customers far more than we did in the past.

    This hard work has meant that all BetStation terminals across our retail estate have now been converted to Group BetStation, this is a transformational achievement. It has redefined the in-shop experience, driven engagement, and accelerated our journey toward retail digitalisation.

    Key to the platform’s success has been extensive collaboration across Entain’s Retail, Product & Technology, Commercial, and Operational teams globally — including colleagues from the UK, Austria, Gibraltar, India, and beyond. Feedback from over 14,000 UK retail employees has shaped product refinement, ensuring GBS delivers intuitive, responsive, and feature-rich functionality.

    GBS is reshaping customer behaviour in retail, enabling a shift toward more complex and personalised bets, including accumulators and bet builders. As a result, GBS has become the home for innovative betting formats and is central to Entain’s broader multi-channel growth strategy.

    Entain will continue to develop and evolve the GBS platform to enhance the customer experience further, differentiate Entain’s retail offering, and support the Group’s market share growth objectives.

    About Entain plc

    Entain plc (LSE: ENT) is a FTSE100 company and is one of the world’s largest sports betting and gaming groups, operating both online and in the retail sector. The Group owns a comprehensive portfolio of established brands; Sports brands include BetCity, bwin, Coral, Crystalbet, Eurobet, Ladbrokes, Neds, Sportingbet, Sports Interaction, STS and SuperSport; Gaming brands include Foxy Bingo, Gala, GiocoDigitale, Ninja Casino, Optibet, Partypoker and PartyCasino. The Group operates the TAB NZ brand as part of a long-term strategic partnership with TAB New Zealand. The Group owns proprietary technology across all its core product verticals and in addition to its B2C operations, provides services to a number of third-party customers on a B2B basis.

    The Group has a 50/50 joint venture, BetMGM, a leader in sports betting and iGaming in the US. Entain provides the technology and capabilities which power BetMGM as well as exclusive games and products, specially developed at its in-house gaming studios. The Group is tax resident in the UK and is the only global operator to exclusively operate in domestically regulated or regulating markets operating in over 30 territories.

    Entain is a leader in ESG, a member of FTSE4Good, the DJSI and is AAA rated by MSCI. For more information see the Group’s website: www.entaingroup.com

    Continue Reading

  • The UK DUA Act’s Reform Pillars: Divergence from the EU GDPR

    The UK DUA Act’s Reform Pillars: Divergence from the EU GDPR

    Relevant DUA Act Provision: Section 71, Schedule 5; amends Articles 5(1)(b) and 6(4) UK GDPR and adds a new Article 8A and Annex 2 to the UK GDPR.

    The DUA Act reforms the compatibility principle governing further processing of personal data by introducing statutory compatibility conditions and a new provision (Article 8A) in the UK GDPR. These provisions limit the need for a traditional compatibility assessment where certain legal and policy conditions are met.

    Contextual compatibility

    Under the GDPR, controllers are required to assess whether the further processing purpose is compatible with the original purpose of collection, using contextual criteria in Article 6(4) and Recital 50, such as the link to the original purpose, the context of collection, the nature of data, and data subject’s expectations.

    Statutory compatibility

    The DUA Act replaces this framework with a more rules-based framework for further processing, specifying circumstances in which the compatibility assessment under Article 6(4) UK GDPR is not required or is simplified. These statutory conditions are codified in the new Article 8A, which introduces a structured legal framework for compatibility by listing the exempted further processing scenarios. Article 8A(3) then refers to Annex 2, which enumerates specific categories of further processing that are also deemed compatible without a separate compatibility assessment. These exemptions from the compatibility assessment include:  

    • Consent-based further use: the data subject gives consent to the further processing and the  new purpose is specific, explicit and legitimate;
    • Public interest processing: The further processing is carried out for (i) scientific research or historical research, (ii) archiving in the public interest or (iii) statistical purposes, and is subject to safeguards under Article 89(1) (e.g. minimisation, pseudonymisation);
    • Compliance processing: the processing is carried out to ensure that the processing complies with the principles for processing personal data under Article 5(1) UK GDPR
    • Annex 2 disclosure route: the controller discloses personal data in response to a request from another person who needs it to carry out processing under Article 6(1)(e) (official authority or public interest task), with a valid legal basis under Article 6(3), and the processing is necessary to safeguard an objective listed in Article 23(1)(c) to (j) UK GDPR. This includes objectives such as public security, the protection of judicial independence, or the enforcement of civil law claims. The disclosing controller must not be a public authority performing its own tasks.

    In all cases, the further processing must still comply with the principles of fairness and transparency under Article 5, and appropriate safeguards, particularly under Article 89(1), must be applied where applicable.

    Where the controller relied on consent for the original purpose, the further purpose will only be deemed compatible if fresh consent is obtained for the further processing and the processing is either (i) solely to ensure compliance with Article 5(1) data protection principles, or (ii) falls within Annex 2 and the controller cannot reasonably be expected to obtain new consent.

    Annex 2 is legally anchored in Article 8A(3), which delegates to it the role of specifying additional forms of further processing deemed inherently compatible with the original purpose.

    Annex 2 of Schedule 5 sets out additional statutory examples of further processing that shall be treated as compatible with the original purpose. This is a limited list of processing for the purposes of:

    • archiving in the public interest;
    • detection, investigation and prevention of crime and apprehension of offenders;
    • to protect vital interests of the data subject or another individual;
    • safeguarding children and vulnerable individuals
    • the assessment or collection of tax
    • to comply with a legal obligation under an enactment, rule of law or order of a court or tribunal

    The Secretary of State may expand or revise this list by regulation. This mechanism introduces flexibility but also raises rule of law concerns about foreseeability and the scope of ministerial discretion.

    This statutory presumption replaces the open-textured compatibility balancing test for listed  purposes, enhancing legal certainty and operational efficiency. However, for commercial or non-exempted secondary uses, the compatibility analysis under Article 6(4) still applies, albeit with less detailed contextual criteria than under the GDPR. The reform thus creates a two-tier model of further processing in the UK.

    Notably, the DUA Act does not alter the requirement that the further purpose be specified and transparent to data subjects under Article 5(1)(b). Nor does it diminish the relevance of fairness and accountability under Articles 5(1)(a) and 5(2). Controllers must still justify the further use on the basis of proportionality and necessity when outside the statutory exemptions.

    Divergence

    The UK model departs from the EU’s nuanced, case-by-case compatibility framework. It introduces a more rules-based system that simplifies assessments for certain further processing purposes, such as those listed in Annex 2 or expressly permitted under Article 8A(2) and (3), which together form the backbone of the UK’s new statutory compatibility regime. This statutory presumption replaces the open-textured compatibility balancing test for those purposes, enhancing legal certainty and operational efficiency. However, for commercial or non-exempted secondary uses, the compatibility analysis under Article 6(4) still applies, albeit with less prescriptive contextual criteria than under the GDPR. The reform thus creates a two-tier model of further processing in the UK. The scope for ministerial discretion over future categories raises regulatory concerns around legal certainty and foreseeability.

    Notably, the DUA Act does not alter the requirement that the further purpose be specified and transparent to data subjects under Article 5(1)(b). Nor does it diminish the relevance of fairness and accountability under Articles 5(1)(a) and 5(2). Organisations must still justify the further use on the basis of proportionality and necessity when outside the statutory exemptions.

    ICO commentary 

    In its updated to the DUA Bill (prior to the Bill receiving parliamentary approval), the ICO stated that amendments, particularly for scientific research, archiving, and statistical purposes are easier to navigate and understand,” provide organisations with greater certainty, and enable responsible reuse of personal data. The ICO emphasises, however, that compliance with safeguards under Article 89(1) remains critical. The ICO intends to publish new updated relevant on Research, Archiving and Statistics with a public consultation planned, in Spring 2026.

    Recommendations

    • Maintain a register of all further processing activities, noting the route used (statutory vs. contextual).
    • For scientific, historical, and statistical processing, document compliance with Article 89(1) safeguards.
    • Use Annex 2 disclosures and consent-based tools appropriately.
    • Update privacy notices to reflect new statutory presumptions and clarify how secondary purposes align with the original lawful basis.
    • Monitor future changes to the statutory list and changes to Annex 2 and Article 8A via secondary legislation.

    This article is part of a twelve-part series analysing the key legal reforms introduced by the Data Use and Access Act (DUA Act), which came into force on 19 June 2025. The series examines the most significant areas of divergence and convergence between the DUA Act and the EU GDPR, drawing on both the legislation itself and provisional guidance from the Information Commissioner’s Office (ICO). Each article provides legal context, highlights regulatory shifts, and offers practical compliance insights. The twelve core areas covered in this series are:

    1. Recognised Legitimate Interests (RLIs)
    2. Further Processing
    3. Automated Decision-Making (ADM)
    4. Data Subject Access Requests (DSARs)
    5. Complaints Handling
    6. Law Enforcement and National Security
    7. Age Appropriate Design Code (AADC or Children’s Code)
    8. Scientific, Historical and Statistical Purposes
    9. International Data Transfers
    10. Cookies and PECR Reform
    11. Information Commissioner’s Office (ICO) Reform
    12. Codified Convergences with EU Law

     

    Continue Reading

  • Fossil fuel financing soared while major banks left NZBA, report finds – Green Central Banking

    1. Fossil fuel financing soared while major banks left NZBA, report finds  Green Central Banking
    2. What role does your money play in the climate crisis?  Times of India
    3. Banks bet big on fossil fuels, boosting financing in 2024, report finds  Mongabay
    4. Fire hazard: Funding the burning of fossil fuels will eventually leave bank money burnt  Mint
    5. Coal Loophole Undermines Bank Pledges to Cut Fossil-Fuel Funding  Bloomberg.com

    Continue Reading

  • Google undercounts its carbon emissions, report finds | Google

    Google undercounts its carbon emissions, report finds | Google

    In 2021, Google set a lofty goal of achieving net-zero carbon emissions by 2030. Yet in the years since then, the company has moved in the opposite direction as it invests in energy-intensive artificial intelligence. In its latest sustainability report, Google said its carbon emissions had increased 51% between 2019 and 2024.

    New research aims to debunk even that enormous figure and provide context to Google’s sustainability reports, painting a bleaker picture. A report authored by non-profit advocacy group Kairos Fellowship found that, between 2019 and 2024, Google’s carbon emissions actually went up by 65%. What’s more, between 2010, the first year there is publicly available data on Google’s emissions, and 2024, Google’s total greenhouse gas emissions increased 1,515%, Kairos found. The largest year-over-year jump in that window was also the most recent, 2023 to 2024, when Google saw a 26% increase in emissions just between 2023 and 2024, according to the report.

    “Google’s own data makes it clear: the corporation is contributing to the acceleration of climate catastrophe, and the metrics that matter – how many emissions they emit, how much water they use, and how fast these trends are accelerating – are headed in the wrong direction for us and the planet,” said Nicole Sugerman, a campaign manager at Kairos Fellowship.

    The authors say that they found the vast majority of the numbers they used to determine how much energy Google is using and how much its carbon emissions are increasing in the appendices of Google’s own sustainability reports. Many of those numbers were not highlighted in the main body of Google’s reports, they say.

    Google did not immediately respond to a request for comment on the figures.

    The authors behind the report, titled Google’s Eco-Failures, attribute the discrepancy between the numbers they calculated and the numbers Google highlights in its sustainability reports to various factors, including that the firm uses a different metric for calculating how much its emissions have increased. While Google uses market-based emissions, the researchers used location-based emissions. Location-based emissions is the average energy the company consumes from local power grids, while market-based emissions include energy the company has purchased to offset its total emissions.

    “[Location-based emissions] represents a company’s ‘real’ grid emissions,” said Franz Ressel, the lead researcher and report co-author. “Market-based emissions are a corporate-friendly metric that obscures a polluters’ actual impact on the environment. It allows companies to pollute in one place, and try to ‘offset’ those emissions by purchasing energy contracts in another place.”

    The energy the tech giant has needed to purchase to power its data centers alone increased 820% since 2010, according to Kairos’ research, a figure that is expected to expand in the future as Google rolls out more AI products. Between 2019 and 2024, emissions that came primarily from the purchase of electricity to power data centers jumped 121%, the report’s authors said.

    “In absolute terms, the increase was 6.8 TWh, or the equivalent of Google adding the entire state of Alaska’s energy use in one year to their previous use,” said Sugerman.

    Based on Google’s current trajectory, the Kairos report’s authors say the company is unlikely to meet its own 2030 deadline without a significant push from the public. There are three categories of greenhouse gas emissions – called Scopes 1, 2 and 3 – and Google has only meaningfully decreased its Scope 1 emissions since 2019, according to the Kairos report. Scope 1 emissions, which include emissions just from Google’s own facilities and vehicles, account for only 0.31% of the company’s total emissions, according to the report. Scope 2 emissions are indirect emissions that come primarily from the electricity Google purchases to power its facilities, and scope 3 accounts for indirect emissions from all other sources such as suppliers, use of Google’s consumer devices or employee business travel.

    “It’s not sustainable to keep building at the rate [Google is] building because they need to scale their compute within planetary limits,” said Sugerman. “We do not have enough green energy to serve the needs of Google and certainly not the needs of Google and the rest of us.”

    Thirsty, power-hungry data centers

    As the company builds out resource-intensive data centers across the country, experts are also paying close attention to Google’s water usage. According to the company’s own sustainability report, Google’s water withdrawal – how much water is taken from various sources – increased 27% between 2023 and 2024 to 11bn gallons of water.

    The amount is “enough to supply the potable water needs for the 2.5 million people and 5,500 industrial users in Boston and its suburbs for 55 days”, according to the Kairos report.

    Tech companies have faced both internal and public pressure to power their growing number of data centers with clean energy. Amazon employees recently put forth a package of shareholder proposals that asked the company to disclose its overall carbon emissions and targeted the climate impact of its data centers. The proposals were ultimately voted down. On Sunday, several organizations including Amazon Employees for Climate Justice, League of Conservation Voters, Public Citizen, and the Sierra Club, published an open letter in the San Francisco Chronicle and the Seattle Times calling on the CEOs of Google, Amazon and Microsoft to “commit to no new gas and zero delayed coal plant retirements to power your data centers”.

    skip past newsletter promotion

    “In just the last two years alone, your companies have built data centers throughout the United States capable of consuming more electricity than four million American homes,” the letter reads. “Within five years, your data centers alone will use more electricity than 22 million households, rivaling the consumption of multiple mid-size states.”

    In its own sustainability report, Google warns that the firm’s “future trajectories” may be impacted by the “evolving landscape” of the tech industry.

    “We’re at an extraordinary inflection point, not just for our company specifically, but for the technology industry as a whole – driven by the rapid growth of AI,” the report reads. “The combination of AI’s potential for non-linear growth driven by its unprecedented pace of development and the uncertain scale of clean energy and infrastructure needed to meet this growth makes it harder to predict our future emissions and could impact our ability to reduce them.”

    The Kairos report accuses Google of relying “heavily on speculative technologies, particularly nuclear power”, to achieve its goal of net zero carbon emissions by 2030.

    “Google’s emphasis on nuclear energy as a clean energy ‘solution’ is particularly concerning, given the growing consensus among both scientists and business experts that their successful deployment on scale, if it is to ever occur, cannot be achieved in the near or mid-term future,” the report reads.

    The Kairos report alleges the way that Google presents some of its data is misleading. In the case of data center emissions, for example, Google says it has improved the energy efficiency of its data centers by 50% over 13 years. Citing energy efficiency numbers rather than sharing absolute ones obscures Google’s total emissions, the authors argue.

    “In fact, since 2010, the company’s total energy consumption has increased 1,282%,” the report concluded.

    Continue Reading

  • DLA Piper advises Ping An Insurance on HKD11.765 billion convertible bond issuance

    DLA Piper has advised its long-standing client Ping An Insurance (Group) Company of China, Ltd. (Ping An) on its successful issuance of HKD11.765 billion (approximately USD1.53 billion) in convertible bonds. This deal is the biggest convertible bond issuance denominated in US dollars or Hong Kong dollars by a Chinese company this year.

    Ping An is one of the largest and most innovative insurance and financial services companies in the world. These convertible bonds, which are due in 2030, carry a zero coupon, and will be listed on the Open Market of the Frankfurt Stock Exchange and convertible into the H shares listed in Hong Kong. The proceeds from this issuance will be used to further develop Ping An’s core business and strengthen its capital position, support new strategic initiatives in the healthcare and elderly care sectors, and for general corporate purposes.

    The deal follows DLA Piper’s earlier advisory role in Ping An’s landmark USD3.5 billion convertible bonds issuance in July 2024, which set multiple records as the largest Reg-S-only convertible bond, the largest convertible bond in the insurance sector, and the first offshore convertible bond ever issued by a Chinese insurance company. The deal was recognized as “Deal of the Year” by China Business Law Journal.  Together, these deals highlight Ping An’s agility in leveraging diverse funding avenues and DLA Piper’s expertise in advising complex, record-setting transactions.

    The DLA Piper team was led by Roy Chan, Senior Partner and Co-Country Managing Partner in China; Philip Lee, Head of Capital Markets, Asia Pacific and Regional Head of DLA Piper’s Financial Services sector in Asia; and Vivian Liu, Head of Capital Market Compliance for Greater China. They were supported by senior associates Yingshi Pan and Le Jing Ong and consultants Daina Wang and Ivy Zou.

    Roy Chan commented: “We are delighted to have supported Ping An on another significant transaction. This issuance not only underscores Ping An’s strong market position but also highlights the growing importance of convertible bonds as a financing tool for leading companies in the region.”

    Vivian Liu added: “Our cross-border team worked seamlessly to ensure the successful execution of this complex transaction, demonstrating our firm’s capability to handle high-profile deals across multiple jurisdictions.”

    Philip Lee stated: “This transaction reflects our commitment to providing top-tier legal services to our clients in the financial sector. We look forward to continuing our support for Ping An as they pursue their strategic objectives.”

    Continue Reading

  • Baker McKenzie Advises Bain Capital on the formation of a leading European Digital Transaction Management software platform | Newsroom

    Baker McKenzie Advises Bain Capital on the formation of a leading European Digital Transaction Management software platform | Newsroom

    Leading global law firm, Baker McKenzie, has advised Bain Capital on the entry into of exclusive negotiations for Signaturit to join the Namirial Group.

    The transaction remains subject to customary regulatory approvals and employee representative consultation.

    Namirial, which Bain Capital announced it was acquiring from Ambienta in March 2025 (closing expected in July 2025), is a leading provider of DTM software solutions. Signaturit is one of the leading providers of cloud-based DTM services in Southern Europe, offering solutions across digital identity management, Digital Signature, KYC & fraud prevention, and eID wallet. The combination of Namirial with Signaturit will create a leading Pan-European DTM provider with a leading position across Italy, Spain, France, and Germany with ~1,400 employees and serving ~240,000 customers worldwide.

    The Baker McKenzie team was led by Private Equity Partners Alex Lewis and David Allen (London) with support from Partners Michael Doumet (Paris) and Juanjo Corral (Madrid), Senior Associates Grace Blackburn and Oliver Feslier-Holmes (London) and Associates Kirstie Trup and Patrick Sharkey (London).

    Continue Reading