Category: 3. Business

  • Google won’t say if UK secretly demanded a backdoor for user data

    Google won’t say if UK secretly demanded a backdoor for user data

    ANKARA, TURKIYE – SEPTEMBER 03: A woman looks at a mobile phone displaying the logo of Google in front of a laptop screen displaying the logo of Google in Ankara, Turkiye on September 03, 2024. (Photo by Dilara Irem Sancar/Anadolu via Getty Images) | Image Credits:Dilara Irem Sancar / Anadolu / Getty Images

    The U.K. government is reportedly backing down from its earlier demand that Apple builds a secret backdoor allowing its authorities access to customer data worldwide, following a harsh rebuke from the U.S. government.

    But one U.S. senator wants to know if other tech giants, like Google, have also received secret backdoor demands from the U.K. government, and Google has so far refused to say.

    Earlier this year, The Washington Post reported that the U.K. Home Office sought a secret court order in the U.K.’s surveillance court demanding that Apple allows U.K. authorities to access the end-to-end encrypted cloud data stored on any customer in the world, including their iPhone and iPad backups. Apple encrypts the data in such a way that only customers, and not Apple, can access their data stored on its servers.

    Under U.K. law, tech companies subject to secret surveillance court orders, such as Apple, are legally barred from revealing details of an order, or the existence of the order itself, despite details of the demand publicly leaking earlier this year. Critics called the secret order against Apple “draconian,” saying it would have global ramifications for users’ privacy. Apple has since appealed the legality of the order.

    In a new letter sent to top U.S. intelligence official Tulsi Gabbard on Tuesday, Sen. Ron Wyden, who serves on the Senate Intelligence Committee, said that while tech companies cannot say whether they have received a U.K. order, at least one technology giant has confirmed that it hasn’t received one.

    Meta, which uses end-to-end encryption to protect user messages sent between WhatsApp and Facebook Messenger, told Wyden’s office on March 17 that the company has “not received an order to backdoor our encrypted services, like that reported about Apple.”

    Google, for its part, has refused to tell Wyden’s office if it had received a U.K. government order for accessing encrypted data, such as Android backups, “only stating that if it had received a technical capabilities notice, it would be prohibited from disclosing that fact,” Wyden said.

    Google spokesperson Karl Ryan told TechCrunch in a statement: “We have never built any mechanism or ‘backdoor’ to circumvent end-to-end encryption in our products. If we say a product is end-to-end encrypted, it is.”

    When explicitly asked by TechCrunch, Google would not say whether or not it has to date received an order from the U.K. government.

    Wyden’s letter, first reported by The Washington Post and shared with TechCrunch, called on Gabbard to make public its “assessment of the national security risks posed by the U.K.’s surveillance laws and its reported secret demands of U.S. companies.”

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  • Gucci owner Kering posts 46% profit slump before new CEO arrives

    Gucci owner Kering posts 46% profit slump before new CEO arrives

    A Gucci store in Paris, where its parent company Kering is based (Sébastien DUPUY)

    French luxury group Kering reported Tuesday a 46 percent plunge in net profit during the first half, with sales slumping again at its flagship Gucci brand, as the group awaits a new CEO to try to regain its footing.

    Group net profit fell to 474 million euros ($547 million) in the first half from 878 million in the same period last year, on sales that were down 16 percent at 7.6 billion euros.

    Kering announced in June that it had poached Luca de Meo, then the head of French automaker Renault, to become chief executive and help turn around the company alongside Francois-Henri Pinault, who will remain board chairman.

    Pinault’s family controls the holding company that is the largest shareholder in Kering, whose crosstown rival LVMH reported last week a 22 percent drop in first-half profit.

    Luxury groups worldwide have been hit hard by slowing Chinese appetite for luxury goods and by US President Donald Trump’s barrage of tariffs since returning to office this year, which could crimp demand in a North American market that represents a fourth of Kering’s sales.

    “Though the numbers we are reporting remain well below our potential, we are certain that our comprehensive efforts of the past two years have set healthy foundations for the next stages in Kering’s development,” Pinault said in a statement.

    Gucci remains the prize in Kering’s stable of brands, generating 44 percent of its sales and roughly two-thirds of its operating profit.

    But it has struggled to turn things around at the Italian fashion house famous for its handbags, and in March it wooed the Georgian designer Demna to take over as artistic director.

    Gucci’s sales dropped 26 percent in the first half to 3.03 billion euros, for an operating profit of 486 million euros — down 52 percent.

    – ‘Vigilance’ –

    But investors may have to wait for a recovery plan from De Meo, who has yet to take up his post.

    “The change in group management is positive, but earnings will remain under pressure in the short term,” analysts at HSBC said in a note before the earnings release.

    “Luca de Meo will not take up his post until September 15, and it’s unlikely that he will present his strategic plan before the publication of full-year results, expected in February 2026,” they said.

    Kering’s two other top brands are also facing headwinds, with Yves Saint Laurent sales falling 11 percent in the first half to 1.29 billion euros, and Bottega Veneta sales up just one percent at 846 million euros.

    Kering must also contend with a debt load that stood at 9.5 billion euros at the end of June, the result of acquisitions and investments in recent years.

    It bought a 30 percent stake in Valentino, took over the beauty brand Creed, and opened stores on key but pricey sites in cities including Paris and Milan.

    “Selling this real estate (below the purchase cost) is a bitter but necessary solution,” analysts at Bernstein wrote ahead of the earnings statement.

    Kering said it was “stepping up the initiatives needed to support the development and growth of its houses, while implementing with determination the efforts required to increase its efficiency”.

    “These actions imply particular vigilance with regards to financial discipline,” it added.

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  • ChatGPT launches study mode to encourage ‘responsible’ academic use | ChatGPT

    ChatGPT launches study mode to encourage ‘responsible’ academic use | ChatGPT

    ChatGPT is launching a “study mode” to encourage responsible academic use of the chatbot, amid rising cases of misuse of artificial intelligence tools at universities.

    The feature, which can be accessed via the chatbot’s tools button, can walk users through complex subjects in a step-by-step format akin to an unfolding academic lesson.

    In one example released by ChatGPT’s developer, OpenAI, the chatbot responds to a prompt asking for help with understanding Bayes’ theorem – a mathematical formula – by asking the user what level of maths they are comfortable with and what their goal is.

    Study mode is being released as academic communities grapple with the issue of AI misuse. A Guardian survey of academic integrity violations in the UK found almost 7,000 proven cases of cheating using AI tools in 2023-24, equivalent to 5.1 for every 1,000 students. That compared with 1.6 cases per 1,000 in 2022-23.

    More than a third of college-age young adults in the US use ChatGPT, according to OpenAI, with about a quarter of their chatbot messages referring to learning, tutoring and schoolwork.

    The study mode is designed to avoid simply serving up a complete essay or exam answer, with OpenAI saying it “doesn’t just offer solutions without helping students make sense of them”. However, students will still be able to take an academic shortcut if they ignore the study mode option.

    Jayna Devani, the international education lead at ChatGPT’s US-based developer, OpenAI, said the company did not want ChatGPT to be misused by students and the tool was a “step toward” encouraging constructive academic use of ChatGPT.

    “How do we take that step forward in showing that there are responsible ways to engage with ChatGPT – to engage with ChatGPT to actually support a learning process? We definitely don’t believe that these tools should be misused and this is one step toward that,” she said.

    Devani acknowledged that tackling academic cheating would require a “whole industry conversation” about changing assessments and drawing up “very unambiguous guidelines about what constitutes responsible AI use”.

    OpenAI said study mode – billed as “study and learn” in the chatbot’s tools options – was especially useful for homework help, exam preparation and learning new topics.

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    Devani said the new mode was designed to encourage users to engage with topics and problems rather than just serve up an answer immediately. “It’s guiding me towards an answer, rather than just giving it to me first-hand,” she said.

    It can also interact with images, meaning it can help students work through past exam papers if they are uploaded to the chatbot.

    OpenAI said it cooperated with teachers, scientists and education experts to develop the tool but warned there could be “inconsistent behaviour and mistakes across conversations”.

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  • Gedatolisib-Based Regimens Prolong PFS in HR+/HER2–, PIK3CA Wild-Type Advanced Breast Cancer

    Gedatolisib-Based Regimens Prolong PFS in HR+/HER2–, PIK3CA Wild-Type Advanced Breast Cancer

    HR+/HER2– Breast Cancer | Image credit:

    © Sebastian Kaulitzki – stock.adobe.com

    Treatment with gedatolisib, a pan‑PI3K/mTOR inhibitor, in combination with palbociclib (Ibrance) and fulvestrant (Faslodex) or in combination with fulvestrant alone led to clinically meaningful improvements in progression‑free survival (PFS) compared with fulvestrant alone in patients with hormone receptor–positive/HER2‑negative advanced breast cancer who had PIK3CA wild‑type disease, according to topline data from the PIK3CA wild-type cohort of the phase 3 VIKTORIA‑1 trial (NCT05501886).1

    Specifically, the gedatolisib triplet reduced the risk of disease progression or death by 76% compared with fulvestrant alone (HR, 0.24; 95% CI, 0.17-0.35; P < .0001). The median PFS was 9.3 months with the triplet vs 2.0 months with fulvestrant per blinded independent central review (BICR).

    Gedatolisib plus fulvestrant reduced the risk of disease progression or death by 67% compared with fulvestrant alone (HR, 0.33; 95% CI, 0.24-0.48; P < .0001). The median PFS was 7.4 months vs 2.0 months, respectively.

    Full results from the PIK3CA wild‑type cohort will be presented at an upcoming medical congress in 2025. Celcuity plans to submit a new drug application for gedatolisib to the FDA in the fourth quarter of 2025.

    “Patients with hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease has progressed while on, or after, treatment with a CDK4/6 inhibitor typically derive limited benefit from subsequent endocrine-based therapy. The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing,” Sara Hurvitz, MD, senior vice president of the Clinical Research Division at Fred Hutchinson Cancer Center; professor and head of the Division of Hematology and Oncology at the University of Washington, Department of Medicine; and co-principal investigator for the trial, stated in a news release.

    VIKTORIA‑1 Trial Breakdown

    VIKTORIA‑1 is a phase 3, open‑label, randomized study evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib in patients with locally advanced or metastatic hormone receptor–positive/HER2‑negative breast cancer who experienced disease progression on or after a CDK4/6 inhibitor and non‑steroidal aromatase inhibitor therapy.2

    Patients needed to have histologically or cytologically confirmed metastatic or locally advanced disease, and they needed to be amendable to treatment with an LHRH agonist. Documented radiological disease progression on or after the last line of therapy was required, and patients needed to have radiologically evaluable disease that was measurable or non-measurable. An ECOG performance status of 0 or 1, a life expectancy of at least 3 months, and adequate bone marrow, hepatic, renal, and coagulation function were required.

    Patients were stratified by confirmed PIK3CA mutation status prior to randomization. Within the PIK3CA wild‑type and PIK3CA‑mutated subgroups, patients were randomly assigned to receive gedatolisib at 180 mg on days 1, 8, and 15 of each 28-day cycle plus palbociclib at 125 mg per day for 3 weeks on and 1 week of in each cycle, and 500 mg of fulvestrant on days 1 and 15 of cycle 1, then on day 1 of subsequent cycles; gedatolisib plus fulvestrant on the same dosing schedules; or fulvestrant alone on the same schedule.

    The primary end point of the trial is PFS, assessed in both PIK3CA wild‑type and PIK3CA‑mutated cohorts. Secondary end points include overall survival (OS), objective response rate, duration of response, clinical benefit rate, safety and tolerability, and patient‑reported outcomes.

    Safety Analysis

    Treatment discontinuations due to treatment‑related adverse effects (TRAEs) were lower for both the triplet and doublet regimens compared with Arm D of the phase 1b trial (NCT02684032) in advanced breast cancer and lower than reported in any phase 3 trials of currently approved combinations in this disease setting.1 The incidence of hyperglycemia and stomatitis was also lower than that observed in the previously reported phase 1b trial.

    “To my knowledge, we have not seen phase 3 results in patients with hormone receptor–positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control,” Hurvitz added.

    Reference

    1. Celcuity announces clinically meaningful improvement in both progression-free survival (“PFS”) primary endpoints from PIK3CA wild-type cohort of phase 3 VIKTORIA-1 trial. News Release. Celcuity. July 28, 2025. Accessed July 29, 2025. https://ir.celcuity.com/press-releases/
    2. Gedatolisib plus fulvestrant with or without palbociclib vs standard-of-care for the treatment of patients with advanced or metastatic HR+/HER2- breast cancer (VIKTORIA-1). ClinicalTrials.gov. Updated June 24, 2025. Accessed July 29, 2025. https://clinicaltrials.gov/study/NCT05501886

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  • CMS proposes new behavioral health integration add-on codes for APCM services in CY 2026 MPFS

    The Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2026 Medicare Physician Fee Schedule (MPFS) Proposed Rule (Proposed Rule) on July 14, 2025. The Proposed Rule includes important proposals to facilitate the addition of behavioral health integration (BHI) and collaborative care management (CoCM) services by physicians, practitioners, rural health clinics (RHCs), and federally qualified health centers (FQHCs) that provide advanced primary care management (APCM) to Medicare beneficiaries.

    In this alert, we summarize the key proposed changes for healthcare providers and accountable care organizations (ACOs).

    Behavioral health integration add-on codes for advanced primary care management

    CMS proposes the creation of three optional G-codes (GPCM1, GPCM2, and GPCM3) to be billed as add-on services to APCM base codes (G0556, G0557, and G0558) when reported in the same month by the same practitioner. The proposed add-on codes are intended to support the integration and billing of complementary BHI or CoCM services with APCM, with the goal of promoting better patient health and preventing chronic disease.

    The codes would also be considered a “designated care management service” incident to the billing practitioner’s professional services and, as such, could be provided by auxiliary personnel under the general supervision of the billing practitioner.

    Code structure and valuation

    CMS states that the services encompassed by the proposed optional add-on codes should be directly comparable to existing BHI and CoCM codes. CMS cross-walks each proposed optional add-on code to its corresponding BHI or CoCM Current Procedural Terminology (CPT) code values for both practice expense and work relative value units (RVUs). Specifically:

    • GPCM1 mirrors CPT 99492, which is the CPT code for the first month of CoCM services
    • GPCM2 mirrors CPT 99493, which is the CPT code for subsequent months of CoCM services, and
    • GPCM3 mirrors CPT 99484, which is a CPT code for 20 minutes or more of BHI services.

    CMS also proposes allowing RHCs/FQHCs to use the new add-on codes for APCM services. However, to implement this change, CMS states that it would need to modify current RHC/FQHC billing and payment policies for CoCM services.

    Under existing policy, CMS requires RHCs/FQHCs to report CoCM services using a bundled CoCM code (G0512) and sets payment for the bundled services at the annual average of the national non-facility Medicare fee schedule rate for CoCM codes 99492 and 99493.

    Under the CY 2026 proposal, RHCs/FQHCs would no longer use G0512 or be paid the bundled rate. Instead, RHCs/FQHCs would be required to bill using individual CoCM codes, and they would receive the national non-facility Medicare fee schedule payment rates set for such codes.

    Documentation

    CMS proposes removing the time-based documentation requirements for both existing BHI and CoCM codes, and will not impose these requirements for the proposed optional add-on codes. CMS cites the need for providers furnishing APCM services to be able to provide BHI and CoCM without the burden of documenting their time spent performing the service. Specifically, CMS reasons that many practices that develop interdisciplinary teams to provide APCM are the ones most likely ready to furnish BHI and CoCM services, and that introduction of the add-on codes will streamline processes.

    CMS believes that removing the time-based documentation would facilitate a more holistic, team-based approach to care coordination. Further, CMS anticipates that reducing documentation requirements may make primary care practitioners more likely to offer and furnish BHI and CoCM services, thereby improving access for primary care patients.

    Changes to the definition of “primary care services” for ACO beneficiary assignment

    CMS proposes amending the definition of “primary care services” used for assigning beneficiaries to Medicare Shared Savings Program ACOs in two key ways:

    1. Inclusion of new BHI/CoCM codes: The Proposed Rule adds “Enhanced Care Model Management Services” to the definition of “primary care services.” These services are comprised of the optional add-on BHI and CoCM service codes – ie, Healthcare Common Procedure Coding System (HCPCS) codes GPCM1, GPCM2, and GPCM3. CMS believes that including such services in the definition will “increase the accuracy of assignment based on the provision of primary care by ensuring that all expenditures for BHI and CoCM are used to determine beneficiary assignment.”
    2. Deletion of Social Determinants of Health code: CMS proposes to delete HCPCS code G0136 for Social Determinants of Health (SDOH) risk assessment services from the definition of “primary care services,” arguing that existing evaluation and management (E/M) service codes already encompass the costs of the service, rendering payments for SDOH risk assessment services duplicative.

    Next steps for stakeholders

    CMS is actively seeking feedback on numerous proposals within the Proposed Rule. Interested stakeholders – particularly interdisciplinary care teams, primary care providers, and ACOs – are encouraged to submit comments to CMS, which are due by September 12, 2025.

    Key areas for consideration and feedback include:

    • CMS’s proposed valuation and direct cross-walking of the proposed APCM add-on codes to existing BHI and CoCM service codes. Stakeholders should consider evaluating whether the new add-on codes and the removal of time-based documentation requirements will streamline care delivery and billing practices.
    • Proposed changes to the definition of “primary care services” for beneficiary assignment and prospective monthly payments to primary care providers by ACOs for APCM services.
    • Whether CMS should consider: (1) new payments to Medicare Shared Savings Program ACOs for prospective monthly APCM payments to primary care practices that fulfill the APCM billing requirements, with payments reconciled under the ACO benchmark; and (2) additional changes to APCM policies, coding, and/or payments that would generate primary care providers’ interest in ACO participation.

    CMS is also evaluating whether APCM services should be defined to include a blend of preventative and treatment services, given that CMS believes balancing these services is often necessary for effective care management.

    CMS is seeking comments on whether it should include the annual wellness visit, depression screening, or other preventative services in the APCM bundles and, if so, how CMS should apply cost-sharing to APCM services – particularly given that cost-sharing obligations are waived for preventative services under Medicare.

    Learn more

    If you have questions about the Proposed Rule, related advocacy efforts, or need assistance evaluating the regulatory impact of the Proposed Rule and possible implications for your organization – or if you need assistance drafting and preparing comments to the Proposed Rule by September 12, 2025 – please contact your DLA Piper relationship partner, the authors of this alert, or any member of our Healthcare practice group.

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  • KERING (KER-FR) earnings Q2 2025

    KERING (KER-FR) earnings Q2 2025

    A Gucci logo is displayed at their store on May 30, 2025 in Washington, DC.

    Kevin Carter | Getty Images News | Getty Images

    Gucci-owner Kering on Tuesday posted worse-than-feared second-quarter results and flagged ongoing geopolitical uncertainty as woes persist at the beleaguered luxury group.

    Sales at the high-end fashion house dropped 15% year-on-year on a comparable basis to 3.7 billion euros ($4.27 billion), compared to the the 3.96 billion euros forecast by LSEG analysts.

    Gucci sales, which typically make up nearly half of total group revenues, plunged 25% over the quarter to 1.46 billion euros.

    Chairman and CEO François-Henri Pinault acknowledged the results were disappointing, but noted ongoing efforts to course correct the struggling luxury giant.

    “Though the numbers we are reporting remain well below our potential, we are certain that our comprehensive efforts of the past two years have set healthy foundations for the next stages in Kering’s development,” Pinault said in a statement accompanying the results.

    “In an economic and geopolitical environment that remains uncertain, Kering continues to deploy its strategy with the aim of achieving a profitable long-term growth trajectory,” the company added.

    The group, which also owns the Saint Laurent and Bottega Veneta brands, said sales were weaker were across all markets, led by Japan and the wider Asia Pacific.

    “Kering is facing a tough reality as its two main luxury markets, China and the United States, are under strain,” Yanmei Tang, analyst at Third Bridge, said in emailed comments shortly after the earnings release.

    New leadership in focus

    Kering’s share price is currently down 8% year-to-date as investors have questioned the company’s ability to turn itself around after several consecutive quarters of soft sales.

    The appointment in June of auto veteran Luca de Meo as group CEO brought positive momentum, with his appointment set to take effect from Sept. 15.

    “[De Meo] has a really strong track record in turning around businesses but also in branding,” Carole Madjo, head of European luxury goods research at Barclays, told CNBC’s “Squawk Box Europe” last week.

    The incoming CEO nevertheless has a tough task ahead of him, as the industry faces the prospect of new 15% tariffs on imports to the U.S. as well as broader concerns around consumer spending, particularly in the key Chinese market.

    Still, analysts suggest the bigger challenge will be reviving the company’s image and desirability, including under Gucci’s new artistic director Demna Gvasalia, while simultaneously not alienating existing consumers.

    “Product desirability is now a bigger problem for Kering than any tariff threat,” Tang said. “Desirable brands like Hermès can nudge prices higher without hurting demand, but brands such as Saint Laurent and Gucci do not currently enjoy that level of pricing power.”

    “Bringing newness, something fresh which has not been seen before, is, I think, what could make Gucci great again,” Madjo added.

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  • A&O Shearman advises J.F. Lehman & Company in sale of Narda-MITEQ to Amphenol Corporation

    A&O Shearman advises J.F. Lehman & Company in sale of Narda-MITEQ to Amphenol Corporation

    A&O Shearman advised J.F. Lehman & Company in its sale of Narda-MITEQ to Amphenol Corp. (NYSE: APH), a supplier of high-technology interconnect, sensor and antenna solutions. The transaction was announced on July 23, 2025 in a press release.

    J.F. Lehman, based in New York and Washington, D.C., is a leading alternative asset manager exclusively focused on the aerospace, defense, maritime, government, environmental and infrastructure sectors. In 2022, A&O Shearman counseled JFL on its purchase of Narda-MITEQ and its bolt-on acquisition of iRF – Intelligent RF Solutions, LLC.

    “We were very happy to advise on the sale of Narda-MITEQ as the dynamic team at J.F. Lehman & Company continues to execute on successful strategic transactions,” said Alain Dermarkar, Head of Private Equity in the US. “This deal exemplified the many skills and international breadth of A&O Shearman.”

    The A&O Shearman team that advised J.F. Lehman in its sale of Narda -MITEQ was led by M&A and Private Equity partners Alain Dermarkar and Kyle Park, and M&A and Private Equity associate Efren Lemus, with the support of M&A associates Emily Kelly, Samantha Favela and Ian Johnson. 

    The team also included partners Tax partners Dave Lewis and John Hibbard, Antitrust partners Ben Gris and Jonathan Cheng, Compensation, Employment, Pensions and Governance partner Jai Garg, Environmental partner Jason Pratt, IP transactional partner JB Betker, Data Privacy partner Helen Christakos, Environmental & Sanctions partner Udo Herbert Olgemöller, Antitrust partner Emilio De Giorgi, Antitrust counsel Christopher Best, M&A and Private Equity associates Jake Lortz and Benjamin Maciejewski, Antitrust associates Jochem de Kok, Brendan Holman, Arianna Fletcher, Benjamin Stievater, Rebecca McCraw, Harlan Rosenson and Kiko Demetrious, Environmental & Sanctions associate Stephan Bühner, Compensation, Employment, Pensions and Governance associates Janice Perri and Katie Cross, IP transactional associate Zach Frankel (NY-IPT) and Data Privacy associate Sonya Aggarwal.

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  • sNDA Submitted to FDA for Venetoclax Plus Acalabrutinib in Untreated CLL

    sNDA Submitted to FDA for Venetoclax Plus Acalabrutinib in Untreated CLL

    Efficacy findings from the phase 3 trial published in the New England Journal of Medicine revealed that the combination elicited a 36-month PFS rate of 76.5% vs 66.5% with chemoimmunotherapy.

    Developers have submitted a supplemental new drug application for a fixed duration, oral combination of venetoclax (Venclexta) in combination with acalabrutinib (Calquence) in patients with previously untreated chronic lymphocytic leukemia (CLL), according to a news release from AbbVie.1

    Results from the phase 3 AMPLIFY trial (NCT03836261) form the basis of the submission, with the combination showing a progression-free survival (PFS) advantage vs chemoimmunotherapy. Efficacy findings from the phase 3 trial published in the New England Journal of Medicine revealed that the combination elicited a 36-month PFS rate of 76.5% (95% CI, 71.0%-81.1%) vs 66.5% (95% CI, 59.8%-72.3%) with chemoimmunotherapy (HR, 0.65; 95% CI, 0.49-0.87; P = .004).2

    Additional efficacy results found that the estimated 36-month overall survival rates in the venetoclax and chemoimmunotherapy arms, respectively, were 94.1% (95% CI, 90.7%-96.3%) vs 85.9% (95% CI, 81.0%-89.6%), with an HR of 0.33 (95% CI, 0.18-0.56; P < .001). Furthermore, the 36-month event-free survival (EFS) rates were 75.9% vs 64.5%.

    Response rates favored the venetoclax-based regimen, with an overall response rate (ORR) of 92.8% vs 75.2% with chemoimmunotherapy. Additionally, 28.1% of patients in the venetoclax arm had a response to treatment but subsequently experienced disease progression vs 33.9% in the chemoimmunotherapy group.

    “This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of [venetoclax] and acalabrutinib for [patients with] previously untreated chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care,” Svetlana Kobina, MD, vice president of Global Medical Affairs, Oncology at AbbVie, said in the news release.1

    Patients with previously untreated CLL were randomly assigned 1:1:1 to receive venetoclax/acalabrutinib (n = 291), acalabrutinib/venetoclax/obinutuzumab (Gazyva; n = 286), or investigator’s choice of chemoimmunotherapy (n = 290). Crossover was not permitted on trial, and patients were stratified by age, IGHV mutational status, Rai stage, and region.

    Those assigned to venetoclax/acalabrutinib received 100 mg of acalabrutinib twice daily from cycles 1 to 14 and venetoclax once daily from cycles 3 to 14, and a ramp-up dose over 5 weeks from 20 mg to 400 mg. Patients in the chemoimmunotherapy group received intravenous fludarabine/cyclophosphamide/rituximab (Rituxan) or bendamustine (Bendeka)/rituximab for the first 6 cycles according to standard dosing procedures. All treatments were given in 28-day cycles.

    In the acalabrutinib/venetoclax and chemoimmunotherapy arms, the median age was 61 years (range, 31-84) and 61 years (range, 26-86), respectively. Most patients in either arm were male (61.2% vs 63.1%), treated in Europe (63.2% vs 63.1%), had an ECOG performance score of 0 or 1 (90.0% vs 90.3%), and unmutated IGHV (57.4% vs 59.3%). Additionally, 38.8% vs 42.8% of the respective arms had bulky disease greater than 5 cm, 47.1% vs 43.8% had Rai stage III or IV disease, and the median time from initial diagnosis to randomization in either arm was 28.5 months (IQR, 8.0-62.2) vs 29.6 months (IQR, 9.3-53.9).

    The primary end point of the trial was PFS per blinded independent central review. Undetectable minimal residual disease was a key secondary end point. Other secondary end points included EFS, ORR, complete response rate with incomplete marrow recovery, and duration of response, as well as safety.

    In the venetoclax/acalabrutinib and chemoimmunotherapy arms, respectively, 92.8% vs 91.1% of patients experienced any grade adverse effects (AEs). Grade 3 AEs occurred in 53.6% vs 60.6% of the respective arms, and serious AEs occurred in 24.7% vs 27.4%. Serious AEs leading to death occurred in 3.4% vs 3.5% of each arm, 2.7% vs 2.7% of which were related to COVID-19 infection.

    The most frequent AEs of any-grade included neutropenia, hemorrhage, and COVID-19 infection in the acalabrutinib-venetoclax arm, and tumor lysis syndrome was only observed in 0.3% of this arm vs 3.1% of patients who received chemoimmunotherapy. No new safety signals were identified in the trials.

    References

    1. AbbVie submits for U.S. FDA approval of combination treatment of VENCLEXTA® (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukemia (CLL). News release. AbbVie. July 29, 2025. Accessed July 29, 2025.
    2. Brown JR, Seymour JF, Jurczak W, et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia. N Engl J Med. 2025;392(8):748-762. doi:10.1056/NEJMoa2409804

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  • Kirkland Advises Bridgepoint on Acquisition of Majority Stake in HBC | News

    Kirkland & Ellis advises Bridgepoint on the acquisition of a majority stake in Hanseatic Broking Center (“HBC”) from Preservation Capital Partners. Bridgepoint will partner with the HBC management team and founders, who will remain significantly invested in HBC, while Preservation Capital Partners will fully exit its holding in HBC.

    The transaction is subject to customary regulatory approvals.

    Founded in 2022, HBC is an owner-managed, independent platform for insurance brokers headquartered in Hamburg, Germany. HBC manages a premium volume of more than €600 million and serves more than 40,000 broking clients across multiple insurance lines.

    Read the transaction press release

    The Kirkland team includes corporate lawyers Sebastian Pitz, Tobias Larisch, Alexander Herzog, Mattias Prange, Jenia Dimitrova, Melissa Afraz and Fabian Waterhölter; debt finance lawyers Alexander Längsfeld, Vanessa Xu, Alexander Bond, and Emma Shi; and tax lawyer Tim Nobereit. 

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  • IMF upgrades global growth forecast as tariffs ease

    IMF upgrades global growth forecast as tariffs ease

    Tom Espiner

    Business reporter, BBC News

    Getty Images Shipping containers being lifted by a crane at Los Angeles docks onto a tankerGetty Images

    The International Monetary Fund (IMF) has predicted stronger global economic growth than it forecast in April in part due to some US tariffs on goods being softened.

    A surge in US imports as firms tried to beat impending higher import taxes and actions by some governments to boost growth bumped up its latest forecast.

    However, higher tariffs and more uncertainty could lead to weaker growth and slower economic activity, the IMF warned.

    Meanwhile, UK growth is predicted to be 1.2% this year, and 1.4% in 2026, unchanged from revised forecasts set out in May.

    The UK is set to be the third fastest growing economy out the world’s so-called most advanced economies this year and the next, after US and Canada.

    The IMF, which is a group of 190 countries that work together to try to stabilise the global economy, said the upgrade to its global predictions included trade “front-loading” in recent months – referring to the rush of imports into the US.

    It forecast global growth of 3% in 2025 and 3.1% in 2026, up from 2.8% and 3% in its April report.

    However, that is still below the 3.3% rate it had projected for both years in January, prior to US President Donald Trump taking office, and the pre-pandemic historical average of 3.7%.

    American firms rushed products into the country earlier this year to try to get ahead of new taxes on imports pledged by Trump.

    The IMF said this created risks that could add to any future economic shocks, including companies, having too much stock, making future imports less necessary.

    Also, firms may have to pay more to store goods, and there was also a risk of items becoming obsolete, it said.

    Pierre-Olivier Gourinchas, the IMF’s chief economist, said a modest decrease in trade tensions, however fragile, had contributed to the resilience of the global economy.

    However, he added: “The world economy is still hurting, and it’s going to continue hurting with tariffs at that level, even though it’s not as bad as it could have been.”

    He added that the boost from front-loading is going to “fade away” and it risked being a drag on economic activity in the second half of the year and into 2026.

    The IMF said the global pace of price rises was expected to fall to 4.2% in 2025 and 3.6% in 2026.

    But it said inflation would probably remain above target in the US as import taxes were passed through to US consumers in the second half of the year.

    Trump’s trade policies, which he argues will boost US manufacturing and jobs, have upended global trade.

    He brought in a universal tariff of 10% on goods from nearly all countries from April and is threatening higher duties to be imposed from Friday.

    Far higher tariffs that the US and China have imposed on each other have been paused until 12 August, with the parties engaged in talks in Stockholm this week.

    Steeper tariffs that have been announced on products including cars, steel and other metals, pharmaceuticals and computer chips, have not been included in the IMF forecast.

    Trade deals with Japan and the EU have also not been included in the numbers.

    “We’ll have to see whether these deals are sticking, whether they’re unravelled, whether they’re followed by other changes in trade policy,” Mr Gourinchas said.

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