Ministers are hiring a new EU negotiator as Sir Keir Starmer seeks to reset Britain’s relationship with Europe. The post, worth at least £150,000 a year and advertised by the Cabinet Office, would act as a “sherpa” for all of the UK’s dealings with the bloc. The role is described as “principal adviser to the Prime Minister and the minister for European Union relations (Nick Thomas-Symonds) on matters relating to relations with the EU and delivering the ‘EU reset’ and on international economic issues”. The applicant would also need to represent the Prime Minister at negotiations. The Trade and Co-operation Agreement, the basis for the UK-EU relationship after Brexit, will be subject to renewal talks in 2025. The sherpa, ultimately appointed by the Prime Minister, would likely be responsible for overseeing these talks. The civil service position is being filled through an open and competitive process and will receive a salary between £153,000 and £200,000. Sir Keir has stressed the importance of resetting ties with Europe, and in his first months as Prime Minister has visited capitals across the continent to meet national leaders. However, the Tories sought to suggest hiring a new EU negotiator showed the Prime Minister was attempting to “undermine Brexit and our status as a sovereign nation with his plan to take the country back into the EU”. Shadow foreign secretary Dame Priti Patel added: “The Conservative Party will not stand by and allow the will of the British people be reversed while Labour arrogantly capitulates to the EU.” But a Labour source said: “This is truly desperate stuff from the Conservatives. There will be no return to the EU, customs union, single market or freedom of movement. “We are focused on acting in the national interest – tackling barriers to trade, improving co-operation on smashing the criminal people-smuggling gangs and working closely with our allies to stand up to Putin’s aggression. “We won’t take Britain back to the Tory days of chaos and division.” A Cabinet Office spokesperson said: “As we reset our relationship with the EU, building closer trade and security links and encouraging more investment from around the world, this new role will oversee that work. “Reporting to the Minister for European Union Relations, they will lead official-level discussions with the EU as we drive economic growth.”UCLA women’s basketball earns first-ever No. 1 ranking in weekly AP pollTitle: "Black Myth: Wukong" Updates with 6.09GB Size! First to Land on Epic Platform
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4. Neglect of Employee Concerns: Lelarcho disregarded the concerns raised by employees regarding Tenghag, further exacerbating the tension within the postal service.By TRÂN NGUYỄN SACRAMENTO, Calif. (AP) — California, home to some of the largest technology companies in the world, would be the first U.S. state to require mental health warning labels on social media sites if lawmakers pass a bill introduced Monday. The legislation sponsored by state Attorney General Rob Bonta is necessary to bolster safety for children online, supporters say, but industry officials vow to fight the measure and others like it under the First Amendment. Warning labels for social media gained swift bipartisan support from dozens of attorneys general, including Bonta, after U.S. Surgeon General Vivek Murthy called on Congress to establish the requirements earlier this year, saying social media is a contributing factor in the mental health crisis among young people. “These companies know the harmful impact their products can have on our children, and they refuse to take meaningful steps to make them safer,” Bonta said at a news conference Monday. “Time is up. It’s time we stepped in and demanded change.” State officials haven’t provided details on the bill, but Bonta said the warning labels could pop up once weekly. Up to 95% of youth ages 13 to 17 say they use a social media platform, and more than a third say that they use social media “almost constantly,” according to 2022 data from the Pew Research Center. Parents’ concerns prompted Australia to pass the world’s first law banning social media for children under 16 in November. “The promise of social media, although real, has turned into a situation where they’re turning our children’s attention into a commodity,” Assemblymember Rebecca Bauer-Kahan, who authored the California bill, said Monday. “The attention economy is using our children and their well-being to make money for these California companies.” Lawmakers instead should focus on online safety education and mental health resources, not warning label bills that are “constitutionally unsound,” said Todd O’Boyle, a vice president of the tech industry policy group Chamber of Progress. “We strongly suspect that the courts will set them aside as compelled speech,” O’Boyle told The Associated Press. Victoria Hinks’ 16-year-old daughter, Alexandra, died by suicide four months ago after being “led down dark rabbit holes” on social media that glamorized eating disorders and self-harm. Hinks said the labels would help protect children from companies that turn a blind eye to the harm caused to children’s mental health when they become addicted to social media platforms. “There’s not a bone in my body that doubts social media played a role in leading her to that final, irreversible decision,” Hinks said. “This could be your story.” Common Sense Media, a sponsor of the bill, said it plans to lobby for similar proposals in other states. California in the past decade has positioned itself as a leader in regulating and fighting the tech industry to bolster online safety for children. The state was the first in 2022 to bar online platforms from using users’ personal information in ways that could harm children. It was one of the states that sued Meta in 2023 and TikTok in October for deliberately designing addictive features that keep kids hooked on their platforms. Gov. Gavin Newsom, a Democrat, also signed several bills in September to help curb the effects of social media on children, including one to prohibit social media platforms from knowingly providing addictive feeds to children without parental consent and one to limit or ban students from using smartphones on school campus. Federal lawmakers have held hearings on child online safety and legislation is in the works to force companies to take reasonable steps to prevent harm. The legislation has the support of X owner Elon Musk and the President-elect’s son, Donald Trump Jr . Still, the last federal law aimed at protecting children online was enacted in 1998, six years before Facebook’s founding.Data from the ongoing Phase 1/2 ATALANTA-1 study in a heavily pretreated R/R NHL patient population demonstrate high antitumor activity and an encouraging safety profile in all NHL subtypes studied. 96% of patients received an infusion of fresh, fit, stem-like, early memory CD19 CAR T-cell therapy with a median vein-to-vein time of seven days, avoiding the need for cryopreservation and bridging therapy. These data reinforce the potential of Galapagos' decentralized cell therapy manufacturing platform to deliver fresh, fit cells, fast, driving positive patient outcomes. Mechelen, Belgium; December 7, 2024, 18:30 CET; Galapagos NV ((Euronext &, NASDAQ: GLPG ) today announced additional data from the ongoing Phase 1/2 ATALANTA-1 study of its CD19 CAR T-cell therapy, GLPG5101. The results, featured in an oral presentation at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition, demonstrate an encouraging efficacy and safety profile in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). Most patients in the study received GLPG5101 as a fresh, fit, stem-like, early memory CD19 CAR T-cell therapy, with a median vein-to-vein time of seven days. "Shorter vein-to-vein time can lead to improved patient outcomes and remains an important unmet need in CAR-T therapy," said Marie José Kersten, MD, ATALANTA-1 Principal Investigator and Professor of Hematology at the Department of Hematology at Amsterdam University Medical Center. "I am impressed by the latest data on GLPG5101, which demonstrate a promising efficacy and safety profile. With a median vein-to-vein time of just seven days, GLPG5101 has the potential to offer speed and scheduling flexibility, comparable to off-the-shelf therapies." "CAR-T therapies are highly personalized treatments that currently undergo a time-intensive manufacturing process taking multiple weeks to months. For many patients with rapidly progressing cancers, every day counts, and treatment delays can be detrimental," said Jeevan Shetty, MD, Head of Clinical Development Oncology at Galapagos. "We are steadfast in our commitment to bring innovation to cell therapies to address the most significant medical challenges. Our latest data at ASH strongly support the feasibility of our innovative decentralized cell therapy manufacturing platform in delivering fresh, fit cells with a median vein-to-vein time of just seven days, driving positive patient outcomes." The new ATALANTA-1 data are summarized below: The ongoing ATALANTA-1 study included updated data on patients with mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL). As of the April 25, 2024, data cut-off, 49 patients received CD19 CAR T-cell therapy infusion, and safety and efficacy results were available for 45 patients and 42 patients, respectively. High objective response rates (ORR) and complete response rates (CRR) were observed in the pooled Phase 1 and Phase 2 efficacy analysis set, split by indication: In patients with MCL, all 8 of 8 efficacy-evaluable patients responded to treatment (ORR and CRR 100%). In patients with MZL, FL, objective and complete responses were observed in 20 of 21 efficacy-evaluable patients (ORR and CRR 95%). In patients with DLBCL, 9 of 13 efficacy-evaluable patients responded to treatment (ORR 69%), with 7 patients achieving a complete response (CRR 54%). Of the 7 patients with DLBCL who received the higher dose, 6 responded to treatment (ORR 86%) with 5 achieving a complete response (CRR 71%). Of the 15 minimal residual disease (MRD)-evaluable patients with a complete response, 12 patients (80%) achieved MRD negativity and remained in complete response at data cut-off. The median study follow-up was 3.3 months for FL and DLBCL with a range of 0.9-21.2 months, and 4.4 months for MCL with a range of 1-24.4 months. GLPG5101 showed an encouraging safety profile, with the majority of Grade ≥ 3 treatment emergent adverse events being hematological. One case of CRS Grade 3 was observed in Phase 1 and one case of ICANS Grade 3 was observed in Phase 2. 96% of patients (47 of 49) received an infusion with fresh, fit, stem-like early memory CD19 CAR T-cell therapy, with 91.5% (43 of 47) achieving a vein-to-vein time of seven days, thereby avoiding cryopreservation, and eliminating the need for bridging therapy. Strong and consistent in vivo CAR-T expansion levels and products consisting of stem-like, early memory phenotype T cells were observed in all doses tested. About the ATALANTA-1 study (EudraCT 2021-003272-13) ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of decentralized manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The primary objective of the Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×10 6 (DL1), 110×10 6 (DL2) and 250×10 6 (DL3) CAR+ viable T cells. The primary objective of the Phase 2 part of the study is to evaluate the objective response rate (ORR), while the secondary objectives include complete response rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. About Galapagos' cell therapy manufacturing platform Galapagos' innovative decentralized cell therapy manufacturing platform has the potential for the administration of fresh, fit, stem-like, early memory T-cells within a median vein-to-vein time of seven days, greater physician visibility, and improved patient experience. The platform consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza's Cocoon®) and a proprietary quality control testing and release strategy. About Galapagos We are a biotechnology company with operations in Europe and the U.S. dedicated to transforming patient outcomes through life-changing science and innovation for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules and cell therapies in oncology and immunology. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, and the financial strength to invest strategically for the near- and long-term, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most. For additional information, please visit www.glpg.com or follow us on LinkedIn or X . For further information, please contact: Media inquiries: Marieke Vermeersch +32 479 490 603 Jennifer Wilson + 44 7539 359 676 media@glpg.com Investor inquiries: Srikant Ramaswami +1 412 699 0359 Sandra Cauwenberghs +32 495 58 46 63 ir@glpg.com Forward-looking statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made through the use of words or phrases such as "anticipate," "expect," "plan," "estimate," "will," "continue," "aim," "intend," "future," "potential," "could," "indicate," "forward," "may," as well as similar expressions. Forward-looking statements contained in this press release include, but are not limited to, statements regarding preliminary, interim and topline data from the ATALANTA-1 study and other analyses related to Galapagos' CD19 CAR-T programs, statements related to Galapagos' plans, expectations and strategy with respect to the ATALANTA-1 study, and statements regarding the expected timing, design and readouts of the ATALANTA-1 study, including the expected recruitment for such studies, and the potential benefits of Galapagos' product candidates, including GLPG5101, and partnered programs, including uza-cel. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause Galapagos' actual results to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical studies, the risk that ongoing and future clinical studies with Galapagos' product candidates, including GLPG5101, may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical study and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG5101 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partners Lonza and Adaptimmune), and that Galapagos' estimations regarding its GLPG5101 development programs and regarding the commercial potential of GLPG5101 may be incorrect, as well as those risks and uncertainties identified in Galapagos' Annual Report on Form 20-F for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management's current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. Attachment Galapagos Press Release_ASH ATALANTA-1_ENG_Final © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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TEHRAN – Iran's Deputy Foreign Minister for Political Affairs Majid Takht Ravanchi reaffirmed Iran's commitment to tackling regional and global issues through cooperation during talks with Russian Deputy Foreign Ministers Andrey Rudenko and Sergei Ryabkov in Moscow. During these discussions, emphasis was placed on the significance of ongoing international consultations and the advancement of multilateralism. The conversations spanned various subjects, such as bilateral relations, regional and global developments, and collaboration within the BRICS framework. Takht-Ravanchi took to X on Friday to describe the discussions as "constructive and fruitful," emphasizing potential negotiations on nuclear issues and sanctions termination. He expressed Iran's determination to continue consultations with its partners to address regional and global challenges. The two sides emphasized the need for continued dialogue on legal and customs incentives to facilitate trade, strengthen economic ties, and advance a comprehensive cooperation agreement. Initiatives like the North-South Corridor and the 3+3 consultative mechanism for the Caucasus region were highlighted as key areas of focus. Another part of the discussions involved exchanging views on enhancing international peace and security, especially in the face of pressures from states engaging in unilateral actions that violate international law, human rights, and humanitarian principles. Additionally, the senior Iranian diplomat discussed the country's relations with North and South American countries, cooperation with BRICS nations, and broader international security matters. Reaffirming Iran’s commitment to transparency in its nuclear activities, Takht-Ravanchi reiterated Iran's dedication to its international obligations and its support for a constructive approach to global affairs.Britain's finance ministry has announced plans to clamp down on wasteful expenditures, urging government departments to align their spending with policy priorities. In a bid to overhaul the public sector, Prime Minister Keir Starmer is implementing strategies to ensure each pound is spent efficiently and effectively. The move includes resurrecting the 'zero-based review' of public spending, last undertaken 17 years ago, to bring transparency and accountability to government expenses. Finance minister Rachel Reeves emphasized the importance of reforming public services to meet modern demands, ultimately saving money while improving service delivery. Letters have been dispatched to each department, advising that 'difficult' decisions may be needed to halt spending not aligned with government priorities. The finance ministry's comprehensive review, set for next year, will form part of their strategy to balance day-to-day spending with tax revenues, setting strict budget limits for public services. (With inputs from agencies.)