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Samsung has slashed £100 off its latest smartwatch in the Black Friday sale. The Samsung Galaxy Watch Ultra is currently reduced to £499, down from the usual £599. The deal is also available at Amazon , while other Samsung discounts include £50 off the Galaxy Watch7 at £239, down from £289. Shoppers can bag an even bigger discount by trading in their old device, with savings of up to £190 off the already reduced price. The Galaxy Watch Ultra is touted as the ‘toughest Galaxy Watch ever’ and is crafted with Sapphire Crystal glass that’s designed to withstand dust, snow, rain and more. Samsung says the device has been tested to military standards and can resist temperatures between -20C and 55C, withstand altitude between -500m and 9,000m, and features 10ATM pressure-resistance up to 100m in fresh or salt water. READ MORE: 'I'm a shopping writer and these are my top Dunelm Black Friday picks' READ MORE: I tried out Marshall's Major V headphones and they have a massive edge on rivals It has a 47mm face, ‘aerospace-grade’ titanium casing and a rugged rubber strap, as well as a powerful battery that can run for up to 100 hours in Power saving mode and up to 48 hours in Exercise power saving mode. The Galaxy Watch Ultra is ideal for fitness fanatics as it can track a range of exercises and provide records and the number of calories burned at the end of a workout. It can also monitor your heart rate, sleep patterns and help you navigate the world with accurate dual-frequency GPS. There’s also a range of AI-powered functions, including the option to send quick-reply messages in the best tone by analysing previous messages. The Samsung Galaxy Watch Ultra has racked up a 4.6-star rating after 445 reviews, with 89 percent of reviewers leaving a positive score. One happy customer said: “Super smashing great. Absolutely love the watch, upgrading from the Watch4 to the Ultra is a massive upgrade. The screen is unbelievably clear and snappy. The battery life [is] incredible, three days and eight hours I’ve managed. Highly recommend.” Another said: “The Galaxy Watch Ultra is a game-changer in the smartwatch industry. It combines rugged design with top-tier performance, making it an excellent choice for both tech enthusiasts and fitness lovers. Its robust set of features, impressive battery life and stylish design make it worth every penny. If you’re in the market for a high-end smartwatch that excels in both functionality and aesthetics, the Galaxy Watch Ultra should be at the top of your list.” A third glowing review says: “Brilliant smart watch. Really good, smart and the battery life is very good. The display is vibrant and high quality. The health metrics are good [but] haven’t tried out the swimming or multisport tracking at the moment. The fit of the band is highly adjustable and the connectivity with the S24 Ultra is seamless.” However, despite leaving a four-star review, one shopper noted the Ultra can feel ‘heavy’, writing: “Overall a nice product, clean and neat look, stylish, good battery backup. One disadvantage I felt is it’s a bit heavy.” Elsewhere, Sky Mobile is offering the Samsung Galaxy Watch7 for £9 when spreading the cost. For those who prefer Apple products, Sky also stocks the Apple Watch Series 10 for £13.Châtillon, France, December 11 th , 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025 Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old Company to host investor webcast today at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study. “DBV is pleased to have received, what we believe to be, a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. This comes on the heels of our October 22 nd press release announcing details in support of our separate Viaskin Peanut programs in 4 – 7 year-olds and in 1 – 7 year-olds in Europe,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. “We believe we have decreased the regulatory pathway risk of our programs. DBV can now fully focus on executing the remaining studies that will support two distinct BLAs across age groups and an MAA in Europe. We are grateful to the Agency for its attentive collaboration as we continue to work towards introducing this novel therapy to caregivers and patients as expeditiously as possible.” Accelerated Approval Pathway The FDA recently issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 – 3-years-old. As a reminder, current FDA guidance for Accelerated Approval includes three qualifying criteria: That the product candidate treats a serious condition That the product candidate generally provides a meaningful advantage over available therapies That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit As DBV previously announced , FDA confirmed via written communication that the Viaskin Peanut patch already met criteria one and two. FDA and DBV have been engaged in ongoing dialogue throughout Q4 of this year regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recent written communication, the FDA confirmed the efficacy data from the Company’s Phase 3 EPITOPE study can serve as an intermediate clinical endpoint. The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for Accelerated Approval. In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch used in EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch. No changes, including patch shape or size, were made to the device components that are in contact with the patient’s skin. Further, to increase the volume of patch production for future commercialization, changes needed to be made to the manufacturing process and location. Although the intended commercial Viaskin Peanut patch is currently being used (N=304) in the ongoing 3-year Open Label Extension to EPITOPE, the collective changes to the commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. The Company intends to use the commercial Viaskin Peanut patch in both the COMFORT Toddlers study and the post-marketing confirmatory study. Post-Marketing Confirmatory Study In the recent written communication, FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1 – 3-years-old. DBV and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. To date, the commercial patch has been used in 304 subjects with over 234,695 patient-days of therapy in the placebo crossover and the EPITOPE Open Label Extension, with no clinically relevant differences in efficacy or safety vs. the clinical patch used in the EPITOPE Phase 3 trial. The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study. Adhesion data for the post-marketing confirmatory study will be collected in a similar manner relative to the COMFORT Toddlers study. The Company expects these data will further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling. “When it comes to food allergy management, what works for one family, might not work for another. That is why having varied treatment options available is so incredibly important to our community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education). “I’m pleased to learn that DBV’s constructive dialogue with the FDA has resulted in this Accelerated Approval guidance outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we look forward to the possibility that one day, if approved, caregivers and families will have this exciting new treatment as an option to consider.” COMFORT Toddlers Supplemental Safety Study COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) study designed to generate additional safety (primary endpoint) and adhesion data of the Viaskin Peanut patch in peanut allergic toddlers 1 – 3-years old. DBV is pleased to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn school of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study. “I am thrilled to assume the role of Global Principal Investigator of the COMFORT Toddlers study,” stated Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn school of Medicine at Mount Sinai in New York. “Viaskin Peanut, if approved, would offer a much-needed alternative treatment option for patients and caregivers. I look forward to working with the DBV team to advance this important clinical trial.” The Company anticipates that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 (active: placebo) at approximately 80 – 90 study centers across the U.S., Canada, Australia, and Europe. COMFORT Toddlers will be a six-month study followed by an optional 18-month open-label treatment phase, to provide 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Thus, the COMFORT Toddlers study will increase the total subjects exposed to the Viaskin Peanut patch for at least six-months in a controlled study to 600, as required by FDA. In total, there will be approximately 240 subjects with the clinical patch in EPITOPE and 360 with the commercial patch in COMFORT Toddlers. As previously disclosed , DBV and FDA have aligned on a patch wear time collection methodology, analysis and study objective hierarchy in the COMFORT Toddlers study. The agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators. The methodology is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway (i.e., collecting patch adhesion data with a focus on daily wear time at relevant time points). We believe there are three positive outcomes coming out of the productive discussions with FDA: FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory endpoint. Next, adhesion should be assessed in the overall totality of benefit to risk (i.e., in the context of efficacy and safety). The third success is that we have aligned on what DBV believes is a very feasible approach to collecting adhesion data. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. Biologic License Application Submission in 1 – 3 Year-Olds There will be two Phase 3 studies in 1 – 3-year-olds using the Viaskin Peanut patch. The data generated from the studies will be used to inform a BLA submission: Twelve months of DBPC efficacy and safety data from the previously completed Phase 3 EPITOPE study (published in the New England Journal of Medicine i n May 2023), and 36 months of open-label extension data. Six months of DBPC data generated in COMFORT Toddlers supplemental safety study. DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old under the Accelerated Approval program will be submitted in 2H 2026. Investor Conference Call and Webcast DBV management will host an investor conference call and webcast today, Wednesday, December 11 th , at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call. United States: +1-877-346-6112 International: +1-848-280-6350 A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/ . A replay of the presentation will also be available on DBV’s website after the event. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPITTM), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn . Forward Looking Statements This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin® Peanut patch and EPITTM, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, DBV’s expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies. Investor Contact Katie Matthews DBV Technologies katie.matthews@dbv-technologies.com Media Contact Angela Marcucci DBV Technologies angela.marcucci@dbv-technologies.com Attachment PDF Version
The Saudi bid was the only candidate and was acclaimed by the applause of more than 200 FIFA member federations. They took part remotely in an online meeting hosted in Zurich by the soccer body's president Gianni Infantino. "The vote of the congress is loud and clear," said Infantino, who had asked officials on a bank of screens to clap their hands at head level to show their support. The decision was combined with approving the only candidate to host the 2030 World Cup. Spain, Portugal and Morocco will co-host in a six-nation project, with Argentina, Paraguay and Uruguay each getting one of the 104 games. The South American connection will mark the centenary of Uruguay hosting the first World Cup in 1930. The decisions complete a mostly opaque 15-month bid process which Infantino helped steer toward Saudi Arabia without a rival candidate, without taking questions, and which human rights groups warn will put the lives of migrant workers at risk. "We look forward to hosting an exceptional and unprecedented edition of the FIFA World Cup by harnessing our strengths and capabilities to bring joy to football fans around the world," Prince Mohammed said in a statement. FIFA and Saudi officials have said hosting the 2034 tournament can accelerate change, including more freedoms and rights for women, with Infantino on Wednesday calling the World Cup a "unique catalyst for positive social change and unity." "I fully trust our hosts to address all open points in this process, and deliver a World Cup that meets the world's expectations," the FIFA president said. An international collective of rights groups said FIFA made a "reckless decision" to approve Saudi Arabia without getting public assurances, and the Football Supporters Europe group said it was "the day football truly lost its mind." A fast-track path to victory was cleared last year by FIFA accepting the three-continent hosting plan for the 2030 World Cup. It meant only soccer federations in Asia and Oceania were eligible for the 2034 contest, and FIFA gave countries less than four weeks to declare a bid. Only Saudi Arabia did. The win will kick off a decade of scrutiny on Saudi labor laws and treatment of workers mostly from South Asia needed to help build and upgrade 15 stadiums, plus hotels and transport networks ahead of the 104-game tournament. Amnesty International said awarding the tournament to Saudi Arabia represents "a moment of great danger" for human rights. "FIFA's reckless decision to award the 2034 World Cup to Saudi Arabia without ensuring adequate human rights protections are in place will put many lives at risk," said Steve Cockburn, Amnesty International's Head of Labor Rights and Sport." One of the stadiums is planned to be 350 meters (yards) above the ground in Neom — a futuristic city that does not yet exist — and another named for the crown prince is designed to be atop a 200-meter cliff near Riyadh. During the bid campaign, FIFA has accepted limited scrutiny of Saudi Arabia's human rights record that was widely criticized this year at the United Nations. Saudi and international rights groups and activists warned FIFA it has not learned the lessons of Qatar's much-criticized preparations to host the 2022 World Cup. "At every stage of this bidding process, FIFA has shown its commitment to human rights to be a sham," Cockburn said. The kingdom plans to spend tens of billion of dollars on projects related to the World Cup as part of the crown prince's sweeping Vision 2030 project that aims to modernize Saudi society and economy. At its core is spending on sports by the $900 billion sovereign wealth operation, the Public Investment Fund, which he oversees. "It's amazing. The infrastructure, the stadiums, the conditions for the fans and everything. After what I see, I'm more convinced that 2034 will be the best World Cup ever," Cristiano Ronaldo said in a recorded package posted on X. The five-time Ballon d'Or winner has been part of Saudi Arabia's lavish spending on soccer — stunning the sport when agreeing to sign for Al Nassr in 2022 for a record-breaking salary reportedly worth up to $200 million a year. Critics have accused Saudi Arabia of "sportswashing" the kingdom's reputation. The prince, known as MBS, has built close working ties to Infantino since 2017 — aligning with the organizer of sport's most-watched event rather than directly confronting the established system as it did with the disruptive LIV Golf project. The result for Saudi Arabia and FIFA has been smooth progress toward the win Wednesday with limited pushback from soccer officials, though some from women international players. The steady flow of Saudi cash into international soccer is set to increase. FIFA created a new and higher World Cup sponsor category for state oil firm Aramco, and Saudi funding is set to underwrite the 2025 Club World Cup in the United States that is a pet project for Infantino. North American soccer body CONCACAF signed a multi-year deal with PIF, Saudi stadiums host Super Cup games for Italy and Spain, and nearly 50 FIFA member federations have signed working agreements with Saudi counterparts. Lavish spending by PIF-owned Saudi clubs in the past two years buying and paying players – including Cristiano Ronaldo, Neymar, Karim Benzema and Sadio Mané – put hundreds of millions of dollars into European soccer. That influence could be key in talks to agree which months to play the 2034 World Cup. The November-December slot taken by Qatar in 2022 to avoid extreme midsummer heat is complicated in 2034 by the holy month of Ramadan through mid-December and Riyadh hosting the multi-sport Asian Games. Still, January 2034 could be an option — and likely better for European clubs and leagues —after the International Olympic Committee said it saw few issues in clashing with the Salt Lake Winter Games opening Feb. 10, 2034. The IOC also has a major commercial deal with Saudi Arabia, to host the new Esports Olympics.San Francisco 49ers quarterback Brock Purdy will miss Sunday's game against the Packers with a sore throwing shoulder
In a groundbreaking moment for the NFL, Beyoncé took centre stage at the Christmas Day halftime show during the Ravens vs Texans game, as per PEOPLE. While Thanksgiving has traditionally been the NFL's marquee holiday event with the Super Bowl show, the league's decision to invest heavily in a Christmas Day spectacle proved to be a masterstroke. And with Beyoncé headlining, it's clear no expense was spared. Titled A Cowboy Carter Christmas, the performance marked the first-ever live showcase of songs from her latest album, Cowboy Carter. From the moment the event was announced in November, anticipation among fansand especially the Beyhivereached fever pitch. Beyoncé last graced an NFL stage in 2013 at the Super Bowl, where she delivered an unforgettable show featuring a Destiny's Child reunion. This time, she set an entirely new standard. Opening with 16 Carriages, Beyoncé seamlessly moved through a curated selection of tracks, including Jolene, YA YA, and Levii's Jeans. The halftime show was further elevated by a series of surprise appearances from stars like Post Malone, Shaboozey, and Beyoncé's own daughter, Blue Ivy Carter. As soon as the show concluded, social media erupted with admiration. Celebrities and fans alike flooded platforms with praise. Tennis legend Serena Williams wrote, "Honestly, can't get enough of you," tagging Beyoncé in her post. On X, a fan declared, "Beyoncé makes 95 per cent of the industry look mediocre when it comes to performances and stage presence, this is insane." Singer Renee Rapp joined in, calling Beyoncé, "the world's most beautiful person alive." Meanwhile, Halle Bailey, star of The Little Mermaid, posted, "Oh my goodness Beyoncé," followed by a stream of heart emojis. Another fan on Instagram simply stated, "This is why she's the Number 1 pop star of the century." Netflix has now announced that A Cowboy Carter Christmasnow dubbed the Beyoncé Bowlwill be available to stream later this week as a standalone special. COMMENTS Comments are moderated and generally will be posted if they are on-topic and not abusive. For more information, please see our