Dreams on a Pillow is a video game experience about the 1948 Nakba, an event where roughly 700,000 people were displaced from their land and homes due to Zionist occupation. The game, described as “a pseudo-3D stealth adventure game about a land full of people being made into a people without land,” is from Palestinian developer Rasheed Abu-Eideh. But before I tell you more about that, let me tell you about his previous game. In 2016, Abu-Eideh released Liyla and the Shadows of War , a game about a 2014 assault on Gaza by Israel, known as Operation Protective Edge. Liyla follows a Palestinian girl and her family as they navigate attacks in their neighborhood. It’s short but emotional, and it blends elements of platformers and choose-your-own-adventure storytelling. In 2021, the game was a part of an Indie Bundle Pack that raised nearly $900,000 for Palestinian aid through UNRWA USA. Currently, Liyla and the Shadows of War is free on mobile and Windows. But back in 2016, it was initially rejected as a game in the Apple App Store. Abu-Eideh was told to remove all description of it as a “Game” and re-categorize it as “News” or “Reference” due to its political nature. The hypocrisy of the decision was noted by many at the time: As reported by Eurogamer , Apple denied Liyla as a game, but allowed a game called Israeli Heroes in the game section. After Abu-Eideh spoke about Apple’s decision on social media, Apple finally allowed Liyla to be categorized as a game. Dreams on a Pillow is currently being crowdfunded by Abu-Eideh on LaunchGood till Jan. 13, and funds raised from the LaunchGood campaign will go towards asset creation, outsourcing, and salaries for the current team of 9 individuals. The game is aiming to launch in Q4 2026. Gaming News Video
AdTech Market Expected to Expand to USD 2854.3 Billion by 2031 at 14.7% CAGR | AMRMillions of homes to get grants and cheap loans for solar panelsSEATTLE--(BUSINESS WIRE)--Dec 11, 2024-- Starbucks Corporation (NASDAQ: SBUX) today announced that its Board of Directors has approved a quarterly cash dividend of $0.61 per share of outstanding Common Stock. The dividend will be payable in cash on February 28, 2025, to shareholders of record on February 14, 2025. About Starbucks Since 1971, Starbucks Coffee Company has been committed to ethically sourcing and roasting high-quality arabica coffee. Today, with more than 40,000 stores worldwide, the company is the premier roaster and retailer of specialty coffee in the world. Through our unwavering commitment to excellence and our guiding principles, we bring the unique Starbucks Experience to life for every customer through every cup. To share in the experience, please visit us in our stores or online at about.starbucks.com or www.starbucks.com . Forward-Looking Statements Certain statements contained herein are “forward-looking” statements within the meaning of applicable securities laws and regulations. Generally, these statements can be identified by the use of words such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “feel,” “forecast,” “intend,” “may,” “outlook,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. By their nature, forward-looking statements involve risks, uncertainties, and other factors (many beyond our control) that could cause our actual results to differ materially from our historical experience or from our current expectations or projections. Our forward-looking statements, and the risks and uncertainties related thereto, include, but are not limited to, those described under the “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” sections of the company’s most recently filed periodic reports on Form 10-K and Form 10-Q and in other filings with the SEC, as well as, among others: In addition, many of the foregoing risks and uncertainties are, or could be, exacerbated by any worsening of the global business and economic environment. A forward-looking statement is neither a prediction nor a guarantee of future events or circumstances, and those future events or circumstances may not occur. You should not place undue reliance on the forward-looking statements, which speak only as of the date of this report. We are under no obligation to update or alter any forward-looking statements, whether as a result of new information, future events, or otherwise. View source version on businesswire.com : https://www.businesswire.com/news/home/20241211777419/en/ CONTACT: Starbucks Contact, Investor Relations: Tiffany Willis investorrelations@starbucks.comStarbucks Contact, Media: Emily Albright press@starbucks.com KEYWORD: WASHINGTON UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: RETAIL RESTAURANT/BAR FOOD/BEVERAGE SOURCE: Starbucks Corporation Copyright Business Wire 2024. PUB: 12/11/2024 04:05 PM/DISC: 12/11/2024 04:05 PM http://www.businesswire.com/news/home/20241211777419/en
Labor has gained Senate approval for laws to ease student loans for three million Australians by scaling back the indexation of their debts. The government has also passed laws to back a for public schools and a in the latest stage of a fraught negotiation in the upper house. Education Minister Jason Clare joined Nine’s to discuss the passage of the bills, defending the expense as necessary to tackle the “unfair” indexation of HECS debt. “We got a body of experts together to look at [HECS indexation] and tell us what to do, and they recommended that we set the indexation for HECS every year at either inflation or wages, whatever’s the lowest. And that’s what we’ve done,” Clare said. “But we’ve done more than that. We’ve backdated it to June last year. So that wipes out what happened last year and makes sure that it never happens again.” Young Australians will have to wait, however, for and raise the income threshold that triggers HECS-HELP repayments because Labor says the bigger reform will take place only if it wins the election. The Coalition is opposed to the 20 per cent discount Labor is offering. The grieving families of two backpackers who died after a suspected mass methanol poisoning have returned to Australia, as Foreign Minister Penny Wong pushes for a “thorough and transparent” investigation into the tragedy. The families of Bianca Jones and Holly Bowles travelled from Bangkok to Melbourne on Tuesday night, bringing home the bodies of the two 19-year-old girls. “We miss our daughters desperately,” Bianca’s father Mark Jones said. “We cannot have our girls passing and this continue to happen.” Overnight, Wong confirmed she had spoken to her Laos counterpart, Thongsavanh Phomvihane. Wong said the pair agreed that the investigation into the methanol poisoning tragedy “must be thorough and transparent”. “I appreciate our continuing cooperation,” Wong wrote. Eight people linked to the hostel were on Tuesday, local media reported. Most Australians feel they are poorer now than they were three years ago, as a new poll reveals widespread dissatisfaction with the Albanese government’s priorities. A new Redbridge poll found 52 per cent of those surveyed either disagreed or strongly disagreed with the proposition that the government has the right focus. 40 per cent of voters said Peter Dutton is ready for office, slightly more than the 39 per cent who said he was not. Asked on Seven’s if the polling meant Australia was “in the mood for change”, Social Services Minister Amanda Rishworth said the government was focused on the cost of living, while the Coalition was blocking bills. Directing her comments to Liberal senator Jane Hume, Rishworth said: “You’ve voted against our housing bills. Blocked our cost of living measures. Fought against our energy price measures. Everything we’ve done, the Liberal Party have fought against it...” Hume repeatedly interjected Rishworth’s response, asking “Where have you been for 2 and a half years?” “You spent a year concentrating on the Voice referendum,” Hume quipped. Meanwhile, on Nine’s , Nationals senator Matt Canavan also responded to the poll, saying Australians were poorer because “we’ve adopted a lot of stupid policies that deny Australians the use of their own energy resources that load our country with way too much red tape”. Last month, the found Australians hold Labor accountable for the financial pain of rising prices and the cost of housing. 36 per cent believe the federal government is responsible for their rising living costs – far greater than the 13 per cent who blame global factors outside Australia’s control. Figures to be released to federal parliament show Australia is almost on track to meet its legislated 2030 target for reducing greenhouse gas emissions. The nation’s emissions are projected to be down 42.6 per cent by 2030 under existing government policies, which is a smidgen shy of the legislated target of 43 per cent but better than the 37 per cent projected a year ago. Also signalling an improving trajectory on harmful pollution, total net emissions are projected to be three per cent below the nation’s 10-year carbon budget, according to the annual climate change statement due out on Wednesday. Climate Change and Energy Minister Chris Bowen will tell parliament the nation is on track to beat its legislated emissions budget by 152 million tonnes over the 10 years to 2030, which is equivalent to Australia’s entire electricity sector emissions in 2024. Australia’s latest figures include the impact of a new vehicle efficiency standard for cheaper-to-run cars, progress towards the 82 per cent renewable energy target, and a revamped safeguard mechanism to control industrial emissions. “We know action on climate change is not only a moral imperative but critical for Australian industries to remain competitive, create jobs in the regions and export clean energy to the world,” Bowen said. The 2024 projections provide the latest estimates of future emissions, calculated using the Paris Agreement’s agreed rules on climate accounting. Bowen insisted that Australia’s 43 per cent target was “ambitious but achievable” but the coalition has slammed the 2030 target and plans to dump it if elected in 2025. Opposition Leader Peter Dutton has flagged more gas generation and extensions for coal-fired power plants to keep the lights on, as well as longer-term plans to add nuclear power to the energy mix for a lower carbon electricity grid. Israeli Prime Minister Benjamin Netanyahu has announced he will recommend a proposal for a ceasefire with Hezbollah to his cabinet for approval, setting the stage for an end to nearly 14 months of fighting. In a television address, Netanyahu said he would put the ceasefire accord to his full cabinet later in the evening. Israeli TV reported that the more restricted security cabinet had earlier approved the deal. “We will enforce the agreement and respond forcefully to any violation. Together, we will continue until victory,” he said. “In full co-ordination with the United States, we retain complete military freedom of action. Should Hezbollah violate the agreement or attempt to rearm, we will strike decisively.” Meanwhile, Israel is carrying out its most intense wave of strikes on Lebanon’s capital Beirut and its southern suburbs since the start of the war with Hezbollah, apparently signalling it aims to pummel the country in the hours before any ceasefire takes hold. Good morning and welcome to the national news blog. My name is Josefine Ganko, and I’ll be leading our live coverage until the early afternoon. It’s Wednesday, November 27. Here’s what’s making news this morning.Trump transition says Cabinet picks, appointees were targeted by bomb threats, swatting attacksTech review: Gift options for the cord cutter
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Question: I’m interviewing soon for a dream job. What do I need to know to get hired in this competitive era? What are hiring managers looking for? We asked Jodi Kovitz, CEO of the HRPA (Human Resources Professionals Association), to tackle this one. The HRPA 2024 Summit happens Nov. 28. Ms. Kovitz identified three crucial ways job-seekers can stand out: The future of work requires a new set of skills, specifically around artificial intelligence. That doesn’t mean every individual needs to know how to work with machine learning or build a model. But there are some basic skills you need around how to leverage AI to be more creative and more productive. If you don’t know how to use AI, go figure it out. It’s not as hard as you think. There are awesome classes that are quite accessible. MasterClass has a cool one on how to use ChatGPT and other tools effectively. Google AI Essentials also has a great course. Taking some time to educate yourself and develop some proficiency is going to be critical to getting jobs because that is where the world is going. Another in-demand skill I’m seeing with our membership of 24,000 members is resiliency – being adaptable and able to upskill. As technology evolves, folks will need to adapt, wear many hats and roll with the punches. Employers want to know: Are you resilient? Have you failed? Have you demonstrated an ability to pivot? A willingness to port transferable skills, do different jobs and try different things is what folks are looking for. Also, we’re seeing many organizations shift to AI-based applicant tracking systems, so as you prepare your resume, be thoughtful around identifying the skills you have and the courses you’ve taken, and tailor your resumé to this skills-based approach. It’s critical to even get through the screening process. In an interview, be very clear with the hiring manager that you are excited about this specific opportunity. Why you? Why now? I often talk about this concept of mission meets moment. What is it about this opportunity, this role and this company that aligns with your values? Take the time to prepare very, very well for interviews. The more time you invest in preparing, the crisper and more focused you can be in the interview. If you’re doing 50 interviews at 50 companies and you don’t spend the time up front to figure out who you are, your value and why you want to join the company, you certainly will not stand out. Over the weekend I reread a book that one of my mentors suggested to me years ago. It’s The Confidence Code by Katty Kay and Claire Shipman, and it talks about the need to show up with confidence. People want to believe in you, and for them to do that, you have to first demonstrate that you believe in yourself. Project more confidence than humility. A job interview is the time for you to shine and be proud and bring data and results into the conversation. As one of my mentors said to me last week, ‘What are your numbers on the dashboard?’ Each time you try something new, you develop a new tool in your tool kit. But it’s up to you to make the connection for the people interviewing you so that they can understand how your past experiences are relevant to the opportunity at hand. Newcomer talent is widely underused in Canada, but employers who tap into it see clear benefits to their business, a new report finds. The paper by The Institute for Canadian Citizenship (ICC) and Deloitte outlines how companies working with newcomers can draw on the diverse experiences of those workers to improve performance while helping to close the immigrant unemployment gap. “The data shows that if you can bring people from around the world to play on your team, you’re going to have an edge over other teams where people have the same experiences and are more likely to see things the same way.” In high school, the Scarborough native and hockey star was named – all four years – “most likely to become a professional athlete.” Two Olympic golds, one silver and multiple world championships later, the 34-year-old forward with the Toronto Sceptres, part of the six-team Professional Women’s Hockey League, has already achieved legend status. One of her mottos is “get uncomfortable.” In 2019, Spooner traded in her hockey skates for toe picks to compete on Battle of the Blades, which paired hockey players with top figure skaters. Spooner was terrified – grace isn’t a critical hockey skill – but she was determined to be a positive role model. “If girls see someone like me who’s five-foot-10 and 180 pounds figure skating, there’s hope for anyone,” she said. Bees collaborate. They send scouts out to find the best spot for a new hive, and then work together to make honey. Rather than sitting around waiting for a queen bee to tell them what to do, they step into the individual and collective leadership roles, working in harmony, to ensure hive success. If danger approaches, an individual bee will release an alarm pheromone that signals to the rest of the colony members to come and defend their mate. It’s a model of group dynamics and collective intelligence. And therefore, a model for modern change efforts, says Siobhán McHale, an Australian consultant. Aska Aly knows exactly what kind of employer she wants. A recent graduate from Algonquin College, Ms. Aly, 24, is a marketing manager and graphic designer based in Ottawa. At the top of her employer wish list? Management that is interactive and involved. She notes that in roles like marketing, where one person can end up wearing many different hats from event planning to administration, “people think that you’ll figure it out [without guidance]. But it’s wonderful to have regular check-ins, to make sure there is alignment on goals.”
Messi's son debuts at Argentina youth tournament as grandparents watch
Messi's son debuts at Argentina youth tournament as grandparents watchNoneR ugby union still produces some fascinating individuals and John Dobson, the head honcho at the DHL Stormers, is very much one of them. To say “Dobbo” is not your average coach is self-evident from his CV. In addition to degrees in law and business administration from the University of Cape Town there is surely no other top-level director of rugby with a creative writing degree. As he wryly puts it: “I was the only person on the course who didn’t wear a tweed skirt.” As a player he was also, for two seasons, the only white guy in an otherwise exclusively black working-class club side. “What did I learn? How privileged us white people were.” He was conscripted into the South African army during the apartheid era, has had two novels published and is the son of a noted South African rugby writer, referee and historian. He describes himself as “an accidental coach” having started out as coach of his local university fourth XV, but has subsequently guided the Stormers, then in administration, to the inaugural 2022 URC title, the franchise’s first piece of silverware. Stitch together all these disparate strands – he also loves The Cure and the poetry of Dylan Thomas – and you have someone well worth consulting on subjects such as the soul of rugby and the sport’s current health. And once he has retrieved Norman the family dog from the garden – “He’s a lazy, obese beagle” – some nagging concerns are soon evident on the eve of the Stormers’ Champions Cup tie against Harlequins at the Stoop on Saturday. For starters the Stormers are set to field a weakened team, partly because of injuries and logistics but also because of upcoming games against their local rivals the Lions and the Sharks either side of Christmas. While Dobson’s side will be competitive – “We’ll put up a fight in Harlequins , we’re not coming to get our tummies tickled” – he would love, one day, to send up his first-choice XV. “I think we’ve got to sort out the Champions Cup. Maybe because of our presence it’s a bit unwieldy at the moment. People are a bit confused by it and it’s certainly not what it was – to my mind as an outsider – a couple of years ago. That’s what I worry about: if it becomes really vanilla with teams just going through the motions.” He cites last weekend’s pool game against Toulon in Gqeberha (formerly Port Elizabeth) as a cautionary case study. “We played a Champions Cup game in a beautiful city and I didn’t speak to one Frenchman. Dan Biggar came to our changing room afterwards but we didn’t do anything for them. How is it possible that guys can come from another continent and we don’t even say hello to them? It’s really odd but it’s across the board now. “It feels to me like we’re in a curious space with some of rugby’s values. I’m sounding very old fashioned now but lying down [feigning injury] to try and get the TMO involved? Not speaking to the opposition? I think we’ve all, South Africa included, trampled over rugby’s values a little bit over the last little while. It just feels like [the sport] is a little bit lost.” It is clearly a subject close to the thoughtful Dobson’s heart. “I’m old school. I like that side of the game. When I started with the Stormers some guys weren’t showering after matches. They were just getting into their tracksuits and going home. I said: ‘Jeepers, if we don’t like people here enough to have a cold drink with them afterwards we’re in trouble’. A lot of those old values ... I reckon that’s where the future of rugby could be.” In the meantime he wants his players to appreciate what they have, rather than grumbling about commuting north to play in the freezing British gloom. “I remember last year we were playing London Irish at Brentford and we were training at the Lensbury Club. The guys were complaining having just come down on a long bus ride from Glasgow. I said: ‘Listen, you fuckers. If I’d said a year ago that you could play Champions Cup rugby in London you’d have canoed up the west coast of Africa. Don’t take all this for granted.’” A return to more parochial fixtures, he warns, would be ruinous. “Are we going to go back to playing against the Griquas and Free State like in the 1980s? We’d better behave ourselves; it would be absolutely insane. We’re playing in competitions that are absolutely suited to our DNA. Every breakdown and scrum is a contest, every lineout maul is a fight. That’s actually what winning Test rugby and World Cups are all about.” Once upon a time Dobson played hooker for Western Province and has lived through all kinds of social upheaval in his homeland. Winning World Cups cannot solve every political problem – “The country isn’t united like that for the other three years and 10 months” – but he believes rugby has helped to ease some divisions. “Remember when we had the quota system with a certain number of black players in the team? Now rugby in South Africa has realised how much the so-called disadvantaged communities of the country could bring. Sign up to The Breakdown The latest rugby union news and analysis, plus all the week's action reviewed after newsletter promotion “Players are there on merit and that is where the real transformation is coming. Before there was this stigma surrounding the quota and some of the guys weren’t good enough. I’m not sure about a unified country but in rugby it’s really bedding in deep. And that does help the country, of course it does.” It is another reason why Dobson has chosen the mission statement “Make Cape Town Smile” as his team’s mantra. “What we’ve got in Cape Town is an amazing project. Rugby is so big among all races in the Western Cape so we’ve got this connection with the city. It’s almost a day-by-day version of the Springbok project. “One or two people overseas have approached me to go and coach them, especially after we won the URC. But when the Stormers fire me I’m done in coaching. Panasonic v Mitsubishi would mean nothing to me. If the Stormers win the police say that gender-based violence drops in our poorer suburbs. That makes it a bit more than a game. South African teams always draw on a little extra edge compared to some countries because you’re playing for so much. “Our players get that. If you look at our crowd these people are making amazing sacrifices. It’s not like rugby in the 1980s here when it was all smart people of my background. This team went into administration and was bankrupt. To reconnect it and give it back to the people of Cape Town is my project.” More power to Dobbo and the cause he holds so dear.
The arrest warrant for Israeli Prime Minister Benjamin Netanyahu issued by the International Criminal Court is an embarrassment to our government, as well as to his. The United States is the overly indulgent ally that ought to have stayed his heavy hand in Gaza. For the moment, that’s all there will be to this. Netanyahu isn’t going to jail in The Hague, or anywhere else. Israel and the U.S. are two of the most prominent nations that refuse to join the ICC, which issued the arrest warrants last week, charging him and his former defense minister, Yoav Gallant, with war crimes and crimes against humanity. The other outlier nations include Russia, China and India. Such company we keep. The U.S. and Russia were two of the four victorious powers that tried Nazi henchmen at Nuremberg, convicted 19 and hanged 12 of them. The creation of the ICC was the world’s collective voice saying, “Never again.” But no legalism is any better than the will to enforce it. There are 124 member nations in the ICC, including the United Kingdom, Germany, France, Canada and 13 of our other NATO allies. All are bound by the rules to arrest anyone sought by the ICC who comes their way. Not all have always honored that obligation. Nonetheless, the warrant effectively limits Netanyahu’s travel to nations like the U.S. and others that signify they won’t honor the warrant. Netanyahu is welcome in Hungary, an ICC member ruled by the autocrat Victor Orban, who called the ICC’s decision “shameful.” Germany has implied strongly that it wouldn’t honor the warrant, either. The political fallout may be the most consequential effect. The warrants that accuse Netanyahu and Gallant of war crimes and crimes against humanity in Gaza will strengthen the voices of Israel’s critics abroad. Next time, there may be more than 19 votes when Sen. Bernie Sanders of Vermont tries to cut off supplies of particular weapons to Israel. The warrants will also have the perverse, if predictable, effect of strengthening Netanyahu’s position at home. He most likely would have lost an election had one been held already because he has refused to take responsibility or hold an accounting for the Oct. 7, 2023 Hamas terror attack that started the war. Many Israelis are irate that he has put finishing it on his terms ahead of bringing home however many hostages still remain alive. He expects more Israelis to rally behind him because of the new pressure from the ICC. It’s likely more than coincidence that the Knesset, with his support, has chosen this moment to take another step toward dictatorship by banning all government communications with the widely respected newspaper Haaretz, and blacklisting it from any government advertising. Israel and its U.S. supporters have objected, reasonably, that world reaction to the Hamas terror assault and the ensuing war has been heavily biased against Israel. The 1,200 people whom Hamas slaughtered, including children and the elderly, had not even been buried when American campuses saw pro-Hamas rallies and heard chants of “Palestine will be free from the river to the sea.” Much of it, to tell the truth, reflected open antisemitism — but not all. It is not antisemitic to expect Israel, a nation founded in the aftermath of the Holocaust, to respect human life more than Hamas ever will. It is not antisemitic to believe that Israel should have retaliated with fewer if any of the U.S.-made 2,000-pound bombs that have reduced much of Gaza to a wasteland. It is not antisemitic to say that Israel’s goal of pursuing the war to Hamas’ entire destruction is unattainable. It is not antisemitic to criticize Israel for impeding deliveries of essential food and medical supplies to the 2.3 million civilians in Gaza, who are just as much the hostages of Hamas as the Israeli captives are. Palestinian officials put the current death toll at more than 44,000. They do not distinguish between Hamas guerillas and innocent men, women and children. Two days after the Hamas atrocity, Defense Minister Gallant — whom Netanyahu recently fired — announced a “complete siege on the Gaza Strip.” “There will be no electricity, no food, no fuel, everything is closed. We are fighting human animals and acting accordingly,” Gallant said. Gallant virtually guaranteed his indictment with that statement. The specific charges against him and Netanyahu include “the war crime of starvation as a method of warfare.” The ICC also issued a warrant for Hamas’ military leader, Muhammed Deif, whom the Israelis claimed to have killed. Without proof of his death, the warrant is necessary. It also counters Netanyahu’s claim that his own warrant is antisemitic. Netanyahu’s statement was especially gross because he called it a “modern Dreyfus trial,” comparing himself to the French Army Captain Alfred Dreyfus, who was framed for treason and sent to Devil’s Island in French Guiana in1894. The Dreyfus Affair, as it was known, brought out so much flagrant antisemitism that it inspired Theordore Herzl , a journalist who covered the trial, to found the Zionist movement that led to the establishment of the state of Israel. Dreyfus was eventually exonerated because he was innocent. Netanyahu is not. The Sun Sentinel Editorial Board consists of Opinion Editor Steve Bousquet, Deputy Opinion Editor Dan Sweeney, editorial writers Pat Beall and Martin Dyckman, and Editor-in-Chief Julie Anderson. To contact us, email at letters@sun-sentinel.com .n-Butanol Market Size Estimation, Future Scope, Revenue Opportunities and Forecast by 2029Cord cutting used to refer to abandoning pay TV and putting up an antenna to watch free over-the-air TV.
The long sports-filled Thanksgiving weekend is a time when many Americans enjoy gathering with friends and family for good food, good company and hopefully not too much political conversation. Also on the menu — all the NFL and college sports you can handle. Here’s a roadmap to one of the biggest sports weekends of the year, with a look at marquee games over the holiday and how to watch. All times are in EST. All odds are by BetMGM Sportsbook. What to watch Thursday — NFL: There is a triple-header lined up for pro football fans. Chicago at Detroit, 12:30 p.m., CBS: Rookie quarterback Caleb Williams and the Bears go against the Lions, who are one of the favorites to reach the Super Bowl in February. Lions favored by 10. New York at Dallas, 4:30 p.m., Fox: The Giants and Cowboys are both suffering through miserable seasons and are now using backup quarterbacks for different reasons. But if Dallas can figure out a way to win, it will still be on the fringe of the playoff race. Cowboys favored by 3 1/2. Miami at Green Bay, 8:20 p.m., NBC/Peacock: The Packers stumbled slightly out of the gate but have won six of their past seven games. They’ll need a win against Miami to try to keep pace in the NFC North. Packers favored by 3. — College Football: Memphis at No. 18 Tulane, 7:30 p.m., ESPN. If college football is your jam, this is a good warmup for a big weekend. The Tigers try to ruin the Green Wave’s perfect record in the American Athletic Conference. Tulane is favored by 14. What to watch Friday — NFL: A rare showdown features the league-leading Chiefs. Las Vegas at Kansas City, 3 p.m. Prime Video: The Chiefs and quarterback Patrick Mahomes are 12-point favorites over the Raiders. — College Basketball: Some of the top programs meet in holiday tournaments around the country. Battle 4 Atlantis championship, 5:30 p.m., ESPN: One of the premier early season tournaments, the eight-team field includes No. 3 Gonzaga, No. 14 Indiana and No. 24 Arizona. Rady Children’s Invitational, 6 p.m., Fox: It’s the championship game for a four-team field that includes No. 13 Purdue and No. 23 Mississippi. — College Football: There is a full slate of college games to dig into. Oregon State at No. 11 Boise State, noon, Fox: The Broncos try to stay in the College Football Playoff hunt when they host the Beavers. Boise State favored by 19 1/2. Oklahoma State at No. 23 Colorado, noon, ABC: The Buffaloes and Coach Prime are still in the hunt for the Big 12 championship game when they host the Cowboys. Colorado favored by 16 1/2. Georgia Tech at No. 6 Georgia, 7:30 p.m., ABC: The Bulldogs are on pace for a spot in the CFP but host what could be a tricky game against rival Georgia Tech. Georgia favored by 19 1/2. — NBA. After taking Thanksgiving off, pro basketball returns. Oklahoma City at Los Angeles Lakers, 10 p.m., ESPN: The Thunder look like one of the best teams in the NBA’s Western Conference. They’ll host Anthony Davis, LeBron James and the Lakers. What to watch Saturday — College Football. There are more matchups with playoff implications. Michigan at No. 2 Ohio State, noon, Fox: The Wolverines are struggling one season after winning the national title. They could make their fan base a whole lot happier with an upset of the Buckeyes. Ohio State favored by 21. No. 7 Tennessee at Vanderbilt, noon, ABC: The Volunteers are a fairly big favorite and have dominated this series, but the Commodores have been a tough team this season and already have achieved a monumental upset over Alabama. Tennessee favored by 11. No. 16 South Carolina at No. 12 Clemson, noon, ESPN: The Palmetto State rivals are both hanging on the edge of the CFP playoff race. A win — particularly for Clemson — would go a long way toward clinching its spot in the field. Clemson favored by 2 1/2. No. 3 Texas at No. 20 Texas A&M, 7:30 p.m. ABC: The Aggies host their in-state rival for the first time since 2011 after the Longhorns joined the SEC. Texas favored by 5 1/2. Washington at No. 1 Oregon, 7:30 p.m., NBC: The top-ranked Ducks have been one of the nation’s best teams all season. They’ll face the Huskies, who would love a marquee win in coach Jedd Fisch’s first season. Oregon favored by 19 1/2. — NBA: A star-studded clash is part of the league’s lineup. Golden State at Phoenix, 9 p.m., NBA TV: Steph Curry and the Warriors are set to face the Suns’ Big Three of Kevin Durant, Devin Booker and Bradley Beal. What to watch Sunday — NFL: It’s Sunday, that says it all. Pittsburgh at Cincinnati, 1 p.m., CBS: Joe Burrow is having a great season for the Bengals, who are struggling in other areas. They need a win to stay in the playoff race, hosting a Steelers team that’s 8-3 and won five of their past six. Bengals favored by 3. Arizona at Minnesota, 1 p.m., Fox: The Cardinals are tied for the top of the NFC West while the Vikings are 9-2 and have been one of the biggest surprises of the season with journeyman Sam Darnold under center. Vikings favored by 3 1/2. Philadelphia at Baltimore, 4:25 p.m., CBS: Two of the league’s most electric players will be on the field when Saquon Barkley and the Eagles travel to face Lamar Jackson and the Ravens. Ravens favored by 3. San Francisco at Buffalo, 8:20 p.m. NBC/Peacock: The 49ers try to get back to .500 against the Bills, who have won six straight. Bills favored by 7. — NBA. The best teams in the Eastern Conference meet in a statement game. Boston at Cleveland, 6 p.m., NBA TV: The defending champion Celtics travel to face the Cavs, who won their first 15 games to start the season. — Premier League: English soccer fans have a marquee matchup. Manchester City at Liverpool, 11 a.m., USA Network/Telemundo. The two top teams meet with Manchester City trying to shake off recent struggles. — Auto Racing: The F1 season nears its conclusion. F1 Qatar Grand Prix, 11 a.m., ESPN2 — It’s the penultimate race of the season. Max Verstappen already has clinched his fourth consecutive season championship.Trump reaches transition agreement with Biden White House after long delay
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 (TRQX: DBVp ), 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 DBV FR and the Company's ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market DBVT . 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 © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Egypt Daily News – The spokesman for the Chinese Embassy in Washington, Liu Bingyu, commented on US President Donald Trump’s position on increasing customs tariffs on Chinese goods, saying that cooperation between Beijing and Washington is “beneficial to both parties,” warning that this trade battle will only lead to a loss. Earlier on Monday, Trump promised to impose comprehensive new tariffs on the three largest suppliers to the United States: Mexico, Canada, and China, as soon as he takes office, as part of his efforts to eliminate illegal immigration and drugs, saying that he would impose a 25% tax. on products coming from Canada and Mexico, and an additional 10% tariff on goods coming from China. Trump pointed out that these three parties must intervene to solve the problem of illegal immigration, otherwise “it is time for them to pay a heavy price.” In a post on social media, the Republican leader said: “On January 20, I will sign the necessary documents to impose additional tariffs on all products coming into Washington and its ridiculous open borders,” complaining about the thousands of illegal immigrants from Canada and Mexico, who are “causing... High levels of crime and drug use. Trump noted that the new tariffs will remain in place “until such time as drugs, especially fentanyl, and all the illegal aliens stop this invasion of our country!” Speaking about China, Trump said he had many conversations about the huge amounts of smuggled drugs, particularly fentanyl, being sent to the United States, but these conversations remained to no avail. “Until such time as they stop, we will impose an additional 10% tariff on China, on top of any existing tariffs, on all of their many products coming into the USA,” he threatened. On the other hand, the Chinese embassy in Washington warned that the trade war between the two poles would only bring loss. “Economic and trade cooperation between China and the United States is of a mutually beneficial nature,” embassy spokesman Liu Bingyu said on the X website. “No one is going to win a trade war or a tariff war,” he added. He noted that China took steps last year to help stop drug trafficking.