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Last night at Anfield was supposed to be about a battle between two attacking superstars but Kylian Mbappe and Mohamed Salah fluffed their lines. Instead, the battle between two of European football’s two giant clubs was dominated by some lesser names. For Liverpool , it was homegrown players Conor Bradley and Caoimhin Kelleher who took star billing as Salah missed a penalty while Real’s other big-name players were unable to help out Mbappe as the home side ran out 2-0 winners. There was also crazy late drama in Eindhoven and a piece of history in Bologna. Here are the big talking points from tonight. Have Liverpool got a homegrown Alexander-Arnold replacement? Liverpool supporters might soon have to picture life without Trent Alexander-Arnold . And last night it did not look too bad. With the Merseyside-born full-back’s contract due to expire at the end of this season, his hometown club remain hopeful that he will commit to an extension. But should he choose to try his luck elsewhere, Real would appear to be his most likely free-transfer destination. Advertisement So last night, with Alexander-Arnold on the substitutes’ bench as he continues his recovery from injury, it was a chance for Bradley to stake a claim as a long-term successor. The 21-year-old, who followed the same path as Alexander-Arnold through the Anfield academy, probably dreamed of playing in huge occasions like last night. But when he was turning out as a substitute for Bolton Wanderers in front of 2,381 people in the unglamorous English Football League Trophy in November 2022, he probably did not expect to be thwarting Real superstar Mbappe and then laying on a superb goal in front of a packed Anfield just two years later. Yet that was how it turned out last night. Early in the first half, Bradley drew acclaim from the home crowd for a superbly-timed challenge that ended a powerful break by Mbappe. "There's only one Conor Bradley" 🗣️🎶 Liverpool fans are making their appreciation of the youngster's performance known! pic.twitter.com/T8NbPkYDwu — CBS Sports Golazo ⚽️ (@CBSSportsGolazo) November 27, 2024 Then in the second half, he showed he is more than just a rugged defender with a brilliantly-weighted pass to set up Alexis Mac Allister for the opening goal. Video for UK audience Take a bow, Alexis Mac Allister! 👏 Anfield erupts with noise as Liverpool take the lead 🔊 📺 @tntsports & @discoveryplusUK pic.twitter.com/fQSTG1Gl56 — Football on TNT Sports (@footballontnt) November 27, 2024 Video for U.S. readers MAC ALLISTER FINISHES A LOVELY MOVE FROM LIVERPOOL TO HIT REAL MADRID EARLY IN THE SECOND HALF ⚡ pic.twitter.com/7iYRlrN9Vg — CBS Sports Golazo ⚽️ (@CBSSportsGolazo) November 27, 2024 Mbappe’s frustration continued when he had a penalty saved by Kelleher and Salah then blasted another spot-kick wide for Liverpool before Cody Gakpo eventually scored Liverpool’s second. 3 – Caoimhín Kelleher has now saved three of the four penalties he has faced for Liverpool in all competitions (ex. shootouts), while this was only the second penalty Kylian Mbappé has failed to convert in the UEFA Champions League. Reflex. pic.twitter.com/20lpa3lTYJ — OptaJoe (@OptaJoe) November 27, 2024 It all meant that, with two rounds of games remaining, Real might not even reach the knockout stage, which was probably not what UEFA had in mind when they changed the format of the competition. Why was Bellingham booed at Anfield? Jude Bellingham is greeted as the golden boy almost everywhere he goes but Anfield was in no mood to roll out the red carpet for the England midfielder. In fact, the Real Madrid star was booed for much of the evening by a lively home crowd as he failed to inspire the Spanish giants to victory on Merseyside. The reason for the jeering is probably a little nuanced, but the main reason was almost certainly the fact that Bellingham moved to Real Madrid despite Liverpool’s interest in him . There is also the added factor that Bellingham and Alexander-Arnold are close friends in the England squad so, if the Liverpool full-back is seriously considering Real’s advances ahead of a possible free transfer, it seems inconceivable that he will not pick Bellingham’s brains. The former Birmingham youngster was public enemy No.1 at Anfield, although his side’s defeat probably bothered him more than getting the bird. USMNT pair shine in comeback for the ages If you were a fan of PSV Eindhoven and decided to leave the Philips Stadion early last night with your team 2-0 down in the closing stages, you probably won’t do it again. If you were a viewer in the United States who switched over from the same game at the same stage, you might think twice in the future, too. Because the ending to the game in the Netherlands was crazy... and very American. Advertisement It seemed to be going the way of Ukraine ’s Shakhtar Donetsk when they led 2-0 thanks to goals from Danylo Sikan and Oleksandar Zubkov in the first half. Even the second-half sending off of Shakthar’s Pedro Henrique seemed to have made little impact when his side still held their two-goal lead on 87 minutes. But it did. U.S. Men’s National Team midfielder Malik Tillman scored to give his side hope and spark a finish that was frankly crazy. On 90 minutes Tillman scored again to level for his side and the Americans were not done yet. Ricardo Pepi , another U.S. international, popped up to score a winner for the home side five minutes into added time. Video for U.S. readers RICARDO PEPI TO THE RESCUE FOR PSV!! 🇺🇸 EL Tren’s hot streak continues! 🚂 pic.twitter.com/FypgbeKOHU — CBS Sports Golazo ⚽️ (@CBSSportsGolazo) November 27, 2024 If you left early to beat the traffic, did you enjoy your extra 10 minutes at home? And if you switched over, were any of the other games really worth it? But a moment USMNT defender will want to forget Champions League nights at Celtic Park are always memorable. But United States Men’s National Team defender Cameron Carter-Vickers would prefer to forget the latest one. The former Tottenham Hotspur player scored an own goal for the ages to hand Celtic ’s opponents, the Belgian side Club Brugge, a bizarre leg-up in the form of a 1-0 lead in the first half. With the two clubs jostling for places in the middle section of the 36-team league, Celtic began their latest home game with designs on climbing above their opponents to solidify their spot in the group of clubs between ninth and 24th, who will take part in play-offs for places in the last 16. So having one of their own defenders beat goalkeeper Kasper Schmeichel with a shot that nestled perfectly in the bottom corner was... not ideal. Advertisement Brugge’s pressing in the 26th minute was admirable but it did not really get Carter-Vickers off the hook for one of the more bizarre own goals the Champions League has seen. Video for UK readers That is not the start Celtic were hoping for 🙈 Carter-Vickers' mistake gifts Brugge the lead 😬 📺 @tntsports & @discoveryplusUK pic.twitter.com/AwI6R9o56Q — Football on TNT Sports (@footballontnt) November 27, 2024 Video for U.S. readers A shocking error from Cameron Carter-Vickers gives Club Brugge the lead 😳 pic.twitter.com/ZH7Wq555Om — CBS Sports Golazo ⚽️ (@CBSSportsGolazo) November 27, 2024 Schmeichel’s positioning when Nicolas Kuhn rolled a pass into Carter-Vickers did not appear ideal, but he could not really have expected the defender to sidefoot the ball past him and inside the far post. Kudos to Celtic captain Callum McGregor , who immediately called an impromptu huddle with the aim of lifting his team-mates and ended up raising the home crowd too. But it was tough to recover from such a crazy self-inflicted wound. A moment of history for Lucumi – and Bologna Jhon Lucumi is not a well-known name in European football but the Colombia striker now has a permanent place in the history of Bologna. The Italian side are playing their first campaign in the Champions League in its modern iteration, having last played in its predecessor, the European Cup, 60 years ago. And in the first four runs of matches, they had not managed to score a goal. Lucumi changed that with the club’s first-ever Champions League goal on 63 minutes of their home game against Lille, cancelling out Ngal’ayel Mukau’s opener. The joy lasted for just three minutes before Mukau struck again with what proved to be a match-winning goal to leave Bologna still without a win and with just one point. Wednesday’s results What’s next? Round six of the eight-round group stage begins on Tuesday, December 10, with nine games. (Top photo: Justin Setterfield/Getty Images)
HOUSTON (AP) — An elaborate parody appears to be behind an effort to resurrect Enron, the Houston-based energy company that exemplified the worst in American corporate fraud and greed after it went bankrupt in 2001. If its return is comedic, some former employees who lost everything in Enron’s collapse aren’t laughing. “It’s a pretty sick joke and it disparages the people that did work there. And why would you want to even bring it back up again?” said former Enron employee Diana Peters, who represented workers in the company’s bankruptcy proceedings. Here’s what to know about the history of Enron and the purported effort to bring it back. Once the nation’s seventh-largest company, Enron filed for bankruptcy protection on Dec. 2, 2001, after years of accounting tricks could no longer hide billions of dollars in debt or make failing ventures appear profitable. The energy company's collapse put more than 5,000 people out of work and wiped out more than $2 billion in employee pensions. Its aftershocks were felt throughout the energy sector. Twenty-four Enron executives , including former CEO Jeffrey Skilling , were convicted for their roles in the fraud. Enron founder Ken Lay’s convictions were vacated after he died of heart disease following his 2006 trial. On Monday — the 23rd anniversary of the bankruptcy filing — a company representing itself as Enron announced in a news release it was relaunching as a “company dedicated to solving the global energy crisis.” It also posted a video on social media, advertised on at least one Houston billboard and a took out a full-page ad in the Houston Chronicle In the minute-long video full of generic corporate jargon, the company talks about “growth” and “rebirth.” It ends with the words, “We’re back. Can we talk?” In an email, company spokesperson Will Chabot said the new Enron was not doing any interviews yet, but "We’ll have more to share soon.” Signs point to the comeback being a joke. In the “terms of use and conditions of sale” on the company's website, it says “the information on the website about Enron is First Amendment protected parody, represents performance art, and is for entertainment purposes only.” Documents filed with the U.S. Patent and Trademark Office show College Company, an Arkansas-based LLC, owns the Enron trademark. The co-founder of College Company is Connor Gaydos, who helped create a joke conspiracy theory claiming all birds are actually government surveillance drones. Peters said she and some other former employees are upset and think the relaunch was “in poor taste.” “If it’s a joke, it’s rude, extremely rude. And I hope that they realize it and apologize to all of the Enron employees,” Peters said. Peters, 74, said she is still working in information technology because “I lost everything in Enron, and so my Social Security doesn’t always take care of things I need done.” “Enron’s downfall taught us critical lessons about corporate ethics, accountability, and the consequences of unchecked ambition. Enron’s legacy was the employees in the trenches. Leave Enron buried,” she said. But Sherron Watkins, Enron’s former vice president of corporate development and the main whistleblower who helped uncover the scandal, said she didn’t have a problem with the joke because comedy “usually helps us focus on an uncomfortable historical event that we’d rather ignore.” “I think we use prior scandals to try to teach new generations what can go wrong with big companies,” said Watkins, who still speaks at colleges and conferences about the Enron scandal. This story was corrected to fix the spelling of Ken Lay’s first name, which had been misspelled “Key.” Follow Juan A. Lozano on X at https://x.com/juanlozano70
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 VersionNigeria’s renewable energy sector open for German businesses — Tinubu
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15% VAT plan has PM vexedBritish Columbia Premier David Eby says his fellow premiers and the federal government have hatched a game plan to fight U.S. tariffs, with conservative premiers lobbying Republican counterparts, left-leaning provincial leaders courting the Democrats, and Ottawa focusing on president-elect Donald Trump. The premiers and Prime Minister Justin Trudeau talked about using their political diversity and connections to thwart the prospect of Trump's proposed 25 per cent tariffs on imports from Canada and Mexico, Eby said Thursday in a year-end interview. He said it was discussed that conservative premiers Danielle Smith in Alberta, Doug Ford in Ontario and Nova Scotia's Tim Houston are well-placed to lobby Republican governors and business leaders. Eby said as a New Democrat he will likely have more in common with Democrat governors and business leaders from the West Coast states. "I can easily have conversations with governors and businesses down the West Coast of the U.S., where we have close relationships and our politics are very similar," he said. "Premier Smith can have conversations with Republican governors. That would be more challenging for me, and (she) would have more connections potentially with the Trump administration than an NDP administration in B.C. would." He said a meeting last week between the premiers and Trudeau discussed Canada's diversity of representation, and how it could bring leverage and advantages in tariff talks. "It's interesting, there was a lot of talk about what unity means in terms of Canada's response to the tariffs," he said. "There's obviously a diversity of views around the Council of the Federation table of all the premiers. Certainly, mine is not the same as Premier Smith's or Premier Ford's or Premier Houston's, and that diversity of views is actually potentially a significant strength for us as we enter into these discussions." Eby also said he was prepared to appear on American's right-leaning Fox News TV network, as did premiers Ford and Smith. "Anything that I can do to support the national effort to protect the families in Canada from the impact of tariffs and also families in the U.S. from those unjustified tariffs," he said. "Absolutely, if I thought it was helpful." This report by The Canadian Press was first published Dec. 5, 2024.
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