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WEST PALM BEACH, Fla. — An online spat between factions of Donald Trump’s supporters over immigration and the tech industry threw internal divisions in his political movement into public display. The rift laid bare the tensions between the newest flank of Trump’s movement — wealthy members of the tech world including billionaire Elon Musk and fellow entrepreneur Vivek Ramaswamy and their call for more highly skilled workers in their industry — and people in Trump’s Make America Great Again base who championed his hard-line immigration policies. The debate touched off this week when Laura Loomer, a right-wing provocateur with a history of racist and conspiratorial comments, criticized Trump’s selection of Sriram Krishnan as an adviser on artificial intelligence policy in his coming administration. Krishnan favors the ability to bring more skilled immigrants into the U.S. Loomer declared the stance to be “not America First policy” and said the tech executives who aligned themselves with Trump did so to enrich themselves. Much of the debate played out on the social media network X, which Musk owns. Loomer’s comments sparked a back-and-forth with venture capitalist and former PayPal executive David Sacks, whom Trump tapped to be the “White House A.I. & Crypto Czar.” Musk and Ramaswamy, whom Trump tasked with finding ways to cut the federal government, weighed in, defending the tech industry’s need to bring in foreign workers. It bloomed into a larger debate with more figures from the hard-right weighing in about the need to hire U.S. workers, whether values in American culture can produce the best engineers, free speech on the internet, the newfound influence tech figures have in Trump’s world and what his political movement stands for. Trump had not yet weighed in on the rift. His presidential transition team did not respond to questions about positions on visas for highly skilled workers or the debate between his supporters online. Instead, his team instead sent a link to a post on X by longtime adviser and immigration hard-liner Stephen Miller that was a transcript of a speech Trump gave in 2020 at Mount Rushmore in which he praised figures and moments from American history. Musk, the world’s richest man who has grown close to the president-elect, was a central figure in the debate, not only for his stature in Trump’s movement but his stance on the tech industry’s hiring of foreign workers. Technology companies say H-1B visas for skilled workers, used by software engineers and others in the tech industry, are critical for hard-to-fill positions. Critics say they undercut U.S. citizens who could take those jobs. Some on the right called for the program to be eliminated, not expanded. Born in South Africa, Musk was once on an a H-1B visa himself and defended the industry’s need to bring in foreign workers. “There is a permanent shortage of excellent engineering talent,” he said in a post. “It is the fundamental limiting factor in Silicon Valley.” Trump’s own positions over the years reflected the divide in his movement. His tough immigration policies, including his pledge for a mass deportation, were central to his winning presidential campaign. He focused on immigrants who come into the U.S. illegally but he also sought curbs on legal immigration, including family-based visas. As a presidential candidate in 2016, Trump called the H-1B visa program “very bad” and “unfair” for U.S. workers. After he became president, Trump in 2017 issued a “Buy American and Hire American” executive order, which directed Cabinet members to suggest changes to ensure H-1B visas were awarded to the highest-paid or most-skilled applicants to protect American workers. Trump’s businesses, however, hired foreign workers, including waiters and cooks at his Mar-a-Lago club, and his social media company behind his Truth Social app used the the H-1B program for highly skilled workers. During his 2024 campaign for president, Trump said immigrants in the country illegally are “poisoning the blood of our country” and promised to carry out the largest deportation operation in U.S. history. However, Trump told a podcast this year that he wants to give automatic green cards to foreign students who graduate from U.S. colleges. “I think you should get automatically, as part of your diploma, a green card to be able to stay in this country,” he told the “All-In” podcast with people from the venture capital and technology world. Those comments came on the cusp of Trump’s budding alliance with tech industry figures, but he did not make the idea a regular part of his campaign message or detail any plans to pursue such changes. Get local news delivered to your inbox!
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Man Arrested for Spreading Fake News About Amit Shah’s ‘Demise’Torrid Reports Third Quarter Fiscal 2024 ResultsWASHINGTON (AP) — A person accused of accosting U.S. Rep. Nancy Mace in a Capitol Office building pleaded not guilty on Wednesday to a misdemeanor assault charge. Witnesses told police that James McIntyre, 33, of Chicago, shook Mace's hand in an “exaggerated, aggressive” manner after approaching the South Carolina Republican in the Rayburn House Office Building on Tuesday evening, according to a police affidavit. Mace, who is identified only by her initials in a court filing, posted a string of social media messages about the incident. She said she was “physically accosted” at the Capitol, and she thanked President-elect Donald Trump for calling her Wednesday morning to check on her condition. “I’m going to be fine just as soon as the pain and soreness subside,” Mace wrote. Mace declined to be treated by a paramedic after her encounter with McIntyre, who was arrested Tuesday by the Capitol Police, the affidavit says. Mace told police that McIntyre said, “Trans youth serve advocacy,” while shaking her hand. Last month, Mace proposed a resolution that would prohibit any lawmakers and House employees from “using single-sex facilities other than those corresponding to their biological sex.” Mace said the bill is aimed specifically at Delaware Democrat Sarah McBride — the first transgender person to be elected to Congress. A magistrate judge ordered McIntyre’s release after an arraignment in Superior Court of the District of Columbia. Efforts to reach an attorney for McIntyre weren't immediately successful.
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The tight end position was starting to look appealing again. We know what happens when that is the case. Taysom Hill is out for the year. Dallas Goedert is week-to-week. Mark Andrews , Hunter Henry , and Zach Ertz are on bye. Kyle Pitts and Will Dissly combined for zero catches. There's probably more than one team in your league looking for a starter. It's possible this week's starter looks like last month's starter. There is a chance that both Jake Ferguson and Dalton Kincaid could return in Week 13. Ferguson is listed in the waiver wire options below, but Kincaid is 71% rostered, so he doesn't make the cutoff. He also seems like the longest shot to play. If he does, I'll add and start him. Another guy who is rostered in 71% of leagues is Tucker Kraft . He may be dependent on an injury, but not one to a tight end. Kraft had his second highest target total in Week 13 without Romeo Doubs . If Doubs remains out I will view Kraft as a top-10 tight end. If Doubs returns, I'll prefer a couple of the streamers below. Here's everything else you need to know about tight end in Week 13: The following players are not being projected to play in Week 14 at this time. Here's what it means: 15.5 -- The Bengals have allowed a tight end to score 15.5 or more Fantasy points against them three weeks in a row. Start whoever starts for Dallas against them. 41% -- Kyle Pitts' 41% snap share was the lowest of his career. 5 -- Evan Engram has at least five catches in six of his last seven games. He's much better in PPR. 0 -- Trey McBride still has zero receiving touchdowns. But he's somehow averaging 14.8 PPR FPPG anyway. 10 -- Cade Otton has scored 10 combined PPR Fantasy points in the two games since Mike Evas returns. He gets one more week as a starter due to byes. My full set of Week 14 Fantasy football projections for every position are now available on SportsLine . You can find them here. Find out which of my favorite plays are projected to score higher than consensus rankings and which don't live up to their draft hype, at least in Week 14. Projected stats for all starting tight ends are available, so be sure to check out the full set of projections at SportsLine .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.
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NEW YORK (AP) — U.S. stocks drifted to a mixed close, as gains for tech stocks nudged the S&P 500 and the Nasdaq to more records. The S&P 500 eked out a gain of under 0.1% Tuesday, while the Nasdaq composite rose 0.4%. The Dow Jones Industrial Average fell 0.2%. Treasury yields held relatively steady after a report showed U.S. employers were advertising slightly more job openings at the end of October than a month earlier. The value of the South Korean won sank against the dollar after its president declared martial law and then later said he’ll lift it. THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below. NEW YORK (AP) — U.S. stocks are drifting around their records on Tuesday as Wall Street's white-hot rally lets off the accelerator. The S&P 500 was virtually flat in afternoon trading, a day after rising tech stocks helped it set an all-time high for the 54th time this year. It's climbed in nine of the last 10 days and is on track for one of its best years since the turn of the millennium. The Dow Jones Industrial Average was down by 56 points, or 0.1%, with 45 minutes remaining in trading, while the Nasdaq composite added 0.2% to its own record set a day earlier. AT&T rose 3.9% after it boosted its profit forecast for the year. It also announced a $10 billion plan to send cash to its investors by buying back its own stock, while saying it expects to authorize another $10 billion of repurchases in 2027. On the losing end of Wall Street was U.S. Steel, which fell 7.9%. President-elect Donald Trump reiterated on social media that he would not let Japan’s Nippon Steel take over the iconic Pennsylvania steelmaker. Nippon Steel announced plans last December to buy the Pittsburgh-based steel producer for $14.1 billion in cash, raising concerns about what the transaction could mean for unionized workers, supply chains and U.S. national security. Earlier this year, President Joe Biden also came out against the acquisition. Tesla s sank 2.1% after a judge in Delaware reaffirmed a previous ruling that the electric car maker must revoke Elon Musk’s multibillion-dollar pay package. The judge denied a request by attorneys for Musk and Tesla’s corporate directors to vacate her ruling earlier this year requiring the company to rescind the unprecedented pay package. In the bond market, Treasury yields held relatively steady after a report showed U.S. employers were advertising slightly more job openings at the end of October than a month earlier. Continued strength there would raise optimism that the economy could keep avoiding a recession that many investors had earlier thought was inevitable. The yield on the 10-year Treasury rose to 4.22 from 4.20% from late Monday. Yields have seesawed since Election Day amid worries that Trump's preferences for lower tax rates and bigger tariffs could spur higher inflation along with economic growth. But traders are still confident the Federal Reserve will cut its main interest rate again at its next meeting in two weeks. They’re betting on a nearly three-in-four chance of that, according to data from CME Group. Lower rates can help give the economy more juice, but they can also give inflation more fuel. The key report this week that could guide the Fed’s next move will arrive on Friday. It’s the monthly jobs report , which will show how many workers U.S. employers hired and fired during November. It could be difficult to parse given how much storms and strikes distorted figures in October. Based on trading in the options market, Friday's jobs report appears to be the biggest potential market mover until the Fed announces its next decision on interest rates Dec. 18, according to strategists at Barclays Capital. Since his victory, Trump has broadcasted his plans for tariffs , including for goods coming from China . Trade relations between the U.S. and China took another step backward after China said it is banning exports to the U.S. of gallium, germanium, antimony and other key high-tech materials with potential military applications. The counterpunch came swiftly after the U.S. Commerce Department expanded the list of Chinese technology companies subject to export controls to include many that make equipment used to make computer chips, chipmaking tools and software. The 140 companies newly included in the so-called “entity list” are nearly all based in China. In financial markets abroad, the value of South Korea's currency fell 0.9% against the U.S. dollar following a frenetic night where President Yoon Suk Yeol declared martial law and then later said he'd lift it after lawmakers voted to reject military rule. Stocks of Korean companies that trade in the United States also fell, including a 1.3% drop for SK Telecom. Japan’s Nikkei 225 jumped 1.9% to help lead global markets. Some analysts think Japanese stocks could end up benefiting from Trump’s threats to raise tariffs on China and other countries. Indexes rose 1% in Hong Kong and 0.4% in Shanghai amid unconfirmed reports that Chinese leaders would meet next week to discuss planning for the coming year. Investors are hoping it may bring fresh stimulus to help spur growth in the world’s second-largest economy. In France, the CAC 40 rose 0.3% amid continued worries about politics in Paris , where the government is battling over the budget. ___ AP Business Writers Yuri Kageyama and Matt Ott contributed. Stan Choe, The Associated PressShort Sellers Lose $1.4 Billion as Super Micro Computer (SMCI) Stock Rises 53% - TipRanksHealth Catalyst chief commercial officer sells $67,073 in stock