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A world-champion quant trader with a 491% gain shares a strategy with a 75% win ratio and 3-to-1 profit potentialValerie Bertinelli has confidently responded to critics who body-shamed her after posting a selfie in her lingerie on social media. On Monday (December 2), the 64-year-old One Day at a Time star shared an intimate message about body positivity on Instagram , as she posed for a mirror selfie while wearing a black two-piece underwear set. “At some point I will talk about the madness my body has been through this year,” she began in the caption. “But right now every lump, bump, wrinkle, and saggy part of me just feels acceptance and simple appreciation to be standing in front of a mirror in a hotel bathroom in downtown Manhattan ready to color my roots late on a Monday night.” Bertinelli’s post was met with an outpouring of support from her followers, as many people thanked her for motivating them to love their bodies too. However, her picture was also the target of several crude remarks from people attempting to break her confidence. Instead, the Golden Globe winner followed up her post with a second message, calling out the critics who continued to pass judgment on her figure. “First of all, to those of you who felt a connection to my prior post and identified with what I was talking about, (empowering ourselves to focus on our own self-acceptance and self-love), thank you and thank you for your kindness,” she wrote in her subsequent Instagram post shared on Tuesday. “I see you. We are in this together,” Bertinelli continued. “To all of you that would sit in judgment of my body, the photo, and my reason for posting it, I hope you find a place in your heart to not judge yourself as harshly as you judge others. “I have dealt with judgment my entire life starting from when I was a young girl. It has taken me a long time to realize that my judgment, with patient discernment, is the only judgment that counts,” the Hot in Cleveland star said. “I have no power over someone else’s judgment of me and now I have no interest. Finally.” She added: “It’s taken me almost three years of emotional labor to get to this point mentally and for the first eight months of this year I had physical setbacks. I don’t care what you think of my body. I don’t care what you think about my posting about it.” Bertinelli went on to admit she “hated” her body when she was 20. Now, she said she wishes she didn’t have that perception back then. “Yes, it was a very different body than the one I now inhabit, but it hadn’t yet been through the journey I needed to go through,” she noted. “Even as challenging as it’s been and is, I am grateful for this journey and I wouldn’t trade this body for my 20-year-old body any day. Ever.” Back in May, Bertinelli opened up about another personal topic to her Instagram followers; she revealed that she knew her ex-husband Eddie Van Halen — with whom she welcomed her 33-year-old son Wolfgang Van Halen — wasn’t her “soulmate.” In her post, the actor admitted that her relationship with the late rocker, who died in 2020, was somewhat of a whirlwind romance. Although they were together for more than 26 years, Bertinelli said their love “rapidly declined into drugs, alcohol, and infidelity” after their initial honeymoon period when she was 20. Ultimately, it became clear these behaviors didn’t “scream soulmate.” Bertinelli and Van Halen tied the knot in 1981. They announced they were separating in 2001 before officially getting divorced in 2007. She remarried Tom Vitale in 2011, but the pair announced their split in 2022 .

Iowa turns to former walk-on QB to start against MarylandSkeena Resources Limited ( TSE:SKE – Get Free Report )’s share price was up 2.1% on Friday . The stock traded as high as C$13.44 and last traded at C$13.41. Approximately 296,787 shares were traded during mid-day trading, a decline of 9% from the average daily volume of 324,396 shares. The stock had previously closed at C$13.13. Analysts Set New Price Targets A number of brokerages have issued reports on SKE. Desjardins upgraded Skeena Resources to a “moderate buy” rating in a research note on Thursday, October 31st. CIBC dropped their price objective on Skeena Resources from C$17.00 to C$16.00 in a research report on Monday, December 2nd. Finally, Royal Bank of Canada boosted their target price on shares of Skeena Resources from C$17.00 to C$18.00 in a research note on Friday, December 6th. Three equities research analysts have rated the stock with a buy rating and one has issued a strong buy rating to the company. According to data from MarketBeat, Skeena Resources presently has an average rating of “Buy” and an average price target of C$16.96. View Our Latest Research Report on SKE Skeena Resources Price Performance Insiders Place Their Bets In other news, Director Craig Andrew Parry sold 70,000 shares of the stock in a transaction on Thursday, November 14th. The shares were sold at an average price of C$10.58, for a total value of C$740,509.00. Company insiders own 1.51% of the company’s stock. About Skeena Resources ( Get Free Report ) Skeena Resources Limited explores for and develops mineral properties in Canada. The company explores for gold, silver, copper, and other precious metal deposits. It holds 100% interests in the Snip gold mine comprising one mining lease and nine mineral tenures that covers an area of approximately 4,724 hectares; and the Eskay Creek gold mine that consists of eight mineral leases, two surface leases, and various unpatented mining claims comprising 7,666 hectares located in British Columbia, Canada. Read More Receive News & Ratings for Skeena Resources Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Skeena Resources and related companies with MarketBeat.com's FREE daily email newsletter .

ENTRUSTED with our readers’ deep secrets, the Dear Deidre team really have a unique insight into what dilemmas the nation is grappling with. Of course, there are some constants — cheating, differing sex drives, low self-esteem and loneliness. But some issues loom larger in certain years as new problems come to the fore. As 2024 nears an end, we take a look at what exactly our readers have been writing in about. Every year, we help thousands of people by answering every single dilemma with a personalised answer, and we’ve kept a record of the issues we’ve tackled. Relationship issues consistently come out on top, with 23 per cent of the emails Dear Deidre receives focused on romantic problems. Sex came a close second, with 19 per cent of readers writing in with a sexual dilemma. Interestingly, half of every single relationship message addressed cheating. Sometimes, the unfaithful party would be writing in, otherwise a suspicious or heartbroken partner worried about their relationship. Among the emails about cheating on partners, home surveillance and doorbell cameras featured more prominently, with some partners forgetting to turn off cameras before inviting flings to come back to their homes. A growing number of readers also wrote in because, although they were separated, financial constraints meant they could not move out of the marital home. The reluctant house sharers were frustrated at being unable to move on — a trend that reflects economic uncertainty in the UK. Notable developments this year have been new requests for support with quitting vaping. Another new issue came in the form of pensioners worrying about losing their winter fuel allowance. Social media has been a common theme in all the categories. It is impossible to quantify but has had a huge impact. So many of the relationship problems relate to partners ogling scantily clad influencers or flirting with others they have met online. Plenty don’t see this as cheating but the feeling of betrayal is real for those on the receiving end. And it’s not just cheating that worries people. Time spent watching endless videos encourages weird infatuations, with one woman complaining her husband had become obsessed with the French election. He insisted they spend their family holiday in France watching speeches — and had previously had no interest in politics. The issue of phone addiction came up, particularly for parents fretting about not only what their children were being exposed to, but also how their mobile activity was affecting their own behaviour. They asked our team for help on how to manage this. And a huge number of adults wrote in fed up with their partner, who had little interest in them but spent all hours playing online games or scrolling through their socials. It’s clear that while technology enables us to do far more and do it efficiently, left unchecked it threatens our real-world connections and provides more opportunity for temptation. Next year, I will be recording when social media, phone usage and the internet are mentioned as part of the problem, and I predict this will be a huge growth area. Below is a reader’s letter about ogling, followed by one about winter fuel allowance. I also break down what percentages of our mail different types of letter make up. DEAR DEIDRE: MY ex saw me having sex with a one-night stand using the camera security system he’d installed as a favour to me. I was completely unaware that he was watching this, until he turned up the next morning and got very upset with me. Originally, I was grateful for his help setting up the system, but now I feel really uncomfortable. He said he’d received an alert on his phone and checked it by chance, but I can’t help worrying he’s keeping an eye on me. He insists he hasn’t been watching and that was a one-off, but the whole experience has really unsettled me. I’m 36, my ex is 39, and we were together for eight years before we broke up five months ago. Our split was both mutually agreed, and amicable, and we decided to remain friends. We still met up and sometimes even had sex, but as we didn’t discuss what this meant I thought we were simply friends with benefits. I really appreciated still having him in my life. When I was moving house, he offered to help, knowing how useless I am at DIY. He helped put up shelves, and installed security cameras which he set up online so I could view them through an app. I knew he had access to it all while he set it up but assumed he’d log out. So when I brought a man home, I didn’t think twice. Now I feel mortified. He says he didn’t mean to breach my privacy, but I feel so conflicted. DEIDRE SAYS: Watching you have sex with another man was a huge breach of your privacy, and you shouldn’t take it lightly. As a priority, please ensure that you are the only one with access to your security system. Make sure you’re the primary account holder and change your password so that he doesn’t have access. It’s completely understandable that this experience has made you question the sort of person he is. Unless you decide you can trust him completely, you would be wise to stay away. At the very least, it’s clear that the lines are blurred between you and your ex and some boundaries need to be re-established. As for your relationship with him, you need to decide if there’s any hope of a future together. If you decide there’s not, it would be best to step away so you can both move on. My support pack Moving On will help. DEAR DEIDRE : SINCE the Government cut my Winter Fuel Payment, I’ve been struggling to afford my bills. Now I’m forced to choose between putting my heating on or buying food, and the stress is making me unwell. I’m a 76-year-old pensioner, and live alone. Until this year, I was receiving £200 payments to cover the cost of my heating bills, and I heavily relied on it. So when the Government announced the change, I went into a complete panic. My pension is already low as it is, so without the extra payments I knew it was going to be a hard couple of months. When I contacted the council for help, they told me that, while I was eligible to apply, I had missed the deadline so now I’d have to go without. Ever since, my life has been an absolute nightmare. Now I wake up every morning to a freezing house – and no matter what I do, I can’t keep warm. The constant dread is getting me down, and I’m now struggling to cope. DEIDRE SAYS: I can only imagine how distressing this must be for you. While the qualifying week for this year’s Fuel Payment has now passed, you may still be eligible if you successfully apply for Pension Credit by December 21. Please note that you only have two days to do this, so please take action today. You may also be eligible for a £150 Warm Home Discount. You can find out more about this on the government website ( gov.uk/the-warm-home-discount-scheme ). TOP TOPICS: Relationships 23% Sex 19% Family 8% Parenting 7% Friendships 4% Workplace issues 5% Mental health 11% Health 5% Addictions 8% Bereavement 5% Sexuality 4% Other 1% SEX WOES Sex drive 43% Fetishes 16% Threesomes 12% Erection problems 11% Fantasies 7% Climaxing 4% Menopause 3% Other 4% LOVE Cheating 49% Domestic abuse 12% Addictive love 10% Broken heart 14% Online romance 6% Age gaps 5% Other 4% ADDICTION Alcohol 42% Porn 22% Drugs 13% Smoking 8% Vaping 5% Gambling 9% Shopping and spending 1%

But alongside his stark warning of the threats facing Britain and its allies, Admiral Sir Tony Radakin said there would be only a “remote chance” Russia would directly attack or invade the UK if the two countries were at war. The Chief of the Defence Staff laid out the landscape of British defence in a wide-ranging speech, after a minister warned the Army would be wiped out in as little as six months if forced to fight a war on the scale of the Ukraine conflict. The admiral cast doubt on the possibility as he gave a speech at the Royal United Services Institute (Rusi) defence think tank in London. He told the audience Britain needed to be “clear-eyed in our assessment” of the threats it faces, adding: “That includes recognising that there is only a remote chance of a significant direct attack or invasion by Russia on the United Kingdom, and that’s the same for the whole of Nato.” Moscow “knows the response will be overwhelming”, he added, but warned the nuclear deterrent needed to be “kept strong and strengthened”. Sir Tony added: “We are at the dawn of a third nuclear age, which is altogether more complex. It is defined by multiple and concurrent dilemmas, proliferating nuclear and disruptive technologies and the almost total absence of the security architectures that went before.” He listed the “wild threats of tactical nuclear use” by Russia, China building up its weapon stocks, Iran’s failure to co-operate with a nuclear deal, and North Korea’s “erratic behaviour” among the threats faced by the West. But Sir Tony said the UK’s nuclear arsenal is “the one part of our inventory of which Russia is most aware and has more impact on (President Vladimir) Putin than anything else”. Successive British governments had invested “substantial sums of money” in renewing nuclear submarines and warheads because of this, he added. The admiral described the deployment of thousands of North Korean soldiers on Ukraine’s border alongside Russian forces as the year’s “most extraordinary development”. He also signalled further deployments were possible, speaking of “tens of thousands more to follow as part of a new security pact with Russia”. Defence minister Alistair Carns earlier said a rate of casualties similar to Russia’s invasion of Ukraine would lead to the army being “expended” within six to 12 months. He said it illustrated the need to “generate depth and mass rapidly in the event of a crisis”. In comments reported by Sky News, Mr Carns, a former Royal Marines colonel, said Russia was suffering losses of around 1,500 soldiers killed or injured a day. “In a war of scale – not a limited intervention, but one similar to Ukraine – our Army for example, on the current casualty rates, would be expended – as part of a broader multinational coalition – in six months to a year,” Mr Carns said in a speech at Rusi. He added: “That doesn’t mean we need a bigger Army, but it does mean you need to generate depth and mass rapidly in the event of a crisis.” Official figures show the Army had 109,245 personnel on October 1, including 25,814 volunteer reservists. Mr Carns, the minister for veterans and people, said the UK needed to “catch up with Nato allies” to place greater emphasis on the reserves. The Prime Minister’s official spokesman said Defence Secretary John Healey had previously spoken about “the state of the armed forces that were inherited from the previous government”. The spokesman said: “It’s why the Budget invested billions of pounds into defence, it’s why we’re undertaking a strategic defence review to ensure that we have the capabilities and the investment needed to defend this country.”India opposition leader demands tycoon Adani’s arrest after US charges

Wahoo defense too much for Central City in C-1 final

Key posts 5.02am Penny Wong responds to ICC arrest warrants for Netanyahu, Hamas leader 4.34am Up to 80,000 non-citizens could be deported under proposed law 4.12am Former treasurers sent in to bat for and against Future Fund changes 3.52am Social media age ban coming ‘as soon as possible’: PM 3.41am ICC issues arrest warrants for Israel’s Netanyahu, Gallant, and Hamas leader 3.32am What’s making news this morning Hide key posts Posts area Latest 1 of 1 Latest posts Latest posts 5.02am Penny Wong responds to ICC arrest warrants for Netanyahu, Hamas leader By Josefine Ganko Foreign Minister Penny Wong has responded to the International Criminal Court issuing arrest warrants for Israel’s Prime Minister Benjamin Netanyahu, former defence chief Yoav Gallant, and Hamas leader Ibrahim Al-Masri, for alleged war crimes and crimes against humanity in the Gaza conflict. “Australia respects the independence of the ICC and its important role in upholding international law,” Wong wrote in a statement posted to X. “Australia is focused on working with countries that want peace to press for an urgently needed ceasefire.” 4.55am Employment minister ‘confident’ Woolworths strike will be resolved By Josefine Ganko Supermarket giant Woolworths has told customers it doesn’t expect any “immediate” impact on stock levels at its stores in two states, after a strike by warehouse workers. Up to 1500 unionised workers at three of the retailer’s distribution centres in Victoria and another in NSW walked off the job indefinitely on Thursday. The workers want better pay amid a cost of living crisis and an end to a performance framework the United Workers Union says pushes them to work faster in ways that risk safety. Striking Woolworths workers warn their industrial action could impact supermarket shelves at Christmas. Credit: Louie Douvis With Christmas just over a month away, the union warned the liquor, frozen and refrigerated goods shelves at Woolworth could run bare unless its conditions are met. But Woolworths, and its distributor Primary Connect, said there would be little impact. Employment Minister Murray Watt was asked about the strikes on Seven’s Sunrise, where he said these types of disputes weren’t unusual, and that he was confident the issue would be resolved. “I would encourage, obviously, the parties to keep trying to work it out,” Watt said. “It is in the interests of workers at Woolworths to come to an agreement about the wages, and it is in the interest of Woolworths to make sure operations keep going, not to mention the rest of us who want to keep shopping at Woolworths.” With AAP 4.34am Up to 80,000 non-citizens could be deported under proposed law Up to 80,000 people of various visa categories could be potentially removed to third countries under the Albanese government’s plan to pay countries to accept its deported non-citizens, as legal experts criticise the bill. The Albanese government has not detailed which countries it has been in discussions with, in a bill that passed the House of Representatives and was examined in a Senate inquiry on Thursday. At the inquiry, several human rights and legal groups, including the Law Council of Australia, slammed the sweeping powers. Greens senator David Shoebridge questioned how many non-citizens could be deported under the bill at a senate inquiry on Thursday. Credit: Alex Ellinghausen “Detaining individuals pre-emptively [in Australia or overseas] to prevent them from committing future crimes must not become normalised in an otherwise free and liberal society,” council president Greg McIntyre told the Legal and Constitutional Affairs Legislation committee. The proposed amendments to the Migration Act seek to deport non-citizens, including not just those convicted of crimes, and to pay those third countries for their part in the removal regime. It would also grant extensive immunity to government officials and those in third countries involved with the removals as well as reversing protection findings for refugees. Loading Greens senator David Shoebridge pushed Department of Home Affairs officials to clarify which categories of visa holders who were not citizens would be affected. They said that 4452 people on Bridging Visa E, 986 in immigration detention, 193 in community detention, 246 on Bridging Visa R from the NZYQ cohort, a further 96 individuals also on the same visa and potentially “a fluid cohort” of up to 75,400 people could be included. Earlier in the hearing, former Manus Island detainee and award-winning Kurdish-Iranian writer Behrouz Boochani said the proposed bill was draconian, citing his personal experience being detained in Papua New Guinea. He pleaded with the senators to vote down the bill: “What Australia has done is to banish refugees to be out of sight and out of mind.” AAP Advertisement 4.12am Former treasurers sent in to bat for and against Future Fund changes By Josefine Ganko and Shane Wright Former treasurer Peter Costello has rounded on Treasurer Jim Chalmers’ plan to have the $230 billion Future Fund favour investment in housing, renewable energy and cybersecurity infrastructure, labelling it a “very bad” idea that would ultimately hurt taxpayers. Costello, who created the fund in 2006 and served as its chairman until this year, said the proposal – which the Coalition has vowed to overturn if it wins office – would reduce international respect for the fund. In an opinion piece in The Australian Financial Review , Costello said Labor never raised the proposal with him during his decade as the chair of the fund’s board and that if they had, he “would not have agreed to it”. “A key reason why [the Future Fund] has done so well is because of its independence from government,” Costello wrote. Loading Meanwhile, in comments given to The Australian, former prime minister John Howard says the changes are “fiscal vandalism with a great dollop of hypocrisy”. But coming in to defend the government was another former treasurer, ALP president Wayne Swan, who questioned “how desperate” the Liberal Party is to “drag out” Howard and Costello. “The fact is, the government has not changed the mandated investment return at all. And that is the critical point,” Swan told Nine’s Today. “I think Australians want their money invested in this country if they can get the required return. What’s wrong with saying that there are some national priorities? “This is just absurd political criticism in the lead-up to the next election. Nothing more, nothing less.” 3.52am Social media age ban coming ‘as soon as possible’: PM Popular social media platforms Tiktok, Snapchat and Instagram are among the sites that will have to ban children younger than 16, with reforms likely to pass parliament by the end of the fortnight. Federal Communications Minister Michelle Rowland introduced world-first legislation to the House of Representatives on Thursday, saying it would make the online environment safer for young people. TikTok, Facebook, Snapchat, Reddit, Instagram and X (formerly Twitter) will have to impose age limitations on users. But Messenger Kids, WhatsApp, Kids Helpline, Google Classroom and YouTube are expected to be classified as “out-of-scope services”. Prime Minister Anthony Albanese said the government wanted this “action to happen as soon as possible”, as the opposition confirmed it would work constructively to see the bill passed next week. Concerns with the speed at which the bill is slated to pass through the parliament have been raised, with only 24 hours allowed for submissions to a Senate enquiry initiated on Thursday. It will report its findings on Tuesday. Advocacy groups, including the Australian Human Rights Commission, have come out against the ban. The AHRC said it would likely have negative human rights impacts on young people: “If there are less restrictive options available to achieve the aim of protecting children from harm, they should be preferred over a blanket ban.” Companies that breach the minimum age obligation will face fines of up to $49.5 million. Under the draft laws, the onus will be on social media platforms to take reasonable steps to prevent children younger than 16 from having accounts. There will be a minimum lead-in period of 12 months before the ban is activated. Parents will not be able to give consent for their children to use social media, and users will not be required to hand over sensitive ID documents to platforms. Australia would be the first country to have an age ban on social media. Age verification trials are underway to determine how the ban will be enforced. AAP with Josefine Ganko 3.41am ICC issues arrest warrants for Israel’s Netanyahu, Gallant, and Hamas leader The International Criminal Court issued arrest warrants on Thursday for Israeli Prime Minister Benjamin Netanyahu and his former defence chief, as well as a Hamas leader, Ibrahim Al-Masri, for alleged war crimes and crimes against humanity in the Gaza conflict. In their decision, the ICC judges said there were reasonable grounds to believe Netanyahu and Yoav Gallant were criminally responsible for acts including murder, persecution and starvation as a weapon of war as part of a “widespread and systematic attack against the civilian population of Gaza”. Read the full story here. Israeli Prime Minister Benjamin Netanyahu and former defence minister Yoav Gallant. Credit: AP Reuters Advertisement 3.32am What’s making news this morning By Josefine Ganko Good morning and welcome to the national news blog. As always, my name is Josefine Ganko, and I’m here to guide you through the news as it develops through the first half of the day. It’s Friday, November 22. There’s been plenty of international news overnight, so here’s what you might have missed. The International Criminal Court issued arrest warrants on Thursday for Israeli Prime Minister Benjamin Netanyahu and his former defence chief, as well as a Hamas leader, Ibrahim Al-Masri, for alleged war crimes and crimes against humanity in the Gaza conflict. Far-right Republican Matt Gaetz has withdrawn his bid to become Donald Trump’s attorney-general amid ongoing revelations of alleged sexual misconduct involving an underage girl. A British woman has become the fifth victim of a suspected mass methanol poisoning in Laos after Melbourne teenager Bianca Jones died on Thursday. In Australia, Coalition immigration spokesman Dan Tehan dined with education and migration agents at a breakfast to discuss immigration issues the day before sinking Labor’s bill to crack down on private colleges and education providers. The major parties are preparing their campaign war rooms , as Labor MPs in Canberra are speculating about an election being called for March. Latest 1 of 1 Latest Most Viewed in National LoadingMr Carter, a former peanut farmer, served one term in the White House between 1977 and 1981, taking over in the wake of the Watergate scandal and the end of the Vietnam War. After his defeat by Ronald Reagan, he spent his post-presidency years as a global humanitarian, winning the Nobel Peace Prize in 2002. His death on Sunday was announced by his family and came more than a year after he decided to enter hospice care. He was the longest-lived US president. His son, Chip Carter, said: “My father was a hero, not only to me but to everyone who believes in peace, human rights and unselfish love. “My brothers, sister and I shared him with the rest of the world through these common beliefs. “The world is our family because of the way he brought people together, and we thank you for honouring his memory by continuing to live these shared beliefs.” Mr Carter is expected to receive a state funeral featuring public observances in Atlanta and Washington DC before being buried in his home town of Plains, Georgia. A moderate democrat born in Plains in October 1924, Mr Carter’s political career took him from the Georgia state senate to the state governorship and finally the White House, where he took office as the 39th president. His presidency saw economic disruption amid volatile oil prices, along with social tensions at home and challenges abroad including the Iranian revolution that sparked a 444-day hostage crisis at the US embassy in Tehran. But he also brokered the Camp David Accords between Egypt and Israel, which led to a peace treaty between the two countries in 1979. After his defeat in the 1980 presidential election, he worked for more than four decades leading the Carter Centre, which he and his late wife Rosalynn co-founded in 1982 to “wage peace, fight disease, and build hope”. Mrs Carter, who died last year aged 96, had played a more active role in her husband’s presidency than previous first ladies, with Mr Carter saying she had been “my equal partner in everything I ever accomplished”. Earlier this year, on his 100th birthday, Mr Carter received a private congratulatory message from the King, expressing admiration for his life of public service.Wien, Austria, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Aurora Finanzen , a rapidly growing trading platform specializing in delivering high-impact results for German investors, has officially cemented its position as the leading choice for crypto and financial trading in 2024. With a combination of cutting-edge technology, AI-driven trading tools, and an unmatched commitment to client success, Aurora Finanzen is setting a new standard in the trading industry. The Announcement: Leading the Trading Revolution In a bold move that has captured the attention of the trading community, Aurora Finanzen announced record-breaking performance metrics for the year. With an average success rate exceeding 95% in its advanced algorithmic trading strategies and a growing user base of satisfied investors, the platform has effectively outpaced its competitors. The company's zero-fee structure and state-of-the-art AI-powered tools have been pivotal in attracting both seasoned and novice traders. Aurora Finanzen has reported a 200% increase in active users over the past year, a milestone attributed to its user-friendly platform and the promise of delivering consistent returns even in volatile markets. " Aurora Finanzen 's success is a direct result of our relentless focus on innovation and client satisfaction,” said the company's CEO. "We are proud to offer German investors a platform that not only simplifies trading but also delivers consistent, high-value returns. Our goal is to remain at the forefront of the industry by continuously raising the bar.” Relevance in Today's Market Aurora Finanzen's performance comes at a time when market uncertainty and economic challenges have made investors more cautious about their financial choices. The platform's ability to navigate these challenges with precision and deliver profitability has positioned it as a trusted partner for traders seeking stability and growth. What sets Aurora Finanzen apart is its tailored approach to trading. The platform leverages advanced machine learning and AI algorithms to provide actionable market insights, helping users make informed decisions quickly. This technological edge ensures that clients can capitalize on opportunities in real-time, maximizing their potential for success. Moreover, Aurora Finanzen 's zero-fee structure eliminates a significant barrier for traders, making the platform accessible to all. By removing hidden costs, the company allows users to retain more of their profits-a key factor driving its popularity in Germany. Expert Insights and Client-Centered Approach The company's leadership emphasizes the importance of combining advanced technology with a personalized trading experience. "While technology is at the heart of our platform, our real strength lies in understanding the needs of our clients,” the CEO added. "Our team is dedicated to providing tools and resources that empower investors to achieve their financial goals, no matter their level of experience.” Aurora Finanzen's success stories highlight its ability to deliver results. From beginner traders experiencing their first significant profits to professional investors scaling their portfolios with ease, the platform has proven to be a game-changer in the industry. Its innovative AI tools have been credited with enabling users to identify lucrative opportunities and mitigate risks effectively. One long-term user shared, " Aurora Finanzen has completely transformed the way I approach trading. The platform's AI tools are incredibly accurate, and I've been able to see consistent growth in my investments. It's by far the best trading platform I've ever used.” Staying Ahead of the Competition Aurora Finanzen's rise to the top is no accident. The company continuously invests in research and development, ensuring that its platform evolves to meet the demands of an ever-changing market. By staying ahead of industry trends and incorporating client feedback, Aurora Finanzen remains uniquely positioned to outperform its competitors. Key features that have driven the company's success include: Aurora Finanzen invites investors across Germany to experience the future of trading. Whether you're a seasoned trader looking to scale your portfolio or a beginner eager to make your first trade, Aurora Finanzen provides the tools, insights, and support needed to succeed in today's fast-paced market. About Aurora Finanzen Aurora Finanzen is a leading trading platform specializing in AI-driven solutions for crypto and financial markets. Committed to empowering clients with innovative tools and unparalleled support, Aurora Finanzen has become Germany's top choice for trading success. Disclaimer: Trading involves significant risk and may not be suitable for all investors. Past performance is not indicative of future results. Please ensure you fully understand the risks involved and seek independent advice if necessary. Aurora Finanzen does not guarantee profits and is not responsible for losses incurred through trading activities. CONTACT: Sophia Becker aurorafinanzen sophia-at-aurorafinanzenbot.com

Elon Musk causes uproar for backing Germany's far-right party ahead of key elections

California’s employment safety net is still broken. Will anyone fix it?MAGA Conservatives Accuse Elon Musk of Censorship Over Immigration Disagreements on XThe country’s citizens are lucky, with uninterrupted electrical power supply met from large and small hydro power plants, thermal power stations owned by Ceylon Electricity Board (CEB) and private, also to a lesser degree with bio-energy, solar and wind power. The situation could be improved with moving over to more solar and wind power. Electricity generated from hydro-power, wind, solar and bio-energy are referred to as renewable energy. The country’s hydro power sources are almost exhausted. Wind and solar power have enormous potential, initial investments are slightly higher then thermal, but running costs are low, without imports. Solar is only during the day with intensity reducing with clouds, wind throughout the day and night, but wavering over the time and months. The country’s highest electricity demand is from 6:30 to 9 p.m. Thus solar could only contribute towards meeting the day time demand with hydro contributing throughout. Today, balance is met with thermally generated power. Recently pumped water storage is proposed, using excessive solar power during the day time to pump water to higher levels and using the same to generate electricity during the peak hours (more later). Biomass projects generate power by burning tree branch cuttings or paddy husk under controlled conditions. Branch cuttings of plants (mostly grilicedia) are collected from rural farmers and paddy husk produced during milling of paddy, that are normally disposed by burning. Gliricedia plant roots known for its nitrogen fixing abilities and improve soil fertility, whose leaves are generally used as animal feed, rots easily is an excellent manure. Most dendro-power plants located in the dry rural sector, provide employment and income opportunities to growers and transporters. Wind and solar power are highly acclaimed throughout the world, with energy produced causing least pollution and free, neither available uniformly nor throughout the day. Solar power is popular in Arab countries with massive investments. Technologies and equipment for solar and wind are imported from developed countries and are expensive, but with low running costs. Currently, Hambantota wind farm owned by CEB has a production capacity of 3 MW and the Puttalam farm with a capacity of 10 MW. A wind farm consisting of 30 towers generating 100 MW (Phase 1 – Thambapawani) was established on the southern coast of Mannar Island in 2021, with financial assistance from the Asian Development Bank (ADB). The Buruthakanda Solar Park in Hambantota by Sri Lanka Sustainable Energy Authority (SLSEA), first commercial scale solar power station completed in 2012, producing 737 KW in the first stage and 500 KW in the second stage. The Ambassador of the Republic of Korea, officially handed over Sri Lanka’s first-ever floating solar photovoltaic power plant located at Chandrika Wewa and Kiriibban Wewa reservoirs. The $ 5 million project, with floating solar photovoltaic power plant capable of generating 1MW, uses the reservoir surface, conserving land resources while reducing environmental impact. A World Bank report of August 2007 identified nearly 5,000 sq. km with good-to-excellent wind resource potential of 24,000 MW. About 4,100 sq. km of land and 700 sq. km in lagoons, largely concentrated in the north western coast from Kalpitiya Peninsula north to Mannar Island, Jaffna Peninsula, also central highlands. A strong stream of wind passes through the Strait of Mannar. The high speed winds moving from south to north and vice versa between central mountains of Sri Lanka and South Indian mountains through Strait of Mannar, allows generation of electricity power. Using the same, State of Tamil Nadu has installed six wind power projects, with a capacity of 7,450 MW becoming the leader in India. The largest is the Muppandal Wind Farm with a capacity of 1,500 MW, making it the world’s forth largest onshore wind farm. CEB installed a 103 MW wind power plant in Mannar Island with ADB assistance, costing $ 135 million and commissioned on 18 May 2021, named “Thambapavani”. The plant with 30 wind turbine generators located along the southern coast of Mannar Island. The produced electricity generated by the wind plant cost less than 4 US Cents a kWHr. But the proposed project located on the narrow ‘movement corridor’ where millions of migratory birds moving from north to south and back are severely objected by the environmentalists. CEB’s Long Term Generation Expansion Plans (LTGEP) prepared for 2023-2042 proposes: In addition, the plan allows pumped storage of 300 MW each for years 2029 and 2030, also are 1,400 MW Pumped Hydro Storage development by 2032 and 3,365 MW Battery Energy Storage development by 2042, requiring an average annual investment of $ 1.4 billion for generation and storage capacity additions. As per CEB generation statistics on 21 November, the combined output from the Laxapana, Mahaweli, and Samanala hydro complexes, along with CEB and Small Power Producer (SPP), wind energy and SPP solar, biomass, and mini-hydro sources, amounted to 27.22 GWh. Considering total energy generated was 47.47 Gwh, renewable energy amounts approximately to 57.35% of total energy generation. Thus achieving 70% target by 2030, Sri Lanka needs to increase its RE contribution by 27% within the next five years. Up to now, CEB showed reluctance to connect small and medium renewable plants, claiming the connection will destabilise their distribution system. But, recently, ADB agreed to provide a loan of $ 200 million to Sri Lanka to upgrade the power sector infrastructure, enhancing the reliability of transmission and distribution facilities of renewable energy, which will enable CEB to connect the renewable systems. The Phase II of the Mannar Wind Energy Park of capacity 200 MW, similar to Phase I with a 5 km 132 kV transmission line. The proposed turbines located 2 km away from the existing wind turbines and production costs would be similar. In 2022, the billionaire Indian businessman Gautham Adani visited Sri Lanka and met the President Gotabaya Rajapaksa and visited the proposed wind power project site. Subsequently, the Ministry of Power and Energy, received an unsolicited proposal for the construction and operation of the Mannar Wind Power Project (Phase-II), as Build, Own and Operate project for a 25-year period with an investment of $ 500 million. But with a lawsuit filed in New York court, by the Securities and Exchange Commission, Adani family are facing serious allegations of bribing personnel in implementing projects. Thus offering a project to Adani family would no longer feasible. Sri Lanka being close to the equator, receives an abundant supply of solar radiation year around without a marked seasonal variation. Roof-top solar is possible throughout the country except in higher elevations. Solar-parks are possible in the western coastal belt from Kalpitiya to Jaffna, Northern Province, also Hambantota and Monaragala districts due to flat dry terrain and low rain. In addition, parts of lagoons, lakes and reservoirs could host solar-parks. Thus the country’s solar and wind production capacity is beyond imagination, only needs implementation. SLSEA introduced rooftop solar power units in 2010 which became a success, and led to Surya Bala Sangramaya or the battle for solar energy in 2016. New program targets adding 1,450 MW by 2025. Currently 20,000 solar systems supply 215 MW to national grid, dominated by small roof-top solar installations. Thus rooftop solar needs to be promoted vehemently. Under the current system, rooftop solar producers up to 500 KWs are paid a Rs. 37 flat rate for 20 years, while systems above 50 KWs are paid Rs. 34.50 per unit. Sri Lanka’s first and the largest power station implemented as a joint venture by CEB with aid from EXIM Bank of China. It was constructed by China Machinery Engineering Corporation at a cost of $ 1.35 billion. The contract was signed in 2006 and the first phase of 300 MW was commissioned in 2011, including the construction of 115 km transmission line connecting the plant to the national grid through the Veyangoda substation. The Norochcholai Coal Power Plant located in Puttalam District, on the West Coast of the Kalpitiya Peninsula. The power plant proposed as 3 phases, each phase adding 300 MW, making the total power generated as 900 MW. A 300 MW unit of the Norochcholai plant would use between 650,000 to 700,000 tonnes of coal a year. There are large number of small and medium scale industries, who are occupied during daytime (when the sun is shining) with large roofs. Also are large number of supermarkets, all with large roofs. These roofs could be utilised effectively by installing solar power systems. Solar panels on the roof will reduce the sun-light on the roof, reducing the air-conditioning load below. Some Supermarkets already have solar panels on their roofs, others too could follow and owners cannot claim to be short of funds. I have installed a 14 kW solar system on my roof-top, costing Rs. 2.1 million, the system consisting of 34 solar panels. I have paid all requirements to CEB and am awaiting them to connect the solar power system. Now that Adani’s wind power proposal is no longer acceptable, the Governments need to call for expression of interest world-wide for future installation wind power systems in Mannar, Jaffna regions as well as up on the hills. In the hilly areas, most grounds are Government owned and there would be no objection for the locals. A pumped storage hydro-electric plant generally consists of two water reservoirs at different levels, connected with each other. During low electricity demand, excess generation capacity (excessive solar power) is used to pump water into the upper reservoir. With the high demand in peak hours, water is released back into the lower reservoir through a turbine (usually a Francis turbine), generating electricity. Pumped storage plants, usually use reversible turbine/generator assemblies, acting both pump and as a turbine generator at variable speed operation, further optimising the efficiency in pumped hydro storage tanks. For pumping of water, also for power generation, the same pump is used by changing rotational direction and speed. Pumped storage power plants (PSPPs) have been identified as a viable solution for power generation for Sri Lanka. Wewatenna was identified in the Electricity Sector Master Plan Study of Sri Lanka conducted in 2018 as a suitable site. This study develops the basic design configuration and calculates the peaking energy of the proposed PSPP at Wewathenna using the methodologies employed in previous studies conducted in 2015. The proposed Wewathenna project uses existing Victoria reservoir as the lower pond. The catchment area of the existing “Victoria” is 6.64 km2 and to construct an artificial dam on the eastern side of Victoria Lake serving as the upper pond of capacity 0.33 km2. The net head and maximum discharge are planned as 686 m and 240 m3/s respectively, with a potential capacity of 1,400 MW. However, due to various restrictions, Wewatenna was based on 500 MW. But adhering to manufacturing limit of pump-turbines, the unit capacity was set at 350 MW. The regulator PUCSL requested CEB a revised plan for tariff reduction starting 1 January 2025, and set a deadline for submission by 6 December 2024. But CEB refused any reductions of rates, claiming excess water in reservoir need to be saved to cater till April, end of dry period. Failure will require power generation through oil and coal. Former PUCSL Chairman Janaka Ratnayake added that the generation cost of electricity has decreased from Rs. 50 to Rs. 28, and electricity tariffs should be reduced by at least 30% passing relief to the public. The consumers have noted that recent heavy rains have significantly boosted hydropower generation and would allow reduction of electricity charges. Meanwhile, CEB unions called for bonuses, highlighting that the CEB recorded a profit of Rs. 43 billion in 2023 and Rs. 161 billion in 2024. But CEB rejected the demand for bonus. Also no reduction in electricity prices during the next six months, due to lack of low cost energy sources. The country has almost exhausted its cheapest power hydro-electricity. Only possibility is major movement towards solar power, especially by small and medium scale industries and house owners. Most convenient new solar users would be factories and offices, who normally work during day-light hours. Also, most schools have fans in the classrooms. They could install solar panels on the roofs, eliminating electricity bills. The parents who installed the fans in classrooms could also install solar panels. Meanwhile, it was reported that Orion City, the nation’s premier IT and business park has invested in a 700 kW solar power at its Colombo 9 complex, ensuring 24/7 uninterrupted power supply to its customers, would be an example to others. Thus, the Government needs to submit a plan to encourage installation of solar power by individual homes and the industry, with reduced interest loans from commercial banks. Recently, delegates from Japan and Qatar met the President and have offered assistance for renewable energy. Also, a number of European countries have offered low interest loans for renewable power. If the Government takes initiative to get their assistance, new solar investors could be offered low interest loans, will be a great support to the new investors, and will improve the solar power industry and the country.

Jimmy Carter, 39th US president, Nobel winner, dies at 100100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy SAN DIEGO , Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ ) today announced new frontline data featuring TECVAYLI ® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings. The MajesTEC-5 ( Abstract #493 ) and MajesTEC-4 ( Abstract #494 ) studies establish the potential of TECVAYLI ® for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile. These data were highlighted as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting. 1,2 Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI ® in combination with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone (Tec-DRd) or DARZALEX FASPRO ® , bortezomib, lenalidomide and dexamethasone (Tec-DVRd) as induction therapy in the MajesTEC-5 study. 1 All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10 -5 ) and maintained through cycle 6. 1 "These data from the MajesTEC-5 study build on the growing body of evidence of TECVAYLI combinations that support the potential combinability of TECVAYLI with other effective therapies, demonstrating high rates of MRD-negative responses for evaluable patients with newly diagnosed multiple myeloma," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. "At Johnson & Johnson, our deep expertise and understanding of multiple myeloma has shaped the regimens we're developing, including our bispecific antibodies in new combinations, and we're committed to exploring the full potential of our therapies to improve outcomes for patients." The safety profiles were manageable and consistent with individual safety profiles. 1 No treatment-emergent adverse events (TEAEs) led to study treatment discontinuation or death; cytokine release syndrome (CRS; Grade 1 or 2) occurred in 65 percent of patients. 1 No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). 1 Grade 3/4 TEAEs included lymphopenia (43 percent), neutropenia (57 percent) and infections (35 percent). 1 "There remains opportunity to achieve even deeper and more sustained outcomes for a broader patient population in the frontline setting," said Marc S. Raab , M.D., Heidelberg University Hospital, Germany .* "These data reinforce the potential of TECVAYLI when used in earlier lines and show that TECVAYLI can be leveraged to optimize existing standard regimens in combination." Results from the safety run-in of the Phase 3 MajesTEC-4 study highlighted the potential of TECVAYLI ® to be administered as a maintenance therapy following autologous stem cell transplant (ASCT). 2 MajesTEC-4 is the first study to present data on a B-cell maturation antigen (BCMA) bispecific as monotherapy or combination therapy after ASCT. 2 Low rates of non-hematologic Grade 3/4 TEAEs and discontinuation of treatment due to all TEAEs (5.3 percent) were observed. CRS events were all Grade 1/2, mostly occurring during step-up dosing, and ICANS was not observed. Neutropenia and infections were the most common Grade 3/4 TEAEs. 2 Grade 3/4 neutropenia at 6 months showed a decreased trend in cohorts 2 and 3 with less frequent TECVAYLI ® dosing (cohort 1: 94 percent, cohort 2: 63 percent, cohort 3: 47 percent). 2 A similar trend was observed for all-grade infections (cohort 1: 94 percent; cohort 2: 78 percent; cohort 3: 77 percent). 2 All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6. 2 Further analysis of combination therapies will be evaluated in the Phase 3 MajesTEC-7 study, which is currently enrolling. About MajesTEC-5 Study MajesTEC-5 ( NCT05695508 ) is an ongoing, Phase 2 study of teclistamab and talquetamab, evaluating the safety and efficacy of combination regimens in participants with newly diagnosed transplant eligible multiple myeloma. 3 About MajesTEC-4 Study MajesTEC-4 ( NCT05243797 ) is an ongoing, multicenter, randomized, open-label, Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation. 4 About MajesTEC-7 Study MajesTEC-7 ( NCT05552222 ) is a Phase 3 randomized study comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab SC and lenalidomide (Tal-DR) versus daratumumab SC, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. 5 About TECVAYLI ® TECVAYLI ® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. 6 The European Commission (EC) granted TECVAYLI ® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023 , the EC granted the approval of a Type II variation application for TECVAYLI ® , providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI ® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In February 2024 , the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI ® for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months. For more information, visit www.TECVAYLI.com . About DARZALEX FASPRO ® and DARZALEX ® DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX FASPRO ® is co-formulated with recombinant human hyaluronidase PH20, Halozyme's ENHANZE ® drug delivery technology. DARZALEX ® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX ® -based regimens have been used in the treatment of more than 585,000 patients worldwide and more than 239,000 patients in the U.S. alone. In August 2012 , Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. For more information, visit https://www.darzalexhcp.com. About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 7 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors. 8 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease. 9 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease. 10 People living with multiple myeloma have a 5-year survival rate of 59.8 percent. 11 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections. 12,13 TECVAYLI ® IMPORTANT SAFETY INFORMATION INDICATION AND USAGE TECVAYLI ® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). WARNINGS AND PRECAUTIONS Cytokine Release Syndrome - TECVAYLI ® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI ® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI ® . The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI ® accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI ® based on severity. TECVAYLI ® is available only through a restricted program under a REMS. Neurologic Toxicity including ICANS - TECVAYLI ® can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI ® at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI ® . In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI ® at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI ® . The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI ® based on severity per recommendations and consider further management per current practice guidelines. Due to the potential for neurologic toxicity, patients are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI ® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves. TECVAYLI ® is available only through a restricted program under a REMS. TECVAYLI ® and TALVEY ® REMS - TECVAYLI ® is available only through a restricted program under a REMS called the TECVAYLI ® and TALVEY ® REMS because of the risks of CRS and neurologic toxicity, including ICANS. Hepatotoxicity - TECVAYLI ® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Infections - TECVAYLI ® can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%. Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI ® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Monitor immunoglobulin levels during treatment with TECVAYLI ® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Neutropenia - TECVAYLI ® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of patients. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI ® based on severity. Hypersensitivity and Other Administration Reactions - TECVAYLI ® can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue. Local Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI ® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI ® and for 5 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Please read full Prescribing Information , including Boxed WARNING, for TECVAYLI ® . DARZALEX FASPRO ® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI) In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS DARZALEX FASPRO ® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation. WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO ® . Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO ® . Systemic Reactions In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO ® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO ® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients. Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO ® . Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO ® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO ® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO ® . Local Reactions In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management. Neutropenia Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO ® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO ® , higher rates of Grade 3-4 neutropenia were observed. Thrombocytopenia Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO ® until recovery of platelets. Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO ® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO ® and for 3 months after the last dose. The combination of DARZALEX FASPRO ® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy. Interference With Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO ® . Type and screen patients prior to starting DARZALEX FASPRO ® . Interference With Determination of Complete Response Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO ® -treated patients with IgG kappa myeloma protein. ADVERSE REACTIONS In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO ® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema. The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO ® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to see the full Prescribing Information for DARZALEX FASPRO ® . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JanssenUS and @JNJInnovMed . Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TECVAYLI ® (teclistamab-cqyv ) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. * Marc S. Raab , M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Raab, Marc, S., et al, 493 Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 2 Zamagni, Elena, et al., 494 Phase 3 Study of Teclistamab (Tec) in Combination with Lenalidomide (Len) and Tec Alone Versus Len Alone in Newly Diagnosed Multiple Myeloma (NDMM) As Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT): Safety Run-in (SRI) Results from the MajesTEC-4/EMN30 Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 3 GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX). https://clinicaltrials.gov/study/NCT05695508 . Accessed November 2024 . 4 Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4). https://clinicaltrials.gov/study/NCT05243797 . Accessed November 2024 . 5 A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7). https://classic.clinicaltrials.gov/ct2/show/NCT05552222 . Accessed November 2024 . 6 U.S. FDA Approves TECVAYLI ® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma . Accessed November 2024 . 7 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178 8 National Cancer Institute. Plasma Cell Neoplasms. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq . Accessed November 2024 . 9 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma . Accessed November 2024 . 10 American Cancer Society. Key Statistics About Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women . Accessed November 2024 . 11 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/ . Accessed November 2024 . 12 American Cancer Society. What is Multiple Myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html . Accessed November 2024 . 13 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html . Accessed November 2024 . SOURCE Johnson & Johnson