Fencers have a ‘medieval time’ at Fort Williams
Jimmy Carter dedicated his life to public service and taking care of his family. Remember his legacy with his photos, here. President Jimmy Carter led a remarkable life filled with numerous achievements and accolades. He served as the President of the United States from 1977 to 1981, and following his tenure, dedicated himself to a life of public service. In addition to his role as President, Carter served as a Georgia State Senator from 1963 to 1967 and as the 76th Governor of Georgia from 1971 to 1975. Throughout his life, President Carter was supported by his loving wife, Rosalynn Carter , whom he has been married to since 1946. She died in November 2023. Together, they raised a family of three sons, one daughter, grandsons and granddaughters. In February 2023, the Carter Foundation shared that the former President had entered hospice treatment at the age of 98. “After a series of short hospital stays, former U.S. President Jimmy Carter today decided to spend his remaining time at home with his family and receive hospice care instead of additional medical intervention,” the statement read. “He has the full support of his family and his medical team. The Carter family respectfully requests privacy during this time and expresses gratitude for the concern shown by his many admirers.” In December 2024, Jimmy died at the age of 100. For more photos of President Jimmy Carter, check out this gallery below. Jimmy Carter & Wife Rosalynn Carter In 2021 Jimmy Carter and his wife Rosalynn attended a ribbon cutting ceremony at the Jimmy and Rosalynn Carter Boys & Girls Club in Plains, Georgia in 2021. Jimmy Carter in 2019 Here, President Carter was seen engaging with students during the annual Carter Town Hall at Emory University in Atlanta in 2019. He answered an array of questions about the upcoming presidential election. Jimmy Carter & Rosalynn Carter in 2019 Jimmy Carter and Rosalynn Carter in Nashsville in 2019. Jimmy & Rosalynn Carter at George H.W. Bush’s Funeral Jimmy Carter and wife Rosalynn hold hands as they attend George H.W. Bush’s funeral in 2018. Carter remains the oldest ex-president. Jimmy Carter & Rosalynn Carter in 2015 Jimmy Carter and Rosalynn Carter attending the MusiCares Person of the Year Gala in 2015. More About Jimmy Carter Jimmy Carter’s Cause of Death: About the Former President’s Passing Jimmy Carter & Rosalynn Carter in 2010 Jimmy and Rosalynn joined volunteers to rehabilitate homes in Baltimore, Maryland, in October 2010. Jimmy & Rosalynn Carter In 1993 Former President Jimmy Carter and his wife, Rosalyn posed together for this 1993 portrait. They founded the Carter Center in 1982, to resolve civil and international conflicts, advance democracy, human rights, and economic opportunity. Jimmy Carter & Family In 1977 President-elect Jimmy Carter had wife Rosalynn and daughter Amy Carter by his side during his Inauguration Day, which took place on Jan. 20, 1977. They posed for photographers and smiled on the special day. The Carters In 1976 Rosalynn Carter and daughter Amy were with then-Georgia governor Jimmy Carter at the Democratic National Convention in New York City on Jul. 15, 1976. They looked like they were getting used to the spotlight. Jimmy Carter at Home in Georgia Jimmy Carter is seen here at his home in Plains, Georgia. The Carters moved back to their hometown after leaving the White House in 1981. Jimmy Carter & Wife Dance President Jimmy Carter got to dance with First Lady Rosalynn Carter during the 1977 inaugural ball. The couple have been married since 1946. Rosalynn Carter Speaks Rosalynn Carter addressed a crowd after a diplomatic trip to Latin America in Jun. 1977. The First Lady met with leaders of Jamaica, Costa Rica, Ecuador, Peru, Brazil, Colombia, and Venezuela to discuss commerce human rights disarmament, and the drug trade. Jimmy Carter On Air Force One Jimmy Carter (center right) relaxed with cabinet members Zbigniew Brzezinski, Michael Blumenthal, and Cyrus Vance (left to right) aboard Air Force One during a trip to London for the G7 economic summit. President Jimmy Carter & The First Lady In 1977 President Jimmy Carter and Rosalynn Carter beamed in their official 1977 White House portrait. Rosalynn was a politically active First Lady, serving as her husband’s closest adviser and often sitting in on cabinet meetings. Jimmy Carter’s Presidential Portrait President Jimmy Carter poses for his official portrait in 1977. Carter would serve one term as president, leaving the White House in 1981. Jimmy Carter Teaches Sunday School Former President Jimmy Carter teaches Sunday school at Maranatha Baptist Church in Plains, Georgia in 2019. He has been teaching at the church for years. President Ford & Wife With President-elect Carter President Gerald Ford and Betty Ford chatted with President-elect Jimmy Carter and Rosalynn Carter following the Carter’s tour of the White House in Dec. 1976, ahead of his inauguration. The ladies’ hairdos were a retro treat! Jimmy Carter & Ed Kennedy Senator Edward Kennedy looked like he and President Jimmy Carter were making things happen during this 1977 Oval Office meetings. Carter was known for his affable nature. President Carter & Senator Byrd Senator Robert Byrd presented President Jimmy Carter with a copy of his album Mountain Fiddler in 1978. What a relic! Cyrus Vance & President Carter In 1977 Secretary of State Cyrus Vance pulled President Carter aside for a word on the White House lawn in March of 1977. Vance was one of Carter’s closest confidantes during his one-term presidency. President Carter In The Oval Office President Jimmy Carter was hard at work during this deskside portriat taken in the White House Oval Office. Following his time at 1600 Penn., Jimmy received the Nobel Prize. Trending Now
IIT Tirupati to host grand finale of Smart India Hackathon 2024
A claim is doing rounds on social media that far-right streamer Nick Fuentes had allegedly set his house on fire. Fuentes had been the center of attention since the election of Donald Trump as the next US president after he made a controversial comment taunting abortion rights activists. As part of the backlash from the comment, Fuentes' address in Berwyn, Illinois was made public on social media and women started visiting the address to confront Fuentes. Amid that, a claim surfaced that the 26-year-old set his house on fire to escape the wrath of the women visiting Fuentes' house. However, Times Now Digital can confirm that Nick Fuentes never really set his house on fire. He had said in a stream in reaction to the backlash that he would set his house on fire. Since then, the rumour has been doing rounds on social media that Fuentes had set his house in Illinois on fire. What Caused The Backlash? After Donald Trump was confirmed as the President-elect on the evening of the election day on November 5, Fuentes mocked the abortion rights activist by posting on X, "Your body, my choice. Forever." It was a dig at the popular abortion rights slogan, "my body, my choice." The comment followed a massive backlash on and beyond social media. After Fuentes' address was shared on social media, women visited the far-right activists' house to confront him. Nick Fuentes Booked For Battery One of the women to visit Nick Fuentes' home was Marla Rose. After Fuentes was confronted by the woman, he pepper sprayed her and then seized her phone. In a video recorded by the woman, Fuentes can be seen seizing her phone and stomping it on the ground. The video ends at that point. After Marla Rose pressed charges against Fuentes, the Berwyn Police Department booked Fuentes on November 24 and was later released. He is set to appear in court for his first trial on December 9. Get Latest News Live on Times Now along with Breaking News and Top Headlines from US Buzz, World and around the world.
In a move that could reshape the social media landscape in the United States, Donald Trump is pressing the U.S. Supreme Court to delay the enactment of a federal law that aims to either ban TikTok or compel its sale. The President-elect contends that he needs time after assuming office to negotiate a political settlement. The case pits TikTok and its Chinese parent company, ByteDance, against U.S. lawmakers who voted in April to outlaw the app unless it is divested by January 19. TikTok is seeking to overturn the legislation, and the Supreme Court has agreed to review the case. A decision against ByteDance could see the app effectively banned from American soil just a day before Trump's planned inauguration. Trump's legal stance highlights the complex intersections of free-speech rights, national security, and foreign policy. Free speech advocates argue that banning TikTok mimics censorship tactics of authoritarian regimes, while the U.S. Justice Department maintains that the app's Chinese ties pose an ongoing security threat. TikTok rebuts such claims, stating that its operations and data management are firmly rooted in the United States. (With inputs from agencies.)Heavy travel day starts with brief grounding of all American Airlines flights
Navy QB Blake Horvath's 95-yard TD run in Armed Forces Bowl win is longest play in school historyDENVER — The Denver Broncos signed left tackle Garett Bolles to a four-year extension on Thursday, locking up a big piece to protect rookie quarterback Bo Nix. Bolles has spent his entire career with the organization after being drafted out of Utah with the 20th overall pick in 2017. He has a chance this season to help the Broncos into the postseason for the first time since they won Super Bowl 50 after the 2015 season. The Broncos (8-5) are currently in the seventh and final playoff spot in the AFC. They can put some distance between them and Indianapolis on Sunday (6-7) with a win over the Colts. After an up-and-down start in Denver, Bolles has developed into a dependable pass protector. He's allowed one sack and 24 quarterback pressures over 13 starts this season. What's more, his 4.9 percent quarterback pressure rate is the second-lowest mark among tackles with at least 200 pass blocking snaps this season, according to NextGen Stats. With time to scan the field, Nix leads all rookies in completions (277), yards passing (2,842), offensive touchdowns (22) and passing touchdowns (17). Bolles earned second-team Associated Press All-Pro honors after the 2020 season. On social media , Bolles posted: “Broncos Country, It’s been a great 8 years! Thanks for everything! And ... I’m not leaving. The show goes on!” Since 2017, Bolles has allowed the sixth-fewest sacks (36) among tackles with at least 3,100 snaps. The extension of Bolles means the Broncos have all five starting offensive linemen on board through next season. Guard Quinn Meinerz agreed to four-year contract extension in July. The Broncos also signed cornerback Patrick Surtain II to a four-year contract extension in September worth $96 million, including $77.5 million in guarantees. Linebacker Jonathon Cooper agreed to a four-year, $60 million extension in November.Jimmy Carter biographer E. Stanley Godbold reflects on the life of former President Jimmy Carter on ‘Fox News Live.’ Jimmy Carter, the 39th president of the United States, was long associated with peanuts — an enduring symbol of his humble beginnings and a testament to the values of hard work that he embraced during his lifetime. Before entering the political arena, Carter, who passed away at age 100 on Sunday, Dec. 29, 2024, managed his family's peanut farm in Plains, Georgia, according to the National Park Service (NPS). "The key to peanut harvest was the threshing machine, which we called a ‘picker’ because it picked the nuts from the vines ," said Carter, the NPS noted. JIMMY CARTER SPENT NEARLY 2 YEARS IN HOSPICE CARE BEFORE HIS DEATH "It was most often driven by a flat belt from the rear axle or wheel of a truck , and the dried stacks were hauled to it on wooden sleds, each pulled by a mule," Carter also said, the same source reported. He added, "This was a big and important operation and involved all the men on the place." President Jimmy Carter, who passed away on Dec. 29, 2024, grew up on his family's peanut farm, eventually expanding it into a profitable business. (National Park Service) After his father passed, Carter resigned from the U.S. Navy in 1953. He saw fortune in expanding the three acres of peanuts on the farm. For more Lifestyle articles, visit www.foxnews.com/lifestyle Carter began growing peanut seeds himself, opening "Carter’s Warehouse," which sold seeds and shelling. President Carter was a peanut farmer in Georgia before entering the political arena. (Jessica McGowan/Getty Images) The agri-business also supplied corn, ginned cotton, liquid nitrogen, bulk fertilizer and lime. Carter’s connection to peanuts became a defining feature of his public image. CLICK HERE TO SIGN UP FOR OUR LIFESTYLE NEWSLETTER It became a symbol for his White House bid, reflecting his dedication to representing everyday Americans. The Jimmy Carter Presidential Campaign Committee even handed out bags of peanuts with "Jimmy Carter for President" during his run against Republican Gerald Ford. Carter's favorite crop followed him throughout his lifetime. (Smithsonian Institution) In Oct. 1977, President Carter and first lady Rosalynn Carter hosted a Peanut Brigade Party. CLICK HERE TO GET THE FOX NEWS APP The First Family hosted 500 Georgian supporters on the South Lawn for a barbecue and boiled peanuts , according to the White House Historical Association (WHAA).
Pune: The Pimpri Chinchwad Municipal Corporation (PCMC) faces objection from residents in acquiring land for its solid waste transfer stations planned across the city. The civic body has proposed a ₹ 46-crore project to set up 16 stations. The solid waste transfer stations serve as hubs where waste collected in small vehicles is transferred to big garbage compactors before it is transported to the Moshi garbage depot. The PCMC’s plan to set up the stations in areas like Pimpri, Akurdi, Nigdi and Chinchwad could not kick off as residents expressed concerns over the proximity of these facilities to residential neighbourhoods. Sanjay Kulkarni, chief engineer (environment), PCMC, said, “The stations are designed using advanced technology to ensure it does not affect neighbourhood and eliminate the transfer of waste in the open.” Despite public opposition, PCMC has constructed three stations in Gawalimatha, Kalewadi, and Kasarwadi and work is on to set up the facility in Sangvi and Kiwale. According to a civic official, the estimated construction and machinery cost of each station is ₹ 2 crore.
Orchid Island Capital, Inc. ( NYSE:ORC – Get Free Report ) declared a monthly dividend on Tuesday, December 10th, Wall Street Journal reports. Shareholders of record on Tuesday, December 31st will be given a dividend of 0.12 per share by the real estate investment trust on Thursday, January 30th. This represents a $1.44 annualized dividend and a yield of 18.27%. The ex-dividend date is Tuesday, December 31st. Orchid Island Capital has increased its dividend payment by an average of 164.3% per year over the last three years. Orchid Island Capital has a payout ratio of 576.0% meaning the company cannot currently cover its dividend with earnings alone and is relying on its balance sheet to cover its dividend payments. Equities research analysts expect Orchid Island Capital to earn $0.22 per share next year, which means the company may not be able to cover its $1.44 annual dividend with an expected future payout ratio of 654.5%. Orchid Island Capital Price Performance ORC opened at $7.88 on Friday. The business has a 50 day simple moving average of $7.85 and a 200-day simple moving average of $8.09. Orchid Island Capital has a 12 month low of $7.41 and a 12 month high of $9.08. The stock has a market capitalization of $629.22 million, a P/E ratio of 7.50 and a beta of 1.84. About Orchid Island Capital ( Get Free Report ) Orchid Island Capital, Inc, a specialty finance company, invests in residential mortgage-backed securities (RMBS) in the United States. The company’s RMBS is backed by single-family residential mortgage loans, referred as Agency RMBS. Its portfolio includes traditional pass-through Agency RMBS, such as mortgage pass through certificates and collateralized mortgage obligations; and structured Agency RMBS comprising interest only securities, inverse interest only securities, and principal only securities. See Also Receive News & Ratings for Orchid Island Capital Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Orchid Island Capital and related companies with MarketBeat.com's FREE daily email newsletter .Best Stock to Buy Right Now: Costco vs. Walmart
Heavy travel day starts with brief grounding of all American Airlines flightsHeavy travel day starts with brief grounding of all American Airlines flights
CHARLOTTE, N.C. — Front Row Motorsports, one of two teams suing NASCAR in federal court, accused the stock car series Thursday of rejecting the planned purchase of a valuable charter unless the lawsuit was dropped. Front Row made the claim in a court filing and said it involved its proposed purchase of the charter from Stewart-Haas Racing. Front Row said the series would only approve it if Front Row and 23XI Racing dropped their court case. "Specifically, NASCAR informed us that it would not approve the (charter) transfer unless we agreed to drop our current antitrust lawsuit against them," Jerry Freeze, general manager of Front Row, said in an affidavit filed in the U.S. District Court of Western North Carolina. The two teams in September refused to sign NASCAR's "take-it-or-leave-it" final offer on a new revenue sharing agreement. All other 13 teams signed the deal. Front Row and 23XI balked and are now in court. 23XI co-owner Michael Jordan has said he took the fight to court on behalf of all teams competing in the top motorsports series in the United States. NASCAR has argued that the two teams simply do not like the terms of the final charter agreement and asked for the lawsuit be dismissed. Earlier this week, the suit was transferred to a different judge than the one who heard the first round of arguments and ruled against the two teams in their request for a temporary injunction to be recognized in 2025 as chartered teams as the case proceeds. The latest filing is heavily redacted as it lays out alleged retaliatory actions by NASCAR the teams say have caused irreparable harm. Both Front Row and 23XI want to expand from two full-time cars to three, and have agreements with SHR to purchase one charter each as SHR goes from four cars to one for 2025. The teams can still compete next season but would have to do so as "open" teams that don't have the same protections or financial gains that come from holding a charter. Freeze claimed in the affidavit that Front Row signed a purchase agreement with SHR in April and NASCAR President Steve Phelps told Freeze in September the deal had been approved. But when Front Row submitted the paperwork last month, NASCAR began asking for additional information. A Dec. 4 request from NASCAR was "primarily related to our ongoing lawsuit with NASCAR," Freeze said. "NASCAR informed us on December 5, 2024, that it objected to the transfer and would not approve it, in contrast to the previous oral approval for the transfer confirmed by Phelps before we filed the lawsuit," Freeze said. "NASCAR made it clear that the reason it was now changing course and objecting to the transfer is because NASCAR is insisting that we drop the lawsuit and antitrust claims against it as a condition of being approved." A second affidavit from Steve Lauletta, the president of 23XI Racing, claims NASCAR accused 23XI and Front Row of manufacturing "new circumstances" in a renewed motion for an injunction and of a "coordinated effort behind the scenes." "This is completely false," Lauletta said. Front Row is owned by businessman Bob Jenkins, while 23XI is owned by retired NBA Hall of Famer Jordan, three-time Daytona 500 winner Denny Hamlin and longtime Jordan adviser Curtis Polk. NASCAR had been operating with 36 chartered teams and four open spots since the charter agreement began in 2016. NASCAR now says it will move forward in 2025 with 32 chartered teams and eight open spots, with offers on charters for Front Row and 23XI rescinded and the SHR charters in limbo. The teams contend they must be chartered under some of their contractual agreements with current sponsors and drivers, and competing next year as open teams will cause significant losses. "23XI exists to compete at the highest level of stock car racing, striving to become the best team it can be. But that ambition can only be pursued within NASCAR, which has monopolized the market as the sole top-tier circuit for stock car racing," Lauletta said. "Our efforts to expand – purchasing more cars and increasing our presence on the track – are integral to achieving this goal. "It is not hypocritical to operate within the only system available while striving for excellence and contending for championships," he continued. "It is a necessity because NASCAR's monopoly leaves 23XI no alternative circuit, no different terms, and no other viable avenue to compete at this level." Get local news delivered to your inbox!
100 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 WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL- ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI ® . Initiate treatment with TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI ® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life- threatening reactions, can occur in patients receiving TECVAYLI ® . Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI ® until neurologic toxicity resolves or permanently discontinue based on severity. TECVAYLI ® is available only through a restricted program called the TECVAYLI ® and TALVEY ® Risk Evaluation and Mitigation Strategy (REMS). 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: 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 . Media contacts: Sarah Freeman sfreem21@its.jnj.com Christie Corbett ccorbet6@its.jnj.com Investor contact: Lauren Johnson investor-relations@its.jnj.com U.S. Medical Inquiries +1 800 526-7736 View original content to download multimedia: https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-demonstrates-potential-as-frontline-combination-therapy-for-patients-with-newly-diagnosed-multiple-myeloma-302325575.html SOURCE Johnson & Johnson