nice888ph

nice888ph NoneSyrian insurgents reach the capital's suburbs. Worried residents flee and stock up on supplies

Minnesotans break their own record with $37 million donated to local nonprofits on Give to the Max DayNone

None

YXT.com Reports Unaudited Financial Results for the First Nine Months of 2024

Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif. , Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO ® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. The data are from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8 , at 2 p.m. PT at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego . "Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients," said Jay Bradner , M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "These powerful new data leave us little doubt about the profound impact of this medicine for a large number of children affected by this disease. We are grateful to the Children's Oncology Group, along with the patients, families and clinical teams, for their dedication and partnership in advancing this critical study to improve the lives of children with cancer." Based on the results of the first pre-specified interim analysis for efficacy, the study met its primary endpoint of DFS and study randomization was terminated early based on the recommendation from the data and safety monitoring committee due to the benefit observed in the BLINCYTO arm compared to the chemotherapy-only arm. Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO. At 3 years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone. "The AALL1731 study results are truly practice-changing, further solidifying blinatumomab's role as the standard of care for a large number of children with B-ALL," said Sumit Gupta , M.D., Ph.D., FRCPC, co-chair of the Children's Oncology Group AALL1731 study and oncologist and clinician investigator, Division of Haematology/Oncology at The Hospital for Sick Children (SickKids) and associate professor of pediatrics at the University of Toronto . "These breakthrough data showing a significant improvement in disease-free survival are poised to bring substantial clinical value to children with newly diagnosed B-ALL." The addition of BLINCYTO to chemotherapy in standard risk patients resulted in outcomes similar to those previously achieved in only the most favorable pediatric risk subsets. Among SR-Average patients, 3-year DFS was 97.5% for patients treated with BLINCYTO compared to 90.2% for those treated with only chemotherapy (HR 0.33, CI 0.15-0.69). For SR-High patients, 3-year DFS was 94.1% for those treated with BLINCYTO compared to 84.8% for those treated with only chemotherapy (HR 0.45, 95% CI 0.24-0.85). "Relapsed ALL remains a major cause of pediatric cancer mortality, with nearly half of the relapses occurring in children with standard-risk B-ALL," said Rachel E. Rau , M.D., co-chair of the Children's Oncology Group AALL1731 study, pediatric hematologist-oncologist at Seattle Children's Hospital and associate professor of pediatrics at the University of Washington . "These findings underscore the progress made with blinatumomab in preventing relapse and support its role as a critical addition to current therapeutic strategies." Safety results are consistent with the known safety profile of BLINCYTO. BLINCYTO has demonstrated a positive balance of benefits and risks, with only 0.3% of first courses associated with Grade 3+ cytokine release syndrome (CRS) and 0.7% with seizures. A higher risk of infections was observed in the BLINCYTO arm. These results provide the first evidence supporting BLINCYTO for use in the consolidation phase in newly diagnosed pediatric Philadelphia chromosome-negative (Ph-) B-ALL patients. This groundbreaking first-in-class Bispecific T-cell Engager (BiTE ® ) therapy is now backed by additional evidence reinforcing its role in redefining a standard of care for both adult and pediatric patients, starting from one month old, regardless of measurable residual disease (MRD) status. The findings further establish BLINCYTO as a versatile first-line consolidation therapy across all ages and treatment backbones. The NCI's Cancer Therapy Evaluation Program (CTEP), which sponsored the study will share data with the U.S. Food and Drug Administration as part of their ongoing communications relating to the trial. About The Children's Oncology Group The Children's Oncology Group (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world's largest organization devoted exclusively to childhood and adolescent cancer research. The Children's Oncology Group unites over 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities and cancer centers across North America , Australia , New Zealand and Saudi Arabia in the fight against childhood cancer. Today, more than 80% of the 15,000 children and adolescents diagnosed with cancer each year in the United States are cared for at Children's Oncology Group member institutions. Research performed by Children's Oncology Group institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 86%. The Children's Oncology Group's mission is to improve the cure rate and outcomes for all children with cancer. About AALL1731 (NCT03914625) The AALL1731 study was a Phase 3 randomized trial to determine if two non-sequential cycles of BLINCYTO added to chemotherapy improved disease-free survival (DFS) in children with newly diagnosed pediatric National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL). The study enrolled 4,264 newly diagnosed NCI SR B-ALL patients, of whom 2,334 were risk stratified at the end of induction therapy as either SR-Average or SR-High. At the first planned interim efficacy analysis (data cutoff June 30, 2024 ), 1,440 of the eligible and evaluable patients had been randomized. The AALL1731 study was designed and conducted independently from industry. The Cancer Therapy Evaluation Program (CTEP) of the NCI sponsored the trial and provided funding to the Children's Oncology Group to conduct the study. NCI is part of the National Institutes of Health (NIH). In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement. About Acute Lymphoblastic Leukemia (ALL) ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen and central nervous system. ALL is a rare disease, with an estimated 6,550 new cases, affecting both children and adults, diagnosed in the U.S. in 2024. 1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow. 2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults and approximately 88% in children, the most common cancer in children. 4,5 About BLINCYTO ® (blinatumomab) BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE ® ) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE ® molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE ® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers. BLINCYTO was granted Breakthrough Therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of: In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of: BLINCYTO ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Contraindications BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation. Warnings and Precautions Adverse Reactions Dosage and Administration Guidelines INDICATIONS BLINCYTO ® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with: Please see BLINCYTO ® full Prescribing Information , including BOXED WARNINGS. About Bispecific T-Cell Engager (BiTE ® ) Technology BiTE technology is a targeted immuno-oncology platform that is designed to engage a patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different cancer types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T-cell treatment available to all providers when their patients need it. For more than a decade, Amgen has been advancing this innovative technology, which has demonstrated strong efficacy in hematological malignancies and now a solid tumor with the approval of IMDELLTRA. Amgen remains committed to progressing multiple BiTE molecules across a broad range of hematologic and solid tumor malignancies, paving the way for additional applications in more tumor types. Amgen is further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit BiTE ® Technology 101 . About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads . Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), Amgen's acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on Amgen's acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on Amgen's business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no guarantee that Amgen will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen's information technology systems could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Elissa Snook , 609-251-1407 (media) Justin Claeys , 805-313-9775 (investors) References View original content to download multimedia: https://www.prnewswire.com/news-releases/blincyto-blinatumomab-added-to-chemotherapy-significantly-improves-survival-in-newly-diagnosed-pediatric-patients-with-b-cell-precursor-acute-lymphoblastic-leukemia-b-all-302325381.html SOURCE AmgenSteer goes viral after walking through Tim Horton’s drive thru in central Alberta

Guardiola denies rift with De Bruyne during Man City's dramatic slumpSaquon Barkley has become the Shohei Ohtani of the NFL. There's no better home run hitter playing football right now. Barkley had touchdown runs of 72 and 70 yards for the Philadelphia Eagles in a 37-20 victory over the Los Angeles Rams on Sunday night. He now has five runs of 50-plus yards this season and is on pace to break Eric Dickerson's single-season record of 2,105 yards set in 1984. Barkley's historic performance against the Rams — his 255 yards set a team record — captivated a national audience and turned him into a fan favorite for the AP NFL MVP award. He's not the betting favorite, however. Josh Allen has the best odds at plus-150, according to Bet MGM Sportsbook. Two-time MVP Lamar Jackson is next at plus-250 followed by Barkley at plus-400. Running backs have won the award 18 times, including three-time winner Jim Brown, who was the AP's first NFL MVP in 1957. Quarterbacks have dominated the award, winning it 45 times. Only three players who weren't QBs or RBs have been MVP. It takes a special season for a non-QB to win it mainly because the offense goes through the signal caller. Quarterbacks handle the ball every offensive snap, run the show and get the credit when things go well and the blame when it doesn't. Adrian Peterson was the most recent non-QB to win it when he ran for 2,097 yards and 12 touchdowns for the Minnesota Vikings in 2012. Playing for a winning team matters, too. Nine of the past 11 winners played for a No. 1 seed with the other two winners on a No. 2 seed. The Vikings earned the sixth seed when Pederson was MVP. Barkley is a major reason why the Eagles (9-2) are leading the NFC East and only trail Detroit (10-1) by one game for the top spot in the conference. Does he have a realistic chance to win the MVP award? Kicker Mark Moseley was the MVP in the strike-shortened 1982 season when he made 20 of 21 field goals and 16 of 19 extra points in nine games for Washington. If voters once selected a kicker, everyone has a chance, especially a game-changer such as Barkley. Defensive tackle Alan Page was the MVP in 1971 and linebacker Lawrence Taylor won it in 1986. Running back Christian McCaffrey finished third in voting last year and wide receiver Justin Jefferson placed fifth in 2022. The Offensive Player of the Year award and Defensive Player of the Year award recognize the best all-around players on both sides of the ball, allowing voters to recognize non-QBs if they choose. Wide receivers and running backs have won the AP OPOY award seven times over the past 11 seasons. McCaffrey was the 2023 winner. The AP's new voting format introduced in 2022 also gives non-QBs a better opportunity to get MVP recognition. Voter submit their top five picks for each award, with a weighted point system. Previously, voters made one choice for each award. A nationwide panel of 50 media members who regularly cover the league vote for MVP and seven other awards. The awards are based on regular-season performance. The Chiefs (10-1) and Bills (9-2) already are in position to lock up postseason berths right after Thanksgiving. Kansas City clinches a playoff berth with a win over Las Vegas on Black Friday and a loss by Miami on Thursday night, or a win plus a loss by Denver on Monday night. Buffalo can wrap up a fifth straight AFC East title with a victory over San Francisco on Sunday and a loss by the Dolphins. It's not a given that the Dallas Cowboys will be looking for a new head coach after this season. Owner Jerry Jones said Tuesday on local radio that Mike McCarthy could end up getting a contract extension. "I don't think that's crazy at all. This is a Super Bowl-winning coach. Mike McCarthy has been there and done that. He has great ideas. We got a lot of football left," Jones said. McCarthy led the Cowboys (4-7) to three straight 12-win seasons, but they went 1-3 in the playoffs and haven't reached the NFC championship game since winning the Super Bowl 29 years ago. Injuries have contributed to the team's struggles this season, but Dallas was just 3-5 before Dak Prescott was lost for the rest of the season. The Cowboys upset Washington last week and their next four games are against teams that currently have losing records. If they somehow end up 9-8 or even 8-9, Jones could make a case for keeping McCarthy. Get local news delivered to your inbox!

ISLAMABAD (AP) — Pakistani security forces launched an operation Tuesday night to disperse supporters of imprisoned former Prime Minister Imran Khan who had gathered in the capital to demand his release from prison. The latest development came hours after thousands of Khan supporters, defying government warnings, broke through a barrier of shipping containers blocking off Islamabad and entered a high-security zone, where they clashed with security forces, facing tear gas shelling, mass detentions and gunfire. Tension has been high in Islamabad since Sunday when supporters of the former prime minister began a “long march” from the restive northwest to demand his release. Khan has been in a prison for over a year and faces more than 150 criminal cases that his party says are politically motivated. Khan’s wife, Bushra Bibi, led the protest, but she fled as police pushed back against demonstrators. Hundreds of Khan’s supporters are being arrested in the ongoing nighttime operation, and police are also seeking to arrest Bibi. Interior Minister Mohsin Naqvi told reporters that the Red Zone, which houses government buildings and embassies, and the surrounding areas have been cleared. Leaders from Khan's Pakistan Tehreek-e-Insaf party, or PTI, have also fled the protest site. Earlier Tuesday, Pakistan’s army took control of D-Chowk, a large square in the Red Zone, where visiting Belarusian President Alexander Lukashenko is staying. Since Monday, Naqvi had threatened that security forces would use live fire if protesters fired weapons at them. “We have now authorized the police to respond as necessary,” Naqvi said Tuesday while visiting the square. Before the operation began, protester Shahzor Ali said people had taken to the streets because Khan had called for them. “We will stay here until Khan joins us. He will decide what to do next,” Ali said. “If they fire bullets again, we will respond with bullets,” he said. Protester Fareeda Bibi, who is not related to Khan’s wife, said people have suffered greatly for the last two years. “We have really suffered for the last two years, whether it is economically, politically or socially. We have been ruined. I have not seen such a Pakistan in my life,” she said. Authorities have struggled to contain the protest-related violence. Six people, including four members of the security services, were killed when a vehicle rammed them on a street overnight into Tuesday. A police officer died in a separate incident. Dozens of Khan supporters beat a videographer covering the protest for The Associated Press and took his camera. He sustained head injuries and was treated in a hospital. By Tuesday afternoon, fresh waves of protesters made their way unopposed to their final destination in the Red Zone. Most demonstrators had the flag of Khan’s party around their shoulders or wore its tricolors on accessories. Naqvi said Khan’s party had rejected a government offer to rally on the outskirts of the city. Information Minister Atta Tarar warned there would be a severe government reaction to the violence. He said the government did not want Bushra Bibi to achieve her goal of freeing Khan. “She wants bodies falling to the ground. She wants bloodshed,” he said. The government says only the courts can order Khan’s release. He was ousted in 2022 through a no-confidence vote in Parliament. In a bid to foil the unrest, police have arrested more than 4,000 Khan supporters since Friday and suspended mobile and internet services in some parts of the country. Messaging platforms were also experiencing severe disruption in the capital. Khan’s party relies heavily on social media and uses messaging platforms such as WhatsApp to share information, including details of events. The X platform, which is banned in Pakistan, is no longer accessible, even with a VPN. Last Thursday, a court prohibited rallies in the capital and Naqvi said anyone violating the ban would be arrested. Travel between Islamabad and other cities has become nearly impossible because of shipping containers blocking the roads. All education institutions remain closed. Pakistan's Stock Exchange lost more than $1.7 billion Tuesday due to rising political tensions, according to economist Mohammed Sohail from Topline Securities. Associated Press writers Munir Ahmed in Islamabad and Asim Tanveer in Multan, Pakistan, contributed to this report.Adele Darlington suffered a massive bleed while giving birth to her daughter Jasmine just before Christmas last year. Mrs Darlington, 41, of Stockton Heath in Warrington, needed blood, plasma, cryoprecipitate and platelets during emergency surgery including a hysterectomy to save her life at the end of November 2023. “My husband was told to call in family to prepare to say goodbye, but thanks to everyone’s work I got to spend Christmas with my family and new daughter,” the mother-of-five said during an NHS appeal for Christmas and New Year blood donors. Mrs Darlington, who had placenta previa, a condition where the placenta partly or completely blocks the cervix, started bleeding during a planned C-section and lost 15 litres of blood in total. An average woman’s body contains just under five litres. After a four-hour operation during the C-section, she underwent another nine hours of surgery for a hysterectomy, tube and ovary removal and partial cervix and bladder removal. During surgery, Mrs Darlington received 28 units of red blood cells, 20 units of fresh frozen plasma, nine units of cryoprecipitate, and eight units of platelets – the biggest transfusion at the hospital since 2000. NHS Blood and Transplant’s Liverpool team had to send nine emergency orders overnight to Warrington Hospital for Mrs Darlington and other patients, as a huge team of nurses and doctors, including four surgeons operating at once, worked to save her life. To thank staff and support the Christmas appeal for blood donors, Mrs Darlington visited the regional centre which sent most of the blood for her care. Staff laid out the exact number of units of blood products she received to illustrate how much help she needed. Mrs Darlington said: “It’s been a really humbling experience to meet some of the people who sent blood when I had my transfusion, it’s been a really special day. “It was unbelievable to see the same quantity of blood that I received laid out, knowing that it took so many people to save me. I’m forever indebted to the more than 65 people who gave me the gift of life. “I never thought in a million years that this would happen to me, but trauma and the need for a lot of blood can happen to anyone at any time, including at Christmas, so I would urge anyone who is able to donate to please do so.” Mrs Darlington said she vaguely remember Jasmine being born during the C-section before she passed out. “By this point I’d already lost six litres of blood and it was thought that I’d stabilised, but in the recovery room it become evident that I was still internally bleeding so I was urgently rushed back into theatre,” she said. “They told me I needed a hysterectomy to save my life. “I had this sense of doom that I would not make it. “My blood pressure and heart rate were at dangerous levels. “I remember crying and saying: ‘I think I’m dying’, and telling the theatre staff that I was scared to go to sleep because I didn’t think I would wake up.” Mrs Darlington’s condition was so severe she developed disseminated intravascular coagulation (DIC), a blood-clotting problem in trauma patients so severe it is sometimes informally referred to as ‘death is coming’. “I was told it’s a medical miracle that I’m still here,” Mrs Darlington said. She added: “I’m still on a road to recovery I am just forever grateful that I am here. I am very aware that I shouldn’t be. “All of these amazing people worked together to save me. “Blood donors might think it’s not a big thing to donate – they donate and they have a hot drink and a biscuit – but I can’t thank them enough. “I will be eternally grateful to these selfless donors who took time to voluntarily donate and ultimately save my life.” Her husband Ian, who owns a media business, has signed up as a blood donor, along with many friends and family members. Julie Riley from NHSBT Liverpool Hospital Services, said: “I was on shift issuing the blood, and meeting Adele was absolutely beautiful. “We don’t normally get to meet anyone – we work in labs for eight hours a day. I am glad she got home for her little kiddies.” Michael Kay, NHSBT blood delivery driver, said: “It was the end of my shift but I stayed on to do a blue-light delivery and it’s just amazing to find out it went to Adele”. Chris Philips, NHSBT head of hospital customer service, said: “It was incredibly moving to see Adele visit our teams because that night is very clear in their memories – they won’t forget it any time soon. “This is an amazing example of NHS teams working together but without donors none of this would have happened.” England remains in amber alert for low blood stocks. To register or book an appointment to give blood, visit /, use the GiveBlood app or call 0300 123 23 23.

Maybe it's not the economy, stupidNoneAlex Ovechkin is expected to miss 4 to 6 weeks with a broken left legSEOUL, South Korea (AP) — The president of South Korea early Wednesday lifted the martial law he imposed on the country hours earlier, bending to political pressure after a tense night in which troops surrounded parliament and lawmakers voted to reject military rule. President Yoon Suk Yeol, who appeared likely to be impeached over his actions, imposed martial law late Tuesday out of frustration with the opposition, vowing to eliminate “anti-state” forces as he struggles against opponents who control parliament and that he accuses of sympathizing with communist North Korea. Police and military personnel were seen leaving the grounds of parliament following the bipartisan vote to overrule the president, and the declaration was formally lifted around 4:30 a.m. during a Cabinet meeting. Parliament acted swiftly after martial law was imposed, with National Assembly Speaker Woo Won Shik declaring that the law was “invalid” and that lawmakers would “protect democracy with the people.” In all, martial law was in effect for about six hours. The president’s surprising move harkened back to an era of authoritarian leaders that the country has not seen since the 1980s, and it was immediately denounced by the opposition and the leader of Yoon’s own conservative party. Lee Jae-myung , leader of the liberal Democratic Party, which holds the majority in the 300-seat parliament, said the party’s lawmakers would remain in the Assembly’s main hall until Yoon formally lifted his order. Woo applauded how troops quickly left the Assembly after the vote. “Even with our unfortunate memories of military coups, our citizens have surely observed the events of today and saw the maturity of our military,” Woo said. While announcing his plan to lift martial law, Yoon continued to criticize parliament’s attempts to impeach key government officials and senior prosecutors. He said lawmakers had engaged in “unscrupulous acts of legislative and budgetary manipulation that are paralyzing the functions of the state.” Jo Seung-lae, a Democratic lawmaker, claimed that security camera footage following Yoon’s declaration showed that troops moved in a way that suggested they were trying to arrest Lee, Woo and even Han Dong-hoon, the leader of Yoon’s People Power Party. Officials from Yoon’s office and the Defense Ministry did not respond to requests for comment early Wednesday. Seemingly hundreds of protesters gathered in front of the Assembly, waving banners and calling for Yoon’s impeachment. Some protesters scuffled with troops ahead of the lawmakers’ vote, but there were no immediate reports of injuries or major property damage. At least one window was broken as troops attempted to enter the Assembly building. One woman tried unsuccessfully to pull a rifle away from one of the soldiers, while shouting “Aren’t you embarrassed?” Under South Korea’s constitution, the president can declare martial law during “wartime, war-like situations or other comparable national emergency states” that require the use of military force to maintain peace and order. It was questionable whether South Korea is currently in such a state. When martial law is declared, “special measures” can be employed to restrict freedom of press, freedom of assembly and other rights, as well as the power of courts. The constitution also states that the president must oblige when the National Assembly demands the lifting of martial law with a majority vote. Following Yoon’s announcement of martial law, South Korea’s military proclaimed that parliament and other political gatherings that could cause “social confusion” would be suspended, South Korea’s Yonhap news agency said. The military said anyone who violated the decree could be arrested without a warrant. In Washington, the White House said the U.S. was “seriously concerned” by the events in Seoul. A spokesperson for the National Security Council said President Joe Biden’s administration was not notified in advance of the martial law announcement and was in contact with the South Korean government. Pentagon spokesman Maj. Gen. Pat Ryder said there was no effect on the more than 27,000 U.S. service members based in South Korea. The South Korean military also said that the country’s striking doctors should return to work within 48 hours, Yonhap said. Thousands of doctors have been striking for months over government plans to expand the number of students at medical schools. Soon after martial law was declared, the parliament speaker called on his YouTube channel for all lawmakers to gather at the National Assembly. He urged military and law enforcement personnel to “remain calm and hold their positions. All 190 lawmakers who participated in the vote supported the lifting of martial law. At one point, television footage showed police officers blocking the entrance of the National Assembly and helmeted soldiers carrying rifles in front of the building. An Associated Press photographer saw at least three helicopters, likely from the military, that landed inside the Assembly grounds, while two or three helicopters circled above the site. The leader of Yoon’s conservative party called the decision to impose martial law “wrong.” Lee, who narrowly lost to Yoon in the 2022 presidential election, said Yoon’s announcement was “illegal and unconstitutional.” Yoon said during a televised speech that martial law would help “rebuild and protect” the country from “falling into the depths of national ruin.” He said he would “eradicate pro-North Korean forces and protect the constitutional democratic order.” “I will eliminate anti-state forces as quickly as possible and normalize the country,” he said, while asking the people to believe in him and tolerate “some inconveniences.” Yoon — whose approval rating dipped in recent months — has struggled to push his agenda against an opposition-controlled parliament since taking office in 2022. His party has been locked in an impasse with the liberal opposition over next year’s budget bill. The opposition has also attempted to impeach three top prosecutors, including the chief of the central Seoul prosecutors’ office, in what the conservatives have called a vendetta against their criminal investigations of Lee, who has been seen as the favorite for the next presidential election in 2027 in opinion polls. During his televised announcement, Yoon also described the opposition as “shameless pro-North Korean anti-state forces who are plundering the freedom and happiness of our citizens.” He did not elaborate. Yoon has taken a hard line on North Korea over its nuclear ambitions, departing from the policies of his liberal predecessor, Moon Jae-in, who pursued inter-Korean engagement. Yoon has also dismissed calls for independent investigations into scandals involving his wife and top officials, drawing quick, strong rebukes from his political rivals. Yoon’s move was the first declaration of martial law since the country’s democratization in 1987. The country’s last previous martial law was in October 1979, following the assassination of former military dictator Park Chung-hee. Sydney Seiler, Korean chair at the Center for Strategic and International Studies, argued that the move was symbolic for Yoon to express his frustration with the opposition-controlled parliament. “He has nothing to lose,” said Seiler, comparing Yoon’s move to the Hail Mary pass in American football, with a slim chance of success. Now Yoon faces likely impeachment, a scenario that was also possible before he made the bold move, Seiler said. Natalia Slavney, research analyst at the Stimson Center’s 38 North website that focuses on Korean affairs, said Yoon’s imposition of martial law was “a serious backslide of democracy" that followed a “worrying trend of abuse” since he took office in 2022. South Korea “has a robust history of political pluralism and is no stranger to mass protests and swift impeachments,” Slavney said, citing the example of former President Park Geun-hye, the country’s first female president, who was ousted from office and imprisoned for bribery and other crimes in 2017 . Associated Press writers Hyung-jin Kim in Seoul, South Korea, and Matt Lee, Didi Tang and Tara Copp in Washington contributed to this report.

The Pittsburgh Steelers take on what is typically an unenviable task -- traveling on a short week for a Thursday night primetime game. However, a few things are playing in Pittsburgh's favor as Week 12 of the NFL regular season kicks off. Namely, the "trip" to Cleveland is a little more than two hours by road and when the Steelers arrive there, they'll be facing a backup quarterback at the helm of a massively underwhelming 2-8 Browns team. The Steelers (8-2) are coming off a huge win over Baltimore to stay atop the AFC North. And Pittsburgh is beginning to set its sights on potential home-field advantage come playoff time. ODDS AND TRENDS The Steelers are a consensus 3.5-point favorite. That includes at BetRivers, where they have been backed by 80 percent of the spread-line money. Pittsburgh's -195 moneyline to simply win the game has been even more popular, drawing 95 percent of all money wagered. The Browns enter Thursday night having failed to cover the spread in nine of their past 12 games. Meanwhile, the Steelers have covered the spread in every game during their five-game win streak. The 37.0 total points line has seen the Over backed by 65 percent of the money and 70 percent of the total bets. Each of Cleveland's past eight November home games has gone under the total points line. PROP PICKS --Steelers WR George Pickens Over 50 Receiving Yards (-195 at DraftKings): Russell Wilson has thrown six touchdowns in the four games since he took over as the starting quarterback. Two of those have gone to Pickens, who has at least 74 receiving yards in each of those games. There is some concern that Pittsburgh gains a big early lead and turns to a run-heavy attack, but Wilson throws an excellent deep ball and that plays into Pickens' strength. This is the most popular player prop at the book. --Steelers RB Najee Harris Anytime TD (+100 at BetRivers): That potential for a run-heavy approach should benefit Harris, who found the sledding tough against Baltimore with 63 yards on the ground. He was also held out of the end zone for the second time in three games. Keep in mind that Cleveland has allowed only three touchdowns on the ground all season, but the Browns have allowed 12 through the air. Harris has a trio of scores on the ground and receiving through 10 games. KEY STAT The Browns have won the first quarter in five consecutive home games against the Steelers. THE NEWS The Steelers have certainly been locked in. They are currently riding a five-game winning streak, most recently edging the Baltimore Ravens 18-16 on Sunday. Chris Boswell booted six field goals against Baltimore, while Wilson completed 23 of 36 passes for 205 yards and an interception. Meanwhile, Cleveland continues to go through the wringer. The Browns ended up on the wrong end of a 35-14 blowout while facing the host New Orleans Saints on Sunday, marking their seventh loss in the past eight games. Cleveland now has to go up against one of the most unforgiving defenses in the league. Browns quarterback Jameis Winston is determined to direct a fundamentally sound performance against Pittsburgh, which allows the second-fewest points per game in the NFL (16.2). "It's precision passing. Getting the ball out on time. Elite operation and just doing our job. It's the simple things," Winston said. "This team (the Steelers) is not going to try and fool you. They're going to line up and say, 'Give us your best, we're going to give you our best.'" Winston threw for 395 yards and two touchdowns on 30-for-46 passing in the setback against New Orleans, with Jerry Jeudy hauling in six catches for 142 yards and a score. Star running back Nick Chubb continued to struggle since his return from a knee injury that cut his 2023 season short, finishing with 50 yards on 11 carries. INJURY REPORT The Browns could be without standout defensive end Myles Garrett, who missed practice on Tuesday because of a hip injury. Wide receiver Elijah Moore (shoulder), guard Joel Bitonio (pectoral) and cornerbacks Denzel Ward (ribs/ankle) and Greg Newsome II (shoulder) were among those limited during the session. Linebacker Alex Highsmith is dealing with an ankle issue and was ruled out by the Steelers along with cornerback Cory Trice Jr. (hamstring). THEY SAID IT Wilson is starting to feel like he might be part of something special, but he also doesn't want Pittsburgh to get ahead of itself. "I definitely think that we have a chance (to make a deep playoff run)," said Wilson, who has played in two Super Bowls. "I think the biggest thing for us is continuing to just take each week as the most important week of it all. "I think that it's not really even just the week, it's just the day, it's just the moments in between. I think the greatest teams, the greatest players, in any sport, especially the teams I've been on, is the moment -- it's never too far away. It's right here, right now. And you're just locked into that." PREDICTION Divisional road games on short weeks typically shape up as a daunting task. That's not the case for the Steelers, who will be hyper-focused to put this one out of reach early before enjoying 10 days ahead of a trip to Cleveland. With a second game against the Browns before a huge game at Philadelphia, this is not an under-manned opponent Pittsburgh will look past. --Steelers 27, Browns 19 --Field Level Media

Flag football scours nation with talent camps to uncover next wave of stars DENVER (AP) — So you're the most valuable player of that annual Thanksgiving Day backyard flag football game. Or played tackle football on any level. Or ran track. Or dabbled in basketball. Or toyed with any sport, really. Pat Graham, The Associated Press Nov 26, 2024 2:17 PM Nov 26, 2024 2:20 PM Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message This photo provided by USA Football shows U.S. National Team flag football player Bruce Mapp playing against Brazil at the 2024 IFAF Flag Football World Championships at the Pajulahti Olympic Training Center in Lahti, Finland, Aug. 27, 2024. (Lester Barnes/USA Football via AP) DENVER (AP) — So you're the most valuable player of that annual Thanksgiving Day backyard flag football game. Or played tackle football on any level. Or ran track. Or dabbled in basketball. Or toyed with any sport, really. Well, this may be just for you: USA Football is holding talent identification camps all over the country to find that next flag football star. It's “America’s Got Talent” meets “American Idol,” with the stage being the field and the grand prize a chance to compete for a spot on a national team. Because it’s never too early to start planning for the 2028 Olympics in Los Angeles, where flag football will make its Summer Games debut. Know this, though — it's not an easy team to make. The men's and women's national team rosters are at “Dream Team” status given the men’s side has captured six of the last seven world championships and the women three in a row. To remain on top, the sport's national governing body is scouring every football field, park, track, basketball court and gym to find hidden talent to cultivate. USA Football has organized camps and tryouts from coast to coast for anyone ages 11 to 23. There are more than a dozen sites set up so far, ranging from Dallas (Sunday) to Chicago (Dec. 14) to Tampa (March 29) to Los Angeles (TBD) and the Boston area (April 27), where it will be held at Gillette Stadium, home of the New England Patriots. The organization has already partnered with the NFL on flag football initiatives and programs. The numbers have been through the roof, with engagement on social media platforms increasing by 86% since flag football was announced as an Olympic invitational sport in October 2023 . The participation of boys and girls ages 6 to 17 in flag football last year peaked at more than 1.6 million, according to USA Football research. “We pride ourselves on elevating the gold standard across the sport,” said Eric Mayes, the managing director of the high performance and national teams for USA Football. “We want to be the best in the world — and stay the best in the world.” Flag football was one of five new sports added to the LA28 program. The already soaring profile of American football only figures to be enhanced by an Olympic appearance. Imagine, say, a few familiar faces take the field, too. Perhaps even NFL stars such as Tyreek Hill or Patrick Mahomes, maybe even past pro football greats donning a flag belt for a country to which they may have ties. Soon after flag football's inclusion, there was chatter of NFL players possibly joining in on the fun. Of course, there are logistical issues to tackle before their inclusion at the LA Olympics, which open July 14, 2028. Among them, training camp, because the Olympics will be right in the middle of it. The big question is this: Will owners permit high-priced players to duck out for a gold-medal pursuit? No decisions have yet been made on the status of NFL players for the Olympics. For now, it's simply about growing the game. There are currently 13 states that sanction girls flag football as a high school varsity sport. Just recently, the Pittsburgh Steelers and Philadelphia Eagles helped pave the way to get it adopted in Pennsylvania. Around the world, it's catching on, too. The women's team from Japan took third at the recent word championships, while one of the best players on the planet is Mexico quarterback Diana Flores . “Could flag football globally become the new soccer? That’s something to aspire to," said Stephanie Kwok , the NFL's vice president of flag football. This type of flag football though, isn't your Thanksgiving Day game with family and friends. There's a learning curve. And given the small roster sizes, versatility is essential. Most national team members need to be a version of Colorado’s two-way standout and Heisman hopeful Travis Hunter. Forget bump-and-run coverage, too, because there's no contact. None. That took some adjusting for Mike Daniels, a defensive back out of West Virginia who earned a rookie minicamp invitation with the Cleveland Browns in 2017. “If a receiver is running around, I’m thinking, ‘OK, I can kind of bump him here and there and nudge him,’” Daniels explained. “They’re like, ‘No, you can’t.’ I’m just like, ‘So I’m supposed to let this guy just run?!’ I really rebelled at the idea at first. But you learn.” The competition for an Olympic roster spot is going to be fierce because only 10 players are expected to make a squad. The best 10 will earn it, too, as credentials such as college All-American or NFL All-Pro take a backseat. “I would actually love" seeing NFL players try out, said Daniels, who's also a personal trainer in Miami. “I’m not going to let you just waltz in here, thinking, ‘I played NFL football for five years. I’m popular. I have a huge name.’ I’m still better than you and I'm going to prove it — until you prove otherwise.” Around the house, Bruce Mapp constantly swivels his hips when turning a hallway corner or if his daughter tries to reach for a hug. It’s his way of working on avoiding a “defender” trying to snare the flag. That approach has earned the receiver out of Coastal Carolina four gold medals with USA Football. The 31-year-old fully plans on going for more gold in Los Angeles. “You grow up watching Usain Bolt (win gold) and the ‘Redeem Team’ led by Kobe Bryant win a gold medal, you're always thinking, ‘That's insane.' Obviously, you couldn't do it in your sport, because I played football," said Mapp, who owns a food truck in the Dallas area. "With the Olympics approaching, that (gold medal) is what my mind is set on." It's a common thought, which is why everything — including talent camps — starts now. “Everybody thinks, ‘Yeah, the U.S. just wins,’” Daniels said. “But we work hard all the time. We don’t just walk in. We don’t just get off the bus thinking, ‘We’re going to beat people.’” ___ AP NFL: https://apnews.com/hub/nfl and https://twitter.com/AP_NFL Pat Graham, The Associated Press See a typo/mistake? Have a story/tip? This has been shared 0 times 0 Shares Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message Get your daily Victoria news briefing Email Sign Up More Football (CFL) Bombers GM Walters sees no need to blow up roster despite another Grey Cup loss Nov 26, 2024 2:11 PM Calgary Stampeders acquire quarterback Vernon Adams Jr. from B.C. Lions Nov 26, 2024 11:06 AM Former Tiger-Cats player, general manager Joe Zuger dead at 84 Nov 26, 2024 7:58 AMPhase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif. , Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO ® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. The data are from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8 , at 2 p.m. PT at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego . "Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients," said Jay Bradner , M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "These powerful new data leave us little doubt about the profound impact of this medicine for a large number of children affected by this disease. We are grateful to the Children's Oncology Group, along with the patients, families and clinical teams, for their dedication and partnership in advancing this critical study to improve the lives of children with cancer." Based on the results of the first pre-specified interim analysis for efficacy, the study met its primary endpoint of DFS and study randomization was terminated early based on the recommendation from the data and safety monitoring committee due to the benefit observed in the BLINCYTO arm compared to the chemotherapy-only arm. Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO. At 3 years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone. "The AALL1731 study results are truly practice-changing, further solidifying blinatumomab's role as the standard of care for a large number of children with B-ALL," said Sumit Gupta , M.D., Ph.D., FRCPC, co-chair of the Children's Oncology Group AALL1731 study and oncologist and clinician investigator, Division of Haematology/Oncology at The Hospital for Sick Children (SickKids) and associate professor of pediatrics at the University of Toronto . "These breakthrough data showing a significant improvement in disease-free survival are poised to bring substantial clinical value to children with newly diagnosed B-ALL." The addition of BLINCYTO to chemotherapy in standard risk patients resulted in outcomes similar to those previously achieved in only the most favorable pediatric risk subsets. Among SR-Average patients, 3-year DFS was 97.5% for patients treated with BLINCYTO compared to 90.2% for those treated with only chemotherapy (HR 0.33, CI 0.15-0.69). For SR-High patients, 3-year DFS was 94.1% for those treated with BLINCYTO compared to 84.8% for those treated with only chemotherapy (HR 0.45, 95% CI 0.24-0.85). "Relapsed ALL remains a major cause of pediatric cancer mortality, with nearly half of the relapses occurring in children with standard-risk B-ALL," said Rachel E. Rau , M.D., co-chair of the Children's Oncology Group AALL1731 study, pediatric hematologist-oncologist at Seattle Children's Hospital and associate professor of pediatrics at the University of Washington . "These findings underscore the progress made with blinatumomab in preventing relapse and support its role as a critical addition to current therapeutic strategies." Safety results are consistent with the known safety profile of BLINCYTO. BLINCYTO has demonstrated a positive balance of benefits and risks, with only 0.3% of first courses associated with Grade 3+ cytokine release syndrome (CRS) and 0.7% with seizures. A higher risk of infections was observed in the BLINCYTO arm. These results provide the first evidence supporting BLINCYTO for use in the consolidation phase in newly diagnosed pediatric Philadelphia chromosome-negative (Ph-) B-ALL patients. This groundbreaking first-in-class Bispecific T-cell Engager (BiTE ® ) therapy is now backed by additional evidence reinforcing its role in redefining a standard of care for both adult and pediatric patients, starting from one month old, regardless of measurable residual disease (MRD) status. The findings further establish BLINCYTO as a versatile first-line consolidation therapy across all ages and treatment backbones. The NCI's Cancer Therapy Evaluation Program (CTEP), which sponsored the study will share data with the U.S. Food and Drug Administration as part of their ongoing communications relating to the trial. About The Children's Oncology Group The Children's Oncology Group (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world's largest organization devoted exclusively to childhood and adolescent cancer research. The Children's Oncology Group unites over 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities and cancer centers across North America , Australia , New Zealand and Saudi Arabia in the fight against childhood cancer. Today, more than 80% of the 15,000 children and adolescents diagnosed with cancer each year in the United States are cared for at Children's Oncology Group member institutions. Research performed by Children's Oncology Group institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 86%. The Children's Oncology Group's mission is to improve the cure rate and outcomes for all children with cancer. About AALL1731 (NCT03914625) The AALL1731 study was a Phase 3 randomized trial to determine if two non-sequential cycles of BLINCYTO added to chemotherapy improved disease-free survival (DFS) in children with newly diagnosed pediatric National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL). The study enrolled 4,264 newly diagnosed NCI SR B-ALL patients, of whom 2,334 were risk stratified at the end of induction therapy as either SR-Average or SR-High. At the first planned interim efficacy analysis (data cutoff June 30, 2024 ), 1,440 of the eligible and evaluable patients had been randomized. The AALL1731 study was designed and conducted independently from industry. The Cancer Therapy Evaluation Program (CTEP) of the NCI sponsored the trial and provided funding to the Children's Oncology Group to conduct the study. NCI is part of the National Institutes of Health (NIH). In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement. About Acute Lymphoblastic Leukemia (ALL) ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen and central nervous system. ALL is a rare disease, with an estimated 6,550 new cases, affecting both children and adults, diagnosed in the U.S. in 2024. 1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow. 2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults and approximately 88% in children, the most common cancer in children. 4,5 About BLINCYTO ® (blinatumomab) BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE ® ) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE ® molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE ® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers. BLINCYTO was granted Breakthrough Therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of: In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of: BLINCYTO ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Contraindications BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation. Warnings and Precautions Adverse Reactions Dosage and Administration Guidelines INDICATIONS BLINCYTO ® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with: Please see BLINCYTO ® full Prescribing Information , including BOXED WARNINGS. About Bispecific T-Cell Engager (BiTE ® ) Technology BiTE technology is a targeted immuno-oncology platform that is designed to engage a patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different cancer types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T-cell treatment available to all providers when their patients need it. For more than a decade, Amgen has been advancing this innovative technology, which has demonstrated strong efficacy in hematological malignancies and now a solid tumor with the approval of IMDELLTRA. Amgen remains committed to progressing multiple BiTE molecules across a broad range of hematologic and solid tumor malignancies, paving the way for additional applications in more tumor types. Amgen is further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit BiTE ® Technology 101 . About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads . Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), Amgen's acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on Amgen's acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on Amgen's business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no guarantee that Amgen will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen's information technology systems could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Elissa Snook , 609-251-1407 (media) Justin Claeys , 805-313-9775 (investors) References View original content to download multimedia: https://www.prnewswire.com/news-releases/blincyto-blinatumomab-added-to-chemotherapy-significantly-improves-survival-in-newly-diagnosed-pediatric-patients-with-b-cell-precursor-acute-lymphoblastic-leukemia-b-all-302325381.html SOURCE Amgen

King and Northeastern knock off Florida International 60-58US Senate Republicans Eye Two-Step Trump Legislative AgendaNo. 13 Duke 73, No. 9 Kansas St. 62

Week 12 TNF: Steelers-Browns Preview, Props & PredictionMinisters told ‘incompetence’ at Met Office led to underestimation of Storm Bert