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Discover the Secret Behind Cabo Platinum's 5-Star Excellence: Is Their Concierge Service the Best in the Industry? Experts Say Yes!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 Amgen
NEW YORK (AP) — U.S. stocks closed at more records after Donald Trump’s latest talk about tariffs created only some ripples on Wall Street. The S&P 500 rose 0.6% to reach another all-time high. The Dow Jones Industrial Average added 0.3% to its own record set the day before, while the Nasdaq composite rose 0.6% as Big Tech stocks helped lead the way. Stock markets abroad saw mostly modest losses, after President-elect Trump said he plans to impose sweeping tariffs on Mexico, Canada and China as soon as he takes office. U.S. automakers and other companies that could be hurt particularly by such tariffs fell. THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below. NEW YORK (AP) — U.S. stocks are rising toward records Tuesday after Donald Trump’s latest talk about tariffs created only some ripples on Wall Street, even if they could roil the global economy were they to take effect. The S&P 500 climbed 0.5% and was on track to top its all-time high set a couple weeks ago. The Dow Jones Industrial Average added 81 points, or 0.2%, to its own record set the day before, while the Nasdaq composite was 0.5% higher, with less than an hour remaining in trading. Stock markets abroad were down, but mostly only modestly, after President-elect Trump said he plans to impose sweeping new tariffs on Mexico, Canada and China as soon as he takes office. Stock indexes were down 0.1% in Shanghai and nearly flat in Hong Kong, while Canada's main index edged down by just 0.1%. Trump has often praised the use of tariffs , but investors are weighing whether his latest threat will actually become policy or is just an opening point for negotiations. For now, the market seems to be taking it more as the latter. Unless the United States can prepare alternatives for the autos, energy products and other goods that come from Mexico, Canada and China, such tariffs would raise the price of imported items all at once and make households poorer, according to Carl Weinberg and Rubeela Farooqi, economists at High Frequency Economics. They would also hurt profit margins for U.S. companies, while raising the threat of retaliatory tariffs by other countries. General Motors sank 8.2%, and Ford Motor fell 2.6% because both import automobiles from Mexico. Constellation Brands, which sells Modelo and other Mexican beer brands in the United States, dropped 3.9%. Beyond the pain such tariffs would cause U.S. households and businesses, they could also push the Federal Reserve to slow or even halt its cuts to interest rates. The Fed had just begun easing its main interest rate from a two-decade high a couple months ago to offer support to the job market . While lower interest rates can boost the overall economy and prices for investments, they can also offer more fuel for inflation. “Many” officials at the Fed's last meeting earlier this month said they should lower rates gradually, according to minutes of the meeting released Tuesday afternoon. Unlike tariffs in Trump's first term, his proposal from Monday night would affect products across the board. Trump’s tariff talk came almost immediately after U.S. stocks rose Monday amid excitement about his pick for Treasury secretary, Scott Bessent. The hope was the hedge-fund manager could steer Trump away from policies that balloon the U.S. government deficit, which is how much more it spends than it takes in through taxes and other revenue. The talk about tariffs overshadowed another set of mixed profit reports from U.S. retailers that answered few questions about how much more shoppers can keep spending. They’ll need to stay resilient after helping the economy avoid a recession, despite the high interest rates instituted by the Fed to get inflation under control. Kohl’s tumbled 17.6% after its results for the latest quarter fell short of analysts’ expectations. CEO Tom Kingsbury said sales remain soft for apparel and footwear. A day earlier, Kingsbury said he plans to step down as CEO in January. Ashley Buchanan, CEO of Michaels and a retail veteran, will replace him. Best Buy fell 4.7% after likewise falling short of analysts’ expectations. Dick’s Sporting Goods topped forecasts for the latest quarter thanks to a strong back-to-school season, but its stock lost an early gain to fall 1.4%. A report on Tuesday from the Conference Board said confidence among U.S. consumers improved in November, but not by as much as economists expected. J.M. Smucker jumped 5.4% for one of the biggest gains in the S&P 500 after topping analysts' expectations for the latest quarter. CEO Mark Smucker credited strength for its Uncrustables, Meow Mix, Café Bustelo and Jif brands. Big Tech stocks also helped prop up U.S. indexes. Gains of 2.8% for Amazon and 2% for Microsoft were the two strongest forces lifting the S&P 500. In the bond market, Treasury yields rose following their big drop from a day before driven by relief following Trump’s pick for Treasury secretary. The yield on the 10-year Treasury climbed to 4.30% from 4.28% late Monday, but it’s still well below the 4.41% level where it ended last week. In the crypto market, bitcoin continued to pull back after topping $99,000 for the first time late last week. It's since dipped back toward $91,600, according to CoinDesk. It’s a sharp turnaround from the bonanza that initially took over the crypto market following Trump’s election. That boom had also appeared to have spilled into some corners of the stock market. Strategists at Barclays Capital pointed to stocks of unprofitable companies, along with other areas that can be caught up in bursts of optimism by smaller-pocketed “retail” investors. AP Business Writer Elaine Kurtenbach contributed. Copyright 2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission. Get the latest local business news delivered FREE to your inbox weekly.
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