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House passes $895 billion defense policy bill with pay raise for troops, sending measure to SenateLopsided loss sinks the reeling Saints further into evaluation modePhase 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
Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/) 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 AmgenDyfed-Powys Police has confirmed that an arrest has been made following the death of thirty-eight-year-old Aaron Jones (pictured) of Llanpumsaint last night, who was hit by a car whilst out walking his dog in the Carmarthenshire village. Police can now confirm the vehicle believed to be involved in the fatal road traffic collision in Llanpumsaint on Monday, December 23 has been located. A spokesperson for Dyfed-Powys Police stated: “One man, aged 27, has been arrested on suspicion of causing death by dangerous driving, failing to stop for a collision, and failing to report a collision. “The road remains closed. Residents will see an increased police presence in the area while the investigation continues. “The family of the man who died in the collision continue to be supported by specially trained officers. They have asked for privacy at this difficult time. “The force would like to thank everyone who responded to their appeal with information. The collision happened near to Caer Salem Baptist Chapel sometime between 6.45pm and 7.45pm on December 23 while Mr Jones was walking his dog. Officers are continuing to appeal for anyone travelling in the area at the time who have dashcam on their vehicles, or anyone with a doorbell camera or CCTV to check the footage and get in touch. Anyone with information that could help officers with their investigation is asked to report it to Dyfed-Powys Police, either through a direct message on social media, online at: , by emailing , or by calling 101. If you are deaf, hard of hearing, or speech impaired text the non-emergency number on 07811 311 908. Quote reference: DP-20241223-290. Alternatively, contact the independent charity Crimestoppers anonymously by calling 0800 555111, or visiting crimestoppers-uk.orgAnxiety about money, gun violence and hate crimes ranked high on list of American's concerns Limiting your news consumption may help ease stress and anxiety More than before, Americans surveyed say they'll make mental health resolutions for 2025 FRIDAY, Dec. 27, 2024 (HealthDay News) -- Should you cut back on doom scrolling in 2025? Worries about money, gun violence and hate crimes ranked high among many people's lists of worries at the end of 2024, according to a poll that is part of American Psychiatric Association (APA) Healthy Minds Monthly opinion poll series. The survey included 2200 U.S. adults. Reducing news consumption may be beneficial for your mental health , experts say. "If current events seem overwhelming it may be time to limit your news consumption,” Dr. Marketa Wills , medical director of the APA, said. “While we like to stay informed, the news can also impact our mental health, and being mindful of that impact is important," Wells said in a news release. According to the APA's research, American adults have remained most anxious about the economy and gun violence throughout 2024. Looking ahead to 2025, more than 1/3 of Americans surveyed (33%) say they will make mental health-related New Year’s resolutions, which is a 5% increase from last year. In fact, the increase is the highest result the APA has collected since it began asking the question in 2021. As usual, many people report that they will pledge to be more physically active in 2025; other resolutions focus on participating in mentally healthy activities. Spend more time in nature (46%) Meditation (44%) Focus on spirituality (37%) Take a social media break (30%) Journaling (29%) “A new year brings with it new opportunities but also renewed concerns about the very important issues that impact our lives,” Wills said, adding that “any time of the year, mental health matters. Staying mindful of how we’re doing while taking active steps to care for ourselves is a terrific resolution.” More information The Centers for Disease Control (CDC) has more on stress and anxiety management. SOURCE: American Psychiatric Association (APA), news release, Dec. 13, 2024; APA, press release, Dec. 18, 2024 If you make resolutions, consider starting or re-starting a practice that will nurture your mental health, such as meditating or taking a break from social media.
France celebrated the re-opening of Notre Dame cathedral on Saturday at a special church service that featured a standing ovation for the firefighters who saved the 12th-century landmark from destruction during a 2019 blaze. A two-hour service attended by incoming US president Donald Trump among other world leaders began with the archbishop of Paris knocking on the doors of the cathedral three times. "Notre Dame, model of faith, open your doors to bring together the far-flung children of God in joy," archbishop Laurent Ulrich commanded, banging with a wooden staff crafted from a roof beam that survived the inferno five years ago. Trump could be seen sitting on the front row as guest of honour next to French President Emmanuel Macron, with invitees marvelling at the freshly cleaned walls, new furniture and state-of-the-art lighting installed as part of the overhaul. In a short speech, Macron expressed the "gratitude of the French nation" for the restoration work, achieved at frenzied speed over the last five years. France had "rediscovered what great nations can do -- achieve the impossible", he said. One of the most moving moments came when firefighters in their protective gear walked through the congregation to thunderous applause as the word "Merci" ("Thank you") was beamed on the intricate facade and famous belltowers of the Gothic masterpiece. Small crowds of Parisians and tourists braved wet weather and high winds outside to witness the renaissance of a monument, which came close to collapsing due to the intensity of the inferno that toppled its roof and spire. "I find it really beautiful, even more so now that the spire has been restored," Marie Jean, a 27-year-old dentist from southwest France, told AFP outside. The reconstruction effort cost around 700 million euros ($750 million), financed from donations, with the re-opening achieved within a five-year deadline despite predictions it could take decades. Workers had to overcome problems with lead pollution, the Covid-19 epidemic, and the army general overseeing the project falling to his death while hiking in the Pyrenees last year. Saturday's service featured classical music, the cathedral's choir as well as the "re-awakening" of the 8,000-pipe organ which is considered the voice and soul of the cathedral. A televised public concert planned outside featuring Chinese piano virtuoso Lang Lang and possibly US singer and fashion designer Pharrell Williams had to be pre-recorded on Friday night because of the stormy weather. Held up as an example of French creativity and resilience by Macron, Notre Dame's renaissance so soon after the fire comes at a difficult time for the country. The sense of national accomplishment in restoring a symbol of Paris has been undercut by political turmoil that has left France without a proper government since last week when prime minister Michel Barnier lost a confidence vote. Macron is hoping the re-opening might provide a fleeting sense of national pride and unity -- as the Paris Olympics did in July and August. He scored a major coup by attracting Trump along with around 40 heads of state and government, including Ukrainian leader Volodymyr Zelensky, who was given a round of applause as he entered Notre Dame. Macron hosted three-way talks with Zelensky and Trump at the presidential palace shortly before the ceremony, with future US military support for Ukraine's war effort against Russia's invasion expected to have been discussed. Trump has vowed to end the nearly three-year Ukraine war when he takes office on January 20, sparking fears in Kyiv that he will force Ukraine to make territorial concessions to Russia. "It seems like the world is going a little crazy right now and we will be talking about that," Trump told reporters as he prepared to sit down for talks with Macron. One surprising absentee on Saturday was Pope Francis, the head of the Catholic Church. He sent a message addressed to the French people and weighed into a row about whether the place of worship and tourist attraction should remain free to enter. The "immense" numbers set to visit Notre Dame should be welcomed "generously and free of charge", he said, clearly opposing a proposition from the French culture ministry to charge for entry. The exact cause of the 2019 blaze has never been identified despite a forensic investigation by prosecutors, who believe an accident such as an electrical fault was the most likely reason. On Sunday, the first mass with 170 bishops and more than 100 Paris priests will take place at 10:30 am (0930 GMT), followed by a second service in the evening at 6:30 pm which will be open to the public. adp-sjw/jj
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Revolution or Evolution? Discover NVIDIA’s Latest Game-ChangerGolden State Warriors superstar Stephen Curry reflected on his impact surrounding the increased three-point shooting in the NBA over the past few years. "I don't think you want me to answer that question because it's now the talk of the talk of how everybody shooting threes," Curry said during a Tuesday appearance on ESPN's NBA Today. "I love it personally, because it's if you think about just yeah, the sheer numbers of it, but how you create threes and the beauty in the game, like, everybody does it just a little bit differently. It's new, and a lot of people have a little different viewpoint on it, but for me, like, it is cool to kind of have seen the evolution of it." The 10-time All-Star also gave his thoughts on the criticism of teams attempting more long-range shots each night. "I mean, everybody has their opinion," Curry said. "It's not like I can go out and do a 360 windmill and, you know, drive down the lane and dunk on somebody. So for me, like, I'm never gonna fight three-point shots. That's just, you know, how I see the game, it's how I've seen the game forever. But like everybody has a different viewpoint and certain skill sets that start coming to the league. You see how many bigs are dominating, you know, down on the post and it's like a kind of either extreme. And the cool part, like defenses adjust, and it just takes time for that to happen. So, we'll see, you know, what how it goes. But I'm going to keep shooting threes, so don't worry about that." This article will be updated soon to provide more information and analysis. For more from Bleacher Report on this topic and from around the sports world, check out our B/R app , homepage and social feeds—including Twitter , Instagram , Facebook and TikTok .
Musk's net worth surpasses $400 billion after Trump's Nov victoryLisa Simpson once said during an episode of “The Simpsons:” What could be more exciting than the savage ballet that is pro football? On Monday night, the entire Simpsons universe gets to experience it in a way not many could have imagined. The prime-time matchup between the Cincinnati Bengals and Dallas Cowboys will also take place at Springfield’s Atoms Stadium as part of “The Simpsons Funday Football” alternate broadcast. The altcast will be streamed on ESPN+, Disney+, and NFL+ (on mobile devices). ESPN and ABC have the main broadcast, while ESPN2 will carry the final “ManningCast” of the regular season. The replay will be available on Disney+ for 30 days. Globally, more than 145 countries will have access to either live or on replay. “We’re such huge football fans, and the Simpsons audience and the football audience, I feel, are like the same audience of just American families and football. And the Simpsons are so much a part of the DNA of the American family and culture that for us to, like, mush them together in this crazy video game, it’s so fun,” said Matt Selman, executive producer of “The Simpsons.” While the game is the focal point, the alternate broadcast, in some ways, will resemble a three-hour episode of “The Simpsons.” It starts with Homer eating too many hot dogs and having a dream while watching football. Homer joins the Cowboys in the dream while Bart teams up with the Bengals. Lisa and Marge will be sideline reporters. “That’s the beginning of the story, and the story continues through the entire game until Homer wakes up from his dream at the end of the game. It is like a complete story, and the NFL game will happen in between. It’s just going to be an amazing presentation with tons of surprises,” said Michael “Spike” Szykowny, ESPN’s VP of edit and animation. This is the second year ESPN has done an alternate broadcast for an NFL game. It used the characters from “Toy Story” for last year’s Sunday morning game from London between the Atlanta Falcons and Jacksonville Jaguars. “The Simpsons” has featured many sports-themed episodes during its 35 seasons. Even though “Homer at the Bat” remains the consensus favorite sports episode for many Simpsons fans, there have been football ones such as “Bart Star” and “Lisa The Greek.” There also was a Super Bowl-themed one after Fox’s broadcast of Super Bowl 33 between Denver and Atlanta in 1999. Even though “The Simpsons” remains a staple on Fox’s prime-time schedule, it is part of the Disney family after their acquisition of 20th Century Fox in 2019. All 35 seasons are on Disney+. The show’s creators have worked with ESPN and the NFL to make sure the look and sound is definitely Simpsonsesque. The theme song is a mash-up of “The Simpsons” opening and “Monday Night Football’s” iconic “Heavy Action.” There have also been pre-recorded skits and bits to use during the broadcast featuring Simpson’s legendary voices Hank Azaria, Nancy Cartwright, Dan Castellaneta, Julie Kavner, and Yeardley Smith. The telecast will be entirely animated, with the players’ movements in sync with what is happening in real-time on the field. That is done through player-tracking data enabled by the NFL’s Next Gen Stats system and Sony’s Beyond Sports Technology. While Next Gen Stats tracks where players are on the field with a tracking chip in the shoulder pads, there is skeletal data tracking and limb tracking data — which uses 29 points per player — to get closer to the player’s movements. The other data tracking will allow Beyond Sports and Disney to add special characters to the game. For example, there might be a play where Lisa catches the ball and goes 30 yards instead of Cincinnati’s Tee Higgins. “Lisa is much smaller than the rest of the players. So, in real life, the ball would go over her head, but now, with data processing, we can take the ball and make it go exactly into her hands. So for the viewer, it still looks believable, and it all makes sense,” said Beyond Sports co-founder Nicolaas Westerhof. The other major challenge is making “The Simpsons” two-dimensional cartoon characters into 3-D simulations. Szykowny and his team worked to make that a reality over the past couple of months. “That’s a big leap of faith for them to say, hey, we trust you to make our characters 3-D and work with it. Our ESPN creative studio team has done a wonderful job,” Szykowny said. Lisa, Krusty, Nelson, Milhouse and Ralph will be with Bart and the Bengals; while Carl, Barney, Lenny and Moe join up with with Homer and the Cowboys. The broadcast will also feature ESPN personalities Stephen A. Smith, Peyton Manning and Eli Manning. ESPN’s Drew Carter, Mina Kimes and Dan Orlovsky will call the game from Bristol, Connecticut, and also be animated. They will wear Meta Quest Pro headsets to experience the game from Springfield using VR technology. For Kimes, being part of the broadcast and being an animated Simpsons character is a dream come true. She is a massive fan of the show and has a framed photo of Lisa Simpson — who she said is a personal hero and icon — as part of her backdrop when she makes appearances on ESPN NFL shows from her home in Los Angeles. “I didn’t have any input, and I didn’t see anything beforehand, so I wasn’t sure if it would look like me, but it kind of does, which is very funny,” said Kimes, who drew Simpsons characters when she was a kid. “To see the actual staff turn me into one was a dream.” Even though the Bengals (4-8) and Cowboys (5-7) have struggled this season, Selman thinks both teams have personalities that appeal to “The Simpsons” universe. “We were just so lucky also that the Cowboys are sort of like a Homer Simpson-type team, American team, and Mike McCarthy might be a Homer-type guy, one might imagine,” he said. ”And then you have Joe Burrow on the other side who is a cool young, spiky-haired, blonde bad boy -- he’s like Bart. And that fits our character archetypes so perfectly. “If Homer is mad at Bart and has a hot dog dream while watching ’Monday Night Football’, and then it’s basically McCarthy versus Burrow, Homer versus Bart, and that’s the simple father versus son strangling — Homer strangling Bart dynamic that has been part of the show for 35 years. I don’t know if that would have worked as well if it was like Titans versus Jacksonville. We would have found something. We would have made it work.” AP NFL: https://apnews.com/hub/nflLopsided loss sinks the reeling Saints further into evaluation mode
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Eight legacy handloom products from South India are set to receive Geographical Indication (GI) recognition, following the Union govt's Handloom Exports Promotion Council filing applications for them with the GI registry. Among them are Aruppukkottai saris and Paramakudi Pumper saris from Tamil Nadu; Chendamangalam saris and Palakkad saris from Kerala; Yemmiganur double layer bedsheet, Jammalamadugu dupion silk , and Karimnagar double cloth bedsheet from Andhra Pradesh; and Devara Vasthra from Karnataka. **Aruppukkottai Saris** Blessed with black soil that yields high-quality cotton, Aruppukkottai was long recognised as a vital centre for cotton weaving. The town's artisans mastered the art of creating lightweight, breezy, and sustainable cotton saris, says the application filed by Kanchithalaivan Handloom Weavers Co-operative Production and Sales Society Limited. **Palakkad Saris** Palakkad handloom saris are celebrated for their fine cotton fabric, lightweight texture, and minimalist yet elegant designs. They are typically characterised by their plain weaves, subtle checks, or stripes. A defining feature is the use of traditional zari borders, crafted with gold or silver threads. Occasionally, motifs inspired by Kerala's cultural heritage, such as temple patterns or floral designs, are woven into the saris. **Chendamangalam Saris** Originally, Chendamangalam handloom weaving in Kerala primarily focused on creating garments for the royal members of the Paliam family, who served as Prime Ministers to the Kingdom of Cochin. The women of the royal household would use Chendamangalam handloom items such as neriyathu, kasavu dhotis, and saris to flaunt their social standing, while the men dressed in simple white dhotis made of fine muslin cloth. Currently, the Chendamangalam clusters in Kochi continue to produce the traditional dhotis and saris for both men and women, maintaining the town's reputation in weaving, says the application. **Jammalamadugu Dupion Silk** The Jammalamadugu dupion silk is characterised by its textured surface, vibrant colours, and durability, which make it highly sought after in the fashion industry for bridal wear, formal garments, and decorative textiles. Its distinctiveness arises from the use of double cocoons in the production process, where two silkworms spin their threads together, creating a naturally uneven strand. The fabric is also valued for its crisp texture and wrinkle resistance and is ideal for sherwanis, blouses, and jackets, as well as home furnishings like curtains, table runners, and pillow covers. **Karimnagar Double Cloth Bed Sheet** Karimnagar double cloth bed sheets are distinguished by their artistic designs, including traditional geometric patterns, checks, stripes, and floral motifs. These patterns are deeply influenced by the cultural heritage of the region. The bed sheets incorporate Kalamkari motifs - mythological themes, floral designs, and symbolic patterns. **Devara Vasthra** Devara Vasthra is a sacred textile used in Karnataka exclusively for ritualistic purposes, particularly in cleaning, covering, or decorating idols in temples and homes. Devotees often purchase Devara Vasthra to cover coconuts and lemons during poojas, says Sanjay Gandhi. "After performing the pooja, the fabric is hung in houses to ward off evil spirits, serving both a spiritual and symbolic function. The fabric is crafted using dyed, bleached, and semi-bleached cotton yarn, with 20s count in both warp and weft, ensuring its durability and suitability for ritualistic applications." **Yemmiganur Double Layer Bed Sheet** The fabric of the Yemmiganur double layer bedsheets is unique in two ways. A single layer of thread or yarn is used to produce two layers of cloth, or the double cloth, as it is famously known. Also, azo-free dyes are used in the making. The azo-free or natural dyes are an ancient, non-toxic technique of dyeing clothes, which Yemmiganur continues to preserve, even after the commercial world shifted towards azo-dyes. Stay updated with the latest news on Times of India . Don't miss daily games like Crossword , Sudoku , Location Guesser and Mini Crossword . Spread love this holiday season with these Christmas wishes , messages , and quotes .