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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: Adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-ALL during the consolidation phase of multiphase therapy. CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% in adults and pediatric patients one month or older. Relapsed or refractory CD19-positive B-ALL in adults and pediatric patients one month or older. In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of: Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. Patients with Philadelphia chromosome-positive B-ALL should have failed treatment with at least two tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Adults with Philadelphia chromosome-negative CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1%. Pediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19-positive B-ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation. Pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome-negative CD19-positive B-ALL as part of the consolidation therapy. BLINCYTO ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO ® . Interrupt or discontinue BLINCYTO ® and treat with corticosteroids as recommended. Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO ® . Interrupt or discontinue BLINCYTO ® as recommended. Contraindications BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation. Warnings and Precautions Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in patients receiving BLINCYTO ® . The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO ® overlap with those of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS). Using all of these terms to define CRS in clinical trials of BLINCYTO ® , CRS was reported in 15% of patients with R/R ALL, in 7% of patients with MRD-positive ALL, and in 16% of patients receiving BLINCYTO ® cycles in the consolidation phase of therapy. If severe CRS occurs, interrupt BLINCYTO ® until CRS resolves. Discontinue BLINCYTO ® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS. Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome: BLINCYTO ® can cause serious or life-threatening neurologic toxicity, including ICANS. The incidence of neurologic toxicities in clinical trials was approximately 65%. The median time to the first event was within the first 2 weeks of BLINCYTO ® treatment. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Grade 3 or higher neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. The majority of neurologic toxicities resolved following interruption of BLINCYTO ® , but some resulted in treatment discontinuation. The incidence of signs and symptoms consistent with ICANS in clinical trials was 7.5%. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. There is limited experience with BLINCYTO ® in patients with active ALL in the central nervous system (CNS) or a history of neurologic events. Patients with a history or presence of clinically relevant CNS pathology were excluded from clinical studies. Patients with Down Syndrome over the age of 10 years may have a higher risk of seizures with BLINCYTO ® therapy. Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO ® as outlined in the PI. Advise outpatients to contact their healthcare professional if they develop signs or symptoms of neurological toxicities. Infections: Approximately 25% of patients receiving BLINCYTO ® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO ® as needed. Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO ® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO ® as needed to manage these events. Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO ® infusion and interrupt BLINCYTO ® if prolonged neutropenia occurs. Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures and ICANS, patients receiving BLINCYTO ® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO ® is being administered. Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO ® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO ® , although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and total blood bilirubin prior to the start of and during BLINCYTO ® treatment. BLINCYTO ® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if total bilirubin rises to > 3 times ULN. Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO ® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO ® and dexamethasone as needed. Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO ® , especially in patients previously treated with cranial irradiation and antileukemic chemotherapy. Preparation and administration errors have occurred with BLINCYTO ® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose). Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO ® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO ® . Benzyl Alcohol Toxicity in Neonates: Serious adverse reactions, including fatal reactions and the "gasping syndrome," have been reported in very low birth weight (VLBW) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) who received intravenous drugs containing benzyl alcohol as a preservative. Early preterm VLBW neonates may be more likely to develop these reactions, because they may be less able to metabolize benzyl alcohol. Use the preservative-free preparations of BLINCYTO ® where possible in neonates. When prescribing BLINCYTO ® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO ® (with preservative), other products containing benzyl alcohol or other excipients (e.g., ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway. Monitor neonatal patients receiving BLINCYTO ® (with preservative) for new or worsening metabolic acidosis. The minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known. The BLINCYTO ® 7-Day bag (with preservative) contains 7.4 mg of benzyl alcohol per mL. Embryo-Fetal Toxicity: Based on its mechanism of action, BLINCYTO ® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO ® and for 48 hours after the last dose. Adverse Reactions The safety of BLINCYTO ® in adult and pediatric patients one month and older with MRD-positive B-cell precursor ALL (n=137), relapsed or refractory B-cell precursor ALL (n=267), and Philadelphia chromosome-negative B-cell precursor ALL in consolidation (n=165) was evaluated in clinical studies. The most common adverse reactions (≥ 20%) to BLINCYTO ® in this pooled population were pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea. Dosage and Administration Guidelines BLINCYTO ® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm. It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose). 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: Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy. Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission. Relapsed or refractory disease. 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. 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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 National Institute of Health. Cancer Stat Facts: Leukemia — Acute Lymphocytic Leukemia (ALL). Available at: https://seer.cancer.gov/statfacts/html/alyl.html . Accessed on October 28, 2024 . Terwilliger T, et al. Blood Cancer J . 2017;7(6):e577. American Cancer Society. What is Acute Lymphocytic Leukemia (ALL)? Available at: https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html . Accessed on October 28, 2024 . Leukemia & Lymphoma Society. Acute Lymphoblastic Leukemia (ALL). Available at: https://www.lls.org/research/acute-lymphoblastic-leukemia-all . Accessed on October 28, 2024 . National Cancer Institute. Childhood Acute Lymphoblastic Leukemia (PDQ ® )–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/child-all-treatment-pdq . Accessed on November 19, 2024 . 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 AmgenOne of AliGame's key strengths lies in its cutting-edge technology. The company is constantly pushing the boundaries of what is possible in gaming, utilizing the latest advancements in AI, virtual reality, and augmented reality to create truly unique and unforgettable gaming experiences. With a focus on both traditional gaming platforms and emerging technologies, AliGame is well-positioned to cater to a diverse audience.CINCINNATI (AP) — The Cincinnati Bengals have found all manner of ways to lose close games this season. Sunday's 44-38 loss to AFC North rival Pittsburgh can be blamed on a defense that missed tackles and allowed 520 yards of offense, and three turnovers by Joe Burrow. It's become a familiar story in this disappointing season. Cincinnati (4-8) keeps scoring lots of points but can't close out games. Seven of the Bengals’ eight losses this year have been by one score. Burrow has stopped talking about the possibility of going on a run and making the playoffs. He'd just like to win another game or two. “Playoffs are the furthest thing from my mind,” the fifth-year quarterback said. “You never know what can happen, so I’ll keep putting one foot in front of the other and try to be the best player I can be for the rest of the season, week in and week out.” The Bengals allowed Steelers quarterback Russell Wilson to throw for a season-high 414 yards and three touchdowns. After Wilson threw an interception that was returned for a touchdown, the Steelers (9-3) scored on seven of their last nine possessions. They didn't punt until early in the fourth quarter. Burrow lost two fumbles and threw an interception. “We haven’t done enough to earn the win,” coach Zac Taylor said. “It’s a simple as that. It’s nobody else’s fault but our own. We haven’t earned it.” Turnovers aside, Burrow had another strong game, finishing with 28 for 38 for 309 yards with three touchdowns. Burrow is having a great season statistically, and he hasn't hidden his disappointment and frustration about Cincinnati's narrow losses. ... WR Ja'Marr Chase had a touchdown catch to bring his league-leading total to 13. The defense missed tackles and couldn't hold off the Steelers, even with Burrow keeping the game close. It didn’t help that LB Logan Wilson (knee) and DT Sheldon Rankins (illness) had to sit out. The Bengals have allowed 34 or more points six times, including in four of the past five games. Cincinnati became the first NFL team to lose four games in a season in which it scored 33 points or more. RB Chase Brown has been dependable as the featured back since Zack Moss went down with a neck injury. He rushed for 70 yards and a touchdown against the Steelers. He also had three catches for 30 yards. The second-year back has 677 yards rushing and six TDs. “He’s really coming along, improving his game every single week,” Burrow said. “Pass game, run game, running hard, understanding his protection responsibilities. He’s a guy that practices hard, plays hard, and a guy you can count on.” The Bengals' coaching staff. Something has got to give. There was no excuse for the defense to play this badly after a bye week. The unit gave up 500-plus yards for the second time this season. None were reported in the game. 30.3 — The average points per game by the Bengals against teams with a .500 or better record this season. They are 0-7 in those games. The Bengals will try to regroup before facing the Dallas Cowboys (5-7) next Monday night. AP NFL: https://apnews.com/hub/NFL

Elon Musk defended his support for Germany’s far-right AfD party in an opinion piece in the Welt am Sonntag newspaper on Saturday, prompting a senior editor to resign. The world’s richest man doubled down on his comments from December 20 that “only the AfD can save Germany”, writing that the anti-immigration AfD was the “last ray of hope for the country” at the “brink of cultural and economic collapse”. Despite various branches of the AfD being labelled “extremist” by Germany’s domestic security agency, Musk said the AfD’s classification as far-right was “clearly false” as party leader Alice Weidel “has a partner from Sri Lanka”. With Musk set to play a key role in US President-elect Donald Trump’s administration, the billionaire’s interventions have triggered accusations of meddling in Germany’s democracy. The country is set to head to the polls on February 23, with the AfD polling at around 19* of the vote. Musk’s guest opinion piece in the Welt am Sonntag provoked outraged reactions and the resignation of the conservative title’s opinion editor. “Today a piece by Elon Musk appeared in the Welt am Sonntag. Yesterday I handed in my resignation after it went to print,” Eva Marie Kogel wrote on the X social media platform Musk owns. Meanwhile the Greens’ campaign director Andreas Audretsch wrote: “We must not allow the Elon Musks of this world, the Chinese state or Russian troll factories to undermine our democracies in Europe.” The Association of German Journalists (DJV) protested against the “election advertising” allowed by the newspaper’s editorial staff. “The German media must not allow itself to be manipulated into acting as a mouthpiece for autocrats and their friends,” said DJV leader Mika Beuster. Even the *Welt’s new editor-in-chief Jan Philipp Burgard was compelled to disagree with Musk in the opinion piece, writing: “Even a genius can be wrong”. Arguing that the AfD “is a danger to our values and our economy”, Burgard pointed out that Bjoern Hoecke, the AfD’s leader in Thuringia state, “has been convicted several times for using a banned Nazi slogan”. *Die Welt belongs to Axel Springer, Germany’s most influential press group. Its lineup includes the Bild tabloid, the country’s most-read newspaper. Related Story German teachers pushed out for calling out 'far-right' pupilsAuthored by Roger Kimball via American Greatness, Last week in this virtual space, I wrote that Donald Trump would make a renewed effort during his second term to dismantle “the administrative state.” As in his first term, he would employ various strategies to blunt the effects of the administrative apparatus that governs us. He would, for example, disperse some parts of the government outside the overwhelmingly left-progressive swamp of Washington, D.C. As an aside, I should note that I regard the persistence of Washington as the seat of our government as a serious impediment to the goal of “ deconstructing ” the administrative state. “It has,” I wrote back in 2022, “long been obvious to candid observers that there is something deeply dysfunctional about that overwhelmingly Democratic, welfare-addicted city.” It is a partisan sinkhole. Jefferson wanted the capital moved from New York to Washington in part to bring it closer to the South, but also to place it in a locality that was officially neutral. There is nothing neutral about Washington today. The city has some impressive architecture and urban vistas. They should be preserved and staffed as tourist attractions. But the reins of power should be relocated. I doubt that will happen. Which means that the eternal vigilance that MAGA must maintain around its enemies will have to be redoubled. Trump attempting to govern from Washington will be like Ike trying to undertake the Normandy invasion with half his planners on loan from the German general staff. Still, there are some symbolic gestures that he and his aides might consider. I have long suggested that the inauguration be held somewhere other than Washington, D.C. There is nothing in the Constitution that requires the inauguration be in Washington. LBJ, remember, was sworn in on Air Force One just a couple of hours after Kennedy was assassinated. When Warren Harding died, Calvin Coolidge was visiting the family homestead in Vermont. His father, a justice of the peace, administered the oath of office in the parlor. I think the next inauguration should be well away from the swamp of Washington. Mar-a-Lago in Palm Beach is one venue that springs to mind, but I am sure there are other attractive spots. At a minimum, I hope the inauguration committee will consider having some of the parties elsewhere. A ball in Butler, PA, for example, would not only be celebratory but also serve as a useful reminder of how close Trump came to a fatal encounter with an assassin’s bullet. But the trouble with “Washington”—I use scare quotes to indicate that we are dealing with spiritual as well as geographical dispensation—is not only its partisan nature. There is also its apparently unstoppably expansionist character. No matter which party is in power, the business of Washington is to make government bigger—forever. Republicans talk about “limited government.” They then sign on to nearly every scheme to make government bigger and more intrusive. Democrats do the same, of course, but they generally skip the rhetorical foreplay about making government smaller. One huge difference this time around will be the Department of Government Efficiency, DOGE for short, an ad hoc executive initiative that will be overseen by Elon Musk and Vivek Ramaswamy. They outlined their bold plan in an op-ed for The Wall Street Journal last week. “Unlike government commissions or advisory committees,” they noted, “we won’t just write reports or cut ribbons. We’ll cut costs.” Will they? It would be pretty to think so. Musk has said that he wants to cut government expenditures by $2 trillion. If he could manage even a quarter of that amount, it would be something to write home about. It may seem utopian. But remember, Musk bought Twitter and instantly cut the workforce by 80 percent. He vastly improved the platform, salvaged free speech, and transformed a dying company into a dynamic one. As usual, the devil will be in the details. Musk and Ramaswamy may identify the ideal candidates for downsizing or elimination. Exactly how will they move from pen to scissors is the $64,000—or rather, the $2 trillion—question. I take solace from the thought that if anyone can do it, the triumvirate of Trump, Musk, and Ramaswamy can. Naturally, opposition will be ferocious. Will it also be effective? Time will tell. I have not yet answered the question posed in my title: “What is the administrative state?” A friend asked me that in the course of our conversation about my column last week. Isn’t it possible, he asked, that “administrative state,” like its scarier sounding cousin, “deep state” is just a polysyllabic synonym for “state,” for the complex activities of government in a complex, technologically advanced polity? Maybe “administrative state” is just an invention of right-wing “conspiracy theorists” who find goblins where there are only harmless bureaucrats? I nattered on about the growth of the regulatory state, the battalions of unelected and unaccountable bureaucrats who govern us from their perches in the alphabet soup of modern, Kafkaesque governance, and put in a plug for Tocqueville’s analysis of “democratic despotism.” I also noted that the phrase “conspiracy theorist” is generally used in a prophylactic, not a descriptive sense. That is, it is a phrase that is wheeled out when the aim is to end, not further, the conversation. The problem is not conspiracy theories, but conspiracies in fact. One example. When revelation of the contents of Hunter Biden’s “laptop from hell” threatened to upend Joe Biden’s 2020 presidential campaign, Anthony Blinken asked acting CIA director Michael Morell to organize a letter signed by 51 former intelligence officers stating that the laptop bore all the signs of “Russian disinformation.” Morell did this, he said, in order to give Biden a “talking point” for his forthcoming debate with Donald Trump. The public did not know this at the time. When the truth leaked out, the establishment claimed it was only a “conspiracy theory” put about by Trump supporters. But it wasn’t a conspiracy theory . It was a conspiracy in fact. I stand by everything I said, but I did not say enough, and what I did say was not precise enough. Formulating definitions is often a mug’s game. This is because, for any important matter, a definition that is true will also have to be so general as to be vacuous or at least unilluminating. What is love? What is virtue? What is knowledge? In everyday life, these chestnuts from the philosophy seminar tend to get assimilated to the indefinite definition Justice Potter Stewart offered for “obscenity”: “I know it when I see it.” Still, there’s something to be said for making the effort. So here goes. “‘The administrative state’ is that quota of political power that covertly fills the vacuum left by the failure of the legislative branch to discharge its obligations.” Two things are critical. One is the displacement of sovereignty. No longer are the people sovereign. The bureaucracy is. The second critical thing is the covert nature of the enterprise. The question “What is the administrative state?” can seem difficult to answer because it is not supposed to exist in the first place. You know it only by its actions. You cannot look it up in the statute book, much less in the Constitution. Indeed, the very fact of the administrative state violates any number of Constitutional norms, not least its being a sort of “fourth branch” of government when the Constitution provides for only three. Edmund Burke touched on an essential aspect of this process in Thoughts on the Cause of the Present Discontents (1770). Criticizing the Court of George III for circumventing Parliament and establishing by stealth what amounted to a new regime of royal prerogative and influence-peddling, Burke saw how George and his courtiers maintained the appearance of parliamentary supremacy while simultaneously undermining it. “It was soon discovered,” Burke wrote with sly understatement, “that the forms of a free, and the ends of an arbitrary Government, were things not altogether incompatible.” That malign co-habitation stands behind the growth of the administrative state. We still vote. We still have a bicameral legislature. But behind these forms of a free government, the essentially undemocratic activities of an increasingly arbitrary and unaccountable regime pursue an expansionist agenda that threatens liberty in the most comprehensive way, by circumventing the law. The shadowy nature of the administrative state helps to explain why it is so hostile to free speech and, by the same token, why it tends to be receptive to the deployment of censorship and police power to achieve its ends and stymie the ends of its critics. That is why the rise of the administrative state goes hand in hand with the loss of public confidence in society’s guiding institutions. Talk of “democracy” and “our democracy” is ever on their lips. SWAT teams, prosecutorial abuse, and lawfare are out on the street for all to see. Bottom line: The age of the administrative state is at the same time an age of declining legitimacy in the foundational institutions of civil society. Officially, the administrative state is not supposed to exist. Having people talk about the fact that it does exist and that it often pursues ends that are contrary to the ends of the people outside its magic circle of custodians means that by definition free inquiry is a threat to its perpetuation. That is one reason that the administrative state is so hostile to democracy. It is also an important reason why it must be dismantled and returned to the graveyard of rebarbative systems of political obfuscation and bureaucratic tyranny.

When Katja Vogt considers a Jaguar, she pictures a British-made car purring confidently along the Italian coastline — a vision of familiarity that conveys "that dreaming, longing feeling we all love." She's not sure what to think about Jaguar now after the 89-year-old company announced a radical rebranding that featured loud colors and androgynous people — but no cars. Jaguar, the company says, will now be JaGUar. It will produce only electric vehicles beginning in 2026. Bad attention is good attention, Jaguar execs would appear to believe. The car brand has prompted mockery online for posting a glitzy ad without a single car in it. Say goodbye to British racing green, Cotswold Blue and black. Its colors are henceforth electric pink, red and yellow, according to a video that sparked backlash online. Its mission statement: "Create exuberance. Live vivid. Delete ordinary. Break moulds." "Intrigued?" @Jaguar posted on social media. "Weird and unsettled" is more like it, Vogt wrote on Instagram. "Especially now, with the world feeling so dystopian," the Cyprus-based brand designer wrote, "a heritage brand like Jaguar should be conveying feelings of safety, stability, and maybe a hint of rebellion — the kind that shakes things up in a good way, not in a way that unsettles." Jaguar was one of several iconic companies that announced significant rebrandings in recent weeks, upending a series of commercial — and cultural — landmarks by which many modern human beings sort one another, carve out identities and recognize the world around them. Campbell's, the 155-year-old American icon that artist Andy Warhol immortalized in pop culture decades ago, is ready for a new, soupless name. Comcast's corporate reorganization means there will soon be two television networks with "NBC" in their name — CNBC and MSNBC — that will no longer have any corporate connection to NBC News, a U.S. legacy news outlet. CNBC One could even argue the United States itself is rebranding with the election of former President Donald Trump and Republican majorities in the House and Senate. Unlike Trump's first election in 2016, he won the popular vote in what many called a national referendum on American identity. Are we, then, the sum total of our consumer decisions — what we buy, where we travel and whom we elect? Certainly, it's a question for those privileged enough to be able to afford such choices. Volumes of research in the art and science of branding — from "brandr," an old Norse word for burning symbols into the hides of livestock — say those factors do contribute to the modern sense of identity. So rebranding, especially of heritage names, can be a deeply felt affront to consumers. "It can feel like the brand is turning its back on everything that it stood for — and therefore it feels like it's turning its back on us, the people who subscribe to that idea or ideology," said Ali Marmaduke, strategy director with the Amsterdam-based Brand Potential. He said cultural tension — polarization — is surging over politics, wars in Russia and the Mideast, the environment, public health and more, creating what Marmaduke said is known as a "polycrisis": the idea that there are several massive crises converging that feel scary and complex. Campbell's soups "People are understandably freaked out by that," he said. "So we are looking for something that will help us navigate this changing, threatening world that we face." Trump's "Make America Great Again" qualifies. So did President Joe Biden's "Build Back Better" slogan. Campbell's soup itself — "Mmm Mmm Good" — isn't going anywhere, CEO Mark Clouse said. The company's new name, Campbell's Co., will reflect "the full breadth of our portfolio," which includes brands like Prego pasta sauce and Goldfish crackers. None of the recent activity around heritage brands sparked a backlash as ferocious as Jaguar's. The company stood as a pillar of tradition-loving British identity since World War II. The famous "leaper" cat Jaguar logo is pictured in 2019 at the Auto show in Paris, France. Jaguar said its approach to the rebrand was rooted in the philosophy of its founder, Sir William Lyons, to "copy nothing." What it's calling "the new Jaguar" will overhaul everything from the font of its name to the positioning of it's famous "leaper" cat. "Exuberant modernism" will "define all aspects of the new Jaguar world," according to the news release. The approach is thought to be aimed at selling fewer cars at a six-figure price point to a more diverse customer base. The reaction ranged from bewilderment to hostility. Memes sprouted up likening the video to the Teletubbies, a Benetton ad and — perhaps predictably — a bow to "woke" culture as the blowback intersected with politics. Get the latest local business news delivered FREE to your inbox weekly.Dec. 24—Before the Penguins brought aboard a former first-rounder in Philip Tomasino last month, president of hockey operations Kyle Dubas consulted coach Mike Sullivan. Dubas, who spoke with SportsNet Pittsburgh broadcasters Josh Getzoff and Phil Bourque during the second period of Monday night's 7-3 win against the Philadelphia Flyers, candidly discussed his exchange with Sullivan just prior to dealing a 2027 fourth-round pick to the Nashville Predators for Tomasino. "I went down and talked to [Sullivan] before we did it just to get his perspective on bringing a player like that in," Dubas said. "Were we going to be able to bring him in and give him some runway and get the most out of him?" Contrary to some of Sullivan's more vocal critics when it comes to his handling of younger players, Tomasino, 23, has received ample opportunities when healthy. Since joining the Penguins on Nov. 25, Tomasino has skated in 12 games and scored four times, including a power play goal during the club's latest victory. Dating back to Nov. 25, the Penguins have also posted a 9-3-1 record to enter the three-day holiday break with a 16-15-5 overall record. No question the Penguins' winning ways have been fueled in part by the top line, with wingers Rickard Rakell and Bryan Rust pacing the team with 16 and 15 goals, respectively. But the rest of the roster, one that Dubas' fingerprints are all over 18 months into the job, is holding its own. Younger players who were acquired during Dubas' watch like forwards Tomasino, Michael Bunting, Blake Lizotte and Cody Glass have all to varying degrees either met or exceeded expectations depending on their roles. The influx of such talent is intended to complement aging superstars Sidney Crosby, Evgeni Malkin, Kris Letang and Erik Karlsson in the short term, as well as help the Penguins in the future. "Even in my job now and coming into it, Pittsburgh, the key to us has been, 'Can we build it back into contention in the long run?' " Dubas said. "So — more so than even, 'Can we be a playoff team?' — the focus is on, 'What do we have to do to get ourselves back into contention?' " With a 16-15-5 record, the Penguins have squarely returned to the Stanley Cup playoff picture. Though they've played more games than nearly every other Eastern Conference team (save for the New Jersey Devils), the Penguins have vaulted themselves within a point of playoff position. "I think you learn a lot about your group when you struggle and you get to a bit of a funk. Can you bring yourself back out of it?" Dubas said. "I think we obviously dug in, starting with that game against Vancouver [on Nov. 29]. "I'm proud of the group for the way they responded." With five games to go until they reach their own halfway point in the season, the Penguins still have plenty of issues. Defenseman Ryan Graves, whom Dubas signed through the 2028-29 season, has fluctuated between being a healthy scratch and third-pair defenseman. Goalie Tristan Jarry has yet to play up to his two-time All-Star form since returning from the AHL, accruing an .894 save percentage from Nov. 15 onward. Of course, Jarry struggled so mightily in October that he was sent to Wilkes-Barre/Scranton for a conditioning loan after three lackluster showings in the NHL. "It was a real tough go at the beginning of the year, and I think understandably that comes with a lot of criticism," Dubas said. "Tristan, to his credit, has got himself stabilized and back on track. Obviously, the coaching staff have felt enough trust in him to give him a little bit of a run here." It would have been easy for the Penguins to fully embrace a youth movement after stumbling to a 7-12-4 start. But to the Penguins' and Dubas' credit, they improved their play while only mildly tinkering with the roster. As Dubas noted on the broadcast, established veteran center Lars Eller was shipped to the Washington Capitals for a couple picks. The Penguins were able to acquire Tomasino in the first place, after all, because Dubas got a 2027 fourth-round pick back for depth defenseman Chad Ruhwedel last spring. Without welcoming an overarching rebuild, Dubas has slowly deepened Sullivan's roster and believes he has in turn better positioned the Penguins for sustained success. "The coaches and players, it's on the day to day. They're trying to win the day," Dubas said. "Obviously, in management, we're trying to set the environment that enables them to do so while at the same time building the organization into a spot where it can contend every single year again." In this instance, Dubas is referring to the Penguins legitimately contending for a Stanley Cup title, which hasn't truly been the reality now in Pittsburgh for the better part of a decade. The Penguins haven't won a playoff series since the 2017-18 season, and the franchise wasn't getting any closer to breaking that trend before Dubas came aboard. Much has certainly gone awry over a year and change into Dubas' Penguins tenure outside of the Graves and Jarry signings. Welcoming Reilly Smith into the fold in 2023 didn't work out as intended, nor did Eller turn out to be a great fit to name a few. But, perhaps wisely, Dubas has quickly reversed course and sought to make the Penguins younger with trades like last month's for Tomasino, among others. These moves alone won't be enough to push the Penguins back to the postseason after missing it in the last two seasons, yet their early returns suggest Dubas' plan to reconfigure the roster isn't so far-fetched — and that he's learned a lesson or two along the way. "When you're in management, the mistakes, they showcase every night," Dubas said. "So when you make a bad trade or a bad signing or you let a player move on that goes elsewhere that has success, people don't forget that, nor should they because we're paid very well to be in these positions, and those are the mistakes that we try to learn from every single day." (c)2024 the Pittsburgh Post-Gazette Visit the Pittsburgh Post-Gazette at www.post-gazette.com Distributed by Tribune Content Agency, LLC.

San Francisco, known for its sky-high rent prices, is finally experiencing a welcome downward trend in rental rates. The exodus of tech workers and the shift to remote work arrangements have contributed to an oversupply of rental units in the city. Landlords are now facing increased vacancy rates, prompting them to lower rents in order to attract tenants. This drop in rent prices is a significant departure from the continuous increases seen in the past decade.Gan's appointment as Vice Governor of Shanxi Province has been met with widespread support and enthusiasm from both the public and his colleagues. Many see Gan as a dynamic and visionary leader who has the potential to bring about positive change and transformation in Shanxi Province. With his inclusive leadership style and strong work ethic, Gan is expected to inspire confidence and trust among the people of Shanxi.

Jordan Scoville’s two-touchdown, one interception performance in S-E-M’s 38-12 State Semifinal win over Garden County earned him Athlete of the Week honors. The Pleasanton Bulldogs clawed their way into the Class D top 10 at last year's state wrestling meet, riding the shoulders of two state runner-ups — Gatlin Krepela (51-4) at 138 pounds and Luke Pawloski (35-3) at 215 pounds. While Krepela has transferred to Omaha Skutt Catholic for his senior season, Pawloski returns to lead the Bulldogs this year. Also back is Chase Gillming, a senior who was 24-18 and a state qualifier a year ago. Other lettermen on the Pleasanton roster are senior Kenan Hasenauer (285), junior Evan Kucera (126) and sophomores Dylan Phillips (120), Sawyer Gillming (132), Riegen Reissland (138) and Sam Smith (160)/ "We have 11 wrestlers out this year and hope to be competitive in quads and dual meets and get better as the year goes on," said coach Mike Herman, who is in his 39th year of coaching. Pleasanton’s Tyra Sekutera, left, and Cassidee Paitz, right, go after a loose ball during a game with S-E-M. The Pleasanton girls are looking for a rebound — the ones under the basket and the one in the standings. Plenty of indications point in that direction, too. "We have a team that is hungry to get back to competing for conference championships and getting back to Lincoln," coach Jordan Arensdorf said. "We had one of the best summers that I can remember as a coach. The girls put an emphasis on putting in the work to improve their overall game." Pleasanton returns four starters and three other letter winners from last year's 10-12 team, the first team with a losing record since 2015. Leading scorer Natalie Rasmussen was one of three seniors on that saw a lot of younger players get playing time. Back to restore the Bulldogs in the standings are 5-7 senior guard Tyra Sekutera, 5-9 junior guard Brittany Riley, 5-7 senior guard/forward Cassidee Paitz and 5-9 junior forward/center Cadence Dixon. Sekutera will be a three-year starter at Pleasanton. She averaged nearly nine points per game last season. Riley averaged seven points per game and was the team's leading rebounder. Other returning letter winners are 5-7 junior guard Brecken Wendt, 5-8 sophomore guard Emme Westland and 5-7 junior forward Claire Ahrens. "We will need some young players ... to step up and play like experienced players, which I believe they are capable of," Arensdorf said. Those players include Westland and freshmen Tenley Flood and Kenlie Zwiener, both of whom Arensdorf said will have a big impact on the varsity. "It will be important for this group to keep their composure and to be strong mentally in tough situations," Arensdorf said. "If we can control the controlables, not worry about the outside noise, I look for us to have an improved season." Former Kearney High girls basketball coach Jason Boyd returns to the coaching ranks with 20 years of experience and 310 victories under his belt. He takes over a Bulldog team that went 6-17 last year while starting four underclassmen. "I believe this team is ready to take the next step in their development and have a lot of success this season," Boyd said. "We have a competitive group that is hungry to turn things around and win now." That happened for the Bulldogs in football, but with the good came some bad as senior Ryelan Kingston, who averaged 9. 1 points and 5.4 rebounds per game last year, is out with an injury. Others starters returning include 6-foot senior Gavin Zwiener, 6-1 junior Brennan Lindner and 6-2 senior Jayson Cronin. Lindner averaged more than nine points, three assists and three rebounds per game last season. Zwiener contributed six points and four rebounds per game. Other returning lettermen are 6-8 senior guard Cohen Cruise, 6-foot senior guard/forward Josh Pierce, 5-10 senior Gavin Stark, 6-4 junior center Cade Klein, 6-0 junior guard/forward Haden Smith, 6-1 sophomore guard/forward Owen Janitscheck and 6-0 junior forward Austin Hollingsworth. Boyd said the Bulldogs will rely on their experience for leadership in "holding the team accountable for working hard, having a good attitude and competing." Get local news delivered to your inbox!

With its strong team, innovative technology, and commitment to player engagement, AliGame is well-positioned to challenge the status quo in the gaming industry. As the company continues to grow and expand its reach, one thing is clear – AliGame is a force to be reckoned with in the world of gaming.Olivia Hussey, star of the 1968 film 'Romeo and Juliet,' dies at 73