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betfred championship table
Young Congolese refugee paints new Australian life
Liverpool v Leicester: Premier League – liveLisa 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/nfl
Will Democrats Finally Learn A Lesson?British author Vicky Ball is an unlikely bestseller after a simple post on X about selling two at a local event catapulted her novel up the bestseller charts. After showcasing her two novels — and — at an authors event on Tuesday (December 3) at Galleywood Heritage Centre in Chelmsford, Essex, the 48-year-old shared her excitement online. “Sold two books 😁😁,” she wrote, adding, “I’ve done some events where I haven’t sold any.” A whirlwind of support followed, which she has described as “amazing” and “unbelievable.” Her post has amassed over 24 million views and 745,000 likes. In the days following, — a thriller with “lots of twists” about a missing girl’s return — soared to No. 3 in Amazon’s “Teen and Young Adult Fiction on Sexual Abuse” category. Reflecting on her viral success, Ball told the , “I was completely surprised really, and it was all a bit overwhelming — I was just amazed and couldn’t believe it.” Messages of support poured in from across the globe. “I’ve been getting messages on Instagram of people saying: ‘I’m in Colombia and just bought your book’; ‘I’m in Salt Lake City’; ‘I’m in Belgium.’ It’s amazing really,” she added to . Ball, who works at the University of Essex and is currently pursuing a master’s degree in creative writing, wrote during the lockdown in 2020. Balancing her work as a teacher at the time, she wrote mostly on weekends, seated in her lounge with her laptop on her knees. Sold 2 books 😁😁 — Vicky (@VickyBall3) She said writing provided an outlet during the pandemic, offering purpose and a distraction from the stress and isolation. “It was so helpful having a purpose and something to keep my mind off the stress and worry.” When offering advice to aspiring writers, Ball emphasized simplicity and enjoyment. “Just write! I just go with it. It’s like a journey, and I really enjoy the process. You never know where it’s going to go,” she told Her second novel, , tells the story of an alcoholic mother with a dark secret. Despite her newfound fame, Ball has remained focused on her work and the supportive writing community on X. “Social media can be a really positive place, especially on X because there’s a big writing community and we are very supportive of each other,” she told the BBC. Looking ahead, Ball plans to continue writing while balancing her job and studies. “I’m quite happy at the moment doing a master’s in creative writing and working at the university,” she admitted, “but I have some ideas for some other books in the pipeline.”
Stocks closed higher on Wall Street, sending the Dow Jones Industrial Average to another all-time high. The Dow added 1% Monday to the record it set on Friday. The S&P 500 rose 0.3%, while the Nasdaq composite rose 0.3%. Treasury yields eased in the bond market after President-elect Donald Trump said he wants Scott Bessent, a hedge fund manager, to be his Treasury Secretary. Smaller companies can feel a big boost from easier borrowing costs, and the Russell 2000 index of small stocks jumped 1.5%, closing just shy of the record high it set three years ago. On Monday: The S&P 500 rose 18.03 points, or 0.3%, to 5,987.37. The Dow Jones Industrial Average rose 440.06 points, or 1%, to 44,736.57. The Nasdaq composite rose 51.18 points, or 0.3%, to 19,054.84. The Russell 2000 index of smaller companies rose 35.36 points, or 1.5%, to 2,442.03. For the year: The S&P 500 is up 1,217.54 points, or 25.5%. The Dow is up 7,047.03 points, or 18.7%. The Nasdaq is up 4,043.48 points, or 26.9%. The Russell 2000 is up 414.96 points, or 20.5%.Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif. , Dec. 7, 2024 /PRNewswire/ -- Amgen 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. 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 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 Amgen © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Jake Paul wants “to set the record straight,” when no straightening is required. If anyone would understand that we moved on from his “fight” against Mike Tyson, it should be Paul, who has made a fortune in the split-second entertainment world of social media. Paul’s Most Valuable Promotions issued a statement on Monday to dispel the rumor that his fight at AT&T Stadium on Nov. 15 against Tyson was rigged. The intention is to change the narrative of what was an embarrassing, if highly profitable, evening, and maintain the interest in Paul’s boxing career. The fight was not rigged, and no statement was needed. The fight was simply awful. The statement begins: “Following the wide circulation of incorrect and baseless claims that undermine the integrity of the Paul vs. Tyson event, Most Valuable Promotions (MVP) would like to set the record straight regarding the contractual agreements and the nature of the fight.” “Integrity” and “Tyson v. Paul” have no business of being in the same sentence. “Rigging a professional boxing match is a federal crime in the United States of America. Paul vs. Tyson was a professional match sanctioned by the Texas Department of Licensing and Regulations (TDLR). Both fighters in good faith performed to the best of their abilities with the goal of winning the fight,” the statement said. The Texas Department of Licensing and Regulations did sanction this kitten fight between a Disney kid turned YouTuber against a 58-year-old man with serious health issues. The fight had judges, and Paul was awarded a decision when none was needed. “Best of their abilities” is subjective. After landing one of his first punches, a left to Paul’s head, Tyson looked like he may have something in what was once one of the most feared boxers who ever lived. He flashed some of that old Tyson head movement, but mostly he looked like an old boxer. Because that’s what he is. The event quickly became an awkward money grab embarrassment, an indictment on the ticket-buying audience more than the promoters, who were doing their job, and leaving Netflix blushing over streaming issues. “There were absolutely no restrictions – contractual or otherwise – around either fighter. Each boxer was able to use his full arsenal to win the fight. Any agreement to the contrary would violate TDLR boxing rules,” the statement said. No restrictions is a liberal use of the term. The fight was eight rounds, not 10 or 12. The rounds lasted two minutes, not three. The gloves the boxers used were 14 oz., not 10. President Jimmy Carter could take a few shots from a 14 oz. glove. The statement continues, “Trash talk and speculation are common in sports, and athletes and promoters need to tolerate nonsensical commentary, jokes and opinions. But suggesting anything other than full effort from these fighters is not only naïve but an insult to the work they put into their craft and to the sport itself.” Accusations of rigged outcomes have been hurled at sporting events in the United States since the New York Nine defeated the Knickerbockers 23-1 in four innings, the first recorded baseball game ever played in America, in 1846. The New York Nine did not release a statement to the press that the game was rigged. Such accusations are hallow, but every now and then there is a Chicago Black Sox. “It is further illogical and inane that MVP, in the debut of a hopeful long-term partnership with the world’s biggest streamer—an organization that made its first-ever foray into live professional sports with Paul vs. Tyson—would even so much as consider such a perverse violation of the rules of competition,” the statement said. That’s not how rigged works. You don’t tell the broadcast partner that the live event is staged. Making sure his boss knows he’s working, MVP co-founder Nakisa Bidarian issued his own words to this statement, saying, “This is not the first time Jake Paul has faced unfounded skepticism or outright disbelief as a professional athlete, and frankly, the claim that his bout must have been rigged is just the latest backhanded compliment to come his way.” Paul, 27, beat a 58-year-old man in a fight that looked like two-hand touch. There is no compliment. “From day one in this sport, people have doubted his abilities — unable to reconcile how someone with his background has accomplished so much in such a short time. Jake has not only proven himself repeatedly, but he has continuously set historic records that speak for themselves,” Bidarian wrote. Paul has created a niche for himself in the sport by carefully fighting opponents who are names, but are not boxers. Older guys. Ex-UFC fighters looking for one more check. He’s also spent the necessary time to train, and learn how to box. He knows how to promote himself, and an event. He created “boxing entertainment,” but his fights are not traditional boxing matches. They are also not scripted WWE. “As long as Jake continues to exceed expectations, there will always be those who try to discredit his achievements.” Bidarian said. “We embrace the doubt — it only fuels Jake to work harder and achieve greater success.” Herein lies the “need” for this press statement. Paul wants to continue to fight, but not against fighters who may knock him out. Considering the type of money his fights have generated, he would have no problem finding a line of potential traditional opponents waiting to pummel him through the canvas. He has avoided real fighters for a reason. Because he’s smart. Because he can. Because there is a market for the fights he stages. The fallout from his bout against Tyson is that Paul could have unintentionally knocked out the audience for these matches that are staged, not rigged, which is really why he wants to “set the record straight.” ©2024 Fort Worth Star-Telegram. Visit star-telegram.com . Distributed by Tribune Content Agency, LLC.
How to Watch Top 25 Women’s College Basketball Games – Friday, November 22
NEW YORK — Vincent Shavers wore a grin and a black practice jersey he’d been eyeing all season. The Miami kid never would have guessed the next step in his college football career would play out in the snowy Big Apple. Not that the Nebraska freshman linebacker has not done plenty already in his Husker debut. He is the only 2024 signee to appear in every regular-season game on defense as a steady contributor while making plays on special teams too. His role in Saturday’s Pinstripe Bowl will be more. Through merit. And because multiple other NU linebackers transferred elsewhere. He’ll rotate with seniors John Bullock and Javin Wright against a run-heavy Boston College attack. “I kept working, kept working, staying patient, waiting for my time to come,” Shavers said Thursday after a brisk and sunny practice at Fordham’s home stadium in the Bronx. “Just kept putting in the work and finally got my Blackshirt. I’m proud, I’m happy, I’m ready to work.” People are also reading... Saturday is about winning one more game for the seniors, Shavers said. It’s also about the next wave of Huskers setting a tone inside Yankee Stadium for what’s to come in 2025. Nebraska’s depth chart is littered with names of those getting an opportunity amid transfers and opt-outs. Many of those snaps will become harder to earn when a fresh crop of portal additions and high-school signees arrive in January. Chances abound at defensive line where — beyond outgoing seniors Ty Robinson and Nash Hutmacher — new contributors must emerge on a more full-time basis next season. Riley Van Poppel is a lead candidate to do so now free from redshirt restrictions. His first trip to New York City has been fun, he said, but now it’s time to win a game. That’s the top priority. “Go out there and get a win to not only finish this year right... but then that leads you into next year,” the 6-foot-5, 290-pound Van Poppel said. “That really sets the tone for when we get back in January for winter workouts how those go, spring ball and then next season. This game is going to show a lot about who our team is next year.” The extra bowl work — something Nebraska hasn’t had in eight winters — means more runway for what’s coming. Like culture, with coach Matt Rhule emphasizing that trips like this are a chance to act like professionals and leave places better than players found them. Like development, with former quarterback Heinrich Haarberg leaning more into a shift to tight end as one example of bowl-season tinkering. Like relationships too. Shavers is around snow for just the second time in his life, he said. But this is the first time he’s spent this much quality time with teammates at any level, touring the 9/11 memorial and snowball fight in Central Park included. It’s leaving him thankful and motivated. “Everybody’s happy,” Shavers said. “It’s like a brotherhood. We family. I’m happy for them. It’s all for the seniors.” Shavers, perhaps not jokingly, said he’s embracing a bigger role Saturday even if it means playing long snapper or safety or something else. A glance at the defensive depth chart suggests he won’t be alone with the likes of underclassmen like linemen Keona Davis and Van Poppel, linebacker Dylan Rogers, rover Rahmir Stewart, safety Caleb Benning and others to potentially see their first extended looks. Shavers is the latest success story from Nebraska’s Miami freshmen after Jacory Barney, who broke out quickly as the team’s leading pass-catcher. Linebacker Willis McGahee IV is also seeing a role increase while defensive backs Amare Sanders and Larry Tarver continue to impress behind the scenes. New receivers coach Daikiel Shorts called the value of bowl practices “phenomenal.” They’ve helped him integrate quicker into the program in the few weeks since he left Kentucky. They’ve provided more practice repetitions to rising playmakers like Jaylen Lloyd and Carter Nelson. One game left to show the gains. Then take that momentum in a carry-on back to Nebraska and into an offseason blessedly shorter than the Huskers are used to navigating. “All the younger guys, we know what to do,” Shavers said. “We know the standard. Let’s get it done. We don’t got time to be playing no more. It’s going to be our show.” Subscribe for the best Husker news & commentary Be the first to know Get local news delivered to your inbox!
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Top 5 Cybersecurity Careers To Watch In 2025MINNEAPOLIS (AP) — Minnesota Vikings coach Kevin O'Connell's stirring locker room tribute to his team last week at Seattle was respectfully interrupted by seven-year veteran right tackle Brian O'Neill, who flipped the script on the game ball awards by tossing one to the boss in honor of his second 13-win season in three years. The Vikings have obliterated even the most optimistic of external predictions for this transitional season, taking a sparkling 13-2 record into their matchup against the Green Bay Packers that has made O'Connell the current favorite for the NFL Coach of the Year award. “It’s a credit to who he is as a person, as a coach and as a leader,” tight end T.J. Hockenson said. “We’re very fortunate to be able to play under him.” The Vikings can not only win the NFC North for a second time in three seasons, but get the No. 1 seed with a first-round bye and home-field advantage throughout the NFC tournament if they beat both the Packers at home on Sunday and the Detroit Lions on the road next week. Don't expect the Vikings to ponder that possibility, though, as tantalizing as it would be. “It can be a very tired cliché to talk about going 1-0 until you’ve systematically built your entire operation daily of just trying to do that every single day,” O'Connell said after Minnesota's eighth consecutive victory . “These guys, it’s not a cliché at that point. It becomes part of your football foundation and the makeup of your locker room, of your leadership, your coaching staff.” The Packers could be forgiven for being less than impressed by the impact O'Connell has made, for a reason beyond simply him coaching their biggest rival. Green Bay enjoyed even better out-of-the-gate success under coach Matt LaFleur, who was hired in 2019 and won 13 regular-season games in each of his first three years. Though they're in third place at 11-4, two games behind the Lions and the Vikings, the Packers too have secured a place in the playoffs even if they can't win their loaded division. They'll likely be the visiting team as long as they're alive this postseason. "I think that just all of us going against one another, it’s forced you to be at your best every week," LaFleur said. “You can’t afford a slip-up, just to keep up with everybody.” The road team has won each of the past three matchups in this series. The Packers are 0-4 against the teams with the top three records in the NFC: Detroit, Minnesota and Philadelphia. “We’ve got to be able to go win these games against the really good teams in the league and set ourselves up for the situation we’ll be in for the playoffs,” quarterback Jordan Love said. The running men Aaron Jones rushed for 93 yards on 22 carries for Minnesota in a 31-29 victory at Green Bay on Sept. 29. Released by the Packers for salary cap relief in favor of their premier free agency addition, the three-plus-years-younger Josh Jacobs, Jones just hit the 1,000-yard mark last week and can't hide from the significance of facing his former team. "They respect you because they were on your team or they've seen the work that you put in, but you want to gain their respect in another way from playing against them, like, ‘Man, this dude is really as good as I thought he was,’" Jones said. Jacobs, for his part, is fourth in the NFL entering Week 17 with 1,216 rushing yards for the most by a Packers player in a season since Ryan Grant (1,253) in 2009. Minimizing their mistakes The earlier matchup this season featured seven combined turnovers, four by the Packers and three by the Vikings. Both of these teams are among the NFL's best in the turnover department, with Green Bay at a plus-12 margin and Minnesota at a plus-10. The Packers have allowed a total of three sacks and have committed just two turnovers over their past five games. Picking up the Pace The Vikings are eagerly anticipating the return of second-year linebacker Ivan Pace, the sparkplug who has missed four games on injured reserve with a hamstring strain. They’ll be cautious with him and the tricky nature of that injury, but getting Pace back in the middle of the action with fellow linebacker Blake Cashman would be a big boost to the play-calling options for defensive coordinator Brian Flores. “He flies around. When he blitzes, he’s as impactful as anybody, and when you can really get him and Cash out there at the same time, they both can really play to their strengths,” O’Connell said. “They’re both really good blitzers. Cash is phenomenal in coverage and reading the quarterback, and when you can kind of pair those guys together, run and pass, that’s when we’re at our best.” Kicking correction Brayden Narveson missed both of his field-goal attempts for Green Bay, from 37 and 49 yards, in the two-point decision at Lambeau Field in Week 4. The Packers released Narveson a couple of weeks later in favor of 11-year veteran Brandon McManus, who has gone 16 of 17 on field-goal tries including game-winners as time expired against Houston and Jacksonville. ___ AP NFL: https://apnews.com/hub/NFL Dave Campbell, The Associated Press
TOMS RIVER, N.J. (AP) — Gov. Phil Murphy has asked the Biden administration to put more resources into an investigation of mysterious drone sightings that have been reported in New Jersey and nearby states. Murphy, a Democrat, made the request in a letter Thursday, noting that state and local law enforcement remain “hamstrung” by existing laws and policies in their efforts to successfully counteract any nefarious activity of unmanned aircraft. He posted a copy of the letter on the social media platform X . “This leaves action surrounding the (drones) squarely on the shoulders of the federal government,” Murphy said. “More federal resources are needed to understand what is behind this activity.” Murphy and other officials have repeatedly stressed that there is no evidence that the aircraft pose a national security or a public safety threat, or have a foreign nexus. The Pentagon also has said they are not U.S. military drones. The drones have drawn intense public concern and curiosity since residents first reported seeing them last month. Assemblywoman Dawn Fantasia said from four to 180 aircraft have been reported to authorities since Nov. 18, appearing from dusk till 11 p.m. The flying objects have been spotted near the Picatinny Arsenal, a U.S. military research and manufacturing facility, and over President-elect Donald Trump’s golf course in Bedminster, but the number of reported sightings has grown greatly since then. Drones were also spotted in Pennsylvania, New York, Connecticut and other parts of the Mid-Atlantic region. The FBI, Federal Aviation Administration and other state and federal agencies involved in the investigation have not corroborated any of the reported sightings with electronic detection, and reviews of available images appear to show many of the reported drones are actually manned aircraft. They also say there have been no confirmed sightings in restricted air space. It’s also possible that a single drone has been seen and reported more than once, officials said. Some federal lawmakers have called on the military to “shoot down” the drones. The drones also appear to avoid detection by traditional methods such as helicopter and radio, according to a state lawmaker who was briefed by the Department of Homeland Security. In one case, a medevac helicopter was unable to pick up a seriously injured car accident victim in Branchburg Township in Somerset County late last month due to drones hovering near the planned landing zone, according to NJ.com. The FAA said Thursday that it does not have a report on this incident. Drones are legal in New Jersey for recreational and commercial use but are subject to local and FAA regulations and flight restrictions. Operators must be FAA certified. Witnesses say the drones they think they have seen in New Jersey appear to be larger than those typically used by hobbyists.Underdog Fantasy Promo Code BETFPB for Arizona vs. Duke: $1,000 bonus for Nov. 22 college basketballOctober PCE, Macy's earnings, Fed minutes: What to Watch