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Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif. , Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced new data demonstrating that adding BLINCYTO ® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. The data are from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8 , at 2 p.m. PT at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego . "Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients," said Jay Bradner , M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "These powerful new data leave us little doubt about the profound impact of this medicine for a large number of children affected by this disease. We are grateful to the Children's Oncology Group, along with the patients, families and clinical teams, for their dedication and partnership in advancing this critical study to improve the lives of children with cancer." Based on the results of the first pre-specified interim analysis for efficacy, the study met its primary endpoint of DFS and study randomization was terminated early based on the recommendation from the data and safety monitoring committee due to the benefit observed in the BLINCYTO arm compared to the chemotherapy-only arm. Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO. At 3 years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone. "The AALL1731 study results are truly practice-changing, further solidifying blinatumomab's role as the standard of care for a large number of children with B-ALL," said Sumit Gupta , M.D., Ph.D., FRCPC, co-chair of the Children's Oncology Group AALL1731 study and oncologist and clinician investigator, Division of Haematology/Oncology at The Hospital for Sick Children (SickKids) and associate professor of pediatrics at the University of Toronto . "These breakthrough data showing a significant improvement in disease-free survival are poised to bring substantial clinical value to children with newly diagnosed B-ALL." The addition of BLINCYTO to chemotherapy in standard risk patients resulted in outcomes similar to those previously achieved in only the most favorable pediatric risk subsets. Among SR-Average patients, 3-year DFS was 97.5% for patients treated with BLINCYTO compared to 90.2% for those treated with only chemotherapy (HR 0.33, CI 0.15-0.69). For SR-High patients, 3-year DFS was 94.1% for those treated with BLINCYTO compared to 84.8% for those treated with only chemotherapy (HR 0.45, 95% CI 0.24-0.85). "Relapsed ALL remains a major cause of pediatric cancer mortality, with nearly half of the relapses occurring in children with standard-risk B-ALL," said Rachel E. Rau , M.D., co-chair of the Children's Oncology Group AALL1731 study, pediatric hematologist-oncologist at Seattle Children's Hospital and associate professor of pediatrics at the University of Washington . "These findings underscore the progress made with blinatumomab in preventing relapse and support its role as a critical addition to current therapeutic strategies." Safety results are consistent with the known safety profile of BLINCYTO. BLINCYTO has demonstrated a positive balance of benefits and risks, with only 0.3% of first courses associated with Grade 3+ cytokine release syndrome (CRS) and 0.7% with seizures. A higher risk of infections was observed in the BLINCYTO arm. These results provide the first evidence supporting BLINCYTO for use in the consolidation phase in newly diagnosed pediatric Philadelphia chromosome-negative (Ph-) B-ALL patients. This groundbreaking first-in-class Bispecific T-cell Engager (BiTE ® ) therapy is now backed by additional evidence reinforcing its role in redefining a standard of care for both adult and pediatric patients, starting from one month old, regardless of measurable residual disease (MRD) status. The findings further establish BLINCYTO as a versatile first-line consolidation therapy across all ages and treatment backbones. The NCI's Cancer Therapy Evaluation Program (CTEP), which sponsored the study will share data with the U.S. Food and Drug Administration as part of their ongoing communications relating to the trial. About The Children's Oncology Group The Children's Oncology Group (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world's largest organization devoted exclusively to childhood and adolescent cancer research. The Children's Oncology Group unites over 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities and cancer centers across North America , Australia , New Zealand and Saudi Arabia in the fight against childhood cancer. Today, more than 80% of the 15,000 children and adolescents diagnosed with cancer each year in the United States are cared for at Children's Oncology Group member institutions. Research performed by Children's Oncology Group institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 86%. The Children's Oncology Group's mission is to improve the cure rate and outcomes for all children with cancer. About AALL1731 (NCT03914625) The AALL1731 study was a Phase 3 randomized trial to determine if two non-sequential cycles of BLINCYTO added to chemotherapy improved disease-free survival (DFS) in children with newly diagnosed pediatric National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL). The study enrolled 4,264 newly diagnosed NCI SR B-ALL patients, of whom 2,334 were risk stratified at the end of induction therapy as either SR-Average or SR-High. At the first planned interim efficacy analysis (data cutoff June 30, 2024 ), 1,440 of the eligible and evaluable patients had been randomized. The AALL1731 study was designed and conducted independently from industry. The Cancer Therapy Evaluation Program (CTEP) of the NCI sponsored the trial and provided funding to the Children's Oncology Group to conduct the study. NCI is part of the National Institutes of Health (NIH). In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement. About Acute Lymphoblastic Leukemia (ALL) ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen and central nervous system. ALL is a rare disease, with an estimated 6,550 new cases, affecting both children and adults, diagnosed in the U.S. in 2024. 1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow. 2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults and approximately 88% in children, the most common cancer in children. 4,5 About BLINCYTO ® (blinatumomab) BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE ® ) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE ® molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE ® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers. BLINCYTO was granted Breakthrough Therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of: 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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Prime Minister Justin Trudeau was in the hot seat (so to speak) on Thursday, appearing on the latest episode of Hot Ones Quebec . The show, which appears on the streaming platform of Videotron, is a French-language adaptation of Hot Ones, an American YouTube-based show in which celebrities are interviewed while eating increasingly spicy chicken wings. Here’s what we learned from Trudeau’s appearance, which was filmed on Nov. 24. Host Marc-André Grondin joked that he wanted to alert the prime minister’s security team about the name of one of the sauces, called Da’ Bomb, with Trudeau kidding him not to use the name at an airport. Da’ Bomb is rated at 135,600 on the Scoville scale (very hot!) but Trudeau didn’t look concerned as he ate the wing. “You’re very strong,” Grondin said, to which Trudeau replied with a grin: “I like it spicy.” He added: “It burns, I feel it in my mouth, but—” There’s a pause as the heat seems to catch up with him. “It’s true the beer doesn’t help,” he continued, pointing to a pint from which he was drinking. “But it’s good.” “For a certain portion of the population, you’ve kind of become a symbol, seen as responsible for all of the problems on the planet,” Grondin said at one point. “Was there ever a moment when you looked at all this and said: OK that’s it, I’m out?” Trudeau noted: “I see people reacting with so much hate and I’m worried for my children because they all have the name Trudeau. So when you say ‘F–k Trudeau,’ it’s not just me you’re talking to. There’s an anger in the public space right now that worries me.” But he later said: “I think if I thought it was really terrible for my kids I’d no longer be in politics.” Trudeau told Grondin: “I was seven years old when a guy came up to me in the schoolyard to say ‘I don’t like you. My parents didn’t vote for your father and we don’t like you.’” Trudeau was born on Christmas Day, 1971, and his father, Pierre Elliott Trudeau, won elections in 1968, 1972 and 1974 before losing in 1979 and then being re-elected in 1980. He added: “I was 13 when my father quit politics and he quit because he knew being a parent of teenagers was super important, especially as a divorced single parent.” His own son Xavier is now 17, daughter Ella will be 16 in a few months, “and I couldn’t leave politics to be with them. So we’re having moments, they’re teenagers, they go out with their friends, they do silly things, and it’s tough.” “After Donald Trump was elected at the end of 2016, I was with Angela Merkel in Germany,” Trudeau said, referring to the then-chancellor. “She said, ‘What do you think?’ And I said, ‘We’ll see what he’ll be like.’ Then she said, ‘Did you read the Playboy interview?’” Trudeau asked when the interview had run in the magazine, and Merkel told him it was from the 1980s. He told Grondin that he admitted to Merkel: “If I was looking at Playboy in the 1980s it wasn’t to read articles on Donald Trump!” She later sent him the article. “It was interesting to see that already in the 1980s he was saying that we have to put tariffs on Japanese cars, on German cars, that we have to put America first. There’s a real continuity in his political thought. “But you should’ve seen my face when Angela Merkel, the German chancellor, said, ‘So, did you read the article in Playboy?’ I was like: OK, I have to answer this in an honest way.” Our website is the place for the latest breaking news, exclusive scoops, longreads and provocative commentary. Please bookmark nationalpost.com and sign up for our newsletters here .Police release new photos as they search for the gunman who killed UnitedHealthcare CEO NEW YORK (AP) — Two law enforcement officials say a masked gunman who stalked and killed the leader of one of the largest U.S. health insurance companies on a Manhattan sidewalk used ammunition emblazoned with the words “deny,” “defend” and “depose." The official were not authorized to publicly discuss details of the ongoing investigation and spoke Thursday to The Associated Press on condition of anonymity. Police also released photos of a person they say is wanted for questioning in the ambush the day before of UnitedHealthcare CEO Brian Thompson. The words on the ammunition may have been a reference to tactics insurance companies use to avoid paying claims. Elon Musk and Vivek Ramaswamy are bringing Trump's DOGE to Capitol Hill WASHINGTON (AP) — It’s DOGE time at the U.S. Capitol. Billionaire Elon Musk and fellow business titan Vivek Ramaswamy arrived on Capitol Hill for meetings with lawmakers. The two are heading up President-elect Donald Trump's Department of Government Efficiency, or DOGE, with its plans to “dismantle” the federal government. Trump tapped the duo to come up with ways for firing federal workers, cutting government programs and slashing federal regulations — all part of Trump's agenda for a second-term at the White House. House Speaker Mike Johnson said there's going to be “a lot of change” in Washington. Hegseth faces senators' concerns not only about his behavior but also his views on women in combat WASHINGTON (AP) — Pete Hegseth has spent the week on Capitol Hill trying to reassure Republican senators that he is fit to lead President-elect Donald Trump’s Department of Defense in the wake of high-profile allegations about excessive drinking and sexual assault. But senators in both parties have also expressed concern about another issue — Hegseth’s frequent comments that women should not serve in frontline military combat jobs. As he meets with senators for a fourth day Thursday, his professional views on women troops are coming under deeper scrutiny. Hegseth said this week that “we have amazing women who serve our military.” Pressed if they should serve in combat, Hegseth said they already do. Hamas official says Gaza ceasefire talks have resumed after weekslong hiatus ISTANBUL (AP) — A Hamas official says that after a weekslong hiatus international mediators have resumed negotiating with the militant group and Israel over a ceasefire in Gaza, and that he was hopeful a deal to end the 14-month war was within reach. Ceasefire negotiations were halted last month when Qatar suspended its talks with mediators from Egypt and the United States over frustration with a lack of progress between Israel and Hamas. But Bassem Naim, an official in Hamas’ political wing, said Thursday in an interview with The Associated Press that there has been a “reactivation” of efforts to end the fighting, release hostages from Gaza and free Palestinian prisoners in Israel. Why the rebel capture of Syria's Hama, a city with a dark history, matters BEIRUT (AP) — One of the darkest moments in the modern history of the Arab world happened more than four decades ago, when then-Syrian President Hafez Assad launched what came to be known as the Hama Massacre. The slaughter was named for the Syrian city where 10,000 to 40,000 people were killed or disappeared in a government attack that began on Feb. 2, 1982, and lasted for nearly a month. Hama was turned into ruins. The memory of the assault and the monthlong siege on the city remains visceral in Syrian and Arab minds. Now Islamist insurgents have captured the city in a moment many Syrians have awaited for over 40 years. France's Macron vows to stay in office till end of term, says he'll name a new prime minister soon PARIS (AP) — French President Emmanuel Macron has vowed to stay in office until the end of his term in 2027 and announced that he will name a new prime minister within days. In his address to the nation on Thursday, Macron came out fighting, laying blame at the door of his opponents on the far right for bringing down the government of Michel Barnier. He said they chose “not to do but to undo” and that they “chose disorder.” The president also said the far right and the far left had united in what he called “an anti-Republican front.” He said he’ll name a new prime minister within days but gave no hints who that might be. 7.0 earthquake off Northern California prompts brief tsunami warning SAN FRANCISCO (AP) — The National Weather Service has canceled its tsunami warning for the U.S. West Coast after there was a 7.0 magnitude earthquake. According to the U.S. Geological Survey on Thursday, at least 5.3 million people in California were under a tsunami warning after the earthquake struck. It was felt as far south as San Francisco, where residents felt a rolling motion for several seconds. It was followed by multiple smaller aftershocks. There were no immediate reports of major damage or injury. Yoon replaces the defense minister as South Korea's parliament moves to vote on their impeachments SEOUL, South Korea (AP) — South Korea’s president has replaced his defense minister as opposition parties moved to impeach both men over the stunning-but-brief imposition of martial law that brought armed troops into Seoul streets. Opposition parties are pushing for a vote on motion to impeach President Yoon Suk Yeol on Saturday evening. They hold 192 seats but need 200 votes for the motion to pass. Yoon’s office said he decided to replace Defense Minister Kim Yong Hyun with Choi Byung Hyuk, a retired general who is South Korea’s ambassador to Saudi Arabia. Kim earlier apologized and said he ordered troops to carry out duties related to martial law. The Foreign Ministry also worked to mitigate the backlash and concern over South Korea's democracy. The US government is closing a women's prison and other facilities after years of abuse and decay WASHINGTON (AP) — The Associated Press has learned that the federal Bureau of Prisons is permanently closing its “rape club” women’s prison in California and will idle six facilities in a sweeping realignment after years of abuse, decay and mismanagement. The agency informed employees and Congress on Thursday that it plans to shutter the Federal Correctional Institution in Dublin, California, and its deactivate minimum-security prison camps in Wisconsin, Minnesota, Colorado, Pennsylvania, West Virginia and Florida. Staff and inmates are being moved to other facilities. The closures come amid an AP investigation that has uncovered deep, previously unreported flaws within the Bureau of Prisons. From outsider to the Oval Office, bitcoin surges as a new administration embraces crypto NEW YORK (AP) — Bitcoin burst on the scene after trust had withered in the financial system and Washington’s ability to protect people from it. Now, it’s Washington’s embrace of bitcoin that’s sending it to records. Bitcoin briefly surged above $103,000 after President-elect Donald Trump said he will nominate Paul Atkins, who's seen as friendly to crypto, to be the Securities and Exchange Commission's next chair. The crypto industry, meanwhile, did its part to bring politicians friendly to digital currencies into Washington. It's a twist from bitcoin's early days, when it was lauded as a kind of electronic cash that wouldn’t be beholden to any government or financial institution.
This is how much conferences will make for each team in College Football PlayoffLAS VEGAS (AP) — The Broncos are 0-4 in Las Vegas, but in a matchup of teams heading in opposite directions, Denver has more at stake than trying to end a series skid. A victory over the Raiders puts the Broncos that much closer to an unexpected playoff berth, playing with a rookie quarterback and just a year after they went 8-9. The Broncos are 6-5 and coming off a 38-6 victory over the Atlanta Falcons , and would be in the playoff field if the season ended entering Week 12. Not bad for a team given a win total of 5 1/2 games at BetMGM Sportsbook. “Everyone understands the significance of where we are at this point in the season,” Broncos wide receiver Courtland Sutton said. The situation is quite different for the Raiders. They are 2-8, on a six-game losing streak and decimated by injuries. Las Vegas could enter this game without its top two running backs and a reshuffled line on offense, and defensively, the Raiders could have two linemen, three cornerbacks and a safety out of action. “Just been having some bad breaks, but nobody feels sorry for us,” Raiders coach Antonio Pierce said. "Nobody feels sorry for me. You’ve got to roll out there with 11 players, and that’s what we’re going to do come Sunday.” The Raiders are badly in a need of a franchise quarterback and are in a logjam for the top pick in next year's NFL draft. Denver showed with this year's draft how valuable landing such a QB can be to an organization. Bo Nix was selected 12th — one spot ahead of the Raiders — and he is pushing for AP Offensive Rookie of the Year. He was this week's top AFC player and rookie after completing 28 of 33 passes for 307 yards and four touchdowns in the rout of the Falcons. “I think as we’ve gone on, Coach (Sean Payton) and I have found a good rhythm of what we both like, what we can kind of put out there on the field and what we can execute," Nix said. "Then the guys have kind of adapted to it, found our roles within the offense and executed at a high level. It’s just all about slowing the game down and processing things in a manner that you can handle.” Raiders tight end Brock Bowers also could have a say in who wins the season's top offensive rookie award. He is second in the NFL with 70 catches and his 706 yards receiving is 10th among all receivers. His numbers from a historical perspective are even more impressive. Bowers, the 13th pick in this year's draft , is fourth all time among all tight ends in catches through the first 11 weeks and he and Jeremy Shockey in 2002 are the only rookies at that position to have more than one game with at least 10 receptions. “This week's a brand new week,” Bowers said. “I've always got something to prove.” Payton still isn't entirely comfortable splitting carries between running backs Javonte Williams, Jaleel McLaughlin and rookie Audric Estime. Asked how he determines the right balance in his rotation, Payton said, “That's the $6 million question. It’s difficult. We know kind of what we have with those three players. I think it’s always hard to feed three. "I'm used to — and it’s easy — to feed two. So we kind of do that a little bit. I thought Javonte had some really good runs (last week). Certainly the game ends and we’re like, ‘Gosh, we have to get Jaleel more touches.’ So it’s a tough, but a good problem to have.” With injuries to running backs Alexander Mattison (ankle) and Zamir White (quadriceps), 10-year veteran Ameer Abdullah could get the start for the Raiders this weekend. He has just 17 carries for 82 yards and a touchdown this season and started just one game his previous six seasons. “I see myself as a starter,” Abdullah said. “I think every guy in the room does. I consider myself the best back on this team just like every back does. This is my opportunity to go out there and put my best foot forward.” Patrick Surtain II had a pair of interceptions, including one he returned for 100 yards and a touchdown, in the team's first meeting this season and that fueled the Broncos' 34-18 win in Denver . Both of the passes were intended for Bowers, who caught a 57-yard touchdown pass in the first quarter. Surtain isn't expecting the Raiders to avoid him Sunday, however. “You don't want to go into a game thinking they're not gonna throw it your way,” Surtain said, “because it's the pros at the end of the day, everybody's ready, everybody's capable.” AP Pro Football Writer Arnie Stapleton in Englewood, Colorado, contributed to this report. AP NFL: https://apnews.com/hub/nflOverhauls of 'heritage brands' raise the question: How important are our products to our identities?Trump risks legal clashes in plans to not spend appropriations
NEW YORK (AP) — lawyers urged a judge again Friday to throw out his hush money conviction, balking at the prosecution’s suggestion of preserving the verdict by treating the case the way some courts do when a defendant dies. They called the idea “absurd.” The Manhattan district attorney’s office is asking Judge Juan M. Merchan to “pretend as if one of the assassination attempts against President Trump had been successful,” Trump’s lawyers wrote in a blistering 23-page response. In court papers made public Tuesday, office proposed an array of options for keeping the historic conviction on the books after Trump’s lawyers filed paperwork earlier this month asking for the case to be dismissed. They include freezing the case until Trump leaves office in 2029, agreeing that any future sentence won’t include jail time, or closing the case by noting he was convicted but that he wasn’t sentenced and his appeal wasn’t resolved because of presidential immunity. Trump lawyers Todd Blanche and Emil Bove reiterated Friday their position that the only acceptable option is overturning his conviction and dismissing his indictment, writing that anything less will interfere with the transition process and his ability to lead the country. The Manhattan district attorney’s office declined comment. It’s unclear how soon Merchan will decide. He could grant Trump’s request for dismissal, go with one of the prosecution’s suggestions, wait until a federal appeals court rules on Trump’s parallel effort to get the case moved out of state court, or choose some other option. In their response Friday, Blanche and Bove ripped each of the prosecution’s suggestions. Halting the case until Trump leaves office would force the incoming president to govern while facing the “ongoing threat” that he’ll be sentenced to imprisonment, fines or other punishment as soon as his term ends, Blanche and Bove wrote. Trump, a Republican, takes office Jan. 20. “To be clear, President Trump will never deviate from the public interest in response to these thuggish tactics,” the defense lawyers wrote. “However, the threat itself is unconstitutional.” The prosecution’s suggestion that Merchan could mitigate those concerns by promising not to sentence Trump to jail time on presidential immunity grounds is also a non-starter, Blanche and Bove wrote. The immunity statute requires dropping the case, not merely limiting sentencing options, they argued. Blanche and Bove, both of whom Trump has tabbed for high-ranking Justice Department positions, expressed outrage at the prosecution’s novel suggestion that Merchan borrow from Alabama and other states and treat the case as if Trump had died. Blanche and Bove accused prosecutors of ignoring New York precedent and attempting to “fabricate” a solution “based on an extremely troubling and irresponsible analogy between President Trump” who survived assassination attempts in Pennsylvania in July and Florida in September “and a hypothetical dead defendant.” Such an option normally comes into play when a defendant dies after being convicted but before appeals are exhausted. It is unclear whether it is viable under New York law, but prosecutors suggested that Merchan could innovate in what’s already a unique case. “This remedy would prevent defendant from being burdened during his presidency by an ongoing criminal proceeding,” prosecutors wrote in their filing this week. But at the same time, it wouldn’t “precipitously discard” the “meaningful fact that defendant was indicted and found guilty by a jury of his peers.” Prosecutors acknowledged that “presidential immunity requires accommodation” during Trump’s impending return to the White House but argued that his election to a second term should not upend the jury’s verdict, which came when he was out of office. Longstanding Justice Department policy says sitting presidents cannot face . Other world leaders don’t enjoy the same protection. For example, is even as he leads that nation’s wars in and . Trump has been fighting for months to reverse his May 30 conviction on . Prosecutors said he fudged the documents to conceal a $130,000 payment to porn actor to suppress her claim that they had sex a decade earlier, which Trump denies. In their filing Friday, Trump’s lawyers citing a social media post in which Sen. used profane language to criticize Trump’s hush money prosecution. The Pennsylvania Democrat suggested that Trump deserved a pardon, comparing his case to that of pardoned son Hunter Biden, who had been convicted of . “Weaponizing the judiciary for blatant, partisan gain diminishes the collective faith in our institutions and sows further division,” Fetterman wrote Wednesday on Truth Social. Trump’s hush money conviction was in state court, meaning a presidential pardon — issued by Biden or himself when he takes office — would not apply to the case. Presidential pardons only apply to federal crimes. Since the election, special counsel has , which pertained to Trump’s efforts to overturn his 2020 election loss and allegations that he hoarded classified documents at his Mar-a-Lago estate. A separate in Fulton County, Georgia, is largely on hold. Trump denies wrongdoing in all. Trump had been scheduled for sentencing in the hush money case in late November. But following Trump’s Nov. 5 election victory, Merchan halted proceedings and indefinitely postponed the former and future president’s sentencing so the defense and prosecution could weigh in on the future of the case. Merchan also delayed a decision on Trump’s to dismiss the case on immunity grounds. A dismissal would erase Trump’s conviction, sparing him the cloud of a criminal record and possible prison sentence. Trump is the first former president to be convicted of a crime and the first convicted criminal to be elected to the office.