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Georgia QB Carson Beck takes hit on throwing arm before halftime, leaving status uncertainBeirut: Insurgents’ stunning march across Syria gained speed on Saturday (Sunday AEDT) with news that they had reached the suburbs of the capital Damascus and with the government forced to deny rumours that President Bashar al-Assad had fled the country. The lightning rebel advance suggests that Assad’s government could fall within the next week, US and other Western officials said. A giant portrait of Syrian president Bashar Assad sets on a building, as empty streets seen in Damascus, Syria, on Saturday. Credit: AP Since the rebels’ sweep into Aleppo a week ago, government defences have crumbled at a dizzying speed as insurgents seized a string of major cities and rose up in places where the rebellion had long seemed over. The twin threats to the strategically vital city of Homs and the capital, Damascus, now pose an existential danger to the Assad dynasty’s five-decade reign over Syria and the continued influence there of its main regional backer, Iran. The rebels’ moves around Damascus, reported by an opposition war monitor and a rebel commander, came after the Syrian army withdrew from much of the southern part of the country, leaving more areas, including several provincial capitals, under the control of opposition fighters. If the insurgents capture Homs, they would cut the link between Damascus, Assad’s seat of power, and the coastal region where the president enjoys wide support. The advances in the past week were among the largest in recent years by opposition factions led by a group that has its origins in al-Qaeda and is considered a terrorist organisation by the US and the United Nations. In their push to overthrow Assad’s government, the insurgents, led by the Hayat Tahrir al-Sham group, or HTS, have met little resistance from the Syrian army. For the first time in the country’s long-running civil war, the government now has control of only four of 14 provincial capitals: Damascus, Homs, Latakia and Tartus. People arrive at the Jordanian side of the border as others wait in their cars, after a ban on crossings into Syria, on December 7, 2024 in Jaber, Jordan. Credit: Getty Images The UN’s special envoy for Syria, Geir Pedersen, on Saturday called for urgent talks in Geneva to ensure an “orderly political transition”. Speaking to reporters at the annual Doha Forum in Qatar, he said the situation in Syria was changing by the minute. Russian Foreign Minister Sergey Lavrov, whose country is Assad’s chief international backer, said he feels “sorry for the Syrian people”. In Damascus, people rushed to stock up on supplies. Thousands went to Syria’s border with Lebanon, trying to leave the country. Many shops in the capital were shuttered, a resident told the Associated Press, and those still open had run out of staples such as sugar. Some were selling items at three times the normal price. “The situation is very strange. We are not used to that,” the resident said, insisting on anonymity, fearing retributions. “People are worried whether there will be a battle [in Damascus] or not.” It was the first time that opposition forces reached the outskirts of Damascus since 2018 when Syrian troops recaptured the area following a years-long siege. The UN said it was moving non-critical staff outside the country as a precaution. Syrian President Bashar al-Assad: Backed by Russia and Iran – both of which are bogged down in separate conflicts. Credit: Saudi Press Agency/AP Assad rumours Syria’s state media denied social media rumours that President Assad had left the country, saying he was performing his duties in Damascus. Assad has had little, if any, help from his allies. Russia is busy with its war in Ukraine and Lebanon’s Hezbollah, which at one point sent thousands of fighters to shore up Assad’s forces, has been weakened by a yearlong conflict with Israel. Iran has seen its proxies across the region degraded by regular Israeli airstrikes. US President-elect Donald Trump on Saturday posted on social media that the US should avoid engaging militarily in Syria. Pedersen said a date for talks in Geneva on the implementation a UN resolution, adopted in 2015, and calling for a Syrian-led political process, would be announced later. The resolution calls for the establishment of a transitional governing body, followed by the drafting of a new constitution and ending with UN-supervised elections. A Syrian opposition fighter holds a rocket launcher in front of the provincial government office. Credit: AP Foreign ministers and senior diplomats from eight key countries, including Saudi Arabia, Russia, Egypt, Turkey and Iran, along with Pederson, gathered on the sidelines of the Doha Summit on Saturday to discuss the situation. No details were immediately available. The insurgents’ march Rami Abdurrahman, who heads the Britain-based Syrian Observatory for Human Rights, an opposition war monitor, said insurgents were in the Damascus suburbs of Maadamiyah, Jaramana and Daraya. Opposition fighters were marching toward the Damascus suburb of Harasta, he added. An insurgent commander, Hassan Abdul-Ghani, posted on the Telegram messaging app that opposition forces had begun the “final stage” of their offensive by encircling Damascus. HTS controls much of northwest Syria and in 2017 set up a “salvation government” to run day-to-day affairs in the region. In recent years, HTS leader Abu Mohammed al-Golani has sought to remake the group’s image, cutting ties with al-Qaeda, ditching hardline officials and vowing to embrace pluralism and religious tolerance. Syrian rebel leader Abu Mohammed al-Golani. Credit: Al Jazeera Syria’s military, meanwhile, sent large numbers of reinforcements to defend the key central city of Homs, Syria’s third largest, as insurgents approached its outskirts. The shock offensive began on November 27, during which rebel fighters captured the northern city of Aleppo, Syria’s largest, and the central city of Hama, the country’s fourth-largest city. Opposition activists said insurgents entered Palmyra on Friday, which is home to invaluable archaeological sites, that had been in government hands since being taken from the Islamic State group in 2017. To the south, Syrian troops left much of the province of Quneitra, including the main Baath City, activists said. The Syrian Observatory said government troops had withdrawn from much of the two southern provinces and were sending reinforcements to Homs, where a battle loomed. If the insurgents capture Homs, they would cut the link between Damascus, Assad’s seat of power, and the coastal region where the president enjoys wide support. The Syrian Army said in a statement that it had carried out redeployment and repositioning in Sweida and Daraa after its checkpoints came under attack by “terrorists”. The army said it was setting up a “strong and coherent defensive and security belt in the area”, apparently to defend Damascus from the south. The Syrian government has referred to opposition gunmen as terrorists since conflict broke out in March 2011. Diplomacy in Doha The foreign ministers of Iran, Russia and Turkey, meeting in Qatar, called for an end to the hostilities. Turkey is a main backer of the rebels. Qatar’s top diplomat, Sheikh Mohammed bin Abdulrahman Al Thani, criticised Assad for failing to take advantage of the lull in fighting in recent years to address the country’s underlying problems. “Assad didn’t seize this opportunity to start engaging and restoring his relationship with his people,” he said. Sheikh Mohammed said he was surprised by how quickly the rebels have advanced and said there was a real threat to Syria’s “territorial integrity.” He said the war could “damage and destroy what is left if there is no sense of urgency” to start a political process. AP, Reuters Get a note directly from our foreign correspondents on what’s making headlines around the world. Sign up for our weekly What in the World newsletter .
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. 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Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen's information technology systems could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Elissa Snook , 609-251-1407 (media) Justin Claeys , 805-313-9775 (investors) References National Institute of Health. Cancer Stat Facts: Leukemia — Acute Lymphocytic Leukemia (ALL). Available at: https://seer.cancer.gov/statfacts/html/alyl.html . Accessed on October 28, 2024 . Terwilliger T, et al. Blood Cancer J . 2017;7(6):e577. American Cancer Society. What is Acute Lymphocytic Leukemia (ALL)? Available at: https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html . Accessed on October 28, 2024 . Leukemia & Lymphoma Society. Acute Lymphoblastic Leukemia (ALL). Available at: https://www.lls.org/research/acute-lymphoblastic-leukemia-all . Accessed on October 28, 2024 . National Cancer Institute. Childhood Acute Lymphoblastic Leukemia (PDQ ® )–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/child-all-treatment-pdq . Accessed on November 19, 2024 . View original content to download multimedia: https://www.prnewswire.com/news-releases/blincyto-blinatumomab-added-to-chemotherapy-significantly-improves-survival-in-newly-diagnosed-pediatric-patients-with-b-cell-precursor-acute-lymphoblastic-leukemia-b-all-302325381.html SOURCE Amgen © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.South Korea's president avoids an impeachment attempt over short-lived martial law
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GM to sell its stake in Michigan battery plant to LG Energy SolutionCOLOGNE, GERMANY – Newsaktuell – 5 December 2024 – VYTAL Global GmbH, the Germany-based digital reuse platform, is thrilled to announce the founding of its U.S.-based subsidiary, VYTAL US Inc. This strategic expansion marks a major step forward in Vytal’s mission to create a global tech platform that enables reuse in all food service settings, from large-scale festivals, sports and entertainment venues to campuses, corporate offices and quick-service restaurants. VYTAL US has acquired certain assets of TURN, a U.S.-based reuse company, and is assuming services for a selected group of TURN’s former clients, primarily operators of large festivals and venues, including some of TURN’s operations in Australia and New Zealand. Additionally, key members of the TURN team will join VYTAL US, ensuring a seamless transition and continuity of service for those clients. This move allows Vytal to enhance its existing expertise with TURN’s proven consumer engagement strategies while bringing its advanced tracking technology and market-leading operational efficiency to the U.S. market. A Strategic Leap Forward “From the start, Vytal’s ambition is to solve the single-use packaging waste crisis on a global scale,” says Dr. Tim Breker, Co-Founder & Managing Director of VYTAL Global GmbH. “Europe, particularly Germany, has long been a leader in reuse. We believe we have a clear competitive advantage to build the most advanced reuse solutions for our clients. By expanding into the U.S., we’re leveraging our sophisticated tech platform, as well as years of operational experience, to deliver high-value reuse solutions. Scaling reuse in Europe is mostly about efficiency and convenience. In the U.S. reuse has a major third growth driver: consumer engagement. Mastering this triad in the most exciting consumer market of the world will further cement Vytal’s leadership of the global reuse movement.” A globally relevant reuse champion Following a record-breaking 2024 serving over 160 events and over 7,000 clients across 17 countries – including high-profile clients like key sites during the Olympics 2024 and several EURO 2024 fan zones across three major cities – VYTAL is well-positioned to replicate this success in the U.S. Leveraging Innovative Technology to Scale Reuse At the heart of Vytal’s success is its cutting-edge technology, which covers the full value chain from logistics and tracking to POS integration and consumer engagement. These innovations make reuse easier, more efficient, and economically beneficial for operators, consumers and brands. The acquired expertise in digital consumer rewards and engagement complements Vytal’s existing technology platform, creating an even stronger value proposition for operators looking to incentivize reuse and enhance customer satisfaction. Vytal’s ability to deliver these innovations at scale promises to unlock immense potential in the U.S. market. Setting a New Standard in Washing Systems Understanding the importance of modern, efficient washing infrastructure, Vytal is investing in a washing facility in Atlanta, Georgia that aims to be the most advanced washing system in the U.S. This state-of-the-art facility will not only optimize the cleaning and handling of reusable packaging but also set a new industry benchmark for operational efficiency, hygiene, and sustainability. Welcoming New Talent Across the Atlantic Vytal is especially excited to welcome some experienced members of the former TURN team. Their deep knowledge of the U.S. market and expertise in tech-enabled reuse will be invaluable in delivering outstanding service to existing and future customers of VYTAL US, significantly growing the U.S. reuse business. Accelerating growth in 2025 With access to new markets, pioneering technologies, and top talent, Vytal is ready to lead the worldwide reuse movement into 2025. Through its data-driven approach, Vytal maximizes economic benefits for all stakeholders, creating a world where reuse becomes the new normal. Hashtag: #VYTALGlobal #VYTALUSInc The issuer is solely responsible for the content of this announcement. VYTAL Global is revolutionizing the packaging industry by eliminating single-use packaging through advanced reusable solutions. Utilizing cutting-edge software and data analytics, VYTAL delivers cost-effective, sustainable packaging options that benefit businesses and the environment. Internationally recognized by the Harvard Business Review for its pioneering data model, Vytal is at the forefront of the global transition to a circular economy. With a network of over 7,000 partners across 22 countries, the company is leading the charge in reducing disposable packaging waste. Vytal established a dedicated subsidiary to expand its impact to bring reusable solutions to the events and entertainment industry. This initiative reflects Vytal’s commitment to sustainability by addressing the unique demands of large-scale events and venues. United under a shared vision, VYTAL Global is transforming packaging systems worldwide, offering innovative, eco-friendly alternatives to create a more sustainable future. VYTAL US Inc., the wholly owned U.S. subsidiary of VYTAL Global, delivers advanced reuse solutions for large-scale events, sports venues, corporate campuses, and quick-service restaurants in the U.S. As of Q2 2025, VYTAL US will operate the country’s most advanced washing facility in Atlanta, Georgia, ensuring top-tier hygiene, efficiency, and sustainability. By partnering with the most progressive companies from the Food & Beverage Industry, VYTAL US aims to make reuse the new normal for campuses and venues in the U.S., creating solutions that benefit businesses, consumers, and the environment.
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MADISON, Wis. (AP) — Wisconsin public worker and teachers unions scored a major legal victory Monday with a ruling that restores collective bargaining rights they lost under a 2011 state law that sparked weeks of protests and made the state the center of the national battle over union rights. That law, known as Act 10, effectively ended the ability of most public employees to bargain for wage increases and other issues, and forced them to pay more for health insurance and retirement benefits. Under the ruling by Dane County Circuit Judge Jacob Frost, all public sector workers who lost their collective bargaining power would have it restored to what was in place prior to 2011. They would be treated the same as the police, firefighter and other public safety unions that were exempted under the law. Republicans vowed to immediately appeal the ruling, which ultimately is likely to go before the Wisconsin Supreme Court. That only amplifies the importance of the April election that will determine whether the court remains controlled 4-3 by liberal justices. Former Gov. Scott Walker, who proposed the law that catapulted him onto the national political stage, decried the ruling in a post on the social media platform X as “brazen political activism.” He said it makes the state Supreme Court election “that much more important.” Supporters of the law have said it provided local governments more control over workers and the powers they needed to cut costs. Repealing the law, which allowed schools and local governments to raise money through higher employee contributions for benefits, would bankrupt those entities, backers of Act 10 have argued. Democratic opponents argue that the law has hurt schools and other government agencies by taking away the ability of employees to collectively bargain for their pay and working conditions. The law was proposed by Walker and enacted by the Republican-controlled Legislature in spite of massive protests that went on for weeks and drew as many as 100,000 people to the Capitol. The law has withstood numerous legal challenges over the years, but this was the first brought since the Wisconsin Supreme Court flipped to liberal control in 2023. The seven unions and three union leaders that brought the lawsuit argued that the law should be struck down because it creates unconstitutional exemptions for firefighters and other public safety workers. Attorneys for the Legislature and state agencies countered that the exemptions are legal, have already been upheld by other courts, and that the case should be dismissed. But Frost sided with the unions in July, saying the law violates equal protection guarantees in the Wisconsin Constitution by dividing public employees into “general” and “public safety” employees. He ruled that general employee unions, like those representing teachers, can not be treated differently from public safety unions that were exempt from the law. His ruling Monday delineated the dozens of specific provisions in the law that must be struck. Wisconsin Republican Assembly Speaker Robin Vos said he looked forward to appealing the ruling. “This lawsuit came more than a decade after Act 10 became law and after many courts rejected the same meritless legal challenges,” Vos said in a statement. Wisconsin Manufacturers and Commerce, the state's largest business lobbying organization, also decried the ruling. WMC President Kurt Bauer called Act 10 “a critical tool for policymakers and elected officials to balance budgets and find taxpayer savings." The Legislature said in court filings that arguments made in the current case were rejected in 2014 by the state Supreme Court. The only change since that ruling is the makeup of Wisconsin Supreme Court, attorneys for the Legislature argued. The Act 10 law effectively ended collective bargaining for most public unions by allowing them to bargain solely over base wage increases no greater than inflation. It also disallowed the automatic withdrawal of union dues, required annual recertification votes for unions, and forced public workers to pay more for health insurance and retirement benefits. The law was the signature legislative achievement of Walker, who was targeted for a recall election he won. Walker used his fights with unions to mount an unsuccessful presidential run in 2016. Frost, the judge who issued Monday's ruling, appeared to have signed the petition to recall Walker from office. None of the attorneys sought his removal from the case and he did not step down. Frost was appointed to the bench by Democratic Gov. Tony Evers, who signed the Walker recall petition. The law has also led to a dramatic decrease in union membership across the state. The nonpartisan Wisconsin Policy Forum said in a 2022 analysis that since 2000, Wisconsin had the largest decline in the proportion of its workforce that is unionized. In 2015, the GOP-controlled Wisconsin Legislature approved a right-to-work law that limited the power of private-sector unions. Public sector unions that brought the lawsuit are the Abbotsford Education Association; the American Federation of State, County and Municipal Employees Locals 47 and 1215; the Beaver Dam Education Association; SEIU Wisconsin; the Teaching Assistants’ Association Local 3220 and the International Brotherhood of Teamsters Local 695. Copyright 2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission. Get local news delivered to your inbox!
DETROIT (AP) — Brandon Noel's 26 points helped Wright State defeat Detroit Mercy 80-72 on Saturday. Noel had seven rebounds for the Raiders (6-5, 1-1 Horizon League). Jack Doumbia scored 21 points while shooting 8 of 16 from the field and 5 for 6 from the line and added 13 rebounds and three blocks. Alex Huibregste shot 5 of 10 from the field, including 2 for 6 from 3-point range, and went 5 for 5 from the line to finish with 17 points, while adding six assists. The Titans (5-6, 1-1) were led in scoring by Orlando Lovejoy, who finished with 14 points, seven rebounds, four assists and two steals. Detroit Mercy also got 12 points from Nate Johnson. Grant Gondrezick II also recorded 11 points and two steals. Wright State's next game is Wednesday against Marshall at home. Detroit Mercy visits Davidson on Saturday. The Associated Press created this story using technology provided by Data Skrive and data from Sportradar .ALTOONA, Pa. — The man accused of killing UnitedHealthcare’s CEO struggled with deputies and shouted while being led into court Tuesday as new details emerged about his possible motivation behind the ambush. In his first public words since a five-day search ended with his arrest at a McDonald’s in Pennsylvania, Luigi Nicholas Mangione emerged from a patrol car shouting about an “insult to the intelligence of the American people” while deputies pushed him inside a courthouse. The 26-year-old Ivy League graduate from a prominent Maryland real estate family is fighting attempts to extradite him to New York to face a murder charge in the Manhattan killing of Brian Thompson, who led the United States’ largest medical insurance company. A law enforcement bulletin obtained by The Associated Press said that at the time of his arrest, Mangione carried a handwritten document expressing anger with what he called “parasitic” health insurance companies and a disdain for corporate greed and power. He wrote that the U.S. has the most expensive health care system in the world and that profits of major corporations continue to increase while “our life expectancy” does not, according to the bulletin. In social media posts, Mangione called “Unabomber” Ted Kaczynski — who carried out a series of bombings while railing against modern society and technology — a “political revolutionary,” according to the bulletin. Mangione remained jailed in Pennsylvania, where he was initially charged with possession of an unlicensed firearm, forgery and providing false identification to police. Manhattan prosecutors began to take steps to bring Mangione to New York, but at a brief hearing Tuesday, defense lawyer Thomas Dickey said his client will not waive extradition and instead wants a hearing on the issue. Mangione was denied bail after prosecutors said he was too dangerous to be released. “You can’t rush to judgment in this case or any case,” Dickey said afterward. “He’s presumed innocent. Let’s not forget that.” Mangione was arrested in Altoona, Pennsylvania, about 230 miles west of New York City, after a McDonald’s customer recognized him and notified an employee, authorities said. An image of Mangione released Tuesday by Pennsylvania State Police showed him pulling down his mask in the corner of the McDonald’s while holding what appeared to be hash browns and wearing a winter jacket and beanie. New York police officials said Mangione was carrying a gun like the one used to kill Thompson and the same fake ID the shooter had used to check into a New York hostel, along with a passport and other fraudulent IDs. A law enforcement official who spoke with The Associated Press on condition of anonymity said a handwritten document found with Mangione included a line in which he claimed to have acted alone. “To the Feds, I’ll keep this short, because I do respect what you do for our country. To save you a lengthy investigation, I state plainly that I wasn’t working with anyone,” the document said, according to the official. It also said, “I do apologize for any strife or traumas but it had to be done. Frankly, these parasites simply had it coming.” Thompson, 50, was killed last Wednesday as he walked alone to a Manhattan hotel for an investor conference. From surveillance video, New York investigators determined the shooter quickly fled the city, likely by bus. Mangione was born into a life of country clubs and privilege. His grandfather was a real estate developer and philanthropist. Valedictorian at his elite Baltimore prep school, he went on to earn undergraduate and graduate degrees in computer science in 2020 from the University of Pennsylvania, a spokesperson said. “Our family is shocked and devastated by Luigi’s arrest,” Mangione’s family said in a statement posted on social media late Monday by his cousin, Maryland Del. Nino Mangione. “We offer our prayers to the family of Brian Thompson and we ask people to pray for all involved.” From January to June 2022, Luigi Mangione lived at Surfbreak, a “co-living” space at the edge of touristy Waikiki in Honolulu. Like other residents of the shared penthouse catering to remote workers, Mangione underwent a background check, said Josiah Ryan, a spokesperson for owner and founder R.J. Martin. “Luigi was just widely considered to be a great guy. There were no complaints,” Ryan said. “There was no sign that might point to these alleged crimes they’re saying he committed.” At Surfbreak, Martin learned Mangione had severe back pain from childhood that interfered with many aspects of his life, from surfing to romance, Ryan said. Mangione left Surfbreak to get surgery on the mainland, Ryan said, then later returned to Honolulu and rented an apartment. Martin stopped hearing from Mangione six months to a year ago. Mangione Mangione Get local news delivered to your inbox!