Wednesday, December 25, 2024 The holiday season is in full swing, and for many, that means embarking on journeys to reunite with loved ones or explore new destinations. However, the festive spirit is often accompanied by the stress of navigating crowded airports, delayed flights, and long lines. This year, the travel industry is witnessing a surge in demand, particularly in regions like America, Europe, Australia, and Asia, which are experiencing a resurgence in tourism following the pandemic. While this is undoubtedly good news for the industry, it also presents challenges for travelers and highlights the need for better infrastructure and more efficient travel solutions. A Global Travel Boom The travel industry is experiencing a significant rebound, with many regions witnessing a surge in demand. In the United States, domestic travel remains strong, with millions of Americans hitting the road or taking to the skies to visit family and friends during the holiday season. International travel is also on the rise, with popular destinations like Mexico, Canada, and the Caribbean attracting a large number of American tourists. Europe, a perennial favorite among travelers, is witnessing a similar trend. Cities like London, Paris, and Rome are teeming with tourists, eager to experience the festive atmosphere and soak in the cultural richness of these iconic destinations. The continent’s efficient transportation network, coupled with its diverse attractions, makes it a popular choice for both leisure and business travelers. Asia, too, is experiencing a travel boom, with countries like Japan, Thailand, and Singapore witnessing a surge in tourist arrivals. The region’s unique cultural experiences, coupled with its stunning natural beauty, are attracting travelers from all corners of the globe. Moreover, the easing of travel restrictions in many Asian countries has further fueled the growth of the tourism sector. Australia, known for its stunning beaches, vibrant cities, and diverse wildlife, is also witnessing a resurgence in tourism. The country’s unique appeal, coupled with its robust infrastructure and welcoming culture, is attracting travelers from all over the world. Challenges and Opportunities While the surge in travel demand is undoubtedly a positive sign for the industry, it also presents several challenges. Overcrowding at airports and tourist hotspots, delayed flights, and long queues are becoming increasingly common, leading to frustration and inconvenience for travelers. To address these challenges, the travel industry needs to invest in infrastructure upgrades, such as expanding airport capacity and improving transportation networks. Additionally, there is a need for more efficient travel solutions, such as self-service kiosks, automated baggage handling systems, and mobile check-in options. The rise of technology is also playing a crucial role in shaping the future of the travel industry. Online travel agencies, travel apps, and social media platforms are empowering travelers with information and making it easier to plan and book their trips. Moreover, the emergence of artificial intelligence (AI) is transforming various aspects of the travel experience, from personalized recommendations to automated customer service. The Human Element Despite the increasing role of technology, the human element remains crucial in the travel industry. The quality of customer service, the warmth of hospitality, and the genuine human connection can make or break a travel experience. As the industry continues to evolve, it is essential to prioritize the human element and ensure that travelers feel valued and appreciated. Looking Ahead The travel industry is poised for continued growth in the coming years, driven by factors such as increasing disposable incomes, a growing global middle class, and a greater emphasis on leisure and experiential travel. However, the industry must also address the challenges associated with this growth, such as environmental sustainability and the impact of tourism on local communities. By embracing innovation, investing in infrastructure, and prioritizing the human element, the travel industry can continue to thrive while ensuring a positive and sustainable future for both travelers and the destinations they visit. Additional Insights Conclusion The travel industry is experiencing a period of significant growth, with regions like America, Europe, Australia, and Asia leading the way. While this surge in demand presents challenges, it also offers exciting opportunities for the industry to innovate and evolve. By embracing technology, prioritizing sustainability, and focusing on the human element, the travel industry can continue to thrive while ensuring a positive and enriching experience for travelers around the world. Discover everything and anything about travel , tourism , trade shows at the Travel And Tour World , including breaking travel news and weekly travel updates for travel trade , airlines , cruise , railways , technology , travel association , DMCs, and video interviews and promotional videos .ATLANTA, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”) (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today celebrates a landmark moment in the cryptocurrency as Bitcoin surpasses its all-time price peak of $100,000. This industry milestone reflects growing global confidence in Bitcoin as a financial asset and highlights the increasing demand for accessible crypto solutions. "Bitcoin reaching $100,000 is an example of its resilience, staying power, and growing role in the financial ecosystem," said Brandon Mintz, CEO and founder of Bitcoin Depot. "This moment shows the growing trust millions place in Bitcoin and further establishes Bitcoin Depot’s commitment of 'Bringing Bitcoin to the Masses®' by providing secure, user-friendly access points that bridge traditional finance and the digital economy." 2024 has been a defining period for the crypto industry, marked by significant advancements such as the U.S. Securities and Exchange Commission's approval of the first Bitcoin spot ETFs and continued growing institutional adoption. These achievements, coupled with increased regulatory clarity and rising global interest in Bitcoin, further demonstrate cryptocurrency's expanding role in the financial landscape. Bitcoin Depot, with over 8,300 Bitcoin ATM kiosks deployed across North America and Puerto Rico, has cemented itself as a key player in facilitating crypto adoption. As the largest BTM operator in North America, the Company has built significant momentum in the last year, marked by key milestones such as bringing its BDCheckout Program to six new states, expanding into Puerto Rico , and introducing strategic retail partnerships with multiple major convenience and grocery store retailers. “Bitcoin’s momentum is driving new users to enter the market, and many are choosing BTMs for secure and convenient access to cryptocurrency,” said Scott Buchanan, COO of Bitcoin Depot. “At Bitcoin Depot, we’ve always believed in providing everyone with easy access to Bitcoin, and as we grow, our focus remains on delivering a simple and reliable way to buy Bitcoin quickly and securely. This is just the beginning for the cryptocurrency industry and Bitcoin Depot as a leading provider.” Bitcoin Depot BTMs are designed to provide a seamless user experience, allowing customers to quickly convert cash into Bitcoin and access the broader digital financial system for payments, transfers, remittances, and investments. About Bitcoin Depot Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 8,486 kiosk locations as of December 05, 2024. Learn more at www.bitcoindepot.com . Cautionary Note Regarding Forward-Looking Statements This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, the anticipated effects of the Amendment, and the closing of the Preferred Sale. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as "anticipate," "appears," "approximately," "believe," "continue," "could," "designed," "effect," "estimate," "evaluate," "expect," "forecast," "goal," "initiative," "intend," "may," "objective," "outlook," "plan," "potential," "priorities," "project," "pursue," "seek," "should," "target," "when," "will," "would," or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change. We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement. Contacts: Investors Cody Slach Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com Media Brenlyn Motlagh, Ryan Deloney Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
NonePhase 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. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), Amgen's acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on Amgen's acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on Amgen's business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no guarantee that Amgen will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen's information technology systems could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Elissa Snook , 609-251-1407 (media) Justin Claeys , 805-313-9775 (investors) References SOURCE AmgenDollar Tree ( NASDAQ:DLTR – Get Free Report ) had its price target upped by research analysts at Truist Financial from $79.00 to $83.00 in a research report issued to clients and investors on Thursday, Benzinga reports. The brokerage presently has a “buy” rating on the stock. Truist Financial’s price objective indicates a potential upside of 15.49% from the company’s previous close. Several other research firms also recently issued reports on DLTR. Melius Research initiated coverage on shares of Dollar Tree in a research note on Monday, September 23rd. They set a “hold” rating and a $70.00 price target for the company. Piper Sandler reaffirmed a “neutral” rating and set a $72.00 target price (up from $67.00) on shares of Dollar Tree in a report on Thursday. StockNews.com cut Dollar Tree from a “hold” rating to a “sell” rating in a research note on Wednesday, November 20th. Evercore ISI cut their price objective on Dollar Tree from $94.00 to $92.00 and set an “in-line” rating on the stock in a research note on Tuesday. Finally, UBS Group decreased their target price on shares of Dollar Tree from $155.00 to $105.00 and set a “buy” rating for the company in a research report on Thursday, September 5th. Seventeen research analysts have rated the stock with a hold rating and five have issued a buy rating to the company’s stock. Based on data from MarketBeat, the company presently has an average rating of “Hold” and an average price target of $85.58. Read Our Latest Stock Analysis on Dollar Tree Dollar Tree Trading Down 1.0 % Dollar Tree ( NASDAQ:DLTR – Get Free Report ) last posted its earnings results on Wednesday, December 4th. The company reported $1.12 EPS for the quarter, beating the consensus estimate of $1.07 by $0.05. The firm had revenue of $7.57 billion during the quarter, compared to the consensus estimate of $7.45 billion. Dollar Tree had a positive return on equity of 15.77% and a negative net margin of 3.44%. The business’s quarterly revenue was up 3.5% on a year-over-year basis. During the same period last year, the company earned $0.97 earnings per share. As a group, sell-side analysts expect that Dollar Tree will post 5.35 EPS for the current fiscal year. Institutional Inflows and Outflows Several institutional investors have recently bought and sold shares of the business. Cetera Investment Advisers increased its position in shares of Dollar Tree by 203.5% during the first quarter. Cetera Investment Advisers now owns 12,596 shares of the company’s stock worth $1,677,000 after acquiring an additional 8,446 shares in the last quarter. Cetera Advisors LLC increased its holdings in Dollar Tree by 119.7% during the 1st quarter. Cetera Advisors LLC now owns 3,234 shares of the company’s stock worth $431,000 after purchasing an additional 1,762 shares in the last quarter. Mather Group LLC. raised its stake in shares of Dollar Tree by 198.9% in the second quarter. Mather Group LLC. now owns 281 shares of the company’s stock worth $30,000 after purchasing an additional 187 shares during the last quarter. Park Avenue Securities LLC lifted its holdings in shares of Dollar Tree by 82.3% in the second quarter. Park Avenue Securities LLC now owns 15,011 shares of the company’s stock valued at $1,603,000 after purchasing an additional 6,779 shares in the last quarter. Finally, Czech National Bank boosted its position in shares of Dollar Tree by 8.4% during the second quarter. Czech National Bank now owns 39,489 shares of the company’s stock valued at $4,216,000 after buying an additional 3,071 shares during the last quarter. Institutional investors and hedge funds own 97.40% of the company’s stock. About Dollar Tree ( Get Free Report ) Dollar Tree, Inc operates retail discount stores. The company operates in two segments, Dollar Tree and Family Dollar. The Dollar Tree segment offers merchandise at the fixed price of $ 1.25. It provides consumable merchandise, which includes everyday consumables, such as household paper and chemicals, food, candy, health, personal care products, and frozen and refrigerated food; variety merchandise comprising toys, durable housewares, gifts, stationery, party goods, greeting cards, softlines, arts and crafts supplies, and other items; and seasonal goods that include Christmas, Easter, Halloween, and Valentine's Day merchandise. Featured Stories Five stocks we like better than Dollar Tree What is Forex and How Does it Work? 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ATLANTA -- Georgia quarterback Carson Beck will not return after he was hit on his throwing hand on the final play of an ugly first half Saturday in the Southeastern Conference championship game against Texas. Beck was hit by outside linebacker Trey Moore, forcing a fumble recovered by Anthony Hill Jr., who then lost the ball on an errant attempt to extend the play with a lateral as time expired. Beck was one of the last players to return to the field following halftime. He was holding his helmet but did not warm up remained on the sideline as backup Gunner Stockton led the offense to its first touchdown on the Bulldogs' first drive of the second half. Georgia coach Kirby Smart told ESPN Beck would not return to the game and said he had no details on the hand injury. Beck had the right arm wrapped in ice on the Georgia bench. No. 2 Texas outgained No. 5 Georgia 260-54 but led only 6-3 at halftime. The Bulldogs netted minus-2 yards rushing and Beck completed 7 of 13 passes for 56 yards. ___ Get poll alerts and updates on the AP Top 25 throughout the season. Sign up here . AP college football: https://apnews.com/hub/ap-top-25-college-football-poll and https://apnews.com/hub/college-footballUSWNT beats Netherlands 2-1 in goalkeeper Alyssa Naeher's final match
A Virginia zoo is celebrating the arrival of an adorable newborn pygmy hippo who made her debut just before Christmas. The baby hippo, a girl who has not yet been named, was born to parents Iris and Corwin at Metro Richmond Zoo on Dec. 9. She's their third female calf in under five years. The zoo said Iris was all smiles on Christmas morning. "Most people don't get a hippopotamus for Christmas at all, so we feel lucky to have received two over the years," the zoo said. Iris and Corwin's previous calf was born on Dec. 6, 2022. Iris delivered her latest newborn after a seven-month gestation, zoo officials said. She gave birth in an indoor pool. "The baby's natural instincts kicked in and she started moving around in the water immediately," the zoo said on its website. The mom and newborn are currently being kept in an enclosure that is not on exhibit to give them privacy while they bond. "Iris is an experienced mother and very protective of her calf," the zoo said. "The calf is nursing and growing quickly." The new pygmy hippo was weighed when she was 5 days old and came in at a healthy 15 pounds, the zoo said. She could grow to weigh up to 600 pounds. Her birth will help preserve the species, which is endangered. Fewer than 2,500 mature pygmy hippos remain in the wild, according to the zoo. The species is native to the swamps and rivers of West Africa, where it's threatened by poaching and loss of habitat. Pygmy hippos do not live in groups, so after they grew up, Iris' two previous calves were moved to other zoological facilities "to live with future mates and continue contributing to the conservation of their species," the zoo said. The species is nocturnal, and the zoo says they can live up to 55 years. Earlier this year, a newborn baby hippo in Thailand named Moo Deng became a global sensation when a zookeeper started sharing her cutest moments on social media. Aliza Chasan is a Digital Content Producer for "60 Minutes" and CBSNews.com. She has previously written for outlets including PIX11 News, The New York Daily News, Inside Edition and DNAinfo. Aliza covers trending news, often focusing on crime and politics.
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