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phmacao com NEW ORLEANS (AP) — A Louisiana civil court judge on Monday halted state agencies' plans to forcibly clear homeless encampments in New Orleans. Orleans Parish Civil District Court Judge Ethel Julien issued a temporary restraining order blocking state police and two other agencies from evicting homeless people from their encampments in New Orleans or seizing their property without following city laws and due process. Republican Gov. Jeff Landry had called earlier this month for the City of New Orleans to remove a large encampment before Thanksgiving and warned he would intervene if the city did not comply. “If a judge believes that people have a right to be on whatever public space they choose, maybe that judge should have them move into her chambers and courtroom," Landry said after the judge issued the restraining order Monday. Louisiana State Police spokesperson Sgt. Katharine Stegall said the agency’s legal team and the state Attorney General’s Office are reviewing the order. State police have “promptly halted activities” and are “complying with the restrictions” of the order, Stegall said. Landry and New Orleans officials have repeatedly clashed over how to address the issue of homelessness in the city. New Orleans City Councilmember Lesli Harris said Monday that directing more resources towards moving homeless people into stable housing was “infinitely more effective than punitive sweeps” of encampments. “Coordination between the government and service providers on the housing of people is imperative, and continuously moving people only makes it that much harder to house them,” Harris said. But the governor has pushed to clear homeless encampments. In late October, Louisiana State Police, the Department of Wildlife and Fisheries and the Department of Transportation and Development converged on a homeless encampment under a highway to remove and relocate dozens of people prior to pop star Taylor Swift’s concerts in the nearby Superdome. Some people who had been away at the time of the clearances returned to the area to find they had lost their personal property including family heirlooms, identification documents and medication, according to testimony in court documents. City officials and advocates for homeless people decried the evictions and said they disrupted ongoing efforts to secure long-term housing for these individuals because they became harder to locate. A judge later granted a temporary restraining order preventing more clearances but declined to extend it beyond early November after lawyers representing the state police indicated in court that removals tied to the Taylor Swift concerts had ceased. But on Friday, homeless people began receiving flyers from state police officers ordering them to leave their encampments within 24 hours, according to a motion for relief filed on behalf of two homeless plaintiffs by the Southern Poverty Law Center and two other legal groups. The planned sweeps preceded the Bayou Classic football game on Saturday between Southern University and Grambling State University at the Superdome. “Your presence is considered a violation,” the flyers stated, according to the motion for relief. However, they were halted by the new temporary restraining order. On Dec. 3, the judge is scheduled to deliberate on whether to issue a preliminary injunction against the three state agencies. “The vulnerable people with disabilities who make up the vast majority of people living in the street deserve to be treated with sensitivity and compassion,” said Joe Heeren-Mueller, director of community engagement for Unity of Greater New Orleans, a homeless outreach organization. There are about 1,450 homeless people in New Orleans and neighboring Jefferson Parish, according to a January survey by the nonprofit Unity of Greater New Orleans. The city has committed to securing housing for these individuals by the end of 2025. Brook is a corps member for The Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues. Follow Brook on the social platform X: @jack_brook96AP Trending SummaryBrief at 6:29 p.m. EST

One day before Texas and Georgia face off in the Southeastern Conference championship game, the Longhorns earned a surprising victory over the Bulldogs on the recruiting trail. Justus Terry, a defensive lineman from Manchester, Georgia, announced Friday he would be leaving his home state to play for Texas next year. Terry, who also was considering Georgia and Auburn, had been the nation’s top remaining uncommitted 2025 prospect. The addition of Terry gives Texas the nation’s No. 1 recruiting class, according to composite rankings of recruiting sites compiled by 247Sports. “We’re super pumped about this recruiting class,” Texas coach Steve Sarkisian said Thursday, before Terry had announced his decision. “This is a very talented group of players that I think not only fit the physical characteristics of what we’re looking for by position in our program, but I think meet the character and are going to fit nicely into our culture.” Although there will be an additional signing period in February, 247Sports officials said Texas should maintain its No. 1 standing. The overwhelming majority of Power Four recruits already finalized their college plans this week. The top 11 classes as of Friday afternoon include eight Southeastern Conference schools and three Big Ten programs. Alabama is second, with Georgia third, Oregon fourth and Ohio State fifth. Auburn, LSU, Texas A&M, Michigan and Tennessee round out the top 10. Florida is 11th. The highest-rated recruiting classes outside the SEC and Big Ten are Notre Dame at No. 12 and Miami at No. 14. Terry is the nation’s No. 2 defensive lineman and No. 10 overall prospect, according to the 247Sports Composite. His decision gives Texas nine of the 247Sports Composite’s top 66 prospects. Texas’ other recruits rated 66th or better include safety Jonah Williams (No. 8), wide receivers Kaliq Lockett (No. 22) and Jamie Ffrench (No. 32), defensive lineman Lance Jackson (No. 25), all-purpose athlete Michael Terry III (No. 43), cornerbacks Kade Phillips (No. 54) and Graceson Littleton (No. 65), and linebacker Elijah Barnes (No. 66). “I think it’s a really versatile class with a variety of positions, highlighted by high-level players,” Sarkisian said. “As always, we really pride ourselves on recruiting the high school ranks. We think when we can get players in here young, then immerse them into our culture, into our off-season conditioning program, develop them as we go throughout their career, that’s when we really reap the benefits of having these guys in our program. This class is no different.” With the early signing period concluding Friday, the focus on college roster construction now turns to transfers. The transfer portal window officially opens Monday, though numerous college players already went to social media this week to announce their intentions to transfer. The early signing period was moved up a few weeks this year so that high school seniors could get their decisions out of the way before the opening of the transfer portal window. This marked the first signing period since the demise of the national letters of intent that prospects had sent in the past after signing with their respective schools. Athletes now are signing their names to a financial aid agreement that can include name, image and likeness agreements along with the standard tuition and room and board details. 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-football

Overhauls of 'heritage brands' raise the question: How important are our products to our identities?Stock market today: Wall Street ends little changed after giving up a big morning gain

Robinson scores 28 off the bench, Hofstra downs Saint Joseph's (N.Y.) 114-46

Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif. , Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO ® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. The data are from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8 , at 2 p.m. PT at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego . "Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients," said Jay Bradner , M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "These powerful new data leave us little doubt about the profound impact of this medicine for a large number of children affected by this disease. We are grateful to the Children's Oncology Group, along with the patients, families and clinical teams, for their dedication and partnership in advancing this critical study to improve the lives of children with cancer." Based on the results of the first pre-specified interim analysis for efficacy, the study met its primary endpoint of DFS and study randomization was terminated early based on the recommendation from the data and safety monitoring committee due to the benefit observed in the BLINCYTO arm compared to the chemotherapy-only arm. Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO. At 3 years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone. "The AALL1731 study results are truly practice-changing, further solidifying blinatumomab's role as the standard of care for a large number of children with B-ALL," said Sumit Gupta , M.D., Ph.D., FRCPC, co-chair of the Children's Oncology Group AALL1731 study and oncologist and clinician investigator, Division of Haematology/Oncology at The Hospital for Sick Children (SickKids) and associate professor of pediatrics at the University of Toronto . "These breakthrough data showing a significant improvement in disease-free survival are poised to bring substantial clinical value to children with newly diagnosed B-ALL." The addition of BLINCYTO to chemotherapy in standard risk patients resulted in outcomes similar to those previously achieved in only the most favorable pediatric risk subsets. Among SR-Average patients, 3-year DFS was 97.5% for patients treated with BLINCYTO compared to 90.2% for those treated with only chemotherapy (HR 0.33, CI 0.15-0.69). For SR-High patients, 3-year DFS was 94.1% for those treated with BLINCYTO compared to 84.8% for those treated with only chemotherapy (HR 0.45, 95% CI 0.24-0.85). "Relapsed ALL remains a major cause of pediatric cancer mortality, with nearly half of the relapses occurring in children with standard-risk B-ALL," said Rachel E. Rau , M.D., co-chair of the Children's Oncology Group AALL1731 study, pediatric hematologist-oncologist at Seattle Children's Hospital and associate professor of pediatrics at the University of Washington . "These findings underscore the progress made with blinatumomab in preventing relapse and support its role as a critical addition to current therapeutic strategies." Safety results are consistent with the known safety profile of BLINCYTO. BLINCYTO has demonstrated a positive balance of benefits and risks, with only 0.3% of first courses associated with Grade 3+ cytokine release syndrome (CRS) and 0.7% with seizures. A higher risk of infections was observed in the BLINCYTO arm. These results provide the first evidence supporting BLINCYTO for use in the consolidation phase in newly diagnosed pediatric Philadelphia chromosome-negative (Ph-) B-ALL patients. This groundbreaking first-in-class Bispecific T-cell Engager (BiTE ® ) therapy is now backed by additional evidence reinforcing its role in redefining a standard of care for both adult and pediatric patients, starting from one month old, regardless of measurable residual disease (MRD) status. The findings further establish BLINCYTO as a versatile first-line consolidation therapy across all ages and treatment backbones. The NCI's Cancer Therapy Evaluation Program (CTEP), which sponsored the study will share data with the U.S. Food and Drug Administration as part of their ongoing communications relating to the trial. About The Children's Oncology Group The Children's Oncology Group (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world's largest organization devoted exclusively to childhood and adolescent cancer research. The Children's Oncology Group unites over 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities and cancer centers across North America , Australia , New Zealand and Saudi Arabia in the fight against childhood cancer. Today, more than 80% of the 15,000 children and adolescents diagnosed with cancer each year in the United States are cared for at Children's Oncology Group member institutions. Research performed by Children's Oncology Group institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 86%. The Children's Oncology Group's mission is to improve the cure rate and outcomes for all children with cancer. About AALL1731 (NCT03914625) The AALL1731 study was a Phase 3 randomized trial to determine if two non-sequential cycles of BLINCYTO added to chemotherapy improved disease-free survival (DFS) in children with newly diagnosed pediatric National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL). The study enrolled 4,264 newly diagnosed NCI SR B-ALL patients, of whom 2,334 were risk stratified at the end of induction therapy as either SR-Average or SR-High. At the first planned interim efficacy analysis (data cutoff June 30, 2024 ), 1,440 of the eligible and evaluable patients had been randomized. The AALL1731 study was designed and conducted independently from industry. The Cancer Therapy Evaluation Program (CTEP) of the NCI sponsored the trial and provided funding to the Children's Oncology Group to conduct the study. NCI is part of the National Institutes of Health (NIH). In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement. About Acute Lymphoblastic Leukemia (ALL) ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen and central nervous system. ALL is a rare disease, with an estimated 6,550 new cases, affecting both children and adults, diagnosed in the U.S. in 2024. 1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow. 2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults and approximately 88% in children, the most common cancer in children. 4,5 About BLINCYTO ® (blinatumomab) BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE ® ) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE ® molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE ® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers. BLINCYTO was granted Breakthrough Therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of: In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of: BLINCYTO ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Contraindications BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation. Warnings and Precautions Adverse Reactions Dosage and Administration Guidelines 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: 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 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

Sisodia’s ‘education manifesto’ assures new schools, better facilitiesPhase 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: In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of: BLINCYTO ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Contraindications BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation. Warnings and Precautions Adverse Reactions Dosage and Administration Guidelines 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: 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 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 AmgenHEMPSTEAD, N.Y. (AP) — Kijan Robinson scored 28 points off of the bench to lead Hofstra past Saint Joseph's (N.Y.) 114-46 on Friday. Robinson added five rebounds and seven assists for the Pride (7-3). Eric Parnell scored 19 points, shooting 6 for 7 (4 for 5 from 3-point range) and 3 of 3 from the free-throw line. Khalil Farmer shot 5 for 7 (3 for 4 from 3-point range) and 3 of 3 from the free-throw line to finish with 16 points. Alec Tabada finished with 14 points for the Golden Eagles. Robinson led Hofstra with 20 points in the first half to help put them up 53-27 at the break. Hofstra pulled away with a 26-3 run in the second half. Parnell led the way with a team-high 15 second-half points. The Associated Press created this story using technology provided by Data Skrive and data from Sportradar .World leaders and American politicians have joined together in paying tribute to former U.S. President Jimmy Carter following his death at the age of 100. Remembered for brokering peace between Israel and Egypt, Carter also received the Nobel Peace Prize for his extensive humanitarian work. President Joe Biden and First Lady Jill Biden described Carter as an extraordinary leader and humanitarian who millions considered a dear friend. President-Elect Donald Trump noted the challenges Carter faced during his presidency and expressed gratitude for his efforts to improve American lives. Among those offering condolences were former Presidents and international leaders, including French President Emmanuel Macron, who emphasized Carter's steadfast advocacy for the vulnerable and tireless fight for peace. From his civil rights work to his dedication to Habitat for Humanity, Jimmy Carter's legacy is one of profound service and commitment to a better future. (With inputs from agencies.)

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Star of the new film, 'Reagan,' Dennis Quaid, discusses the legacy of the former president, the film's perspective and its audience reception. "Reagan," the first full-length feature chronicling the life of former President Ronald Reagan, topped Amazon's Best Sellers list after becoming available on Blu-ray, DVD and Digital earlier this month. The film, which stars Dennis Quaid as the 40th president, was released on Blu-ray on November 19 and immediately rose to the top of Amazon's Best Sellers in Blu-ray charts over the weekend. A press release for the movie said the show leapfrogged past ‘Spider-Man: Across The Spider-Verse’, ‘Despicable Me 4’ and ‘The Lord of the Rings: The Motion Picture Trilogy set." I WORKED FOR RONALD REAGAN AND I LOVE HOW LIBERAL CRITICS ARE UPSET ABOUT THE NEW MOVIE Dennis Quaid plays President Ronald Reagan in the new movie, "REAGAN." ((Noah "Nanea" Hamilton/Rawhide Pictures)) "Reagan" outperformed box office expectations in its opening weekend in September, taking the third spot behind "Deadpool & Wolverine" and "Alien: Romulus." Despite boasting a 98% score on Rotten Tomatoes, the biographical drama became a target of left-wing outlets who widely panned the film. The Daily Beast called "Reagan" "the worst movie of the year." Brutal reviews were also published in The Washington Post, Variety, The Wrap and The Hollywood Reporter ahead of the film's opening weekend. In an interview with Fox News Digital last August, Quaid brushed off concerns that portraying a Republican president would get him "canceled." "It's a biopic. It's a love story. It's about all of us as America, where we used to be," Quaid said. "A lot of that gets twisted because people have agendas. And so, yeah, they tried to cancel me a couple of times, but so what?" Reagan may have been a divisive figure to some on the left, Quaid said, but the film about his life is not "political." ‘REAGAN’ STAR DENNIS QUAID BRUSHES OFF BEING ‘CANCELED,’ SAYS FACEBOOK CENSORED MOVIE The film is based on the 40th president. (Getty Images) "When Reagan was president as well, you know, they called him a warmonger. But this is the guy who ended the Cold War, by the way, and made peace with the Soviets. But it took a cold warrior like that. ... And they called him a third-rate actor, this and that," Quaid remarked. Elya Baskin, who also stars in the film, described the significance of his casting in an op-ed he penned for Fox News Digital last year. "When I was offered a role in a picture called "Reagan," I read the script and knew right away that I had to play this role. You see, the role I was asked to play was that of a Soviet citizen by the name of B.E. Kertchman, who, in the 1920s defected to the United States," he wrote. "When I came to America 45 years ago, I thought that I had landed in paradise. People I met were friendly and generous, and the abundance of goods was mind-blowing. In the Soviet Union, I had to spend hours in lines to buy simple things like toilet paper and I could not speak openly about ideas that were not state approved. In America, I could openly express my opinions on everything without fear of being prosecuted," Baskin continued. "I always assumed that it would stay like that in America forever. Unfortunately, I was wrong. This new country that I cherished deeply began to change. I started to notice Marxist ideology – discredited countless times around the world – slowly creeping in into different aspects of our lives," he said. "Traditional moral values were being overturned and using simple common sense was becoming anathema to the intellectual elite. CLICK HERE TO GET THE FOX NEWS APP "Today, just as in the Soviet Union, I have to hide my true feelings and am afraid to express them openly. Those basking in their subjective opinion of what is politically and socially correct just now control what I'm allowed to say and will soon dictate what I am permitted to think." He described the film as possibly the "most important" of his career, characterizing his role in "Reagan" as a "warning." Yael Halon is a reporter for Fox News Digital. Story tips can be sent to yael.halon@fox.com .Republicans can give thanks for Donald Trump — who redrew the political mapNYC Holiday Happenings & Things to Do: November-December 2024

When I first received an invitation to attend a seminar concerning artificial intelligence in the newsroom, I had mixed feelings. There was a bit of excitement — I am a bit of a computer and technology geek, after all — about exploring some of the tools that are available. I was also a little wary. Most of us have read or have heard about some of the more cringeworthy attempts to bring AI into journalism, and I was more than a little hesitant to entertain the notion here at The Daily Times. Now that the course has completed, though, I came to a startling two-part revelation. The first phase of my resolution was pretty basic. These tools can help — a lot. We’ve started experimenting with AI technology, focusing primarily on routine data processing tasks. Marriage reports, real estate transactions and business licenses are the kind of data-heavy work that has traditionally consumed hours of valuable reporting time. Now, they can be completed in a matter of minutes. The second part of my personal revelation came after I spent more time experimenting with available tools — from programs that can help streamline your email inbox, create possible story outlines and reveal areas of inquiry to audio tools that can simulate human voices (and even clone your own voice) to read text. These tools can be scarily good. I cloned a snippet of my voice, read a two-sentence script and played it for my younger brother. He could tell the difference only after listening several times. But here’s the thought that began the second part of that revelation. As good as these tools are, they can never replace a living, thinking, feeling reporter. AI can immediately tell one of our reporters how much money agencies like The Empty Pantry Fund has raised over the past five years. It cannot, however, describe the dedication of its volunteers, or put into words the joy of being able to help out a neighbor in need. So no, AI will not be writing our stories. It will not conduct interviews. It will not replace our reporters. They are our nerdy assistants, doing some of the more time-consuming data entry so reporters can focus on what matters most — getting out, talking to our neighbors, attending local government meetings and telling the important stories about our lives. The future of journalism will be shaped by how we choose to implement new technologies. I think we’re choosing a path that puts our community first, supports our journalists and ensures that technology serves our mission of delivering reliable, comprehensive local news coverage.

Post datedBATON ROUGE, La. (AP) — Cam Carter hit five 3-pointers and finished with 23 points, Vyctorius Miller added 20 points and LSU never trailed Sunday night in a 110-45 win over Mississippi Valley State, the Tigers' 21st consecutive victory when scoring at least 100 points. LSU's 65-point margin of victory was its largest since the Tigers beat Grambling by 75 (112-37) on Nov. 20, 1999 and is the third biggest against a Division-I opponent in program history. The 110 points were the most by LSU since a 119-108 win over North Florida on Dec. 12, 2015. Carter scored 11 points — including three 3-pointers — in the first six minutes to make it 18-6 and LSU led by double figures the rest of the way. The Delta Devils went 0 for 6 from the field and committed five turnovers as LSU scored 17 consecutive points to take a 28-point lead with 7:44 left in the first half and led 55-13 at halftime. The Tigers allowed the seventh-fewest points in a half by an opponent in program history. Mississippi Valley State (2-11) is averaging 46.2 points and is winless with a scoring margin of minus-44.2 in 11 games against Division-I opponents this season. LSU (11-2) has won three games in a row since a 74-64 loss to SMU at the Compete 4 Cause Classic in Frisco, Texas, on Dec. 14. Jordan Spears and Daimion Collins added 15 points apiece for the Tigers, who shot 66% (46 of 70) from the field and made 12 3s. Alvin Stredic led Mississippi Valley State with eight points. ___ Get poll alerts and updates on the AP Top 25 throughout the season. Sign up here . AP college basketball: https://apnews.com/hub/ap-top-25-college-basketball-poll and https://apnews.com/hub/college-basketballAadi Enters into Exclusive License for Three-Asset ADC Portfolio Developed through a Collaboration between WuXi Biologics and HANGZHOU DAC Aadi Enters Agreement to Sell FYARRO ® and Associated Infrastructure to KAKEN Pharmaceutical for $100M ; Announces PIPE Financing of $100M Cumulative Capital Expected to Fund Operations into Late 2028, Including Anticipated Clinical Data for the ADC Portfolio Co-Founder and Former CEO of ProfoundBio, Baiteng Zhao, Appointed to Aadi Board of Directors Aadi to Hold Webcast and Conference Call on December 20 at 8:00 AM EST LOS ANGELES , Dec. 19, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI) today announced it has entered into an exclusive license agreement for development and global commercialization of a three-asset portfolio of preclinical, next-wave antibody-drug conjugates (ADCs), in collaboration with WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and HANGZHOU DAC BIOTECHNOLOGY CO., LTD. ( HANGZHOU DAC), a global leader in ADC innovation. Per the terms of the license agreement, Aadi is granted exclusive rights to certain patents and know-how pertaining to three preclinical ADC programs leveraging HANGZHOU DAC's CPT113 linker payload technology targeting each of Protein Tyrosine Kinase 7 (PTK7), Mucin-16 (MUC16) and Seizure Related 6 Homolog (SEZ6). Aadi will pay aggregate upfront payments of $44 million for in-licensing such ADC programs. Additionally, Aadi is obligated to pay cumulative development milestone payments of up to $265 million , cumulative commercial milestone payments of up to $540 million and single-digit royalties of sales. To support this transaction, Aadi entered into a subscription agreement with certain qualified institutional buyers and accredited investors for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds of approximately $100 million , before deducting placement agent fees and other offering expenses. The Company is selling an aggregate of 21,592,000 shares of its common stock ("Common Stock") at a price of $2.40 per share, representing a premium of approximately 3.4% to the closing price on December 19, 2024 on Nasdaq, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 20,076,500 shares of Common Stock at a purchase price of $2.3999 per Pre-Funded Warrant share. The syndicate was led by Ally Bridge Group, with participation from new investors OrbiMed, Invus, Kalehua Capital and other accredited investors, Tae Han co-founder of ProfoundBio, as well as existing investors, including Avoro Capital, KVP Capital and Acuta Capital Partners. The PIPE financing is expected to close in the first half of 2025, subject to stockholder vote and satisfaction of customary closing conditions. "I'm thrilled to announce our partnership with WuXi Biologics and HANGZHOU DAC to bring forward this thoughtfully selected ADC portfolio. We were deliberate in identifying broadly expressed tumor targets where first-generation ADCs have already shown proof of concept. With our next wave ADC portfolio, we aim to build upon these earlier therapies to deliver improved outcomes for people living with cancer," said David Lennon , PhD, President and CEO of Aadi Bioscience. "The financing underscores the confidence our investors have in both the potential of this portfolio and the strength of Aadi's management team." About the ADC Portfolio Each of the three ADC assets utilizes HANGZHOU DAC's CPT113 ADC platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The CPT113 platform's linker stability and novel payload has the potential to be highly competitive among the next generation ADC platforms. To effectively leverage the CPT113 platform, Aadi selected tumor targets that are upregulated in high-potential cancer indications and where clinical efficacy has been demonstrated by first-generation ADCs. These assets were discovered through the collaborative efforts of WuXi Biologics and HANGZHOU DAC, utilizing the innovative antibody discovery platform provided by WuXi Biologics and advanced linker-payload technology provided by HANGZHOU DAC. "Leveraging our advanced antibody discovery service, we're glad to enable Aadi to accelerate the discovery of precision therapies targeting some of the most challenging cancers," said Dr. Chris Chen , CEO of WuXi Biologics. "This collaboration underscores our wide recognition as an industry leader in discovery service solutions, and further validates our ability to provide integrated discovery technology platforms for global partners to develop next-generation modalities. We look forward to partnering with Aadi and HANGZHOU DAC to expeditiously move these assets forward into clinical development and benefit patients worldwide." " HANGZHOU DAC's CPT-ADC platform is designed to enable next wave ADC capabilities that surpass first-generation technologies, including two programs already in clinical development in China ," said Dr. Robert Y. Zhao , President and CEO of HANGZHOU DAC Biotechnology. "As a global leader in ADC innovation, we are excited to partner with Aadi and WuXi Biologics to deliver this promising portfolio to patients." Aadi to Sell FYARRO for $100 Million , Cumulative Capital Expected to Fund Operations into Late 2028 In a separate agreement, KAKEN Pharmaceutical Co., Ltd., an R&D driven pharmaceutical company in Japan , has entered into a stock purchase agreement under which KAKEN will acquire Aadi Subsidiary, Inc. and all of its assets, including FYARRO ® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) and associated infrastructure, including the majority of Aadi employees who support the FYARRO ® business. FYARRO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), with cumulative revenue of $25.2 million reported over the prior four quarters ended September 30, 2024 . Per the terms of the agreement, Kaken will pay Aadi $100 million in cash at closing, subject to certain adjustments. The transaction is expected to close in the first half of 2025, subject to Aadi stockholder approval and certain closing conditions. Upon the closing of this transaction, KAKEN will also acquire the rights to the Aadi name and trademark. "We are enormously proud of the impact FYARRO has had for people with PEComa, and Kaken's capabilities, coupled with the proven track record of the Aadi team, ensures physicians and patients will continue to have access to this critical treatment," said Lennon. The net proceeds from the PIPE financing and the sale of FYARRO, together with the Company's existing cash, cash equivalents and marketable securities are expected to fund operations into late-2028, including anticipated clinical data readouts for the ADC portfolio. Baiteng Zhao Appointed to the Board of Directors, Brings Significant ADC Expertise Baiteng Zhao, PhD, joins Aadi's board of directors. Zhao co-founded ProfoundBio, a clinical stage next-gen ADC developer, in 2018 and served as the Chairman and CEO of the company until it was acquired by Genmab for $1.8 billion in May 2024 . Prior to ProfoundBio, Dr. Zhao worked at Seagen (now part of Pfizer) for more than eight years and was responsible for the modeling and simulation strategies for the development pipeline and supported preclinical and clinical development of ADC drug candidates. "We are delighted to welcome Baiteng to our Board. His deep expertise and successful track record in ADC development will be instrumental as we tenaciously move this exciting portfolio forward," said Caley Castelein , MD, Chair of the Board of Directors of Aadi Bioscience. "I am thrilled to join the Board at this pivotal moment for Aadi," said Baiteng Zhao, PhD, Board of Directors of Aadi Bioscience and co-founder of ProfoundBio. "PTK7, MUC16 and SEZ6 represent highly promising targets that are commonly overexpressed in cancers with significant unmet therapeutic needs. Coupled with an advanced linker-payload platform that has the potential to enable next-gen ADCs, I believe Aadi is uniquely positioned to make a meaningful impact on patient outcomes. I look forward to collaborating with the leadership team and fellow Board directors to advance these innovative programs and drive transformative progress for patients." Advisors Leerink Partners is serving as financial advisor to Aadi on the sale of FYARRO and the licensing of the ADC portfolio. Jefferies LLC is acting as exclusive placement agent for the PIPE financing. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Aadi. McDermott Will & Emery LLP is serving as legal counsel to Kaken. Cooley LLP is serving as legal counsel to Jefferies LLC. Nomura Securities Co., Ltd. is serving as financial advisor to KAKEN. Conference Call Information The Aadi management team is hosting a conference call and webcast tomorrow, Friday, December 20 th at 8:00 AM EST ( 5:00 AM PST ) to discuss these updates. Participants may access a live webcast of the call and the associated slide presentation on these data through the "Investors & News" page of the Aadi Bioscience website at aadibio.com . To participate via telephone, please register in advance at this link . Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. Additional Information for Stockholders This communication relates to the proposed sale of FYARRO and the proposed PIPE financing and may be deemed to be solicitation material in respect of such transactions. In connection with these proposed transactions, Aadi will file a Proxy Statement with the SEC. This communication is not a substitute for the Proxy Statement or any other documents that Aadi may file with the SEC or send to Aadi stockholders in connection with the proposed transactions. Before making any voting decision, investors and securityholders are urged to read the Proxy Statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transactions as they become available because they will contain important information about the proposed transactions and related matters. Stockholders may obtain a copy of the Proxy Statement and other documents the Company files with the SEC (when they are available) through the website maintained by the SEC at www.sec.gov , as well as on the Investor and News section of Aadi's website at www.aadibio.com . Certain stockholders of Aadi holding approximately 36% of Aadi's outstanding shares, as of the date hereof, including members of its board of directors and related entities, have entered into voting and support agreements in favor of KAKEN Pharmaceutical and Aadi, pursuant to which such stockholders have agreed to vote in favor of the stock purchase transaction with KAKEN Pharmaceutical and the other transactions described above. Participants in the Solicitation Aadi and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Aadi in connection with the proposed transactions. Information about Aadi's directors and executive officers is set forth in Aadi's definitive proxy statement filed with the SEC on April 26, 2024 , and in subsequent filings made by Aadi with the SEC. Other information regarding the interests of such individuals, as well as information regarding Aadi's directors and executive officers and other persons who may be deemed participants in the proposed transactions, will be set forth in the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of these documents as described in the preceding paragraph. No Offer or Solicitation This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor a solicitation of any vote or approval with respect to the proposed transactions or otherwise, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offer and sale of securities of Aadi described above are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the subscription agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file, following the closing of the PIPE financing, a registration statement with the SEC registering the resale of the shares of Common Stock and the shares of Common Stock underlying the Pre-Funded Warrants sold in the PIPE financing. About Aadi Bioscience Aadi is a precision oncology company with a vision to make bold choices in applying technology to efficiently deliver improved precision oncology therapies for people living with difficult-to-treat cancers. More information on the Company is available on the Aadi website at www.aadibio.com and connect with us on LinkedIn. Forward-Looking Statements This press release contains certain forward-looking statements regarding the business of Aadi Bioscience that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the timing and completion of the proposed sale of FYARRO to Kaken Pharmaceuticals and the anticipated timing of the closing of the transaction; expectations regarding the timing, closing and completion of the PIPE financing; Aadi's expected cash position at the closing and cash runway of the company following the sale of FYARRO and PIPE financing; the future operations of Aadi; the development and potential benefits of any of Aadi's product candidates, including the preclinical ADC assets proposed to be licensed from WuXi; anticipated preclinical and clinical development activities and related timelines, including the expected timing for announcement of data and other preclinical and clinical results and potential submission of IND filings for one or more product candidates; and other statements that are not historical fact. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with (i) the risk that the conditions to the closing of the proposed sale of FYARRO or the PIPE financing are not satisfied, including the failure to timely obtain stockholder approval for the transactions, if at all; (ii) uncertainties as to the timing of the consummation of the proposed transactions and the ability of each of Kaken and Aadi to consummate the proposed sale of FYARRO; (iii) risks related to Aadi's ability to manage its operating expenses and its expenses associated with the proposed transactions pending the closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed transactions; (v) unexpected costs, charges or expenses resulting from the transactions; (vii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed sale of FYARRO or the proposed PIPE financing; (vii) the uncertainties associated with Aadi's product candidates, as well as risks associated with the preclinical and clinical development and regulatory approval of product candidates, including potential delays in the completion of preclinical studies and clinical trials; (viii) risks related to the inability of Aadi to obtain sufficient additional capital to continue to advance these product candidates; (ix) uncertainties in obtaining successful preclinical and clinical results for product candidates and unexpected costs that may result therefrom; (x) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xi) risks associated with the possible failure to realize certain anticipated benefits of the proposed sale of FYARRO or the proposed PIPE financing, including with respect to future financial and operating results. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 , including under the caption "Item 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov . All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: IR@aadibio.com View original content to download multimedia: https://www.prnewswire.com/news-releases/aadi-bioscience-transforms-with-in-licensing-of-novel-adc-portfolio-100-million-sale-of-fyarro-and-100-million-pipe-financing-302336743.html SOURCE Aadi Bioscience

Overhauls of 'heritage brands' raise the question: How important are our products to our identities?‘We’ve sleepwalked into non-sustainability’ – talking points from the immigration debate ahead of Election 2024

DETROIT — China will soon see a massive expansion of electric vehicle battery swapping, as global battery maker CATL said Wednesday it is investing heavily in stations there next year. Battery swapping is not new — but it's had a challenging journey. Adoption of electric vehicles has varied in regions across the globe over the past several years, and that doesn't always bode well for building new infrastructure. While the technology could do well in China, it's uncertain whether it could work in other countries. Battery swapping allows EV drivers to pull into a station on a low battery and receive a swapped, fully-charged battery within minutes. An EV has to be equipped with the right technology to receive a swap — and not many models around the world currently have it. Automakers have to buy into the idea, and EV adoption among consumers also has to grow, so that investing in new infrastructure seems worthwhile. Consumers also have to be comfortable not owning their battery. China is much further along in adopting EVs than other countries. Not only is it the world's largest auto market, but in July, the country hit a milestone with 50% of new sales electric — and it accounts for most of this year's global EV sales. China supports EV growth through government subsidies and mandates. So it makes more sense for companies to invest in unique EV infrastructure there because that's more likely to be needed. The most notable example might be Israeli startup Better Place, which tried its hand at swapping in 2007. But the company shut down a few years later after investing a lot of money and coming up against roadblocks with logistics. EV adoption was especially low at the time. Startup Ample, for example, has a modular battery swapping station that it says can complete a swap in 5 minutes. That’s important as charging time remains a point of concern for prospective EV buyers. Even the fastest fast chargers could take at least 15 minutes for a decent charge. But in the U.S., pure EVs only accounted for 8% of new vehicle sales as of November. Meanwhile Nio, a rival Chinese EV brand, has about 60 swap stations in northern Europe, and the EV adoption is higher there than the U.S., but the same challenges remain. Different automakers put different batteries in their various EV models, so a station would need all of those available if the industry didn't agree to a standardized battery, and not all of those models are out yet in volume. This is something that really needs scale. Swapping could help with EV cost — currently a barrier to adoption for many — because a driver wouldn’t necessarily own the most expensive part of an EV: the battery. Greg Less, director of the University of Michigan Battery Lab, said with proper framing and education, people might like the idea of battery swapping. To him, it's not unlike buying a propane-fueled grill and purchasing a refilled tank every so often. But it would require a rethinking of car ownership. "Where I could see it working is if we went entirely away from vehicle ownership and we went to a use-on-demand model," Less added. “I don’t think we’re there yet.” Battery swapping might make most sense for ride-sharing or other fleet vehicles. Drivers of buses, taxis, Uber or Lyft vehicles want to spend as much time on the road as possible, transporting customers and making money. If battery swapping can shorten the time needed to charge EVs, that makes driving one less disruptive to their business. ___ Alexa St. John is an Associated Press climate solutions reporter. Follow her on X: @alexa_stjohn . Reach her at ast.john@ap.org .

When Katja Vogt considers a Jaguar, she pictures a British-made car purring confidently along the Italian coastline — a vision of familiarity that conveys "that dreaming, longing feeling we all love." She's not sure what to think about Jaguar now after the 89-year-old company announced a radical rebranding that featured loud colors and androgynous people — but no cars. Jaguar, the company says, will now be JaGUar. It will produce only electric vehicles beginning in 2026. Bad attention is good attention, Jaguar execs would appear to believe. The car brand has prompted mockery online for posting a glitzy ad without a single car in it. Say goodbye to British racing green, Cotswold Blue and black. Its colors are henceforth electric pink, red and yellow, according to a video that sparked backlash online. Its mission statement: "Create exuberance. Live vivid. Delete ordinary. Break moulds." "Intrigued?" @Jaguar posted on social media. "Weird and unsettled" is more like it, Vogt wrote on Instagram. "Especially now, with the world feeling so dystopian," the Cyprus-based brand designer wrote, "a heritage brand like Jaguar should be conveying feelings of safety, stability, and maybe a hint of rebellion — the kind that shakes things up in a good way, not in a way that unsettles." Jaguar was one of several iconic companies that announced significant rebrandings in recent weeks, upending a series of commercial — and cultural — landmarks by which many modern human beings sort one another, carve out identities and recognize the world around them. Campbell's, the 155-year-old American icon that artist Andy Warhol immortalized in pop culture decades ago, is ready for a new, soupless name. Comcast's corporate reorganization means there will soon be two television networks with "NBC" in their name — CNBC and MSNBC — that will no longer have any corporate connection to NBC News, a U.S. legacy news outlet. CNBC One could even argue the United States itself is rebranding with the election of former President Donald Trump and Republican majorities in the House and Senate. Unlike Trump's first election in 2016, he won the popular vote in what many called a national referendum on American identity. Are we, then, the sum total of our consumer decisions — what we buy, where we travel and whom we elect? Certainly, it's a question for those privileged enough to be able to afford such choices. Volumes of research in the art and science of branding — from "brandr," an old Norse word for burning symbols into the hides of livestock — say those factors do contribute to the modern sense of identity. So rebranding, especially of heritage names, can be a deeply felt affront to consumers. "It can feel like the brand is turning its back on everything that it stood for — and therefore it feels like it's turning its back on us, the people who subscribe to that idea or ideology," said Ali Marmaduke, strategy director with the Amsterdam-based Brand Potential. He said cultural tension — polarization — is surging over politics, wars in Russia and the Mideast, the environment, public health and more, creating what Marmaduke said is known as a "polycrisis": the idea that there are several massive crises converging that feel scary and complex. Campbell's soups "People are understandably freaked out by that," he said. "So we are looking for something that will help us navigate this changing, threatening world that we face." Trump's "Make America Great Again" qualifies. So did President Joe Biden's "Build Back Better" slogan. Campbell's soup itself — "Mmm Mmm Good" — isn't going anywhere, CEO Mark Clouse said. The company's new name, Campbell's Co., will reflect "the full breadth of our portfolio," which includes brands like Prego pasta sauce and Goldfish crackers. None of the recent activity around heritage brands sparked a backlash as ferocious as Jaguar's. The company stood as a pillar of tradition-loving British identity since World War II. The famous "leaper" cat Jaguar logo is pictured in 2019 at the Auto show in Paris, France. Jaguar said its approach to the rebrand was rooted in the philosophy of its founder, Sir William Lyons, to "copy nothing." What it's calling "the new Jaguar" will overhaul everything from the font of its name to the positioning of it's famous "leaper" cat. "Exuberant modernism" will "define all aspects of the new Jaguar world," according to the news release. The approach is thought to be aimed at selling fewer cars at a six-figure price point to a more diverse customer base. The reaction ranged from bewilderment to hostility. Memes sprouted up likening the video to the Teletubbies, a Benetton ad and — perhaps predictably — a bow to "woke" culture as the blowback intersected with politics. Get the latest local business news delivered FREE to your inbox weekly.