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    UChicago protest: Institute of Politics building, across from Jewish student center, surrounded by pro-Palestinian protesters

    Peter Watson
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    UChicago protest: Institute of Politics building, across from Jewish student center, surrounded by pro-Palestinian protesters

    CHICAGO (WLS) — Pro-Palestinian protesters took over the University of Chicago’s Institute of Politics building Friday afternoon.

    University of Chicago police and Chicago Police Department officers were also on the scene.

    The protest, for the most part, has been peaceful, and it comes on U of C’s busy alumni weekend. Demonstrators say they intend to stay here overnight.

    ABC7 Chicago is now streaming 24/7. Click here to watch

    The protesters unfurled large banners with demands including “Free Palestine,” “Abolish the University” and “Decolonize from Chicago 2 Palestine.” Demonstrators climbed onto a covered patio waving Palestinian flags and at one point pitching a tent.

    The University of Chicago’s Institute of Politics building was surrounded by pro-Palestinian protesters Friday afternoon.

    Demonstrators said in a press release they’re comprise of U of C students, alumni and community members. In a statement the university said “Protesters attempted to bar the entrance, damaged University property and ignored directives from [university police] to clear the way… UCPD officers were able to enter the building and the protesters inside the building exited.”

    Former Senator Heidi Heitkamp was in her office in the building, setting up for a previously scheduled and unrelated live interview with ABC News Live when the group walked in during that setup. She was not harmed.

    At one point a makeshift barricade of chairs was set up at the back of the building, with a line of students standing there with arms interlocked. A tent was also set up on the grounds.

    The U Chicago student paper, The Chicago Maroon, reported it began with a rally and march on campus that ended with some of the marchers entering the IOP building, locking the doors, and even spray painting security cameras.

    The protest also drew counter-demonstrators. A nearby building blasted the national anthem, and with the takeover happening across the street from a Jewish student center, some turned out with Israeli flags.

    “It brings a lot of fear and for no reason, and I feel like it’s not going to accomplish what they think it’s going to accomplish at this point,” said Ryan McDowell, Hyde Park resident.

    U Chicago police cleared an encampment off the quad a week and a half ago. The encampment had been there for several days at that time. Organizers said their campaign to get the school to divest from companies that benefit Israel would continue, but a faculty advisor to that group told us those organizers are not involved in this action.

    “It took me by surprise when it happened. It didn’t take me by surprise that it happened. A lot of people are really angry at the university,” said Callie Maidhof, UChicago professor and member of Faculty for Justice in Palestine.

    Protest organizers declined our request for an on-camera interview, but in a press release said they intended to set up another encampment on the quad. So far, that has not happened, and we did see a noticeable security presence there.

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    FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER| Amgen

    Peter Watson
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    FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER| Amgen

    Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor

    IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study

    Amgen to Host Webcast Investor Call on May 20, 2024 at 1:00 p.m. PT

    THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9246451-fda-approves-imdelltra-tarlatamab-dlle-the-first-and-only-t-cell-engager-therapy-for-the-treatment-of-extensive-stage-small-cell-lung-cancer/

    “The FDA’s approval of IMDELLTRA marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. “This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE®) molecule. IMDELLTRA offers these patients who are in urgent need of new innovative therapies hope, and we’re proud to deliver this long-awaited effective treatment to them.”

    “Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years,” said David P. Carbone, M.D., Ph.D., professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center.1 “In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm.”

    IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient’s own T cells to attack DLL3-expressing tumor cells.2 

    “After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available,” said Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer. “Today’s FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease.”

    The FDA accelerated approval of IMDELLTRA is based on results from the Phase 2 DeLLphi-301 clinical trial that evaluated IMDELLTRA in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. Results from the study found that IMDELLTRA at the 10 mg Q2W dose (N=99) demonstrated a robust objective response rate (ORR) of 40% (95% Confidence Interval [CI]: 31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.3

    The IMDELLTRA label includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity. The most common (> 20%) adverse reactions reported among patients were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%), and nausea (22%). Permanent discontinuations due to treatment-emergent adverse events (TEAEs) were infrequent (7%). CRS was largely confined to the first and second dose, predominantly grade 1 or 2, and was generally managed with supportive care. Details of the Important Safety Information are included below. 

    Amgen‘s Commitment to Patient Support

    Amgen is committed to supporting patients with ES-SCLC and to helping ensure appropriate patients with access to IMDELLTRA. Patients, caregivers, and physicians who need support, tools, or resources can contact Amgen® SupportPlus. Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including for uninsured or under-insured patients through the Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access Amgen medicines at no cost.

    Amgen to Webcast Investor Call on IMDELLTRA FDA Approval

    Amgen will host a webcast call for the investment community on Monday, May 20, 2024 at 1:00 p.m. PT (4:00 p.m. ET). Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen, Murdo Gordon, executive vice president of Global Commercial Operations, and other members of the Amgen team will participate.

    Live audio of the investor call will be simultaneously broadcast over the internet and will be available to members of the news media, investors, and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen‘s business given by management at certain investor and medical conferences, can be found on Amgen‘s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability, and webcast links are noted on Amgen‘s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

    About IMDELLTRA™ (tarlatamab-dlle)

    IIMDELLTRA is a first-in-class immunotherapy engineered by Amgen researchers that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.2,4 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.3,5

    IMDELLTRA™ (tarlatamab-dlle) U.S. Indication

    IMDELLTRA™ (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

    This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    IMDELLTRA™ (tarlatamab-dlle) Important Safety Information

    WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

    • Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA™. Initiate treatment with IMDELLTRA™ using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA™ until CRS resolves or permanently discontinue based on severity.

    • Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA™. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA™ until ICANS resolves or permanently discontinue based on severity.

    WARNINGS AND PRECAUTIONS

    • Cytokine Release Syndrome (CRS): IMDELLTRA™ can cause CRS including serious or life-threatening reactions. In the pooled safety population, CRS occurred in 55% of patients who received IMDELLTRA™, including 34% Grade 1, 19% Grade 2, 1.1% Grade 3 and 0.5% Grade 4. Recurrent CRS occurred in 24% of patients, including 18% Grade 1 and 6% Grade 2.

    Most events (43%) of CRS occurred after the first dose, with 29% of patients experiencing any grade CRS after the second dose and 9% of patients experiencing CRS following the third dose or later. Following the Day 1, Day 8, and Day 15 infusions, 16%, 4.3% and 2.1% of patients experienced ≥ Grade 2 CRS, respectively. The median time to onset of all grade CRS from most recent dose of IMDELLTRA™ was 13.5 hours (range: 1 to 268 hours). The median time to onset of ≥ Grade 2 CRS from most recent dose of IMDELLTRA™ was 14.6 hours (range: 2 to 566 hours).

    Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

    Administer IMDELLTRA™ following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 IMDELLTRA™ infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA™ in an appropriate health care facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA™.

    Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA™. At the first sign of CRS, immediately discontinue IMDELLTRA™ infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA™ based on severity. Counsel patients to seek medical attention should signs or symptoms of CRS occur.

    • Neurologic Toxicity, Including ICANS: IMDELLTRA™ can cause serious or life-threatening neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity, including ICANS, occurred in 47% of patients who received IMDELLTRA™, including 10% Grade 3. The most frequent neurologic toxicities were headache (14%), peripheral neuropathy (7%), dizziness (7%), insomnia (6%), muscular weakness (3.7%), delirium (2.1%), syncope (1.6%), and neurotoxicity (1.1%).

    ICANS occurred in 9% of IMDELLTRA™-treated patients. Recurrent ICANS occurred in 1.6% of patients. Most patients experienced ICANS following Cycle 2 Day 1 (24%). Following Day 1, Day 8, and Day 15 infusions, 0.5%, 0.5% and 3.7% of patients experienced ≥ Grade 2 ICANS, respectively. The median time to onset of ICANS from the first dose of IMDELLTRATM was 29.5 days (range: 1 to 154 days). ICANS can occur several weeks following administration of IMDELLTRATM. The median time to resolution of ICANS was 33 days (range: 1 to 93 days).

    The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.

    Patients receiving IMDELLTRA™ are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, in the event of any neurologic symptoms until they resolve.

    Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment. At the first sign of ICANS, immediately evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA™ or permanently discontinue based on severity.

    • Cytopenias: IMDELLTRA™ can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, decreased neutrophils occurred in 12% including 6% Grade 3 or 4 of IMDELLTRA™-treated patients. The median time to onset for Grade 3 or 4 neutropenia was 29.5 days (range: 2 to 213). Decreased platelets occurred in 33% including 3.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 50 days (range: 3 to 420). Decreased hemoglobin occurred in 58% including 5% Grade 3 or 4. Febrile neutropenia occurred in 0.5% of patients treated with IMDELLTRA™.

    Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with IMDELLTRA™, before each dose, and as clinically indicated. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA™.

    • Infections: IMDELLTRA™ can cause serious infections, including life-threatening and fatal infections. In the pooled safety population, infections, including opportunistic infections, occurred in 41% of patients who received IMDELLTRA™. Grade 3 or 4 infections occurred in 13% of patients. The most frequent infections were COVID-19 (9%, majority during the COVID-19 pandemic), urinary tract infection (10%), pneumonia (9%), respiratory tract infection (3.2%), and candida infection (3.2%).

    Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA™ and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA™ based on severity.

    • Hepatotoxicity: IMDELLTRA™ can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 42%, with Grade 3 or 4 ALT elevation occurring in 2.1%. Elevated AST occurred in 44% of patients, with Grade 3 or 4 AST elevation occurring in 3.2%. Elevated bilirubin occurred in 15% of patients; Grade 3 or 4 total bilirubin elevations occurred in 1.6% of patients. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA™, before each dose, and as clinically indicated. Withhold IMDELLTRA™ or permanently discontinue based on severity.

       

    • Hypersensitivity: IMDELLTRA™ can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA™ and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA™ based on severity.

       

    • Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA™ may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA™ and for 2 months after the last dose.

    ADVERSE REACTIONS

    • The most common (> 20%) adverse reactions were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%) and nausea (22%). The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (57%), decreased sodium (16%), increased uric acid (10%), decreased total neutrophils (6%), decreased hemoglobin (5%), increased activated partial thromboplastin time (5%), decreased potassium (5%), increased aspartate aminotransferase (3.2%), decreased white blood cells (3.8%), decreased platelets (3.2%), and increased alanine aminotransferase (2.1%).

    • Serious adverse reactions occurred in 58% of patients. Serious adverse reactions in > 3% of patients included CRS (24%), pneumonia (6%), pyrexia (3.7%), and hyponatremia (3.6%). Fatal adverse reactions occurred in 2.7% of patients including pneumonia (0.5%), aspiration (0.5%), pulmonary embolism (0.5%), respiratory acidosis (0.5%), and respiratory failure (0.5%).

    DOSAGE AND ADMINISTRATION: Important Dosing Information

    • Administer IMDELLTRA™ as an intravenous infusion over one hour.

    • Administer IMDELLTRA™ according to the step-up dosing schedule in the IMDELLTRA™ PI (Table 1) to reduce the incidence and severity of CRS.

    • For Cycle 1, administer recommended concomitant medications before and after Cycle 1 IMDELLTRA™ infusions to reduce the risk of CRS reactions as described in the PI (Table 3).

    • IMDELLTRA™should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.

    • Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA™ infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.

    • Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with IMDELLTRA™ following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.

    • Prior to administration of IMDELLTRA™ evaluate complete blood count, liver enzymes, and bilirubin before each dose, and as clinically indicated.

    • Ensure patients are well hydrated prior to administration of IMDELLTRA™.

    Please see IMDELLTRA™ full Prescribing Information, including BOXED WARNINGS.

    About Small Cell Lung Cancer (SCLC)

    SCLC is one of the most aggressive and devastating solid tumor malignancies, with a median survival of approximately 12 months following initial therapy and a 3% five-year relative survival rate for ES-SCLC.1,6,7 Current second-line treatments impart a short duration of response (median DoR: 3.3–5.3 months) and limited survival (median OS: 5.8-9.3 months), while current third-line treatments for SCLC, which consist primarily of chemotherapy, yield a short median DoR of 2.6 months and a median OS of 4.4-5.3 months.8-12 SCLC comprises ~15% of the 2.4 million plus patients diagnosed with lung cancer worldwide each year.13-15 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.13

    About Tarlatamab Clinical Trials

    Amgen‘s robust tarlatamab development program includes the DeLLphi clinical trials, which evaluate tarlatamab as both a monotherapy and in combination regimens in earlier lines of SCLC, and DeLLpro clinical trials, which evaluate the efficacy and safety of tarlatamab in neuroendocrine prostate cancer.

    In the Phase 1 DeLLphi-300 study, tarlatamab showed responses in 23.4% of patients with encouraging durability in heavily pre-treated patients with SCLC.16 In the Phase 2 DeLLphi-301 study, tarlatamab administered as 10 mg dose every two weeks demonstrated an ORR of 40% in patients with advanced SCLC who had failed two or more prior lines of treatment. In the DeLLphi-301 Phase 2 trial, the most frequent treatment-related adverse events seen with 10 mg Q2W dosing regimen were CRS (51%), pyrexia (32%), and decreased appetite (23%). CRS events were predominantly grade 1 or 2 and occurred most often after the first or second dose.2 Treatment discontinuation for adverse events occurred in 4-7% of patients in the two trials.3,16

    Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard of care therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab monotherapy with standard of care chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 trial comparing tarlatamab in combination with durvalumab versus durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 trial of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; and DeLLpro-300, a Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.17

    For more information, please visit www.tarlatamabclinicaltrials.com.

    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), our 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 our 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 our 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 our 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 we project. 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 us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.

    Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop 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 we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

    Our results may be affected by our 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 our products and global economic conditions. In addition, sales of our 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, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our 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 our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our 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 we have acquired, may not be successful. There can be no guarantee that we 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. We 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 our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our 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

    1. American Cancer Society. Lung Cancer Survival Rates. www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed on March 15, 2024.

    2. Giffin MJ, Cooke K, Lobenhofer EK, et al. AMG 757, a Half-Life Extended, DLL3-Targeted Bispecific T-Cell Engager, Shows High Potency and Sensitivity in Preclinical Models of Small-Cell Lung Cancer. Clin Cancer Res. 2021;27:1526-1537.

    3. Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023;389:2063-2075.

    4. Baeuerle PA, Kufer P, Bargou R. BiTE: Teaching antibodies to engage T-cells for cancer therapy. Curr Opin Mol Ther. 2009;11:22-30.

    5. Rojo F, Corassa M, Mavroudis D, et al. International real-world study of DLL3 expression in patients with small cell lung cancer. Lung Cancer. 2020;147:237-243.

    6. Paz-Ares L, Chen Y, Reinmuth N, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN. ESMO Open. 2022;7:100408.

    7. Liu SV, Reck M, Mansfield AS, et al. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021;39:619-630.

    8. Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020;21(5):645-654.

    9. Von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999;17(2):658-67.

    10. Von Pawel J, Jotte R, Spigel DR, et al. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014;32(35):4012-9.

    11. Coutinho AD, Shah M, Lunacsek OE, et al. Real-world treatment patterns and outcomes of patients with small cell lung cancer progression after 2 lines of therapy. Lung Cancer. 2019;127:53-58.

    12. Borghaei H, Pundole X, Anderson E, et al. Treatment patterns and outcomes in recent US clinical practice for SCLC patients after two prior lines of therapy.  Presentation at World Conference on Lung Cancer 2023. September 9-12, 2023; Singapore, SGP. Poster #EP13.07-03.

    13. Oronsky B, Abrouk N, Caroen S, et al. A 2022 Update on Extensive Stage Small-Cell Lung Cancer (SCLC). J Cancer. 2022;13:2945-2953.

    14. World Health Organization. Lung. 2020. https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed on March 15, 2024.

    15. Sabari JK, Lok BH, Laird JH, et al. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017;14:549-561.

    16. Paz-Ares L, Champiat S, Lai WV, et al. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023;41:2893-2903.

    17. Clinical Trials. Tarlatamab Clinical Trial Listings. www.clinicaltrials.gov. Accessed March 15, 2024.

     

     

    Cision View original content:https://www.prnewswire.com/news-releases/fda-approves-imdelltra-tarlatamab-dlle-the-first-and-only-t-cell-engager-therapy-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-302148431.html

    SOURCE Amgen

    Ethics Panel Cautions Juan Merchan, Judge in Trump Trial, Over Political Donations

    Peter Watson
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    Ethics Panel Cautions Juan Merchan, Judge in Trump Trial, Over Political Donations

    A state ethics panel quietly dismissed a complaint last summer against the New York judge presiding over the criminal trial of Donald J. Trump, issuing a warning over small donations the judge had made to groups supporting Democrats, including the campaign of Joseph R. Biden Jr.

    The judge, Juan M. Merchan, donated a total of $35 to the groups in 2020, including a $15 donation earmarked for the Biden campaign, and $10 to a group called “Stop Republicans.”

    Political contributions of any kind are prohibited under state judicial ethics rules.

    “Justice Merchan said the complaint, from more than a year ago, was dismissed in July with a caution,” the spokesman for the court system, Al Baker, said in a statement.

    A caution does not include any penalty, but it can be considered in any future cases reviewed by the state’s Commission on Judicial Conduct. A letter outlining the caution was not released because of the commission’s rules, and Justice Merchan did not make the letter available.

    “The Commission on Judicial Conduct is governed by a confidentiality statute and cannot comment on nonpublic dispositions,” said Robert Tembeckjian, the commission’s administrator.

    The commission’s decision was first reported by Reuters.

    In its 2024 annual report, the commission said it was made aware of dozens of New York judges who had violated the rules against political contributions in recent years. Most were modest amounts, the report said, and many appeared to stem from the misperception that the rules only apply to state campaigns. In fact, judges are prohibited from contributing to any campaigns, including for federal office.

    “Like so much of the misconduct the Commission encounters, making a prohibited political contribution is a self-inflicted mistake,” the commission wrote in the report.

    For Justice Merchan, the stakes of such a mistake are considerably higher than most: He is the first judge in American history to preside over the criminal trial of a former president.

    The donations in part fueled Mr. Trump’s efforts to have Justice Merchan removed from the case before the trial began. Mr. Trump’s lawyers also focused on Justice Merchan’s adult daughter and her work at a Democratic consulting firm.

    But Justice Merchan declined to recuse himself, appeals court judges declined to step in, and the trial is now nearing its conclusion.

    The case centers on a hush-money payment to a porn star, Stormy Daniels, in the last days of the 2016 presidential campaign. Ms. Daniels says she had a sexual encounter with Mr. Trump, but a $130,000 payment from Mr. Trump’s fixer bought her silence. Mr. Trump is accused of falsifying business records to cover up his reimbursement of the fixer, Michael D. Cohen, casting them as routine legal expenses.

    Mr. Trump has denied the accusations against him — and has lashed out at Justice Merchan and the Manhattan district attorney, Alvin L. Bragg, who brought the case, noting that both are Democrats.

    Bank of America trader dies following death of Leo Lukenas

    Peter Watson
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    Bank of America trader dies following death of Leo Lukenas

    A 25-year-old Bank of America trader suddenly died Thursday –  just two weeks after the shocking death of Leo Lukenas III, a 35-year-old banker who had been working 100-hour work weeks at the financial giant, The Post has learned.

    Adnan Deumic, who was based at the bank’s London office, was playing in a casual “five-a-side” charity soccer tournament with other finance employees when he collapsed and was administered CPR, a source with knowledge of the matter said.

    No cause of death has been announced, but this person told The Post cardiac arrest is suspected.

    A 25-year-old Bank of America Corp. credit trader died suddenly on Thursday night. Adnan Deumic, a credit portfolio and algorithmic trader, collapsed of a suspected cardiac arrest playing soccer at an industry event and failed to respond to medical treatment including CPR Adnan Deumic/Facebook

    “The death of our teammate is a tragedy, and we are shocked by the sudden loss of a popular, young colleague,” a spokesman for Bank of America told The Post. “We are committed to providing our full support to Adnan’s family, his friends and to our many employees grieving his loss.”

    There is no known connection between Deumic’s unexpected death and his job at Bank of America. The Swedish-born trader was hired in 2022 and worked on the Credit Portfolio and Algorithmic desk.

    Unlike Lukenas, Deumic worked closer to 60 hours a week – but his shift was highly stressful, another source with direct knowledge told The Post.

    He was involved in trades worth as much as $1 billion some days despite his lack of experience, the person said.

    “He probably worked 11 to 12 hours a day and those hours were incredibly intense… he didn’t have time to get coffee,” the source said.

    Adnan Deumic/Linkedin

    “The stress he was under was so much more than any of the other analysts… and he couldn’t take a day off. He was learning to do this all when he was very new to the job.”

    Before his tragic death, Deumic seemed to be the picture of health, running a marathon in Spain last month and had played hockey in high school.

    However, his affable nature hid a growing displeasure with the bank, the source said.

    The “abysmal” management didn’t treat him well or give him the bonus or the affirmation he deserved, according to the insider.

    Leo Lukenas III died on May 2 from an apparent blood clot. Leo Lukenas/linkedin

    It was enough to make Deumic “desperate to get out” and find a similar job at another bank.

    “He was not happy… he was looking at other jobs,” the source said.

    Deumic was primarily motivated to make enough money so he could move back to Sweden to be nearer his friends, his family and his girlfriend — who had been visiting him this week, the person added.

    People who knew Deumic said his colleagues are devastated.

    A London-based trader for Bank of America died on Thursday evening during a charity soccer tournament — the second company employee to die this month. AP

    “He was one of the nicest guys on the floor,” the source said. “The interns loved him because he was so open to helping other people even though there was no incentive to.”

    Deumic’s death was the second to rock the bank this month. Lukenas, a former Green Beret, died from acute coronary artery thrombus. The married father of two worked in New York.

    Crockett slams Greene as ‘racist’ following contentious House committee meeting

    Peter Watson
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    Crockett slams Greene as ‘racist’ following contentious House committee meeting



    CNN
     — 

    Democratic Rep. Jasmine Crockett criticized Republican Rep. Marjorie Taylor Greene, calling her “racist,” following a tense House Oversight markup Thursday evening that quickly devolved into personal attacks.

    As the panel met to advance contempt proceedings against Attorney General Merrick Garland over his refusal to turn over audio recordings of President Joe Biden’s interview with special counsel Robert Hur, Greene, a Georgia Republican, sparked outrage when she commented on Crockett’s appearance. “I think your fake eyelashes are messing up what you’re reading,” Greene said.

    Speaking to reporters on Friday about the incident, Crockett said, “That’s all it is, it is racism. And she decided that she was going to be that person out loud and out front on yesterday. The difference is I just wasn’t going to take it laying down.”

    “She is racist. I mean, I don’t have any questions about that,” she added.

    Asked for comment by CNN, Greene’s office said, “the only member that brought up any reference to color was congresswoman Crockett.”

    The rules of the House dictate members can’t “engage in personalities,” meaning they are not allowed to make offensive comments about or toward another member.

    If it occurs, the member who was insulted can ask for the words to be stricken from the record and, if that happens, the offending member is not allowed to speak for the remainder of the proceeding.

    During the markup, there was a failed vote to strike Greene’s comments from the record and she was allowed to continue her remarks.

    At the markup, Greene started by asking Democrats on the committee if any of them employ the daughter of Judge Juan Merchan, who is overseeing the criminal trial in New York of former President Donald Trump. As Republicans have sought to curry favor with Trump, they have gone after Merchan’s daughter, who has ties to Democrats, as they seek to undermine the case.

    Crockett, a Democrat from Texas, asked Greene, “Do you know what we’re here for?”

    Greene shot back: “I don’t think you know what you’re here for … I think your fake eyelashes are messing up what you’re reading.”

    Democratic Rep. Alexandria Ocasio-Cortez immediately jumped in to get Greene’s words taken down.

    “That is absolutely unacceptable. How dare you attack the physical appearance of another person,” the New York Democrat said.

    After a series of votes in response to Greene’s explosive rhetoric, Crockett made a dig that appeared to be directed at the Republican.

    “I’m just curious. Just to better understand your ruling. If someone on this committee then starts talking about somebody’s bleach blonde bad built butch body, that would not be engaging in personalities, correct,” Crockett said.

    Crockett said on Friday that Greene is unserious and does not respect the process.

    “She’s lacking any ability to actually engage in actual discourse, she doesn’t know her job. She doesn’t know the issues that we’re dealing with when we’re in committee. So instead, she does what most of MAGA does which they seek to insult and personal attacks. She needs to get a staff that can get her up to speed so that she can actually talk about something of substance and actually represent her district,” Crockett said.

    Crockett also said she is a “grown woman” and wasn’t going to take it “laying down.”

    “One thing I’m not going to do is have somebody disrespect me as a duly elected official myself, and then I’m just going to say, well, that’s okay. And rub it off. No, we’re not going to do that.”

    She added: “So if if they can’t follow the rules, I will have to fight for myself.”

    Republican and Democratic members of the House Oversight Committee expressed shock and disgust at the “unacceptable” conduct during the committee meeting.

    “It’s not appropriate. None of it’s appropriate,” said GOP Rep. Tim Burchett, who was seated next to Greene during the hearing. “I mean, ‘butch body’ and ‘bleach blonde’ hair, now that – there’s no place for that up here. And it’s just, it’s disgusting. And I got a little girl, I don’t want to hear her insulting somebody’s appearance like that. And yeah, it was pitiful,” he added.

    The top Democrat on the committee, Rep. Jamie Raskin, said that House Republicans’ behavior “brought disgrace to the whole institution,” criticizing Greene’s conduct in the hearing.

    “When the chairman allowed the distinguished gentlelady from Georgia to attack another members’ eyelashes or her personal appearance, the whole meeting descended at that point,” he said.

    UAW Loses Unionization Vote at Mercedes Factories in Alabama

    Peter Watson
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    UAW Loses Unionization Vote at Mercedes Factories in Alabama

    Workers at two Mercedes-Benz factories near Tuscaloosa, Ala., voted on Friday against joining the United Automobile Workers, a stunning blow to the union’s campaign to gain ground in the South, where it has traditionally been weak.

    The defeat, based on an unofficial union tally, came after Kay Ivey, Alabama’s governor, and other Republican leaders argued that a pro-union vote would choke off the investment that has transformed the state into a major auto producer. Hyundai and Honda also have large factories in Alabama that the U.A.W. is trying to organize.

    The vote took on national significance as a test of whether the U.A.W. could build on a string of recent victories and gain ground in a state whose elected officials have been hostile to organized labor. The union has said it wants to organize every automobile factory in the United States, expanding its membership to include the employees of companies like Toyota and Tesla.

    But the loss at the Mercedes plants will almost surely slow down the union’s campaign and probably force it to do more spadework to secure the support of workers before seeking to hold elections at other auto plants. Union leaders will want to spend time figuring out how best to counter the messages and tactics of local lawmakers and company executives.

    “It hurts to lose, no doubt,” Elizabeth Shuler, president of the A.F.L.-C.I.O., said on Friday. “But we see it not as a loss, but a temporary setback. Workers will persevere no matter what it takes.”

    Auto executives and conservative lawmakers are also likely to closely study the vote at Mercedes to figure out the best approaches to fend off the U.A.W. and other unions in future contests and to deter union campaigns from the get-go.

    The South has become an important battleground. States like Georgia, South Carolina and Tennessee are attracting much of the billions of dollars that automakers and suppliers are investing in electric vehicle and battery factories. The U.A.W. wants to represent workers at those factories.

    Mercedes produces sport utility vehicles at a factory in Vance, Ala., and battery packs for electric vehicles at a plant in nearby Woodstock. Polling had been underway all week at the two factories under the supervision of the National Labor Relations Board.

    In a campaign conducted largely by word of mouth, union activists argued that in addition to better pay and benefits, the U.A.W. would protect Mercedes’ 5,200 workers from abrupt changes in their schedules and long shifts, including on weekends.

    “If it wasn’t for us building those cars, you wouldn’t be putting the money that you’re putting in your pockets,” said Kay Finklea, who works in quality control at Mercedes and campaigned for the union. “So treat us with dignity, treat us with respect and pay us.”

    But activists acknowledged that many workers who were unhappy with working conditions at Mercedes were also reluctant to join the union, swayed by warnings from company executives and politicians that membership would lead to onerous dues and loss of control over their jobs.

    Mercedes tried hard to block the union. Last month, in an apparent attempt to address employee complaints, the company shook up local management, appointing Federico Kochlowski as chief executive of the German company’s U.S. unit.

    Mr. Kochlowski, who has worked at Mercedes for about 20 years in various manufacturing positions in China, Mexico and the United States, acknowledged that there were problems at the Alabama plants and promised to make improvements. “I understand that many things are not OK,” he said in a video posted by Mercedes online. “Give me a shot.”

    Union activists noted that Mr. Kochlowski had already been a member of top management and interpreted his appointment as a last-minute attempt to fend off the U.A.W.

    The U.A.W. has filed six charges of unfair labor practices against Mercedes with the labor relations board, saying the company disciplined employees for discussing unionization at work, prevented organizers from distributing union materials, conducted surveillance of workers and fired workers who supported the union.

    Mercedes denies the claims.

    Previous attempts by the U.A.W. to represent workers at Mercedes and other auto manufacturers in the South have failed. But the U.A.W. is stronger than it has been in years after winning a unionization vote at a Volkswagen plant in Tennessee last month after losing two previous elections at that plant. The union also won hefty pay raises last year for workers at Ford Motor, General Motors and Stellantis, the parent company of Chrysler, Jeep and Ram.

    Mercedes workers who support joining the U.A.W. said they would keep fighting.

    “Mercedes is going to be unionized,” Robert Lett, who works in the Woodstock battery factory and campaigned for the union, said ahead of the vote. “It doesn’t matter if it’s Friday or in the future. There’s too much frustration there for us to not eventually unionize.”

    Scheffler, charged with assault after officer dragged near fatal crash, tees off at PGA Championship

    Peter Watson
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    Scheffler, charged with assault after officer dragged near fatal crash, tees off at PGA Championship

    LOUISVILLE, Ky. — Masters champion Scottie Scheffler was arrested Friday morning on his way to the PGA Championship, with stunning images showing him handcuffed as he was taken to jail for not following police orders during a pedestrian fatality investigation.

    Scheffler, charged with assault after officer dragged near fatal crash, tees off at PGA Championship

    In a span of four hours, the top-ranked golfer in the world was arrested wearing gym shorts and a T-shirt, dressed in an orange jail shirt for his mug shot, returned to Valhalla Golf Club in golf clothes and made his 10:08 a.m. second-round tee time.

    Unlock exclusive access to the latest news on India’s general elections, only on the HT App. Download Now! Download Now!

    Louisville Metro Police Department said Scheffler was booked on four charges, including second-degree assault of a police officer after his vehicle dragged an officer to the ground.

    Scheffler said the incident was a “big misunderstanding.”

    “This morning, I was proceeding as directed by police officers,” he said in a statement released as he was warming up on the range. “It was a very chaotic situation, understandably so considering the tragic accident that had occurred earlier, and there was a big misunderstanding of what I thought I was being asked to do.

    “I never intended to disregard any of the instructions,” he said. “I’m hopeful to put this to the side and focus on golf today. Of course, all of us involved in the tournament express our deepest sympathies to the family of the man who passed away in the earlier accident this morning. It truly puts everything in perspective.”

    His attorney, Steve Romines in Louisville, also described it as a misunderstanding and told The Associated Press, “We will litigate the case as it goes.”

    Louisville mayor Craig Greenberg said tournament vendor John Mills was the pedestrian killed and offered sympathies to his family. Greenberg also said the incident involving Scheffler and LMPD was “unfortunate” and that the police department was investigating.

    Traffic was backed up for about a mile in both directions on the only road that leads to Valhalla in the morning darkness with light rain, with dozens of police vehicles flashing red-and-blue lights near the entrance.

    Police said a pedestrian had been struck by a bus while crossing the road in a lane that was dedicated to tournament traffic and was pronounced dead at the scene about 5:09 a.m.

    ESPN reporter Jeff Darlington witnessed the incident and said Scheffler, the No. 1 player in the world who was to start the second round at 8:48 a.m., drove past a police officer a little after 6 a.m. in his SUV with markings on the door indicating it was a PGA Championship vehicle.

    The officer screamed at him to stop and then grabbed onto the car until Scheffler stopped about 10 yards later, Darlington said. The officer, identified in the arrest report as Det. Gillis, was dragged “to the ground” and suffered “pain, swelling, and abrasions to his left wrist” after the car “accelerated forward,” according to Louisville police.

    Scheffler was booked at 7:28 a.m. — about 2 1/2 hours before his updated tee time after the second round was delayed because of the fatality. In addition to the assault charge, he was booked on charges of third-degree criminal mischief, reckless driving and disregarding traffic signals from an officer directing traffic.

    “The main thing is he was proceeding exactly as he was directed in a marked vehicle with credentials,” Romines said. “He didn’t do anything intentionally wrong.”

    The officer was dressed in a high visibility reflective jacket when he stopped Scheffler’s car to give instructions, the arrest sheet said. Gillis was taken to the hospital for his injuries.

    Darlington said police pulled Scheffler out of the car, pushed him up against the car and immediately placed him in handcuffs.

    “Scheffler was then walked over to the police car, placed in the back, in handcuffs, very stunned about what was happening, looked toward me as he was in those handcuffs and said, ‘Please help me,’” Darlington said. “He very clearly did not know what was happening in the situation. It moved very quickly, very rapidly, very aggressively.”

    Louisville Metro police spokesman Dwight Mitchell told Louisville radio station WHAS the man was crossing Shelbyville Road about 5 a.m. and the bus didn’t see him. Mitchell said the man was pronounced dead on the scene.

    Scheffler was released by police and returned to the course at 9:12 a.m. He made his way to the practice area around 9:30 a.m. and was welcomed by fans — one shouted “free Scottie!” and others arrived later wearing “Free Scottie” T-shirts.

    Scheffler seemed like his normal, relaxed self, sharing a few laughs on the driving range. Then he went out and made a birdie on his first hole of the day after sticking his approach shot to 3 feet.

    With cars backed up in the morning darkness, other PGA-marked vehicles tried to move slowly toward the entrance. Traffic finally began to move gradually a little before 7 a.m.

    It was a surreal start to what already has been a wild week of weather — the Masters champion and top-ranked player in the world, dressed in workout clothes with his hands in cuffs behind his back amid flashing lights.

    Darlington, the ESPN reporter, said police were not sure who Scheffler was. He said an officer asked him to leave and when he identified himself being with the media, he was told, “There’s nothing you can do. He’s going to jail.”

    Darlington said another police officer later approached with a notepad and asked if he knew the name of the person they put in handcuffs.

    Louisville police have attracted negative national attention in recent years after the fatal shooting of Breonna Taylor in 2020 and a federal investigation into its policing practices.

    A Department of Justice report released last year said Louisville officers use excessive force and conduct searches based on invalid warrants. The report said Black motorists in Louisville were more likely to be searched during traffic stops, and officers used neck restraints, police dogs and Tasers against people who posed no imminent threat.

    Taylor, a 26-year-old Black woman, was shot by officers in who had come to her apartment with a warrant that federal officials later said was falsified.

    PGA of America, which runs the PGA Championship, offered sympathies for Mills’ family and said in a statement, “As it relates to the incident involving Scottie Scheffler, we are fully cooperating as local authorities review what took place.”

    Scheffler is coming off four victories in his last five tournaments, including his second Masters title. He was home in Dallas the last three weeks waiting on the birth of his first child, a son that was born May 8.

    Scheffler opened with a 4-under 67 and was five shots out of the lead as he tries to become only the fifth player since 1960 to win the first two majors of the year.

    Associated Press writer Dylan Lovan contributed.

    golf: /hub/golf

    This article was generated from an automated news agency feed without modifications to text.

    Slack users horrified to discover messages used for AI training

    Peter Watson
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    Slack users horrified to discover messages used for AI training

    After launching Slack AI in February, Slack appears to be digging its heels in, defending its vague policy that by default sucks up customers’ data—including messages, content, and files—to train Slack’s global AI models.

    According to Slack engineer Aaron Maurer, Slack has explained in a blog that the Salesforce-owned chat service does not train its large language models (LLMs) on customer data. But Slack’s policy may need updating “to explain more carefully how these privacy principles play with Slack AI,” Maurer wrote on Threads, partly because the policy “was originally written about the search/recommendation work we’ve been doing for years prior to Slack AI.”

    Maurer was responding to a Threads post from engineer and writer Gergely Orosz, who called for companies to opt out of data sharing until the policy is clarified, not by a blog, but in the actual policy language.

    “An ML engineer at Slack says they don’t use messages to train LLM models,” Orosz wrote. “My response is that the current terms allow them to do so. I’ll believe this is the policy when it’s in the policy. A blog post is not the privacy policy: every serious company knows this.”

    The tension for users becomes clearer if you compare Slack’s privacy principles with how the company touts Slack AI.

    Slack’s privacy principles specifically say that “Machine Learning (ML) and Artificial Intelligence (AI) are useful tools that we use in limited ways to enhance our product mission. To develop AI/ML models, our systems analyze Customer Data (e.g. messages, content, and files) submitted to Slack as well as other information (including usage information) as defined in our privacy policy and in your customer agreement.”

    Meanwhile, Slack AI’s page says, “Work without worry. Your data is your data. We don’t use it to train Slack AI.”

    Because of this incongruity, users called on Slack to update the privacy principles to make it clear how data is used for Slack AI or any future AI updates. According to a Salesforce spokesperson, the company has agreed an update is needed.

    “Yesterday, some Slack community members asked for more clarity regarding our privacy principles,” Salesforce’s spokesperson told Ars. “We’ll be updating those principles today to better explain the relationship between customer data and generative AI in Slack.”

    The spokesperson told Ars that the policy updates will clarify that Slack does not “develop LLMs or other generative models using customer data,” “use customer data to train third-party LLMs” or “build or train these models in such a way that they could learn, memorize, or be able to reproduce customer data.” The update will also clarify that “Slack AI uses off-the-shelf LLMs where the models don’t retain customer data,” ensuring that “customer data never leaves Slack’s trust boundary, and the providers of the LLM never have any access to the customer data.”

    These changes, however, do not seem to address a key concern for users who never explicitly consented to sharing chats and other Slack content for use in AI training.

    Users opting out of sharing chats with Slack

    This controversial policy is not new. Wired warned about it in April, and TechCrunch reported that the policy has been in place since at least September 2023.

    But widespread backlash began swelling last night on Hacker News, where Slack users called out the chat service for seemingly failing to notify users about the policy change, instead quietly opting them in by default. To critics, it felt like there was no benefit to opting in for anyone but Slack.

    From there, the backlash spread to social media, where SlackHQ hastened to clarify Slack’s terms with explanations that did not seem to address all the criticism.

    “I’m sorry Slack, you’re doing fucking WHAT with user DMs, messages, files, etc?” Corey Quinn, the chief cloud economist for a cost management company called Duckbill Group, posted on X. “I’m positive I’m not reading this correctly.”

    SlackHQ responded to Quinn after the economist declared, “I hate this so much,” and confirmed that he had opted out of data sharing in his paid workspace.

    “To clarify, Slack has platform-level machine-learning models for things like channel and emoji recommendations and search results,” SlackHQ posted. “And yes, customers can exclude their data from helping train those (non-generative) ML models. Customer data belongs to the Slack AI—which is our generative AI experience natively built in Slack—[and] is a separately purchased add-on that uses Large Language Models (LLMs) but does not train those LLMs on customer data.”

    Sean ‘Diddy’ Combs seen physically assaulting Cassie Ventura in 2016 surveillance video obtained by CNN

    Peter Watson
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    Sean ‘Diddy’ Combs seen physically assaulting Cassie Ventura in 2016 surveillance video obtained by CNN



    CNN
     — 

    A 2016 surveillance video obtained exclusively by CNN shows Sean “Diddy” Combs grab, shove, drag and kick his then-girlfriend Cassie Ventura during an altercation that matches allegations in a now-settled federal lawsuit filed by Ventura in November.

    The footage, compiled from multiple camera angles dated March 5, 2016, appears to show the rapper, producer and business mogul during an incident that, according to Ventura’s complaint, occurred at the now-closed InterContinental Hotel in Century City, Los Angeles. CNN verified the location based on publicly available photos of the former hotel’s interior.

    In the video, Ventura exits a hotel room and walks to a bank of elevators. Combs, holding a towel around his waist, runs down a hall after Ventura. He grabs her by the back of the neck and throws her to the floor. Still holding his towel closed with one hand, he then turns to kick her, the video shows.

    As Ventura is on the ground, Combs retrieves a purse and suitcase from the floor near the elevators. He turns around and kicks Ventura again as she lies motionless on the floor. About four seconds transpire between the two kicks, according to the video. He then briefly drags Ventura by her sweatshirt toward a room before walking away.

    Ventura is then seen slowly standing up. She gathers items from the floor and moves to pick up a phone on the hallway wall near the elevators. Combs, still in a towel and socks, returns. A mirror directly across from the security camera shows Combs appearing to shove Ventura.

    Seconds later, he sits down on a chair, grabs an object off a table and forcefully throws it toward Ventura. Combs is seen walking away, then turns toward Ventura once again when an elevator door opens and someone appears to exit.

    Ventura, who reached an undisclosed settlement with Combs, declined to comment on the video obtained by CNN.

    Ventura’s attorney, Douglas H. Wigdor, said: “The gut-wrenching video has only further confirmed the disturbing and predatory behavior of Mr. Combs. Words cannot express the courage and fortitude that Ms. Ventura has shown in coming forward to bring this to light.”

    CNN has reached out to representatives for Combs and InterContinental Hotels for comment. Combs has previously denied Ventura’s allegations.

    Combs and Ventura, a model and singer known for songs like “Me & U,” were in an off-and-on relationship from 2007 – 2018. The two were photographed together at the Los Angeles premiere of the film “A Perfect Match” on March 7, 2016.

    According to Ventura’s complaint, which cited the altercation as occurring “around March 2016,” Combs became “extremely intoxicated and punched Ms. Ventura in the face, giving her a black eye.”

    After Combs fell asleep, Ventura attempted to leave the hotel room, but he woke up and “followed her into the hallway of the hotel while yelling at her,” the complaint said.

    “He grabbed at her, and then took glass vases in the hallway and threw them at her, causing glass to crash around them as she ran to the elevator to escape,” the complaint alleged.

    After Ventura got in the elevator, her complaint states that she took a cab to her apartment.

    “Upon realizing that her running away would cause Mr. Combs to be even angrier with her, and completely stuck in his vicious cycle of abuse, Ms. Ventura returned to the hotel with the intention of apologizing for running away from her abuser,” the complaint claims. “When she returned, hotel security staff urged her to get back into a cab and go to her apartment, suggesting that they had seen the security footage showing Mr. Combs beating Ms. Ventura and throwing glass at her in the hotel hallway.”

    The complaint alleges Combs paid the InterContinental Century City $50,000 for the hallway security footage of the incident. The incident was part of a number of allegations made in the November lawsuit in which Ventura claimed she was raped in 2018 and subjected to years of repeated physical and other abuses by Combs.

    Chris Delmas/AFP/Getty Images/File

    Sean “Diddy” Combs with Cassie Ventura attend the premiere of ‘The Perfect Match’ in Los Angeles on March 7, 2016.

    Ventura, who was formally signed to Combs’ label, claimed in her suit that he “exerted his power and influence” over her throughout the course of their professional and romantic relationship. According to the complaint, she was 19 when they met and Combs was 37, and their business relationship lasted until 2019. It detailed claims that Combs was physically violent toward Ventura and forced her to engage in various sex acts with other men during that time.

    Ben Brafman, an attorney for Combs, said in a statement to CNN on the day it was filed, “Mr. Combs vehemently denies these offensive and outrageous allegations.”

    The suit was resolved the following day.

    “A decision to settle a lawsuit, especially in 2023, is in no way an admission of wrongdoing,” Brafman told CNN in a statement at the time. “Mr. Combs‘ decision to settle the lawsuit does not in any way undermine his flat-out denial of the claims. He is happy they got to a mutual settlement and wishes Ms. Ventura the best.”

    Details of the settlement were not disclosed.

    Since November, Combs has faced five other civil lawsuits accusing him of a range of sexual misconduct and other illegal activity. He has denied the allegations, and the cases remain active.

    Authorities searched Combs’ homes in California and Florida in April as part of a federal investigation carried out by a Department of Homeland Security team that handles human trafficking crimes, according to a senior federal law enforcement official briefed on the investigation. The investigation stems from many of the same sexual assault allegations put forth in the civil lawsuits, according to a second law enforcement source familiar with the searches.

    Aaron Dyer, an attorney for Combs, issued a statement at the time, calling the searches a “gross overuse of military-level force.”

    “This unprecedented ambush – paired with an advanced, coordinated media presence – leads to a premature rush to judgment of Mr. Combs and is nothing more than a witch hunt based on meritless accusations made in civil lawsuits,” he said. “There has been no finding of criminal or civil liability with any of these allegations. Mr. Combs is innocent and will continue to fight every single day to clear his name.”

    Editor’s Note: If you or someone you know is struggling with intimate partner violence, there are resources available, including the National Domestic Violence Hotline.

    Glasgow woman shares fear of living with Crohn’s and the lifestyle change that helped

    Peter Watson
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    Glasgow woman shares fear of living with Crohn’s and the lifestyle change that helped

    Life coach and radio presenter Aarti Joshi has opened up on her battle with Crohn’s disease, and has shared the one lifestyle change she made which has helped keep the illness at bay.

    Crohn’s is a lifelong condition where parts of the digestive system become inflamed. It’s an unpredictable disease where a person can go from being well to “incredibly unwell” to the point where their life could change completely.

    Aarti’s symptoms included fatigue, an infection and a ‘weird skin rash’. The Scots-Indian who suffers from eczema says that the rash was different and that doctors misdiagnosed what is was because of the colour of her skin.

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    It wasn’t until she was rushed to A&E in 2019 – following a busy weekend working at TRNSMT for DF Concerts – when medics diagnosed her with Crohn’s.

    She told Glasgow Live: “For about six months, I was exhausted but I wasn’t giving into it and refused to accept it. I had been working on TRNSMT that weekend and had known something was wrong.

    “When I walked into the hospital, they asked me what I was up to at the weekend so I told them and they all looked at me really confused. They said “we are going to need to operate on you right away” and were not sure how I walked into the hospital.

    “That was pretty shocking to me.”

    Aarti’s diagnosis came as a relief as she finally knew the cause of her symptoms, however, there was a feeling of dread for what the future looked like.

    Having been the head of marketing for DF Concerts for eight years, she loved her job but admits that it, at times, caused her stress – which doctors said was a factor in her Crohn’s flare up.

    She added: “It can present in hundreds of different ways – you could be really ill or fine and it could be controlled. When I went to the hospital, they said that my Crohn’s was caused by stress, it was a large factor.

    “I was telling everyone I wasn’t stressed and storing it inside. Looking back, I realise that I was in burnout. The minute you feel like that, it’s time to do something about it instead of waiting until you get really ill.

    “When I get a flare up it’s really bad abdominal pain and my skin tends to flare up. I get red patches on my face and will be at the toilet a lot more than normally. I would also wake up and be really tired.”

    Ultimately, Aarti decided to leave her job in March 2022 and went on to work as a presenter on GoRadio as well as a life coach at Freedom and Joy.

    After changing her diet – by cutting out gluten and dairy – she noticed her health improving, including her eczema and asthma. She has not had a significant flare up in two years.

    Aarti added: “The trigger for me was stress and my realisation was that the job I was in would cause stress. I had to do something different.

    “DF were incredibly supportive and understanding throughout that time and I made a wild decision to leave. Making that change has been the best thing for my health.

    “Some of what I was eating must have been causing that reaction but I never knew that. I am now managing the illness through my diet and am not on medication.

    “It does scare me with how unpredictable the disease is. When it happens, you are just really sad and it can make me feel quite negative. Sometimes, I have to cancel coaching calls because I am not in a good place and my clients are understanding about it.”

    Sharing her advice to others who might have or have been diagnosed with Crohn’s disease, Aarti said: “This is a warning to people: I’ve always been somebody who is like ‘it’ll be fine’.

    “I kept going to the doctors for tablets and they weren’t brilliant with investigating this properly and then I ended up in the hospital for three different operations.

    “With this disease, it’s important to understand that you can be very well for a long period of time and then become incredibly unwell – so much so that your life could change completely.

    “As South Asians, we could be a bit closed off and stoic. It would be so great to talk about it more in our communities because I do think it impacts so many people in our community.

    “You can live a really full life with this disease. Most people live with it every day and have great, happy and fulfilling lives.

    “People with Crohn’s are exactly the same, it’s just that sometimes we have really bad days.”

    Join Glasgow Live’s WhatsApp community here and get the latest news sent straight to your messages

    Aarti says that knowing about the Catherine McEwan Foundation when she was first diagnosed would have been a huge support.

    The charity, which aims to provide better treatment, care and life for patients battling Crohn’s or Colitis, has launched a campaign to highlight the isolation that comes with living with inflammatory bowel diseases ahead of World IBD Day this weekend (Sunday May 19).

    Having launched in Glasgow today (Friday May 17), the campaign features a QR code made from 100 empty toilet rolls. On scanning, the QR code comes to life with a straight-talking film about how “sh*t” it is living with IBD.

    The film features Scottish football legend, Alex McLeish OBE, and musician Rick Parfitt Jr, as well as a number of ‘real’ people living with IBD from across Scotland.

    People in Glasgow can view the billboard this weekend on New City Road in Cowcaddens.

    Find out more about the Catherine McEwan Foundation, and watch the video here.

    Sign up to our daily Glasgow Live newsletter here to receive news and features direct to your inbox

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