Washington — TikTok and its parent company ByteDance have asked the Supreme Court to temporarily pause a law that would ban the app in the U.S. as soon as Jan. 19. "A modest delay in enforcing the Act will create breathing room for this Court to conduct an orderly review and the new Administration to evaluate this matter — before this vital channel for Americans to communicate with their fellow citizens and the world is closed," the emergency application said. TikTok has asked the Supreme Court for an injunction on an emergency basis but has not yet sought review on the merits of the case. In its application, TikTok said the company and its users will suffer "immediate irreparable harm" if the ban is not delayed. "Congress's unprecedented attempt to single out Applicants and bar them from operating one of the most significant speech platforms in this Nation presents grave constitutional problems that this Court likely will not allow to stand," the filing said. The move comes days after the U.S. Court of Appeals for the District of Columbia Circuit denied TikTok's bid to delay the ban from taking effect pending a Supreme Court review. TikTok and ByteDance asked the Supreme Court to make a decision on its request to delay the law by Jan. 6 so they can "coordinate with their service providers to perform the complex task of shutting down the TikTok platform only in the United States" if the justices decline. When TikTok challenged the law in May, it argued that it never had a choice between divestment or a ban because a forced sale "is simply not possible: not commercially, not technologically, not legally." The Chinese government vowed to block the sale of TikTok's algorithm which tailors content recommendations to each user. A new buyer would be forced to rebuild the algorithm that powers the app. The petition said "such a fundamental rearchitecting is not remotely feasible" under the restrictions within the legislation. "The platform consists of millions of lines of software code that have been painstakingly developed by thousands of engineers over multiple years," the petition said. President-elect Donald Trump previously supported a ban but has since reversed his position, though several of his administration picks still back restricting the social media platform. Trump takes office a day after the law's implementation. When asked Monday how he plans to stop a ban, Trump praised TikTok saying it helped him with the youth vote. "I have a warm spot in my heart for TikTok," he said.RAHWAY, N.J.--(BUSINESS WIRE)--Dec 16, 2024-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody. Vibostolimab is being evaluated as an investigational fixed-dose combination with pembrolizumab (KEYTRUDA ® ) in the KeyVibe program. Favezelimab is being evaluated as an investigational fixed-dose combination with pembrolizumab in the KEYFORM program. Merck is discontinuing the Phase 3 KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with non-small cell lung cancer (NSCLC), based on the recommendation of an independent Data Monitoring Committee (DMC). In a pre-planned analysis, both trials met the pre-specified futility criteria for the primary endpoint of overall survival. In these studies, the safety profile of vibostolimab/pembrolizumab was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals identified. As expected with dual checkpoint inhibitor therapy, more immune-related adverse events were observed with the fixed-dose combination than with pembrolizumab. Considering the totality of data from the Phase 3 KeyVibe studies, including the efficacy outcomes from KeyVibe-003 and KeyVibe-007, the company has decided to discontinue the Phase 3 KeyVibe-006 trial and other vibostolimab studies. Separately, Merck has decided to end the favezelimab clinical development program, and will stop enrollment in the Phase 3 KEYFORM-008 trial evaluating the fixed-dose combination of favezelimab and pembrolizumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) whose disease has progressed following prior anti-PD-1 therapy. Patients currently in this trial may continue on therapy until study completion. KEYFORM-008 is the only Phase 3 study in the KEYFORM clinical development program for which results are not available. The company has made this decision after a thorough evaluation of data from the favezelimab clinical program and will prioritize the development of other candidates in its comprehensive and diversified oncology pipeline. This decision is not based on any concerns about the safety of this fixed-dose combination. Merck is informing study investigators for these clinical trials and advises patients to speak to their study team and physician regarding next steps and treatment options. Data analyses for the Phase 3 trials are ongoing, and the results will be shared with the scientific community. "Following a careful analysis of the data, the decision has been made to discontinue development of these candidates to prioritize other ongoing programs. We are grateful to all the patients, caregivers and investigators for their many contributions that made these studies possible," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We continue to pursue the most promising science with a focus on agents with the greatest potential to improve outcomes for more patients with cancer." About KeyVibe-003 KeyVibe-003 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT04738487 ) evaluating the fixed-dose combination of vibostolimab and pembrolizumab (MK-7684A) versus pembrolizumab monotherapy, as a first-line treatment for patients with PD-L1 positive metastatic NSCLC. The primary endpoint is overall survival (OS) in participants with PD-L1 TPS ≥50%. Secondary endpoints include OS in participants with PD-L1 TPS ≥1% and TPS 1-49%, progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), safety and quality of life. The trial enrolled 1,264 patients who were randomized (1:1) to receive: Vibostolimab/pembrolizumab fixed-dose combination (pembrolizumab 200 mg and vibostolimab 200 mg intravenously [IV] every three weeks [Q3W] for up to 35 administrations); or Pembrolizumab (200 mg IV Q3W for up to 35 administrations) About KeyVibe-007 KeyVibe-007 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05226598 ) evaluating the fixed-dose combination of vibostolimab and pembrolizumab with chemotherapy in treatment-naïve patients with metastatic NSCLC. The primary endpoint is OS in participants with PD-L1 TPS ≥1%. Secondary endpoints include OS in all participants, PFS, ORR and DOR in TPS ≥ 1% and all participants, safety and patient reported outcomes. The trial enrolled 739 patients who were randomized (1:1) to receive: Vibostolimab/pembrolizumab fixed-dose combination (pembrolizumab 200mg and vibostolimab 200 mg IV) plus platinum doublet chemotherapy (Q3W for 4 cycles); then vibostolimab/pembrolizumab (200mg/200mg IV) for up to 31 cycles (plus pemetrexed 500mg/m 2 Q3W maintenance for nonsquamous histology) Pembrolizumab (200 mg IV) plus platinum doublet chemotherapy (Q3W for 4 cycles); then pembrolizumab (200mg IV) for up to 31 cycles (plus pemetrexed 500mg/m 2 Q3W maintenance for nonsquamous histology) About KeyVibe-006 KeyVibe-006 is a randomized, open-label Phase 3 trial (ClincialTrials.gov, NCT05298423 ) evaluating the fixed-dose combination of vibostolimab and pembrolizumab with concurrent chemoradiotherapy followed by vibostolimab and pembrolizumab versus concurrent chemoradiotherapy followed by durvalumab in patients with stage III NSCLC. The primary endpoints are PFS and OS for all participants and for participants with TPS ≥ 1%. The secondary endpoints are ORR, DOR, safety and patient reported outcomes. The trial enrolled approximately 580 patients who were randomized (1:1) to receive: Vibostolimab/pembrolizumab (200mg/200mg IV) plus platinum doublet (1 cycle); then platinum doublet plus vibostolimab/pembrolizumab (2 cycles) plus thoracic radiotherapy; then vibostolimab/pembrolizumab (200mg/200mg IV Q3W for 17 cycles); or Platinum doublet (1 cycle); then platinum doublet (2 cycles) plus thoracic radiotherapy; then durvalumab (10 mg/kg Q2W for 26 cycles) About KEYFORM-008 KEYFORM-008 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT05508867 ) evaluating the fixed-dose combination of favezelimab and pembrolizumab (MK-4280A) versus physician's choice chemotherapy for the treatment of patients with PD-1 relapsed or refractory classical Hodgkin lymphoma. The primary endpoint is PFS per Lugano Response Criteria as assessed by Blinded Independent Central Review (BICR). The secondary endpoints are OS, ORR, DOR and safety. The trial enrolled 169 patients who were randomized (1:1) to receive: Favezelimab/pembrolizumab (800 mg/200 mg IV on day 1, then Q3W for up to 35 infusions); or Physician's choice of either bendamustine (between 90-120 mg/m 2 IV on day 1 and day 2 of either a 3- or 4-week cycle for up to 6 cycles); or gemcitabine (between 800-1,200 mg/m 2 IV on day 1 and day 8 of a Q3W cycle for up to 6 cycles) About vibostolimab Vibostolimab (MK-7684) is an investigational humanized anti-TIGIT antibody discovered and developed by Merck. Vibostolimab restores antitumor activity by blocking the TIGIT receptor from binding to its ligands (CD112 and CD155), thereby activating T lymphocytes that help destroy tumor cells. About favezelimab Favezelimab (MK-4280) is an investigational anti-lymphocyte activation gene-3 (LAG-3) antibody. LAG-3 is a cell surface immunomodulatory receptor expressed on various immune cells that down-regulates T cell proliferation and activation. Favezelimab aims to restore T cell effector function by preventing LAG-3 from binding to its primary ligand, major histocompatibility complex (MHC) class II molecules. About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%), and vomiting (2.4%). Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA, including infection (2.3%) and thromboembolism (1.3%). KEYTRUDA was permanently discontinued due to adverse reactions in 15% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were infections (1.8%) and diarrhea (1.0%). The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%), and weight loss (20%). In KEYNOTE-590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%). Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. In KEYNOTE-A18, when KEYTRUDA was administered with CRT (cisplatin plus external beam radiation therapy [EBRT] followed by brachytherapy [BT]) to patients with FIGO 2014 Stage III-IVA cervical cancer, fatal adverse reactions occurred in 1.4% of 292 patients, including 1 case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 30% of patients; those ≥1% included urinary tract infection (2.7%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 7% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). For patients treated with KEYTRUDA in combination with CRT, the most common adverse reactions (≥10%) were nausea (56%), diarrhea (50%), vomiting (33%), urinary tract infection (32%), fatigue (26%), hypothyroidism (20%), constipation (18%), decreased appetite and weight loss (17% each), abdominal pain and pyrexia (12% each), hyperthyroidism, dysuria, rash (11% each), and pelvic pain (10%). In KEYNOTE-826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD-L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each). KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%). For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%). For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%). In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%). In KEYNOTE-394, KEYTRUDA was discontinued due to adverse reactions in 13% of 299 patients with previously treated hepatocellular carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was ascites (2.3%). The most common adverse reactions in patients receiving KEYTRUDA (≥10%) were pyrexia (18%), rash (18%), diarrhea (16%), decreased appetite (15%), pruritus (12%), upper respiratory tract infection (11%), cough (11%), and hypothyroidism (10%). In KEYNOTE-966, when KEYTRUDA was administered in combination with gemcitabine and cisplatin, KEYTRUDA was discontinued for adverse reactions in 15% of 529 patients with locally advanced unresectable or metastatic biliary tract cancer. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood cell count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased ALT (2.6%), increased AST (2.5%), and biliary obstruction (2.3%). In KEYNOTE-017 and KEYNOTE-913, adverse reactions occurring in patients with MCC (n=105) were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent. In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%). In KEYNOTE-564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%). In KEYNOTE-868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4). Adverse reactions occurring in patients with MSI-H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent. Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent. Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. In KEYNOTE-522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%). In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%). Lactation Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose. Pediatric Use In KEYNOTE-051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 25 months). Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), leukopenia (30%), vomiting (29%), neutropenia (28%), headache (25%), abdominal pain (23%), thrombocytopenia (22%), Grade 3 anemia (17%), decreased lymphocyte count (13%), and decreased white blood cell count (11%). Geriatric Use Of the 564 patients with locally advanced or metastatic urothelial cancer treated with KEYTRUDA in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. No overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older. Additional Selected KEYTRUDA Indications in the U.S. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf . View source version on businesswire.com : https://www.businesswire.com/news/home/20241216638631/en/ CONTACT: Media Contacts:Robert Josephson (203) 914-2372Sienna Choi (908) 873-4311Investor Contacts:Peter Dannenbaum (732) 594-1579Steven Graziano (732) 594-1583 KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS OTHER HEALTH BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ONCOLOGY OTHER SCIENCE SOURCE: Merck & Co., Inc. Copyright Business Wire 2024. PUB: 12/16/2024 04:30 PM/DISC: 12/16/2024 04:28 PM http://www.businesswire.com/news/home/20241216638631/en
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NEW YORK (AP) — U.S. stock indexes drifted amid mixed trading Monday, ahead of this week’s upcoming meeting by the Federal Reserve that could set Wall Street’s direction into next year. The S&P 500 rose 0.4%, coming off its first losing week in the last four . The Nasdaq composite climbed 1.2% to a record, while the Dow Jones Industrial Average was a laggard and fell 110 points, or 0.3%. Broadcom leaped 11.2% to help lead the S&P 500 for a second straight day after delivering a profit report last week that beat analysts’ expectations. The technology company is riding a wave of enthusiasm about its artificial-intelligence offerings in particular. The market’s main event, though, will arrive on Wednesday when the Federal Reserve will announce its last move on interest rates for the year. The widespread expectation is that it will cut its main rate for a third straight time, as it tries to boost the slowing job market after getting inflation nearly all the way down to its target of 2%. The question is how much more it will cut rates next year, and Fed officials will release projections for where they see the federal funds rate ending 2025, along with other economic indicators, once their meeting concludes. Fed Chair Jerome Powell will also answer questions in a press conference following the meeting. For now, the general expectation among traders is that the Fed may cut a couple more times in 2025, according to data from CME Group. But such expectations have been shrinking following reports suggesting inflation may be tougher to get all the way down to 2% from here. Besides last month’s slight acceleration in inflation, another worry is that President-elect Donald Trump’s preferences for tariffs and other policies could lead to higher inflation down the line. Goldman Sachs economist David Mericle has dropped his earlier forecast of a cut by the Fed in January, for example. Beyond the possibility of tariffs, he said Fed officials may also want to slow their cuts because of uncertainty about exactly how low rates need to go so that they no longer press the brakes on the economy. Expectations for a series of cuts to rates by the Fed have been one of the main reasons the S&P 500 has set an all-time high 57 times so far this year and is heading for one of its best years of the millennium . The economy has held up better than many feared, continuing to grow even after the Fed hiked the federal funds rate to a two-decade high in hopes of grinding down on inflation, which topped 9% two summers ago. On Wall Street, MicroStrategy jumped as much as 7% during the day as it continues to benefit from the surging price for bitcoin , which set another all-time high. But its stock ended the day down by les than 0.1% after bitcoin’s price pulled back below $106,000 after setting a record above $107,700, according to CoinDesk. The software company has been building its hoard of the cryptocurrency, and its stock price has more than sextupled this year. It will also soon join the Nasdaq 100 index. Bitcoin’s price has catapulted from roughly $44,000 at the start of the year, riding a recent wave of enthusiasm that Trump will create a system that’s more favorable to digital currencies . Honeywell rose 3.7% after saying it’s still considering a spin-off or sale of its aerospace business, as part of a review of its overall business. It said it plans to give an update with the release of its fourth-quarter results. They helped offset a drop for Nvidia, whose chips are powering much of the world’s move into AI. Its stock fell 1.7%. Because it’s grown so massive, with a total value topping $3 trillion, it was the single heaviest weight on the S&P 500. All told, the S&P 500 rose 22.99 points to 6,074.08. The Dow Jones Industrial Average fell 110.58 to 43,717.48, and the Nasdaq composite rose 247.17 to 20,173.89. In the bond market, Treasury yields held relatively steady. The yield on the 10-year Treasury edged down to 4.39% from 4.40% late Friday. The two-year yield, which more closely tracks expectations for the Fed, eased to 4.24% from 4.25%. In stock markets abroad, indexes fell modestly across much of Europe and Asia. They sank 0.9% in Hong Kong and 0.2% in Shanghai after China reported lackluster economic indicators for November despite attempts to strengthen the world’s second-largest economy. South Korea’s Kospi fell 0.2% as law enforcement authorities pushed to summon impeached President Yoon Suk Yeol for questioning over his short-lived martial law decree, and the Constitutional Court met to discuss whether to remove him from office or reinstate him. ___ AP Business Writer Elaine Kurtenbach contributed. Stan Choe, The Associated Press
Brazil’s Bolsonaro planned and participated in a 2022 coup plot, unsealed police report allegesStock market today: Nasdaq hits a record as Wall Street drifts ahead of Federal Reserve's meeting
NEW YORK (AP) — Walmart's sweeping rollback of its diversity policies is the strongest indication yet of a profound shift taking hold at U.S. companies that are re-evaluating the legal and political risks associated with bold programs to bolster historically underrepresented groups. The changes announced by the world's biggest retailer on Monday followed a string of legal victories by conservative groups that have filed an onslaught of lawsuits challenging corporate and federal programs aimed at elevating minority and women-owned businesses and employees. The retreat from such programs crystalized with the election of former President Donald Trump, whose administration is certain to make dismantling diversity, equity and inclusion programs a priority. Trump's incoming deputy chief of policy will be his former adviser Stephen Miller , who leads a group called America First Legal that has aggressively challenged corporate DEI policies. “There has been a lot of reassessment of risk looking at programs that could be deemed to constitute reverse discrimination,” said Allan Schweyer, principal researcher at the Human Capital Center at the Conference Board. “This is another domino to fall and it is a rather large domino,” he added. Among other changes, Walmart said it will no longer give priority treatment to suppliers owned by women or minorities. The company also will not renew a five-year commitment for a racial equity center set up in 2020 after the police killing of George Floyd. And it pulled out of a prominent gay rights index . Schweyer said the biggest trigger for companies making such changes is simply a reassessment of their legal risk exposure, which began after U.S. Supreme Court’s ruling in June 2023 that ended affirmative action in college admissions. Since then, conservative groups using similar arguments have secured court victories against various diversity programs, especially those that steer contracts to minority or women-owned businesses. Most recently, the conservative Wisconsin Institute for Law & Liberty won a victory in a case against the U.S. Department of Transportation over its use of a program that gives priority to minority-owned businesses when it awards contracts. Companies are seeing a big legal risk in continuing with DEI efforts, said Dan Lennington, a deputy counsel at the institute. His organization says it has identified more than 60 programs in the federal government that it considers discriminatory, he said. “We have a legal landscape within the entire federal government, all three branches -- the U.S. Supreme Court, the Congress and the President -- are all now firmly pointed in the direction towards equality of individuals and individualized treatment of all Americans, instead of diversity, equity and inclusion treating people as members of racial groups,” Lennington said. The Trump administration is also likely to take direct aim at DEI initiatives through executive orders and other policies that affect private companies, especially federal contractors. “The impact of the election on DEI policies is huge. It can’t be overstated,” said Jason Schwartz, co-chair of the Labor & Employment Practice Group at law firm Gibson Dunn. With Miller returning to the White House, rolling back DEI initiatives is likely to be a priority, Schwartz said. “Companies are trying to strike the right balance to make clear they’ve got an inclusive workplace where everyone is welcome, and they want to get the best talent, while at the same time trying not to alienate various parts of their employees and customer base who might feel one way or the other. It’s a virtually impossible dilemma,” Schwartz said. A recent survey by Pew Research Center showed that workers are divided on the merits of DEI policies. While still broadly popular, the share of workers who said focusing on workplace diversity was mostly a good thing fell to 52% in the October survey, compared to 56% in a similar survey in February 2023. Rachel Minkin, a research associate at Pew, called it a small but significant shift in short amount of time. There will be more companies pulling back from their DEI policies, but it likely won’t be a retreat across the board, said David Glasgow, executive director of the Meltzer Center for Diversity, Inclusion and Belonging at New York University. “There are vastly more companies that are sticking with DEI," Glasgow said. "The only reason you don’t hear about it is most of them are doing it by stealth. They’re putting their heads down and doing DEI work and hoping not to attract attention.” Glasgow advises organizations to stick to their own core values, because attitudes toward the topic can change quickly in the span of four years. “It’s going to leave them looking a little bit weak if there’s a kind of flip-flopping, depending on whichever direction the political winds are blowing,” he said. One reason DEI programs exist is because without those programs, companies may be vulnerable to lawsuits for traditional discrimination. “Really think carefully about the risks in all directions on this topic,” Glasgow said. Walmart confirmed will no longer consider race and gender as a litmus test to improve diversity when it offers supplier contracts. Walmart says its U.S. businesses sourced more than $13 billion in goods and services from diverse suppliers in fiscal year 2024, including businesses owned by minorities, women and veterans. It was unclear how its relationships with such business would change going forward. Organizations that have partnered with Walmart on its diversity initiatives offered a cautious response. The Women’s Business Enterprise National Council, a non-profit that last year named Walmart one of America's top corporation for women-owned enterprises, said it was still evaluating the impact of Walmart's announcement. Pamela Prince-Eason, the president and CEO of the organization, said she hoped Walmart's need to cater to its diverse customer base will continue to drive contracts to women-owned suppliers even if the company has no explicit dollar goals. “I suspect Walmart will continue to have one of the most inclusive supply chains in the World,” Prince-Eason wrote. “Any retailer's ability to serve the communities they operate in will continue to value understanding their customers, (many of which are women), in order to better provide products and services desired and no one understands customers better than Walmart." Walmart's announcement came after the company spoke directly with conservative political commentator and activist Robby Starbuck, who has been going after corporate DEI policies, calling out individual companies on the social media platform X. Several of those companies have subsequently announced that they are pulling back their initiatives, including Ford , Harley-Davidson, Lowe’s and Tractor Supply . Walmart confirmed to The Associated Press that it will better monitor its third-party marketplace items to make sure they don’t feature sexual and transgender products aimed at minors. The company also will stop participating in the Human Rights Campaign’s annual benchmark index that measures workplace inclusion for LGBTQ+ employees. A Walmart spokesperson added that some of the changes were already in progress and not as a result of conversations that it had with Starbuck. RaShawn “Shawnie” Hawkins, senior director of the HRC Foundation’s Workplace Equality Program, said companies that “abandon” their commitments workplace inclusion policies “are shirking their responsibility to their employees, consumers, and shareholders.” She said the buying power of LGBTQ customers is powerful and noted that the index will have record participation of more than 1,400 companies in 2025.Mexico cracks down on drugs and migrants. Will it be enough to stop Trump tariffs?
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Australia's House of Representatives passes bill that would ban children from social mediaThe developer of recently-announced virtual pet simulator game Catly has responded to allegations that the game's trailer and marketing was produced using generative AI, saying that no such technology was used in its announcement at The Game Awards, nor in the game itself. In a statement shared with IGN, a PR representative authorized to speak on behalf of developer SuperAuthenti said that generative AI was not used to produce the trailer, nor the game. Furthermore, the representative said the developer was "very surprised by such speculations," adding that "We do not think there are any existing AI tools that can produce a video like that. Industry experts have echoed this opinion." The PR representative also showed IGN a version of the trailer from The Game Awards that showed in-progress shots interspersed alongside the final version, which did seem to confirm the lack of AI use in the actual trailer production. The spokesperson confirmed to IGN that Catly is being made in Unreal Engine 5, and said the developer uses "various software" to produce hyperrealistic fur and hair. Assertions that Catly was using generative AI technology began to circulate almost immediately after its trailer debuted at The Game Awards last week. The trailer itself featured hyperrealistic cats with brightly colored fur and features bounding around a fantasy playspace and interacting with a human wearing various detailed, high fashion outfits. The art style present was flagged by many critics as reminiscent of the hyperrealistic style often produced by generative AI. That said, Catly's statement is consistent with the current reality that game trailers of this quality are not within the reach of current generative AI technology without significant, obvious artifacting and other issues. However, others pointed out that while the trailer may be legit, the other aspects of Catly's promotion are still giving some off vibes. For instance, the game's Steam description awkwardly reads, "A Cat Open World, with Beautiful Cats. Hyperrealism, Actions, Cuddle, Speed, Islands, Fashion, Dreams, Snow, Robots, Plants -- all with and via Cats." And a few of the game's promotional art pieces had odd details similar to AI artifacting, such as the odd paws and nose of this cat: And the text on the wall inside the right-hand side of the building in this image: Others unearthed more images from the official Catly website that appear to raise even more questions about their veracity. Notably, the Catly website was down as recently as Friday, and remained offline over the weekend through today when we reached out to SuperAuthenti to ask about it. The website has since been reinstated, but a number of the old images have been removed. While SuperAuthenti confirmed to me that it did not use generative AI in either the trailer or the game itself, it did not respond to my question about its promotional images on Steam or on its website. As for web3, speculation of the game's ties to the technology surfaced as individuals unearthed the studio co-founder, Kevin Yeung's, ties to other blockchain games . Additionally, the game's Steam page features a glowing quote from League of Legends and Arcane producer Thomas Vu, who himself is a prominent web3 investor. However, it also contained a quote from Hearthstone and Marvel Snap creator Ben Brode, who has taken to Bluesky to say that he's heard nothing about either AI generation or web3 involved in Catly, and that his interest is sincere. "I saw 20 [minutes] or so of gameplay footage a few months back and thought it looked cool so they asked me for a quote," he wrote . For now, it does seem that SuperAuthenti is telling the truth about the Catly trailer at The Game Awards, though the question of whether or not, or how much, generative AI has been used in Catly's overall development and promotion remains to be seen. Generative AI is becoming an increasingly popular tool for game companies, too. Call of Duty reportedly sold an "AI-generated cosmetic" for Call of Duty: Modern Warfare 3 in late 2023, and fans accused Activision of using generative AI again for a loading screen this year . EA said in September that AI was "the very core" of its business . Unfortunately, as the technology becomes both more prevalent and more complex, it seems likely it will become increasingly difficult to tell the difference between AI-generated and human-crafted work. In Catly's case, we'll have to wait for 2025 to find out more about what exactly is behind those hauntingly rainbow cat eyes from the trailer. Rebekah Valentine is a senior reporter for IGN. You can find her posting on BlueSky @duckvalentine.bsky.social. Got a story tip? Send it to rvalentine@ign.com.DENVER — So you're the most valuable player of that annual Thanksgiving Day backyard flag football game. Or played tackle football on any level. Or ran track. Or dabbled in basketball. Or toyed with any sport, really. Well, this may be just for you: USA Football is holding talent identification camps all over the country to find that next flag football star. It's "America's Got Talent" meets "American Idol," with the stage being the field and the grand prize a chance to compete for a spot on a national team. Because it's never too early to start planning for the 2028 Olympics in Los Angeles, where flag football will make its Summer Games debut. Know this, though — it's not an easy team to make. The men's and women's national team rosters are at "Dream Team" status given the men's side has captured six of the last seven world championships and the women three in a row. To remain on top, the sport's national governing body is scouring every football field, park, track, basketball court and gym to find hidden talent to cultivate. People are also reading... USA Football has organized camps and tryouts from coast to coast for anyone ages 11 to 23. There are more than a dozen sites set up so far, ranging from Dallas (Sunday) to Chicago (Dec. 14) to Tampa (March 29) to Los Angeles (TBD) and the Boston area (April 27), where it will be held at Gillette Stadium, home of the New England Patriots. The organization has already partnered with the NFL on flag football initiatives and programs. The numbers have been through the roof, with engagement on social media platforms increasing by 86% since flag football was announced as an Olympic invitational sport in October 2023. The participation of boys and girls ages 6 to 17 in flag football last year peaked at more than 1.6 million, according to USA Football research. "We pride ourselves on elevating the gold standard across the sport," said Eric Mayes, the managing director of the high performance and national teams for USA Football. "We want to be the best in the world — and stay the best in the world." Flag football was one of five new sports added to the LA28 program. The already soaring profile of American football only figures to be enhanced by an Olympic appearance. Imagine, say, a few familiar faces take the field, too. Perhaps even NFL stars such as Tyreek Hill or Patrick Mahomes, maybe even past pro football greats donning a flag belt for a country to which they may have ties. Soon after flag football's inclusion, there was chatter of NFL players possibly joining in on the fun. Of course, there are logistical issues to tackle before their inclusion at the LA Olympics, which open July 14, 2028. Among them, training camp, because the Olympics will be right in the middle of it. The big question is this: Will owners permit high-priced players to duck out for a gold-medal pursuit? No decisions have yet been made on the status of NFL players for the Olympics. For now, it's simply about growing the game. There are currently 13 states that sanction girls flag football as a high school varsity sport. Just recently, the Pittsburgh Steelers and Philadelphia Eagles helped pave the way to get it adopted in Pennsylvania. Around the world, it's catching on, too. The women's team from Japan took third at the recent word championships, while one of the best players on the planet is Mexico quarterback Diana Flores. "Could flag football globally become the new soccer? That's something to aspire to," said Stephanie Kwok, the NFL's vice president of flag football. This type of flag football though, isn't your Thanksgiving Day game with family and friends. There's a learning curve. And given the small roster sizes, versatility is essential. Most national team members need to be a version of Colorado's two-way standout and Heisman hopeful Travis Hunter. Forget bump-and-run coverage, too, because there's no contact. None. That took some adjusting for Mike Daniels, a defensive back out of West Virginia who earned a rookie minicamp invitation with the Cleveland Browns in 2017. "If a receiver is running around, I'm thinking, 'OK, I can kind of bump him here and there and nudge him,'" Daniels explained. "They're like, 'No, you can't.' I'm just like, 'So I'm supposed to let this guy just run?!' I really rebelled at the idea at first. But you learn." The competition for an Olympic roster spot is going to be fierce because only 10 players are expected to make a squad. The best 10 will earn it, too, as credentials such as college All-American or NFL All-Pro take a backseat. "I would actually love" seeing NFL players try out, said Daniels, who's also a personal trainer in Miami. "I'm not going to let you just waltz in here, thinking, 'I played NFL football for five years. I'm popular. I have a huge name.' I'm still better than you and I'm going to prove it — until you prove otherwise." Around the house, Bruce Mapp constantly swivels his hips when turning a hallway corner or if his daughter tries to reach for a hug. It's his way of working on avoiding a "defender" trying to snare the flag. That approach has earned the receiver out of Coastal Carolina four gold medals with USA Football. The 31-year-old fully plans on going for more gold in Los Angeles. "You grow up watching Usain Bolt (win gold) and the 'Redeem Team' led by Kobe Bryant win a gold medal, you're always thinking, 'That's insane.' Obviously, you couldn't do it in your sport, because I played football," said Mapp, who owns a food truck in the Dallas area. "With the Olympics approaching, that (gold medal) is what my mind is set on." It's a common thought, which is why everything — including talent camps — starts now. "Everybody thinks, 'Yeah, the U.S. just wins,'" Daniels said. "But we work hard all the time. We don't just walk in. We don't just get off the bus thinking, 'We're going to beat people.'" Be the first to know
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