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In conclusion, the Ideal L6 model's official C-NCAP release marks a significant milestone in the pursuit of automotive safety excellence. With its impressive safety performance and innovative safety features, the Ideal L6 is poised to redefine the standards of safety in the automotive industry and set new benchmarks for future car models. As drivers and consumers increasingly prioritize safety when choosing a vehicle, the Ideal L6 stands out as a shining example of what can be achieved when safety becomes a top priority in vehicle design and engineering.3D Machine Vision Market Emerging Trends and Forecast 2024-2031 11-23-2024 07:00 PM CET | IT, New Media & Software Press release from: SkyQuest Technology The 3D Machine Vision Market is a dynamic and rapidly growing sector, driven by technological advancements in hardware, software, and digital infrastructure. It covers a diverse range of services such as cloud computing, cybersecurity, data analytics, and artificial intelligence. The increasing need for digital transformation across industries is propelling market growth. Emerging technologies like 5G, blockchain, and IoT are further unlocking new opportunities. With continuous innovation, the IT sector is poised for significant expansion in the coming years, particularly in the areas of automation and remote work solutions. Download a detailed overview: https://www.skyquestt.com/sample-request/3d-machine-vision-market Market Size and Growth: 3D Machine Vision Market size was valued at USD 5.12 billion in 2022 and is poised to grow from USD 5.81 billion in 2023 to USD 19.66 billion by 2031, growing at a CAGR of 13.5% in the forecast period (2024-2031). The most valuable investment indicators are insights into key market trends, making it easier for potential participants to make informed decisions. The research seeks to identify numerous growth opportunities that readers can consider and capitalize on by utilizing all the relevant information. By closely analyzing critical factors that influence growth, such as pricing, production, profit margins, and value chain dynamics, future market expansion can be predicted with greater precision. Key Market Players: CognexCorporation Basler AG Omron Corporation Keyence Corporation Sick AG Teledyne Technologies Inc. Texas Instruments Inc. Isra Vision AG National Instruments Corporation Stemmer Imaging AG Allied Vision Technologies GmbH Baumer Optronic GmbH Region-wise Sales Analysis: This chapter presents market data by region, including revenue, sales, and market share breakdowns. It also offers forecasts for sales growth rates, pricing strategies, revenue, and other key metrics for each analyzed regional market. Regions covered include: North America: United States, Canada, Mexico Europe: Germany, France, UK, Russia, Italy Asia-Pacific: China, Japan, Korea, India, Southeast Asia South America: Brazil, Argentina, Colombia Middle East & Africa: Saudi Arabia, UAE, Egypt, Nigeria, South Africa Discover Key Trends, Speak with Our Experts @: https://www.skyquestt.com/speak-with-analyst/3d-machine-vision-market Segments covered in the 3D Machine Vision Market include: Application Quality Assurance & Inspection, Positioning & Guidance, Measurement, Identification End-Use Automotive, Pharmaceuticals, Chemicals, Electronics & Semiconductors, Pulp & Paper, Agriculture, Others Component Hardware, Software Product PC Based, Smart Camera Based 3D Machine Vision Market Size and Scope The 3D Machine Vision market has shown significant growth in recent years, fueled by rising demand for power electronics across industries such as automotive, telecommunications, and renewable energy. This market is set to grow further as the global adoption of electric vehicles and renewable energy increases. 3D Machine Vision are highly valued for their superior thermal conductivity, electrical insulation, and mechanical strength, making them essential components in power modules and electronic devices. With ongoing technological and manufacturing advancements, the applications of 3D Machine Vision are expected to expand, encompassing a broader range of uses in the near future. For a Comprehensive Report on the 3D Machine Vision Market 2024, Visit @: https://www.skyquestt.com/report/3d-machine-vision-market Frequently Asked Questions: 1. What are the global trends in sales, production, consumption, imports, and exports across regions (North America, Europe, Asia-Pacific, South America, Middle East, and Africa)? 2. Who are the leading manufacturers dominating the global market? 3. What is their production capacity, sales, pricing, cost, and revenue structure? 4. What are the risks and opportunities in the market? About Us: SkyQuest is an IP-focused Research and Investment Bank and Technology Accelerator. We offer access to technologies, markets, and financing across sectors like Life Sciences, CleanTech, AgriTech, NanoTech, and Information & Communication Technology. We collaborate closely with innovators, entrepreneurs, companies, and investors to help them leverage external R&D sources and optimize the economic potential of their intellectual assets. Our expertise in innovation management and commercialization spans North America, Europe, ASEAN, and Asia Pacific. Contact: Mr. Jagraj Singh Skyquest Technology 1 Apache Way, Westford, Massachusetts 01886, USA (+1) 351-333-4748 Visit our website: Skyquest Technology This release was published on openPR.
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Royal Caribbean Cruises Ltd. ( NYSE:RCL – Get Free Report ) was the recipient of some unusual options trading activity on Thursday. Stock traders acquired 41,401 call options on the company. This is an increase of 387% compared to the average daily volume of 8,501 call options. Wall Street Analyst Weigh In A number of research firms recently weighed in on RCL. Stifel Nicolaus boosted their target price on shares of Royal Caribbean Cruises from $250.00 to $310.00 and gave the company a “buy” rating in a report on Friday, December 6th. Macquarie boosted their price objective on Royal Caribbean Cruises from $189.00 to $250.00 and gave the company an “outperform” rating in a research note on Wednesday, October 30th. Barclays raised their target price on Royal Caribbean Cruises from $245.00 to $287.00 and gave the stock an “overweight” rating in a research note on Friday, December 13th. Citigroup upped their price target on Royal Caribbean Cruises from $257.00 to $283.00 and gave the company a “buy” rating in a research report on Wednesday, December 11th. Finally, Truist Financial raised their price objective on shares of Royal Caribbean Cruises from $204.00 to $272.00 and gave the company a “buy” rating in a research report on Monday, December 2nd. Three analysts have rated the stock with a hold rating and fourteen have issued a buy rating to the company. According to data from MarketBeat, the stock has a consensus rating of “Moderate Buy” and an average price target of $239.75. Check Out Our Latest Stock Report on RCL Insider Activity Institutional Investors Weigh In On Royal Caribbean Cruises A number of large investors have recently added to or reduced their stakes in RCL. Dimensional Fund Advisors LP boosted its holdings in shares of Royal Caribbean Cruises by 24.3% during the second quarter. Dimensional Fund Advisors LP now owns 2,048,501 shares of the company’s stock worth $326,616,000 after purchasing an additional 400,565 shares during the period. D1 Capital Partners L.P. lifted its holdings in Royal Caribbean Cruises by 3.8% in the 3rd quarter. D1 Capital Partners L.P. now owns 1,570,262 shares of the company’s stock worth $278,502,000 after buying an additional 58,159 shares during the period. Swiss National Bank grew its position in shares of Royal Caribbean Cruises by 0.5% in the 3rd quarter. Swiss National Bank now owns 725,638 shares of the company’s stock worth $128,699,000 after buying an additional 3,800 shares during the last quarter. Disciplined Growth Investors Inc. MN increased its stake in shares of Royal Caribbean Cruises by 2.3% during the third quarter. Disciplined Growth Investors Inc. MN now owns 591,552 shares of the company’s stock valued at $104,918,000 after buying an additional 13,520 shares during the period. Finally, APG Asset Management N.V. increased its stake in shares of Royal Caribbean Cruises by 4.0% during the second quarter. APG Asset Management N.V. now owns 461,762 shares of the company’s stock valued at $68,690,000 after buying an additional 17,601 shares during the period. Institutional investors own 87.53% of the company’s stock. Royal Caribbean Cruises Price Performance Shares of Royal Caribbean Cruises stock opened at $232.71 on Friday. The firm has a market capitalization of $62.57 billion, a PE ratio of 23.92, a price-to-earnings-growth ratio of 0.65 and a beta of 2.60. The company has a current ratio of 0.19, a quick ratio of 0.16 and a debt-to-equity ratio of 2.63. Royal Caribbean Cruises has a 12 month low of $113.10 and a 12 month high of $258.70. The business’s 50-day moving average price is $230.87 and its 200-day moving average price is $187.82. Royal Caribbean Cruises ( NYSE:RCL – Get Free Report ) last released its earnings results on Tuesday, October 29th. The company reported $5.20 earnings per share for the quarter, beating analysts’ consensus estimates of $5.05 by $0.15. Royal Caribbean Cruises had a return on equity of 52.92% and a net margin of 16.21%. The company had revenue of $4.89 billion during the quarter, compared to analyst estimates of $4.89 billion. During the same quarter in the previous year, the company posted $3.85 EPS. Royal Caribbean Cruises’s revenue for the quarter was up 17.5% on a year-over-year basis. Sell-side analysts forecast that Royal Caribbean Cruises will post 11.65 EPS for the current fiscal year. Royal Caribbean Cruises Cuts Dividend The company also recently declared a quarterly dividend, which will be paid on Monday, January 13th. Investors of record on Friday, December 27th will be issued a dividend of $0.55 per share. The ex-dividend date is Friday, December 27th. This represents a $2.20 dividend on an annualized basis and a yield of 0.95%. Royal Caribbean Cruises’s dividend payout ratio is currently 22.61%. Royal Caribbean Cruises Company Profile ( Get Free Report ) Royal Caribbean Cruises Ltd. operates as a cruise company worldwide. The company operates cruises under the Royal Caribbean International, Celebrity Cruises, and Silversea Cruises brands, which comprise a range of itineraries. As of February 21, 2024, it operated 65 ships. Royal Caribbean Cruises Ltd. Read More Receive News & Ratings for Royal Caribbean Cruises Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Royal Caribbean Cruises and related companies with MarketBeat.com's FREE daily email newsletter .
North Korean Hackers Strike Again: Secure Your Investment with the Best Crypto Presales of 2025!Angry Bear Damages Infrared Camera After Being Photographed100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy SAN DIEGO , Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new frontline data featuring TECVAYLI ® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings. The MajesTEC-5 ( Abstract #493 ) and MajesTEC-4 ( Abstract #494 ) studies establish the potential of TECVAYLI ® for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile. These data were highlighted as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting. 1,2 Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI ® in combination with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone (Tec-DRd) or DARZALEX FASPRO ® , bortezomib, lenalidomide and dexamethasone (Tec-DVRd) as induction therapy in the MajesTEC-5 study. 1 All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10 -5 ) and maintained through cycle 6. 1 "These data from the MajesTEC-5 study build on the growing body of evidence of TECVAYLI combinations that support the potential combinability of TECVAYLI with other effective therapies, demonstrating high rates of MRD-negative responses for evaluable patients with newly diagnosed multiple myeloma," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. "At Johnson & Johnson, our deep expertise and understanding of multiple myeloma has shaped the regimens we're developing, including our bispecific antibodies in new combinations, and we're committed to exploring the full potential of our therapies to improve outcomes for patients." The safety profiles were manageable and consistent with individual safety profiles. 1 No treatment-emergent adverse events (TEAEs) led to study treatment discontinuation or death; cytokine release syndrome (CRS; Grade 1 or 2) occurred in 65 percent of patients. 1 No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). 1 Grade 3/4 TEAEs included lymphopenia (43 percent), neutropenia (57 percent) and infections (35 percent). 1 "There remains opportunity to achieve even deeper and more sustained outcomes for a broader patient population in the frontline setting," said Marc S. Raab , M.D., Heidelberg University Hospital, Germany .* "These data reinforce the potential of TECVAYLI when used in earlier lines and show that TECVAYLI can be leveraged to optimize existing standard regimens in combination." Results from the safety run-in of the Phase 3 MajesTEC-4 study highlighted the potential of TECVAYLI ® to be administered as a maintenance therapy following autologous stem cell transplant (ASCT). 2 MajesTEC-4 is the first study to present data on a B-cell maturation antigen (BCMA) bispecific as monotherapy or combination therapy after ASCT. 2 Low rates of non-hematologic Grade 3/4 TEAEs and discontinuation of treatment due to all TEAEs (5.3 percent) were observed. CRS events were all Grade 1/2, mostly occurring during step-up dosing, and ICANS was not observed. Neutropenia and infections were the most common Grade 3/4 TEAEs. 2 Grade 3/4 neutropenia at 6 months showed a decreased trend in cohorts 2 and 3 with less frequent TECVAYLI ® dosing (cohort 1: 94 percent, cohort 2: 63 percent, cohort 3: 47 percent). 2 A similar trend was observed for all-grade infections (cohort 1: 94 percent; cohort 2: 78 percent; cohort 3: 77 percent). 2 All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6. 2 Further analysis of combination therapies will be evaluated in the Phase 3 MajesTEC-7 study, which is currently enrolling. About MajesTEC-5 Study MajesTEC-5 ( NCT05695508 ) is an ongoing, Phase 2 study of teclistamab and talquetamab, evaluating the safety and efficacy of combination regimens in participants with newly diagnosed transplant eligible multiple myeloma. 3 About MajesTEC-4 Study MajesTEC-4 ( NCT05243797 ) is an ongoing, multicenter, randomized, open-label, Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation. 4 About MajesTEC-7 Study MajesTEC-7 ( NCT05552222 ) is a Phase 3 randomized study comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab SC and lenalidomide (Tal-DR) versus daratumumab SC, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. 5 About TECVAYLI ® TECVAYLI ® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. 6 The European Commission (EC) granted TECVAYLI ® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023 , the EC granted the approval of a Type II variation application for TECVAYLI ® , providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI ® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In February 2024 , the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI ® for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months. For more information, visit www.TECVAYLI.com . About DARZALEX FASPRO ® and DARZALEX ® DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX FASPRO ® is co-formulated with recombinant human hyaluronidase PH20, Halozyme's ENHANZE ® drug delivery technology. DARZALEX ® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX ® -based regimens have been used in the treatment of more than 585,000 patients worldwide and more than 239,000 patients in the U.S. alone. In August 2012 , Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. For more information, visit https://www.darzalexhcp.com. About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 7 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors. 8 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease. 9 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease. 10 People living with multiple myeloma have a 5-year survival rate of 59.8 percent. 11 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections. 12,13 TECVAYLI ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL- ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI ® . Initiate treatment with TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI ® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life- threatening reactions, can occur in patients receiving TECVAYLI ® . Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI ® until neurologic toxicity resolves or permanently discontinue based on severity. TECVAYLI ® is available only through a restricted program called the TECVAYLI ® and TALVEY ® Risk Evaluation and Mitigation Strategy (REMS). INDICATION AND USAGE TECVAYLI ® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). WARNINGS AND PRECAUTIONS Cytokine Release Syndrome - TECVAYLI ® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI ® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI ® . The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI ® accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI ® based on severity. TECVAYLI ® is available only through a restricted program under a REMS. Neurologic Toxicity including ICANS - TECVAYLI ® can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI ® at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI ® . In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI ® at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI ® . The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI ® based on severity per recommendations and consider further management per current practice guidelines. Due to the potential for neurologic toxicity, patients are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI ® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves. TECVAYLI ® is available only through a restricted program under a REMS. TECVAYLI ® and TALVEY ® REMS - TECVAYLI ® is available only through a restricted program under a REMS called the TECVAYLI ® and TALVEY ® REMS because of the risks of CRS and neurologic toxicity, including ICANS. Hepatotoxicity - TECVAYLI ® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Infections - TECVAYLI ® can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%. Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI ® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Monitor immunoglobulin levels during treatment with TECVAYLI ® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Neutropenia - TECVAYLI ® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of patients. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI ® based on severity. Hypersensitivity and Other Administration Reactions - TECVAYLI ® can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue. Local Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI ® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI ® and for 5 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Please read full Prescribing Information , including Boxed WARNING, for TECVAYLI ® . DARZALEX FASPRO ® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS DARZALEX FASPRO ® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation. WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO ® . Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO ® . Systemic Reactions In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO ® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO ® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients. Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO ® . Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO ® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO ® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO ® . Local Reactions In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management. Neutropenia Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO ® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO ® , higher rates of Grade 3-4 neutropenia were observed. Thrombocytopenia Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO ® until recovery of platelets. Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO ® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO ® and for 3 months after the last dose. The combination of DARZALEX FASPRO ® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy. Interference With Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO ® . Type and screen patients prior to starting DARZALEX FASPRO ® . Interference With Determination of Complete Response Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO ® -treated patients with IgG kappa myeloma protein. ADVERSE REACTIONS In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO ® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema. The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO ® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to see the full Prescribing Information for DARZALEX FASPRO ® . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JanssenUS and @JNJInnovMed . Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TECVAYLI ® (teclistamab-cqyv ) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. * Marc S. Raab , M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Raab, Marc, S., et al, 493 Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 2 Zamagni, Elena, et al., 494 Phase 3 Study of Teclistamab (Tec) in Combination with Lenalidomide (Len) and Tec Alone Versus Len Alone in Newly Diagnosed Multiple Myeloma (NDMM) As Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT): Safety Run-in (SRI) Results from the MajesTEC-4/EMN30 Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 3 GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX). https://clinicaltrials.gov/study/NCT05695508 . Accessed November 2024 . 4 Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4). https://clinicaltrials.gov/study/NCT05243797 . Accessed November 2024 . 5 A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7). https://classic.clinicaltrials.gov/ct2/show/NCT05552222 . Accessed November 2024 . 6 U.S. FDA Approves TECVAYLI ® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma . Accessed November 2024 . 7 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178 8 National Cancer Institute. Plasma Cell Neoplasms. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq . Accessed November 2024 . 9 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma . Accessed November 2024 . 10 American Cancer Society. Key Statistics About Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women . Accessed November 2024 . 11 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/ . Accessed November 2024 . 12 American Cancer Society. What is Multiple Myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html . Accessed November 2024 . 13 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html . Accessed November 2024 . Media contacts: Sarah Freeman sfreem21@its.jnj.com Christie Corbett ccorbet6@its.jnj.com Investor contact: Lauren Johnson investor-relations@its.jnj.com U.S. Medical Inquiries +1 800 526-7736 View original content to download multimedia: https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-demonstrates-potential-as-frontline-combination-therapy-for-patients-with-newly-diagnosed-multiple-myeloma-302325575.html SOURCE Johnson & Johnson
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Frustrated Giants Fans Fly a Plane Over MetLife Stadium With a Clear Message for Owner John Mara, and Social Media Is Loving ItNone
Joe Biden & Donald Trump lead tributes to ‘extraordinary leader and humanitarian’ Jimmy Carter after his death aged 100If there was one thing No. 14 Gonzaga failed to do in nonconference play, it was learn how to finish. And the Bulldogs may not get many chances to play close games in West Coast Conference play, which they'll open Monday against Pepperdine in Malibu, Calif. Sure, the Bulldogs (9-4) trounced then-No. 8 Baylor 101-63 and then-No. 14 Indiana 89-73. But they also lost in overtime to West Virginia (86-78) and No. 4 Kentucky (90-89), dropped a 77-71 decision to two-time defending NCAA champion UConn at Madison Square Garden and are coming off a 65-62 defeat to No. 22 UCLA on Saturday. "Obviously we feel like we've been in a bunch of close games that we felt like we should have won all of them," said Gonzaga point guard Ryan Nembhard, who had 16 points and eight assists against a Bruins defense that is one of the best in the country. "We've got to close out these games and learn to win these close games." Graham Ike led the Bulldogs with 24 points as they rallied from an 11-point deficit and led for most of the final 12 1/2 minutes before stumbling. It didn't help Gonzaga that guard Khalif Battle, who is tied for third on the team with 11.8 points per game, was ejected with 4:13 remaining in the first half for a Flagrant-2 foul against UCLA's Eric Dailey Jr. "We're playing a great schedule and great teams," Gonzaga coach Mark Few said. "And you're in position to win and in college basketball, you hope you can make a play, make a shot and get a stop at the end." Ike leads Gonzaga with 16.2 points and 6.7 rebounds per game. Nembhard averages 12.1 points per game and leads the country with 10.0 assists per game. The Bulldogs have won 47 consecutive games against Pepperdine (6-8, 0-1 WCC) dating to Jan. 18, 2002. It's the third-longest run against an opponent in NCAA Division I history and the longest active streak. The Waves have won four of their past six games, but are coming off a 91-80 loss Saturday at Santa Clara to open their conference slate. Stefan Todorovic led the Waves with 25 points, three rebounds, four assists and a steal. Todorovic tops the WCC with 19.7 points per game. Dovydas Butka added 16 points with eight rebounds and three assists and Moe Odum contributed 14 points, six rebounds, nine assists and two steals. Odum is third nationally with 105 assists, with Gonzaga's Nembhard (130) the leader in that category. "The system that Coach (Ed) Schilling puts us in opens the (court) for everybody," Todorovic said. "Not just me, we can be a threat at all positions on the floor." Schilling is in his first season with the Waves after 13 years as an assistant at UMass, Memphis, UCLA, Indiana and, most recently, Grand Canyon. He also spent 1997-2003 as the head coach of Wright State. Schilling replaced Lorenzo Romar at Pepperdine. --Field Level Media
Oklahoma’s keys to victory against AlabamaImagine sitting in a café with a notepad and talking to a corporate senior who has been there, seen it, and done it. Over a cup of cappuccino, the senior narrates his wisdom about crafting a career that “doesn’t just pay but also gives you joy.” That’s how you could feel reading Pavan Soni’s Design Your Career: Lead Self, Lead Others, Lead Change — inspiring and actionable. Soni lays down six rules, and we explain them with examples. Rule 1: Life is long; pace it well: Imagine you’re at the starting line of a marathon race, and the crowd surges forward at the whistle. Do you sprint? Definitely not if you want to cross the finishing line. Similarly, find the deep motivations that drive you in a career — and pace yourself. Remember, he isn’t giving up when someone steps away from a high-stakes corporate job to mentor start-ups. It’s just pacing for the long game. For example, Dhoni gave up Test cricket in 2013 to prolong his career by a decade. Rule 2 : Deserve before you desire: You have to earn your seat at the power table. It doesn’t get handed out like in a dinner. Take a junior analyst who wants to lead strategy meetings, but his PowerPoint slides are full of errors, and he simply reads out from there. Obviously, he needs to master the craft. Similarly, if you want to sit in the corner room, first become indispensable. The book urges us to build credibility before seeking rewards. Rule 3 : Own your career, or somebody else will: Remember the gym coach constantly reminding you to attend practice? Or the mother who repeatedly follows up on her kid’s homework. In a corporate career, no one will set the pace for you. Instead, it is a long-term portfolio that you have to assiduously build. You have a combination of good stocks in a portfolio of stocks, and you don’t necessarily follow the trend. Similarly, treat your career as an entrepreneurial venture and stay away from the passive “go-with-the-flow” decisions. Rule 4: Focus on high-leverage activities: This one hits the bull’s eye if you’ve spent long nights in busy work that felt productive but wasn’t. Like the long hours you spent reading parts of a subject for the exam, but no question came from there! Soni talks about the ‘Zone of Freedom,’ a space where your choices make the most impact. He tells you to focus and shows you how to do it. For instance, delegate tasks that are outside your core zone. It’s like deciding not to wash your car but spending that hour learning a new skill. Rule 5: Think strategically, act decisively: Soni introduces “future back” thinking, where you imagine the future you want and reverse-engineer the steps to get there. It’s like a young designer sketching out her dream studio and then identifying the skills, networks, and portfolio pieces she’ll need. Stephen Covey wrote this three decades ago: Begin with the end in mind . The idea may not be novel, but many don’t follow it, so it needs repeating. Rule 6: Leadership is a choice, not everyone can make: Leadership is about taking responsibility. Leaders shield, support, and inspire. Imagine a manager who takes the blame for a missed deadline so her team can focus on solutions. Only some are destined to be CEOs. And not every need to. One of India’s best batters, Sachin Tendulkar, gave up captaincy. If your heart is there, go for it. If you think you are not cut for it, be the best in whatever you are now doing. Design Your Career doesn’t give you a checklist; it hands you a compass. It’s for those willing to take charge of their lives, make tough choices, and do the work. The reviewer is Director, ICFAI Group CommentsColorado vs. BYU Set for Alamo Bowl; Deion, Shedeur Sanders, Travis Hunter's 1st Bowl
Furthermore, the ban on windshields has sparked discussions about the importance of safety education and awareness among electric scooter riders. Traffic police authorities are working to increase public awareness about the risks associated with using windshields on electric scooters and the importance of adhering to safety regulations to prevent accidents. Education campaigns, safety workshops, and online resources are being utilized to inform riders about best practices for safe and responsible riding.Cornelious Brown IV throws 5 TD passes to lead Alabama A&M past Mississippi Valley State 49-35
Virtual live streaming has become increasingly popular in recent years, with many influencers and celebrities using green screen technology to create immersive virtual environments for their live broadcasts. However, the use of green screens has enabled these content creators to manipulate their surroundings and present a false façade to their viewers.Canada Post strike update: Union 'frustrated' with proposals, but postal service says it has yet to see formal responseProfessor Ouyang Hui: Four Common Misconceptions about "Trump 2.0"
Aaron Rodgers and New York Jets extend worst streak in all of American professional sports as future plans revealedThrough her actions, Zhao Lusi not only comforted her fans but also sent a powerful message to the online community. She emphasized the importance of standing up against bullying and supporting those who are being targeted. Her act of kindness sparked a movement of positivity and unity among her fans, as they rallied together to spread love and kindness in the face of negativity.
Groups break down barriers on Colorado’s slopes to diversify winter sports that are “just so hard to get into”In a surprising move, Tencent Video has announced a significant change to its VIP service, downgrading the number of devices that can stream content simultaneously. Previously, Tencent Video VIP members were able to stream content on multiple devices at the same time, but now the service has been reduced to allow streaming on only one device at a time.
