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The PGA Tour announced its schedule of seven post-season tournaments for the fall of 2025 on Tuesday with no Las Vegas event on the calendar for the first time since 1983. The lineup is one fewer than this year and tees off with the Procore Championship in Napa, California, on September 11-14, two weeks after the 2025 Tour Championship. Absent from the schedule is the Shriners Children's Open in Las Vegas. After the Ryder Cup next September at Bethpage Black, the PGA Tour events resume with the Sanderson Farms Championship on October 2-5. The PGA Tour's Japan stop, the Baycurrent Classic, will be October 9-12 at Yokohama Country Club followed by the Black Desert Championship on October 23-26 in Utah. The World Wide Technology Championship at Los Cabos, Mexico, will be November 6-9 followed the next week by the Bermuda Championship and the RSM Classic on November 20-23 at Sea Island, Georgia. "With events in four US states, Japan, Mexico and Bermuda, the conclusion to the 2025 golf calendar promises to be exciting for our fans worldwide," said Tyler Dennis, PGA Tour chief competitions officer. Under tighter qualifying rules for the 2026 PGA Tour approved by the Player Advisory Council last month, only the top 70 players in the FedEx Cup standings will secure exempt status with the 50 who reach next year's BMW Championship being exempt into signature events for 2026. Those ranked 51st and beyond will take FedEx Cup points into the fall to try and accumulate eligibility points for the 2026 campaign. Three PGA Tour Challenge season events will be played next December -- the Hero World Challenge in the Bahamas hosted by Tiger Woods, the LPGA-PGA mixed-team Grant Thornton Invitational and the PNC Championship parent-child event. Tour commissioner Jay Monahan also announced Tuesday that the PGA is searching for a new chief executive officer whose job would be to grow the business side of the operation in light of the $1.5 billion investment in PGA Tour Enterprises by Strategic Sports Group, a set of team sports owners. js/bb
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Google and federal officials are battling it out over a proposal that the tech giant be forced to sell its popular Chrome web browser to restore competition to the online search market. The proposal , filed by the U.S. Department of Justice and several states this week, came after a federal judge ruled that Google maintained an illegal monopoly over internet search. The landmark decision opened the door to the current showdown over potential remedies that could reshape the tech giant’s multibillion-dollar business. As part of their proposed penalties, Justice Department officials also suggested the judge impose restrictions on Android, Google’s mobile operating system, to prevent it from favoring Google products. The Department of Justice says forcing Google to divest Chrome would create more competition and stop the search giant’s control over a “browser that for many users is a gateway to the internet.” Google pushed back, calling the request an “unprecedented government overreach” that would harm consumers and U.S. tech leadership. “This is to some extent a negotiating dance,” said George Hay, a Cornell University law professor and antitrust expert. “The DOJ is probably trying to get Google to be more cooperative in coming up with remedies that will fix the problem.” Here’s what you need to know: What are U.S. officials proposing? The Justice Department outlined for the judge several possible solutions in its 23-page court filing , including forcing Google to sell Chrome and potentially Android as well if the company does not adequately address its practice of requiring smartphone makers to use Google products embedded in Android. “The playing field is not level because of Google’s conduct, and Google’s quality reflects the ill-gotten gains of an advantage illegally acquired,” the filing says. “The remedy must close this gap and deprive Google of these advantages.” The Justice Department wants to bar Google from entering into exclusive agreements with content publishers, as well as owning or acquiring any interests in search rivals. Publishers should also be able to opt out of having Google use their content to train artificial intelligence tools, under the proposal. And Justice Department officials want advertisers to have more access to data and control over ads that show up in Google search results. The Justice Department is trying to make consumers more aware of choices outside of Google, the world’s most popular search engine. Another potential fix includes requiring Google to display a “choice screen” on every Google browser when a user hasn’t selected a default search engine. What’s Google’s response? Google thinks the government’s proposal goes too far. Instead, the company thinks the government should focus solutions more narrowly on agreements it has with Apple, Mozilla, smartphone manufacturers and wireless carriers that require the companies to favor Google’s search engine over others. Kent Walker, chief legal officer at Google and its parent company, Alphabet, in a blog post called the government’s proposal a “radical interventionist agenda that would harm Americans and America’s global technology leadership.” Google opposes the idea that it should install “choice screens” on its browser and alleges that would hinder people’s abilities to use the company’s products. Will this affect the way I search online? Because Google’s punishment hasn’t been decided, it is too early to say how internet search could be affected. Antitrust experts said it depends on what remedies the judge in the case decides on and whether they withstand scrutiny by an appeals court. Some experts questioned whether any changes, even a forced sale of Chrome, would be effective in getting people to use other search engines. “It will still be there in some way, shape or form, but it may be more subtle in terms of the effects on consumers,” said Shubha Ghosh, a law professor at Syracuse University. It’s unclear who is interested in buying Google Chrome, which Bloomberg reported could be worth up to $20 billion. Could the Trump administration affect Google’s punishment? Possibly. President-elect Donald Trump has criticized Google over allegations that the search giant censors conservative speech, which the company has repeatedly denied. But Trump, who reportedly took a phone call with Google Chief Executive Sundar Pichai after he won the U.S. presidential election, has also stopped short of saying he would break up the search giant. “It’s a very dangerous thing because we want to have great companies,” Trump said in an October interview moderated by Bloomberg News. “We don’t want China to have these companies. Right now, China is afraid of Google.” Hay said he doesn’t anticipate Trump will pull the plug on the case, but the Justice Department could soften its proposed remedies. What happens next? Google said it will file its own proposals next month. Court hearings on Google’s punishment are scheduled to begin in April. Judge Amit Mehta of the U.S. District Court for the District of Columbia, who is overseeing the case, is expected to make a decision on Google’s punishment by August 2025. The Associated Press was used in compiling this report.Iran, bracing for a possible re-imposition of incoming U.S. president Donald Trump's "maximum pressure" policy, said on Saturday that 2025 would be an important year for its nuclear issue, Reuters reported. ET Year-end Special Reads Take That: The gamechanger weapon's India acquired in 2024 10 big-bang policy moves Modi government made in 2024 How governments tried to rein in the social media beast Trump in 2018 reneged on a deal struck by his predecessor Barack Obama in 2015 in which Iran agreed to curb uranium enrichment, which can yield material for nuclear weapons, in return for the relaxation of U.S. and U.N. economic sanctions. "2025 will be an important year regarding Iran's nuclear issue," Foreign Minister Abbas Araqchi told reporters in Beijing, adding in remarks aired by Iran's state TV that he had discussed the issue in talks with his Chinese counterpart. 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View Program Data Science SQL for Data Science along with Data Analytics and Data Visualization By - Metla Sudha Sekhar, IT Specialist and Developer View Program Artificial Intelligence(AI) AI and Analytics based Business Strategy By - Tanusree De, Managing Director- Accenture Technology Lead, Trustworthy AI Center of Excellence: ATCI View Program Web Development A Comprehensive ASP.NET Core MVC 6 Project Guide for 2024 By - Metla Sudha Sekhar, IT Specialist and Developer View Program Marketing Digital Marketing Masterclass by Pam Moore By - Pam Moore, Digital Transformation and Social Media Expert View Program Artificial Intelligence(AI) AI-Powered Python Mastery with Tabnine: Boost Your Coding Skills By - Metla Sudha Sekhar, IT Specialist and Developer View Program Office Productivity Mastering Microsoft Office: Word, Excel, PowerPoint, and 365 By - Metla Sudha Sekhar, IT Specialist and Developer View Program Marketing Digital marketing - Wordpress Website Development By - Shraddha Somani, Digital Marketing Trainer, Consultant, Strategiest and Subject Matter expert View Program Office Productivity Mastering Google Sheets: Unleash the Power of Excel and Advance Analysis By - Metla Sudha Sekhar, IT Specialist and Developer View Program Web Development Mastering Full Stack Development: From Frontend to Backend Excellence By - Metla Sudha Sekhar, IT Specialist and Developer View Program Finance Financial Literacy i.e Lets Crack the Billionaire Code By - CA Rahul Gupta, CA with 10+ years of experience and Accounting Educator View Program Data Science SQL Server Bootcamp 2024: Transform from Beginner to Pro By - Metla Sudha Sekhar, IT Specialist and Developer View Program He did not mention Trump by name, however, or spell out how the year might be significant. Iranian leaders' main concern may be that Trump could empower Israeli Prime Minister Benjamin Netanyahu to attack Iran's nuclear sites, while further tightening U.S. sanctions on its crucial oil industry. The Iranian rial on Saturday hit a new all-time low against the U.S. dollar amid uncertainty about Trump's arrival in the White House on January 20. The rial plunged to 820,500 to the dollar on the unofficial market, compared to 808,500 rials on Friday, according to Bonbast.com, which reports exchange rates. The bazar360.com website also said the dollar was being sold for about 820,500 rials. Also facing an inflation rate officially put at about 35 per cent, Iranians seeking to shelter their savings have been buying dollars, other hard currencies, gold or cryptocurrencies, and the rial has dropped about 18 per cent in all since Trump was elected in November. FAQs Q1. Who is current President of USA? A1. Incumbent President of the USA is Joe Biden. Q2. What is current designation of Donald Trump. A2. Donald Trump's current designation is US President-elect. (You can now subscribe to our Economic Times WhatsApp channel )AMD's flagship Ryzen 9 9950X3D spotted: boost clocks of over 5.6GHz, 128MB of L3 cacheNone
As part of Mahakumbh 2025 preparations, a state-of-the-art multi-disaster response vehicle has been deployed to enhance safety and disaster readiness. Equipped with advanced tools, it aims to safeguard lives and streamline emergency management during the event. Advertisement The multi-disaster response vehicle features a victim location camera and various state-of-the-art tools for efficient disaster response, ensuring the safety of millions of devotees attending the Mahakumbh. Advertisement Maha Kumbh’s Nodal and Chief Fire Officer Pramod Sharma said here on Saturday that the vehicle features state-of-the-art equipment and is capable of handling situations ranging from natural disasters to road accidents. It includes a lifting bag with a capacity of 10 to 20 tonnes, enabling the rescue of individuals buried under debris, and specialised machines to lift and move heavy objects weighing up to 1.5 tonnes. Additionally, the vehicle is equipped with tools to cut and spread through strong debris during emergencies. The victim location camera is particularly effective in locating individuals trapped in collapsed structures. An inbuilt generator ensures the seamless operation of electronic equipment, even in challenging conditions. Apart from this, to ensure the safety of rescuers, the vehicle is stocked with protective gear such as life jackets, life rings, and life buoys. A temperature-measuring device further enhances its utility by providing accurate temperature readings during fire incidents. Pramod Sharma emphasised that the deployment of the multi-disaster response vehicle will significantly assist the administration in managing potential emergencies during the Mahakumbh. The vehicle will serve not only during the Kumbh Mela but also in other disaster management operations. Advertisement
100 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
These eleven large-cap stocks were the best performers in the last week. Are they in your portfolio? Credo Technology Group Holding Ltd CRDO shares jumped 51.61% after the company reported second-quarter results, and multiple firms raised their price forecast on the stock . Super Micro Computer Inc. SMCI stock escalated 34.59% last week. An internal investigation led by its Special Committee found "no evidence of misconduct or fraud" involving management or the board . DocuSign, Inc. DOCU shares rose 34.26% after the company reported third-quarter results and issued better-than-expected guidance . Several analysts raised their price forecasts for the stock . Rubrik, Inc. RBRK stock rocketed 27.17% after reporting better-than-expected third-quarter results . Several analysts raised the price forecast on the stock . Lululemon Athletica Inc. LULU climbed 24.62% after reporting better-than-expected third-quarter earnings, and analysts boosted the price forecast on the stock. Pure Storage, Inc. PSTG stock grew 22.51% after the company reported better-than-expected third-quarter financial results and fourth-quarter guidance . Several analysts raised the price forecast on the stock . Marvell Technology, Inc. MRVL shares surged 22.46% after the company reported upbeat earnings for the third quarter and analysts boosted the price forecast . Roku, Inc. ROKU stock rose 21.86% last week on analyst commentary from Needham , which maintained a "Buy" rating and reiterated the $100 price target . Aurora Innovation, Inc. AUR stock upped 21.33% last week. American Airlines Group, Inc. AAL shares increased 19.83% after it reported better-than-expected fourth quarter and full-year outlook . Applovin Corporation APP stock jumped 19.23% after some analysts boosted the price forecast . Photo via Shutterstock © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.None
India alleges widespread trafficking of international students through Canada to U.S.At least three people have died in a bus crash in Norway, police say. The accident happened at around 13:30 local time (12:30GMT) in the Hadsel district on the country’s north-western coast. The bus came off the road and ended up partially in the Åsvatnet lake, the authorities said in a press release. It is thought to have been carrying 58 people at the time of the crash – many of whom, police say, are foreign nationals. As well as the fatalities, police said four people had been seriously injured. Three people have been taken to Stokmarknes Hospital by rescue helicopter, while other passengers have been taken to a nearby school. Everyone has now been removed from the vehicle, according to local media. The Norwegian Red Cross said on social media that it was sending teams to help with a “serious bus accident” on the E10 road. Fire, ambulance and police teams have also been working at the scene. There have been reports of heavy snowdrifts and strong winds in the area, which has made rescue efforts difficult. Public broadcaster NRK reported that the bus had been travelling from the town of Narvik to the Lofoten archipelago. The mayor of the nearby Vågan district, Vidar Thom Benjaminsen, said a “crisis team” had been set up, and that a local hotel had been allocated for family members and as a reception centre. Prime Minister Jonas Gahr Støre said the crash was “a very serious situation” and that his thoughts were with everyone affected.
NASA's 2 stuck astronauts face more time in space with return delayed until at least late MarchTown of Monument restricts psychedelic healing centers to limited locations
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