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In a dominant display of talent and teamwork, Team Bahamas has marched into the final of the Under-15 Caribbean Baseball Cup as the only undefeated team. The tournament, organized by the Caribbean Baseball Confederation (COCABE), has seen the Bahamas team triumph over their opponents with remarkable consistency. The Bahamas secured their place in the championship game after a resounding 16-1 victory over St Maarten in the semifinals. This win followed a series of impressive performances throughout the tournament. Earlier, Team Bahamas delivered a crushing 33-0 defeat to St Maarten in their initial encounter. They then continued their strong run with an 11-1 victory over the US Virgin Islands. One of the most notable moments in the tournament was their surprising victory over Cuba. Initially down by two runs in the top of the first inning, Team Bahamas turned the game around in the bottom of the third. They scored eight runs on eight hits, seizing the lead and eventually winning 11-5. This victory was crucial as it highlighted the resilience and adaptability of the team. The championship game is set for tonight at the Andre Rodgers National Baseball Stadium. Team Bahamas will face Cuba once again, this time for the gold medal. The match could promise to be a thrilling encounter as both teams have shown exceptional skill and determination throughout the tournament. The bronze medal game will feature St Maarten against the US Virgin Islands. This match will start at 4 PM, while the gold medal game is scheduled for 8 PM. Both events are open to the public, offering free entry for all fans. The Under-15 Caribbean Baseball Cup has been a showcase of young talent from across the region. Team Bahamas' journey to the final has been marked by strategic plays, and teamwork. As they prepare to face Cuba,The Bahamas team aims to cap off their undefeated run with a championship victory, further establishing their prowess in Caribbean baseball.
Oscar Fairs from Benfleet, Essex, was diagnosed with a rare 7cm ependymoma brain tumour in August 2023 and underwent seven surgeries, one round of chemotherapy and one round of radiotherapy to be told palliative care was the only option. A GoFundMe page was set up to help the family raise £100,000 towards a treatment trial in France. West Ham footballers donated £27,000, chairman David Sullivan donated £10,000 and Arsenal footballer and former West Ham star Declan Rice gave £5,000, according to Ms Fairs. On Friday, West Ham announced that the 15-year-old had died. Sporting director Mark Noble said: “Oscar was adored by everyone at the Academy – not only was he a great goalkeeper, he was a true Hammer and a fantastic young person, who will be deeply missed by everyone who had the pleasure to know him. “I have wonderful memories of Oscar playing in my garden – (my son) Lenny and his teammates all loved him. “He was a friendly, happy, well-mannered and polite young man, who had such a bright future ahead of him, and it is just so unimaginably devastating that he has been taken from his family and friends at this age. “The thoughts and sincere condolences of everyone at the Club are with Oscar’s parents, Natalie and Russell, and his brother Harry, and we kindly ask that the family’s privacy is respected at this extremely difficult time.” All scheduled Academy fixtures over the weekend have been postponed as a mark of respect.
Ultimate Christmas song rich list including artist who makes £1m a YEAR from number one hit (and it’s not Mariah Carey)BY Nick Sabato A year ago seems like an eternity. Imagine how that feels for the Buffalo Bills. Heading into Week 13 last season, the Bills were on their bye. They lost an overtime game to the Philadelphia Eagles after blowing a fourth-quarter lead and another in overtime to fall to 6-6. A playoff berth seemed unlikely and an AFC East championship unfathomable sitting three games behind the Miami Dolphins. And then, of course, the Bills rattled off five consecutive wins to secure their fourth divisional title in a row and the No. 2 seed in the playoffs. Jump ahead to the present and the Bills enter Week 13 coming out of their bye, a 9-2 record and a four-game lead on the Dolphins. This was supposed to be the year the Bills were finally knocked off their throne, but instead, they are a win from clinching a playoff spot and a win and a Dolphins loss from another AFC East banner. While the Bills won’t need to win six in a row to get into the playoffs this time around, they might in order to get home-field advantage and the Dolphins are not quite out of the race for the division yet. This is the time to keep their foot on the gas to avoid any chance of a role reversal. A three-game stretch against the 49ers, Rams and Lions that once seemed to be daunting doesn’t look so tough on paper anymore, but it’s still crucial to come out 2-1. And then there’s the three-game homestretch against the Jets and Patriots (twice). Laugh at the final three games if you will, but the Bills lost to both teams last season and 14 of 27 games within the division have been decided by one score since 2020. And three of their five losses in the AFC East during that span have come against teams that finished below .500. “What we talk about is making sure their habits match our goals as a team and certainly their goals as an individual to be the best version of themselves when they come back,” Bills coach Sean McDermott said. “We're getting into the back third of the season, if you will. ... It's an important time for sure.” If there is a team to avoid a slump, though, it’s the Bills and McDermott is 7-0 coming off a bye week since becoming the team’s head coach in 2017. And by time the Bills kickoff against the 49ers Sunday, the calendar will have flipped to December and that’s when they shine. McDermott’s first three seasons were a slog in December and January, going 6-8. But since 2020, the Bills are 19-2 in those months and outscored opponents by 11.8 points per game. Some of the late-season success is because the Bills fell into precarious situations in the first half. The Bills went 3-2 in the final month and still needed help to squeak into the playoffs in 2017, then they were 7-6 and trailing the Patriots 13 games into 2021, and then, of course, last season’s run to the finish line. Avoiding a drop-off over the final six games is promising for the same reasons that Bills unexpectedly already have nine wins. This is not a roster laden with stars, but one with many players who battled for jobs during training camp, are still battling and will likely have to do so again next year. The Bills have also fostered an environment where goals and expectations are clear. And the Bills have gone out and acquired players to fit into their mold through the draft, free agency and trades. “Last time I checked, nine wins probably doesn't get you in the playoffs,” quarterback Josh Allen said after beating the Chiefs. “So going into this bye week, get to enjoy ourselves a little bit. But coming back ready. You know, a hungry team.” The Bills may also be coming back a healthier team. Tackle Spencer Brown (ankle), receiver Keon Coleman (wrist) and tight end Dalton Kincaid (knee) were not expected to be out long-term and all could return against the 49ers. Receiver Amari Cooper returned against the Chiefs and played with a cast on his left wrist, so another two weeks of rest can only help him. The Bills can open rookie defensive tackle DeWayne Carter’s (wrist) 21-day window to return from injured reserve Saturday, while the Bills expect defensive end Dawuane Smoot (wrist) back before the end of the season. And then there’s the big fish: linebacker Matt Milano. The All-Pro could make his season debut against the 49ers, but they could sit him one more game before having to decide whether to add him to the active roster or shut him down for the year, which has to be determined after the game. What Milano can bring to the Bills at this juncture of the season is unknown, especially for a 30-year-old who hasn’t played a football game in 13 months. Not only is Milano recovering from biceps surgery, but he hasn’t played a game since fracturing his leg in Week 5 last season, although adding Milano to the mix can’t hurt. “We would want to do it,” McDermott said. “If and when we're given the green light — or he's given the green light — to go about it the right way.”Clara Strack, Georgia Amoore help No. 16 Kentucky rout Western Kentucky
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(PRNewsfoto/Johnson & Johnson) 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 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 . 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
TOKYO, Dec 30 — Japan’s national high school football tournament is thriving after more than 100 years, attracting huge crowds, millions watching on TV and breeding future stars, despite professional clubs trying to lure away young talent. The annual tournament kicked off yesterday and is still regarded as the pinnacle of amateur football with young players dreaming of playing in the final in front of tens of thousands at the National Stadium in Tokyo. Matches are a massive occasion for the whole school as student cheering squads wave flags, bang drums and roar on their teams in a spectacle of noise and colour. “All the teams are at a similar level of technical ability so it’s about who wants to win the most,” 18-year-old Junpei Fukuda, the leader of Ryutsukeizai University Kashiwa High School’s cheering squad, told AFP. “We want our voices to be the loudest.” Unlike in Europe, where young players are snapped up by professional club academies, high school football in Japan still attracts elite talent. Many go on to the professional game and play for their country with current Japan stars such as Daizen Maeda and Reo Hatate of Celtic and Crystal Palace’s Daichi Kamada all having played high school football. The landscape has begun to change in recent years, with more top young players turning their backs on the high school game and joining the youth teams of top-flight J. League clubs instead. The school tournament’s quality has taken a hit as a result, but its magic endures for many. Ryutsukeizai Kashiwa midfielder Kanaru Matsumoto, who will turn professional with the J. League’s Shonan Bellmare next year, said the tournament was “the stage I’ve aspired to play on ever since I was little”. “The main reason I came to this school was because I thought I could play at the national high school tournament here,” the 17-year-old said. Millions tune in The national high school tournament was first played in 1917, long before professional football came to Japan with the J. League in 1993. Teams from each of Japan’s 47 prefectures, with two from Tokyo, compete in a knockout competition over 18 days with matches played in and around the capital. All games are televised locally and the semi-finals and final are broadcast to a national audience, with millions tuning in. Last season’s final in Tokyo was played in front of 55,000 fans, comfortably eclipsing most J. League attendances. High school baseball and rugby tournaments are also popular and football journalist Masashi Tsuchiya said it was because school sports strike a chord in Japan. “I’m from Gunma Prefecture and I always support the Gunma team, even if it isn’t my old high school’s team,” he said. “It’s a tournament that places importance on local pride and old school ties.” Not all players who appear at the tournament have ambitions to play at the top level. Some play on at university only, while others give up the sport after graduating from high school. Ryutsukeizai Kashiwa manager Masahiro Enomoto said the tournament marks a transition after three years together as a team. “It’s where kids, who have worked really hard for something, become adults,” he said. Floods of tears TV broadcasts of games go beyond events on the pitch, delving into the players’ back stories, playing up emotional bonds and featuring scenes of beaten teams in floods of tears. “Japanese people love that kind of drama more than they think about the quality of the football,” said Enomoto, even though the standard remains undoubtedly high. School sides still hold their own against J. League youth teams, who are increasingly regarded as a better route to the professional game. The nationwide Prince Takamado Under-18 Premier League features a roughly even split of high school and J. League youth teams, and Ohzu High School were crowned this year’s champions. Tsuchiya said high school football should not be thought of only as a stepping stone to the top. “Yes, you can watch it for the quality of football and the quality of the players,” he said. “But you can also just enjoy watching the kids give everything they’ve got to try to win each game.” — AFP
From Philly and the Pa. suburbs to South Jersey and Delaware, what would you like WHYY News to cover? Let us know! Thirty-five years ago, Bilal Qayyum began working to promote peace and prevent gun violence in Philadelphia. At the time, he says gang-related violence was rampant. In response, he established the Father’s Day Rally Committee, an anti-gun and anti-violence group aiming to counter negative perceptions with positive images of Black men. “During the time when we started the campaign,” said Qayyum, director of the organization. “We realized in our meeting that we all were fathers. And that’s where the name came from.” On the Saturday before Father’s Day in June 1989, about 300 men gathered at Zion Baptist Church in North Philadelphia to hear local speakers highlight the positive work underway in their communities. “We were one of the first groups in this city that actually raised the issue around violence in particular as it relates to the Black community,” Qayyum said. Fast forward to 2024, and while homicides have declined, Qayyum told WHYY News that the proliferation of firearms still threatens public safety. One relatively recent phenomenon is the appearance of “ghost guns,” firearms built from kits or accessible parts and put together by an individual. Federally licensed gun manufacturers must place a serial number on every firearm, so it can be tracked. Ghost guns don’t have serial numbers. The gun-control group Everytown says, “Ghost guns are the fastest-growing gun safety problem facing our country.” Last year, Qayyum’s organization partnered with the Philadelphia Police Department for the city’s gun buyback program, aimed at getting firearms off the streets. “This guy came in and he turned in five ghost guns,” Qayyum said. “This is wild, but the way we do gun buybacks, you turn in the gun, no question asked.” UnitedHealthcare CEO was likely killed with a ghost gun that can be made at home A ghost gun is a firearm without a serial number. Police said Monday that the gun used in last week's shooting of Brian Thompson may have been made with a 3D printer. 4 days ago WHYY News requested data from the Philadelphia Police Department on privately-made weapons from 2020 to Dec. 9, 2024. 3D-printed firearms seized by Philadelphia police. (Philadelphia Police Department) Killing puts ghost guns in spotlight Now, the role of ghost guns is part of the investigation into the murder of UnitedHealth Group CEO Brian Thompson . Police believe University of Pennsylvania graduate Luigi Mangione built the firearm used in the killing to ensure it could not be traced. One law enforcement expert says some ghost guns are completely manufactured through 3D printing, and others use 3D-printed components with parts that are available from gun kits. “They combine what is utilized in the 3D printing with the actual parts that are legitimate,” said Randy Sutton, retired lieutenant with the Las Vegas Metropolitan Police Department and former patrol officer and detective with the Princeton Police Department in New Jersey. He said new advancements in artificial intelligence pose new challenges. “Technology is wonderful. It creates life-saving and life-changing technologies,” Sutton said. “But on the other hand, it also creates opportunities for those who utilize it for nefarious purposes.” Sutton added that because ghost guns are not regulated, making them go away outright is unrealistic. “There’s not a chance in the world we’re going to ban these weapons. It’s impossible,” Sutton said. “You can make them illegal to possess. But the techno barn door has already been opened.” The Biden administration has aimed to treat these firearms like regular weapons, requiring serial numbers on the parts and mandated background checks. Several states’ Attorneys General have filed lawsuits that are now under consideration by the U.S. Supreme Cour t. Shira Feldman, Director of Constitutional Litigation for the gun violence prevention organization Brady United, calls ghost guns a national threat. “Ghost guns have become weapons of choice for criminals and their proliferation cannot be ignored,” Feldman said in an email. “We’re hopeful the court will side with the safety of American people, but this ultra-conservative court, with a conservative majority solidified by former President [Donald] Trump, has proven that it has no issue ignoring the safety of the American people in favor of gun lobby rhetoric.” Gun rights groups are challenging the proposed rules in the Supreme Court , arguing they violate the Second Amendment. In March, the Pennsylvania House passed a bill to close loopholes in the Uniform Firearms Act and prohibit the purchase, sale and production of the untraceable gun parts used in ghost guns. However, the legislation failed in the state Senate . “I don’t see any legislation passing against ghost guns in the state of Pennsylvania. At least, not in my lifetime,” Qayyum said. New Jersey and Delaware are among 15 states that have laws to regulate these weapons. Get daily updates from WHYY News! The free WHYY News Daily newsletter delivers the most important local stories to your inbox. WHYY is your source for fact-based, in-depth journalism and information. As a nonprofit organization, we rely on financial support from readers like you. Please give today.Trump vows to pursue executions after Biden commutes most of federal death row
PHILADELPHIA, PA — Change is here. Philadelphia has introduced Philly Stat 360 , a bold and groundbreaking digital tool aimed at revolutionizing city government transparency and accountability. Launching earlier this month, this state-of-the-art website is no empty political gesture—it’s Mayor Cherelle Parker’s answer to a widespread demand for real-time access to the facts driving the city’s progress. Philly Stat 360 isn’t just about numbers on a screen. It’s a call to action. With over 30 metrics tracking everything from public safety statistics to how many trees have been planted, this interactive dashboard turns data into a conversation between city officials and residents. It’s designed to make government tangible—something you can “see, touch, and feel,” as Mayor Parker so often underscores. A hallmark of Parker’s administration, Philly Stat 360 gives everyday people a front-row seat to City Hall. Want to know how Philadelphia is tackling crime? Click the “Safer” category. Curious about efforts to combat climate change? Click “Greener.” Each metric dives deep, explaining how the information is collected, why it’s important, and even offering historical comparisons to track progress over time. This isn’t just a window into government activity—it’s a magnifying glass. “Philly Stat 360 is not only a tool for measuring progress but also for identifying areas where we need to invest more resources,” said Mayor Parker during the launch. “I believe in a city government that our citizens can see, touch, and feel with visible actions that help people at the neighborhood level, and this is a key link in creating that.” Backing this revolutionary tool is a collaboration between the Mayor’s Office of Philly Stat 360, the Office of Innovation and Technology led by Chief Information Officer Melissa Scott, and the Office of Integrated Data for Evidence and Action (IDEA). Together, they’ve built a portal that simplifies the complexities of government operations for the average Philadelphian. Kristin Bray, Chief Counsel to Mayor Parker and Director of Philly Stat 360, summed it up perfectly, saying, “Philly Stat 360 is a manifestation of that vision—an accessible and interactive tool that empowers residents, enhances transparency, and makes government operations easier to understand.” Each of Philly Stat’s five categories—Safer, Cleaner, Greener, Economic Opportunity, and Core Services—offers insight into significant areas of city functioning. These analytics go beyond sterile statistics. They reflect how Philadelphia is handling critical challenges like crime, neighborhood revitalization, and employment growth. They invite accountability not in speeches but in tangible, visible outcomes. Importantly, the website remains a living project. Expect more metrics and features in the coming months to fully capture the dynamic nature of Philadelphia’s evolution. For government critics, spectators, and the simply curious, Philly Stat 360 is Philadelphia’s bold statement for the future. It’s a tool for progress, a watchdog for accountability, and a tangible sign that the city isn’t just talking about change—it’s delivering it. The launch of Philly Stat 360 signals a new era where accessible data meets actionable results. With the nation’s eyes constantly on Philadelphia’s historic significance, it’s clear the city is ready to be just as celebrated for its forward-thinking government as for its storied past. If you want to see government work in real-time, Philly Stat 360 is where your attention should be. For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN .Your Car Deserves A Gift, So Here Are 30 Very Cool Options
Trump vows to pursue executions after Biden commutes most of federal death row