Latest news with #SantaMonica
Daily Mail
3 hours ago
- Entertainment
- Daily Mail
Tobey Maguire reunites with ex Jennifer Meyer and daughter in rare photo... 5 years after finalizing divorce
Tobey Maguire was ever the proud dad as he celebrated his daughter Ruby's high school graduation on Monday with ex-wife Jennifer Meyer. The Spider-Man actor, 49, was pictured reuniting with his former spouse, 48, in rare but sweet photos shared to her Instagram, five years after they finalized their divorce. In one photo captured at the ceremony, the exes — who also share 16-year-old son Otis — were seen embracing the 18-year-old, who stood between them holding a bouquet of pink roses. Both parents had big smiles on their faces, with Jennifer — who got engaged to billionaire heir Geoffrey Ogunlesi last year — holding her daughter's diploma from the Crossroads School for Arts & Sciences in Santa Monica, California. In another snap Ruby was pictured beaming as she stood surrounded by a number of her family members, including her famous dad and jewelry designer mom. 'Congratulations Ruby!!!!! ♥️ Graduate of our dreams. We are so proud of you in every way. We love love love love love you baby♥️' Jennifer wrote in her caption. Leonardo DiCaprio's close pal opted for a casual cool look for the school event, rocking a grey t-shirt, black sunglasses and a baseball hat. Jennifer looked chic in a green spaghetti strap dress. Meanwhile Ruby proudly wore her cap and gown, with one snap showing her at home posing in front of a giant pink ballon sign spelling out her name and graduation year. Yet another snap saw the mother and daughter posing together and smiling for the camera. Fashion designer Rachel Zoe commented on Jennifer's post, writing 'We love you RUBY!!!!' Australian actress Isla Fisher added, 'Wha? That's gone so fast.... Mazel Tov!' Teen Witch star Mandy Ingber wrote, 'Ruby is gorgeous. And I love seeing Tobey. Xoxoxo congratulations to you. You did it! ❤️❤️❤️ makes me so happy to see.' Amazon founder Jeff Bezos' fiancée Lauren Sanchez also commented, writing, 'Congratulations sweet girl ❤️❤️❤️.' Ruby's not the only child of famous parents graduating from Crossroads this year. Grey's Anatomy star Patrick Dempsey's twin sons Darby and Sullivan were also among the 2025 graduates. Tobey and Jennifer divorced in 2020, ending their nine-year marriage. They had initially separated in 2016, sharing a statement that read: 'After much soul searching and consideration we have made the decision to separate as a couple. As devoted parents, our first priority remains raising our children together with enduring love, respect and friendship.' She has since moved on with billionaire heir Geoffrey, who is the son of Nigerian billionaire Adebayo Ogunlesi. In December, Jennifer was spotted with her fiance and her son during a rare outing together. The trio were seen shopping for a Christmas tree. Jennifer and Geoffrey became engaged in September. 'YES!!!' the mom-of-two wrote in the caption of the Instagram snap, along with a black heart emoji, the infinity symbol, and sparkling stars emoji. Jennifer, whose best pals are Jennifer Aniston and Courteney Cox, and Geoffrey went red carpet official in November 2023, after dating for several months. Jen is the daughter Ron Meyer, the cofounder of CAA, and former executive at NBC, COO/President of Universal. Her red carpet debut with Geoffrey came seven years after she split from Tobey, and three years after she filed for divorce. Meanwhile Tobey was spotted getting cozy with 22-year-old Danish model Mona Tougaard a month after Meyer announced her engagement. Last summer he was linked to a string of young ladies while vacationing in Europe and New York City. Jennifer and Tobey met in 2003 while he was shooting Seabiscuit. They were engaged three years later, and welcomed their daughter Ruby in November 2006. They went on to marry the following year, and welcomed their second child, son Otis, in 2009. Meyer has credited 'angel' Gwyneth Paltrow for her amicable divorce from the actor. Paltrow, 51 was widely ridiculed for announcing her divorce from Coldplay star Chris Martin, 47, as a 'conscious uncoupling' in 2014. But Meyer said the actress' amicable split helped her navigate her own divorce from Maguire. Speaking on the Broad Ideas podcast, jewelry designer Meyer said: 'Right when Tobey and I were starting to break up, I watched what Gwyneth Paltrow was starting to do with Chris — this conscious uncoupling that everyone was making fun of.' 'I got to see it firsthand, and it was the most beautiful thing that I had ever witnessed two human beings go through. She was so loving and kind and open to him and she created this family.' 'I was like, "Wow, that's not what I was taught growing up. I was taught that divorce was ugly … bad and would never be good."' Meyer asked Paltrow: 'How did you do that? Please, what do I do? Because we're just starting to break up, and it's feeling very scary. … How can we come together for [these] human[s] we both created that we love? What do we do?' Meyer added that Paltrow introduced her to Dr. Habib Sadeghi: 'She didn't tell me their process, she didn't tell me anything.' Meyer said she had 'hit the jackpot of ex-husbands' with Maguire and added the pair were still 'best friends' years after their divorce.
Fast Company
7 hours ago
- Business
- Fast Company
The Santa Monica airport is set to close—but some residents would rather keep the noise and pollution than build new housing
In the neighborhoods surrounding the Santa Monica Airport, homeowners know little peace. Every few minutes, the whine of a jet engine intrudes on the suburban soundscape. But relief is coming. In 2017, locals won a more than seven-decade fight to close the airport. It's scheduled to shutter once and for all on Dec. 31, 2028. Santa Monica residents voted in 2014 to build a park on the site of the airport. But as the 2028 closure date approaches, some residents, councilmembers, and pro-housing groups are calling for the construction of affordable housing on the site in addition to a park. With an organized contingent of development opponents determined to stop them, the airport site is shaping up as the latest flashpoint in Southern California's battles over housing construction. Neighbors of the airport say living beneath the jets is maddening and dangerous—many of the smaller planes that land there burn leaded fuel, spraying toxins on the homes and schools below. But some of the airport's neighbors are so opposed to housing construction that they would consider keeping the airport open until the threat of development is quashed. 'A lot of the risk could be reduced simply by delaying closing,' said Marc Verville, who lives near the airport. 'To protect ourselves, we should keep the airport open until we can address the political landscape and correct it,' said Tricia Crane, chair of Northeast Neighbors of Santa Monica, a neighborhood association. The closure of an airport presents a rare opportunity in any urban environment. Spanning more than 200 acres—and comprising around 4% of the city's land—the Santa Monica Airport is poised to become available for redevelopment all at once. Centrally located and publicly owned, it offers a rare chance to address the city's acute affordable housing shortage. In Santa Monica, where average rent is nearly $4,000 a month, such a moment may never come again. Building housing 'would be a win for everybody,' said Rev. Joanne Leslie, a Santa Monica resident and a deacon in the Episcopal Diocese of Los Angeles. Leslie is part of a group advocating for a 3,000-unit affordable housing development on the airport site called Cloverfield Commons. Leslie's group imagines their development amidst the larger park, with buildings arranged around smaller, so-called pocket parks, connected by winding paths. Building a large amount of housing on the site would likely require voter approval through another ballot measure, according to City Councilmember Jesse Zwick, who supports building 'some form of mixed use, mixed income housing' on the site alongside a park. But he says the housing crisis in Santa Monica is so great that another referendum—even if it means a difficult fight—would be worth having. For every four or five new jobs created in Santa Monica over the past 45 years, the city added just one home, he said. The city's failure to build housing has led its population to stagnate during that time period, he added, while California's population has nearly doubled. 'Will it be a fight? Sure,' he said. 'But is it one that I think can be won? Definitely.' Since the 1970s, anti-development groups have largely blocked the construction of new housing across the state—and especially in Santa Monica, where the city has permitted roughly 4,500 units of new housing in the last 20 years. Given the statewide housing shortage, state officials are asking cities to build more housing than they used to. Every eight years, cities are required to submit a plan to the state showing how they intend to meet its increasingly ambitious housing development targets. If they don't adequately plan to meet those targets, they could face penalties including the notorious 'builder's remedy,' in which developers are allowed to build whatever they want, regardless of zoning, as long as 20% of the units are affordable. Verville and Crane are worried Santa Monica will designate the airport site for housing in its next state-mandated housing plan, due in 2029. That's why they are floating the idea of pushing to delay the closure of the airport until after that deadline as a way to keep the airport out of conversations about meeting state housing targets. 'The residents want to stop the airport conversion process until this kind of risk is addressed and mitigated,' said Crane, 'and we can fulfill our vision of a park.' * * * Leslie was drawn to the fight to build affordable housing on the airport site because of her work as a deacon in the Episcopal Church advocating for workers and immigrant rights. Leslie is a member of Clergy and Laity United for Economic Justice (CLUE), which recently participated in the Home Is Sacred rally in support of affordable housing development on the airport site. 'In a place like Santa Monica, so much of the homelessness is directly related to the high cost of housing and rents,' she said. 'We put people in a situation where they can't help themselves, and then we blame them for it.' Crane and Verville say they're not opposed to affordable housing, but that the city, facing a budget deficit, cannot afford to build any and that no subsidies exist to support buildings with lower rents. 'My kids want a lot of things too,' said Crane. 'If I don't have the money for it, they don't get it.' Leslie's group contends that subsidies do exist to build affordable housing on the site, including funds raised by Measure A, the county's new half-cent sales tax, approved by voters in November and aimed at funding homelessness solutions and affordable housing. Verville and Crane think that's not realistic, and that the development at the site will be exclusively luxury apartments, which they say will make the city more expensive, not less. They arrived for their interviews at the airport armed with more than 90 pages of readings, including an academic working paper they said debunks the idea that building market-rate housing lowers rents and home prices. (The National Bureau of Economic Research study finds that higher housing costs are tied to a region's income growth, not to how tightly its housing supply is regulated.) 'It's becoming a city of rich people,' Crane sighed. Santa Monica City Councilmember Zwick says that building housing, including luxury housing, does lead to lower rents and housing prices in the surrounding community. About 80% of the time, new apartments are filled by people already living nearby, he said. 'And when those people move into those new housing units, they open up housing in the spaces where they used to live, creating more available supply and creating downward pressure on prices.' 'Every credible study I've read indicates that that's how it works,' he said, speaking with Capital & Main in an empty office at UCLA, where he is studying for a master's in urban planning. Besides, Zwick argued, parks and housing belong together. Apartments lacking backyards need open, public space. And parks need those who live nearby to use them. 'A lot of people like to say we need our Central Park,' he said. 'But if Central Park in Manhattan had a perimeter entirely of single family homes, it wouldn't function and be as great as it is.'
Daily Mail
21 hours ago
- Business
- Daily Mail
Elle Fanning's older boyfriend Gus Wenner puts his arm around her after a romantic Italian dinner by the beach
Elle Fanning stepped out for dinner at celeb-friendly restaurant Giorgio Baldi in Santa Monica, California on Sunday. She was accompanied by her boyfriend Gus Wenner, 34, and the loved up couple held hands as they exited the Italian eatery. The Maleficent star, 27 looked beautiful in a scoop-neck black top with black slacks and a long black coat. She kept her blonde hair pulled back into a ponytail and as they walked, Gus had a hand on her shoulder and looked at her adoringly. The couple have been together since November 2023 and Elle shares a lot of pictures of their adventures together on Instagram. They made their red carpet debut at the 2024 Golden Globe Awards. From A-list scandals and red carpet mishaps to exclusive pictures and viral moments, subscribe to the DailyMail's new Showbiz newsletter to stay in the loop. Gus was recently named the Executive Chairman of Rolling Stone, after serving as CEO of the magazine co- founded by his father Jann Wenner, 79. He shared a photo with his dad on Instagram upon his promotion. 'It has been an unbelievable journey leading Rolling Stone,' his caption began. 'At the top of the list, working with and learning from my dad, whose vision changed journalism forever. 'There have been so many brilliant contributors and collaborators who have helped transform Rolling Stone from a magazine into a multimedia powerhouse, all while keeping its mission in tact. I 'I am grateful to every single one of them. I look forward to continuing to help guide the ship as Executive Chairman, while embarking on my next chapter. The future is bright,' he concluded. Elle previously dated Max Minghella from 2018 to early 2023 after meeting on the set of School Spirit. The actress confirmed the split in an interview with Harper's Bazaar in April 2023. However, the breakup didn't change her mindset on love. 'I'm a hopeless romantic. I believe in love at first sight. Call me crazy, but I believe in those things. I feel that it's my destiny,' she said. Elle most recently appeared alongside Timothee Chalamet in A Complete Unknown. She is currently filming the AppleTV+ series Margo's Got Money Troubles, based on the same-name novel by author Rufi Thorpe. The series follows Fanning as she stars as Margo Millet, the child of a Hooters waitress (Michelle Pfeiffer) and an ex-pro wrestler (Nick Offerman). Margo becomes pregnant after a brief affair with an English professor at a local junior college. The series follows Margo at age 20 as she struggles to raise an infant as a single mother when she loses her job and is on the verge of eviction.' When her estranged father Jinx (Offerman) shows up on her doorstep, asking for help, she agrees to let him move in but in exchange for help with childcare. She later starts OnlyFans as an experiment and finds herself adapting some of her dad's advice from the world of wrestling once she finds herself having to navigate sudden internet fame. Fanning's older sister Dakota Fanning will also be executive producing alongside David E. Kelley, Matthew Tinker, Nicole Kidman (who also stars), author Thorpe and more. Dakota and Elle are the children of Steve Fanning and Heather Joy Arrington. Both Steve and Heather are former professional athletes. Steve was drafted by the MLB's St. Louis Cardinals in 1988 and played through 1995. Heather is a former pro tennis player. Steve and Heather raised their daughters in Georgia before moving to Los Angeles for the young actors' blossoming careers.
Associated Press
2 days ago
- Business
- Associated Press
Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025
SANTA MONICA, Calif.--(BUSINESS WIRE)--Jun 1, 2025-- Kite, a Gilead Company (Nasdaq: GILD), today announced real-world data evaluating the safety and effectiveness of Yescarta ® (axicabtagene ciloleucel) for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) assigned to treatment in an outpatient setting (no planned hospital stay) versus those assigned to an inpatient setting in a hospital. The analysis, based on data collected from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, observed that safety and effectiveness outcomes for people treated as outpatients were comparable to those patients who received treatment in a hospital. The results were shared in a presentation (Abstract #7023) during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. 'The encouraging results from this study corroborate reports from treatment centers and prior studies in the real world that illustrate the potential feasibility of administering axi-cel in the outpatient setting for people with relapsed or refractory large B-cell lymphoma,' said Dr. Fateeha Furqan, lead investigator, The University of Texas MD Anderson Cancer Center. 'Outpatient administration of axi-cel has cost-effective advantages over inpatient treatment, including less burden on hospitals. These clinical results reflect the fact that the knowledge and experience needed to safely administer the therapy has only grown since axi-cel was first approved in 2017.' Data were collected from the CIBMTR observational database (between July 2021 to Nov 2023). The final analysis assessed data on patients with R/R LBCL from 75 treatment centers, comparing 119 individuals who were assigned to receive Yescarta in the outpatient setting to 119 patients assigned to receive Yescarta in the inpatient setting. With a median follow-up of 12 months, no general differences were found between the 2 groups in the rates of cytokine release syndrome, neurologic events or immune effector cell-associated neurotoxicity syndrome grade ≥ 3. Almost one-fourth of 119 patients who were assigned to receive Yescarta in the outpatient setting did not require hospital admission within 30 days, and half of 119 patients did not require hospital admission within 3 days based on propensity score-matched dataset. These real-world data are not currently in the U.S. Prescribing Information. 'We are seeing a growing body of evidence that suggests outpatient administration of Yescarta could be reliable and safe in suitable settings, with benefits for the patient, their family and healthcare system,' said Dominique Tonelli, M.D., Vice President and Global Head of Medical Affairs, Kite. 'We are confident that these promising results will help inform providers to expand the number of patients who can achieve the curative potential of a one-time treatment with Yescarta.' Patients assigned to the outpatient and inpatient treatment groups were matched by age, sex, comorbidities, lactate dehydrogenase (LDH), bulky disease, prior lines of therapy, chemosensitivity and infusion year. Patients assigned to the outpatient group had a median age of 63 years (25% ≥ 70), 66% were male and 67% had ≥ 1 comorbidity. Half had elevated LDH and 73% had 1 prior line of therapy. Bulky disease was reported in 3% and 60% had chemo-resistant disease. About LBCL Globally, LBCL is the most common type of non-Hodgkin lymphoma. In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment. About Yescarta Please see full Prescribing Information, including BOXED WARNING below and Medication Guide. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES CYTOKINE RELEASE SYNDROME (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system1) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9%. Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1 to 10 days) and the median duration was 7 days (range: 2 to 43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, one patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1 to 20 days) and the median duration was 6 days (range: 1 to 27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) . The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events. CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1 to 8 days) and the median duration of CRS was 7 days (range: 2 to 16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS at which point the patients were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 or higher CRS. The median time to onset of CRS was 5 days (range: 1 to 15 days) and the median duration of CRS was 4 days (range: 1 to 10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Ensure that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. NEUROLOGIC TOXICITIES Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred. The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS. Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly. REMS Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at or 1-844-454-KITE (5483). HYPERSENSITIVITY REACTIONS Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA. SERIOUS INFECTIONS Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. PROLONGED CYTOPENIAS Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion. HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment. SECONDARY MALIGNANCIES Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period. ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. About Kite Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on achieving cures with cell therapy. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Gilead acquired Kite in 2017. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta; uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Yescarta, Gilead, the Gilead logo, Kite, and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information on Kite, please visit the company's website Follow Kite on social media on X (@KitePharma) andLinkedIn. View source version on CONTACT: Blair Baumwell, Media [email protected] Ross, Investors [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: RESEARCH HOSPITALS FDA CLINICAL TRIALS OTHER HEALTH BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ONCOLOGY SOURCE: Gilead Sciences, Inc. Copyright Business Wire 2025. PUB: 06/01/2025 08:00 AM/DISC: 06/01/2025 08:01 AM
Daily Mail
3 days ago
- Entertainment
- Daily Mail
EXCLUSIVE Retired 80s actress who starred in coming-of-age classic looks unrecognizable on rare outing
This retired actress is best known for her leading role in an iconic 1985 movie. The star, now 67, looked unrecognizable as she was seen on a rare public outing 40 years after rising to fame as the love interest of Michael J. Fox. Her first onscreen role was in Zapped alongside Scott Baio and she also appeared in 21 Jump Street, Funland and TV 101. The star stepped away from acting in 1997 and now describes herself as a 'Mom, wife, sister, aunt, philanthropist, and friend.' So can you guess who she is? From A-list scandals and red carpet mishaps to exclusive pictures and viral moments, subscribe to the DailyMail's new Showbiz newsletter to stay in the loop. The star, now 67, looked unrecognizable as she was seen on a rare public outing 40 years after rising to fame as the love interest of Michael J Fox It's Teen Wolf star Susan Ursitti! The actress famously played Lisa 'Boof' Marconi, the love interest of Fox's Scott Howard in the legendary movie. Ursitti starred as Howard's besotted childhood friend in the drama - which sees an ordinary teenager discover he is a werewolf. The film also starred Matt Adler as pal Lewis and James Hampton as Harold Howard. Ursitti cut a stylish figure in denim as she stepped out in Santa Monica, Los Angeles. Teen Wolf was a huge hit, grossing more than $80million worldwide. It spawned a franchise including a sequel, an animated series, a TV series from 2011-2017 and a continuation film in 2023. Fox went on to debut in the legendary Back To The Future franchise that year - cementing his status as a Hollywood legend. Ursitti picked up her next role in 1987 in TV series Charles in Charge and Funland that same year. Her final role was in 1997's short film 976-WISH. Ursitti received a master's degree in Design and Manufacturing In September 1992, she married producer Jonathan Sheinberg and the pair share three children.
