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Everything Joe Mazzulla said about Kristaps Porzingis’ return for CelticsMoreover, the diversification of China's export portfolio has played a crucial role in sustaining the growth of its total export value. While traditional industries such as electronics and textiles continue to dominate China's export landscape, the country has also been successful in expanding into new and emerging sectors such as renewable energy, high-tech products, and e-commerce.
CARLSBAD, Calif. , Dec. 19, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZATM (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis (AP). TRYNGOLZA is the first-ever FDA-approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and provides clinically meaningful reduction in AP events when used with an appropriate diet (≤20 grams of fat per day). TRYNGOLZA is self-administered via an auto-injector once monthly. Experience the full interactive Multichannel News Release here: https://www.multivu.com/ionis-pharmaceuticals/9295551-en-tryngolza-olezarsen-fda-approval "Today's FDA approval of TRYNGOLZA heralds the arrival of the first-ever FCS treatment in the U.S. – a transformational moment for patients and their families. For the first time, adults with FCS can now access a treatment that substantially reduces triglycerides and the risk of debilitating and potentially life-threatening acute pancreatitis," said Brett P. Monia , Ph.D., chief executive officer, Ionis. "We are proud of our long-standing partnership with the FCS community and are grateful to the patients, families and investigators who participated in our clinical studies, enabling Ionis to make this new treatment a reality. The FDA approval of TRYNGOLZA is also a pivotal moment for Ionis, representing our evolution into a fully integrated commercial-stage biotechnology company – a goal we set out to achieve five years ago. With our rich pipeline of potentially life-changing medicines, we expect TRYNGOLZA to be the first in a steady cadence of innovative medicines we will deliver independently to people living with serious diseases." The FDA approval was based on positive data from the global, multicenter, randomized, placebo-controlled, double-blind Phase 3 Balance clinical trial in adult patients with genetically identified FCS and fasting triglyceride levels ≥880 mg/dL. In the Balance study, TRYNGOLZA 80 mg demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months (p=0.0084). Reductions from baseline to 12 months were further improved, with TRYNGOLZA achieving a placebo-adjusted 57% mean reduction in triglycerides. TRYNGOLZA also demonstrated a substantial, clinically meaningful reduction in AP events over 12 months; one patient (5%) experienced one episode of AP in the TRYNGOLZA group compared with seven patients (30%) who experienced 11 total episodes of AP in the placebo group. TRYNGOLZA demonstrated a favorable safety profile. The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and at a >3% higher frequency than placebo) were injection site reactions (19% and 9%, respectively), decreased platelet count (12% and 4%, respectively) and arthralgia (9% and 0%, respectively). Results from the Phase 3 Balance study were previously published in The New England Journal of Medicine (NEJM). "With no treatment options previously available, we were limited to relying only on extremely strict diet and lifestyle changes as the sole preventative treatment option," said Alan Brown , M.D., FNLA, FACC, FAHA, clinical professor of medicine, Rosalind Franklin University of Medicine and Science ; Balance trial investigator. "The FDA approval of TRYNGOLZA is an important moment for people living with FCS, their families and physicians who now, for the first time, have a treatment that significantly lowers triglycerides and decreases the risk of potentially life-threatening acute pancreatitis events, as an adjunct to a low-fat diet. I am excited to have a medicine I can prescribe to my patients that has been shown to change the course of their disease." FCS is a rare, genetic, potentially life-threatening form of sHTG that prevents the body from breaking down fats and severely impairs the body's ability to remove triglycerides from the bloodstream due to an impaired function of the enzyme lipoprotein lipase (LPL). While healthy levels for adults are below 150 mg/dL, people with FCS often have triglyceride levels of more than 880 mg/dL and often have a history of pancreatitis. Those living with FCS have a high risk of potentially fatal AP, which is a painful inflammation of the pancreas, and chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with FCS can also experience psychological and financial stress, which can significantly impact their quality of life. In the U.S., FCS is estimated to impact up to approximately 3,000 people, the vast majority of whom remain undiagnosed. "As a rare and difficult to diagnose disease, FCS has a profound impact on the lives of patients and families. Many people living with FCS have experienced severe pain their whole lives – sometimes so intense they require lengthy hospitalization stays – and struggle through life with daily fatigue, nausea, brain fog and stomach pain," said Lindsey Sutton Bryan , co-founder and co-president, FCS Foundation. "Until now, our treatment options have been limited, relying on diet alone to try to manage triglyceride levels and keep acute pancreatitis attacks at bay. For the first time, adults with FCS have seen their hope for a treatment become a reality." TRYNGOLZA will be available in the U.S. before year end. Ionis is committed to helping people access the medicines they are prescribed and will offer a suite of services designed to meet the unique needs of the FCS community through Ionis Every StepTM. As part of Ionis Every Step , patients and healthcare providers will have access to services throughout the treatment journey provided by dedicated Patient Education Managers and Ionis Every Step Case Managers, including insurance and affordability support, as well as services and resources, such as disease and nutrition education. Visit TRYNGOLZA.com for more information. TRYNGOLZA was reviewed by the FDA under Priority Review and had previously been granted Fast Track designation for the treatment of FCS, Orphan Drug designation and Breakthrough Therapy designation. Olezarsen is undergoing review in the European Union and regulatory filings in other countries are planned. Olezarsen is currently being evaluated in three Phase 3 clinical trials – CORE, CORE2 and ESSENCE – for the treatment of sHTG. Olezarsen has not been reviewed or approved for the treatment of sHTG by regulatory authorities. Webcast Ionis will hold a webcast today at 6:45pm ET to discuss the FDA approval. Interested parties may access the webcast here . A webcast replay will be available for a limited time. About TRYNGOLZATM (olezarsen) TRYNGOLZATM (olezarsen) was approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). TRYNGOLZA is an RNA-targeted medicine designed to lower the body's production of apoC-III, a protein produced in the liver that is a key regulator of triglyceride metabolism. It is the only treatment currently indicated in the U.S. for FCS, a potentially life-threatening disease. For more information about TRYNGOLZA, visit TRYNGOLZA.com . IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count and arthralgia. Please see full Prescribing Information for TRYNGOLZA. About Familial Chylomicronemia Syndrome (FCS) FCS is a rare, genetic disease characterized by extremely elevated triglyceride levels. It is caused by impaired function of the enzyme lipoprotein lipase (LPL). Because of limited LPL production or function, people with FCS cannot effectively break down chylomicrons, lipoprotein particles that are 90% triglycerides. FCS is estimated to impact up to approximately 3,000 people in the U.S. People living with FCS are at high risk of acute pancreatitis (AP) in addition to other chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with FCS are sometimes unable to work, adding to the burden of disease. About the Balance Study Balance is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of olezarsen in patients with FCS at six and 12 months. The primary endpoint was the percent change from baseline in fasting triglyceride levels at six months compared to placebo. Secondary endpoints included percent changes in triglyceride levels at 12 months, percent changes in other lipid parameters and adjudicated acute pancreatitis event rates over the treatment period. Following treatment and the end-of-trial assessments, patients were eligible to enter an open-label extension study to continue receiving olezarsen once every four weeks. About Ionis Pharmaceuticals, Inc. For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has discovered and developed six marketed medicines for serious diseases, including breakthrough medicines for neurologic and cardiovascular diseases. Ionis has a leading pipeline in neurology, cardiology and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter) , LinkedIn and Instagram . Ionis Forward-Looking Statements This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of TRYNGOLZA, Ionis' technologies and other products in development. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended Dec. 31, 2023 , and most recent Form 10-Q, which are on file with the SEC. Copies of these and other documents are available at www.Ionis.com . Ionis Pharmaceuticals® and TRYNGOLZATM are trademarks of Ionis Pharmaceuticals, Inc. Ionis Investor Contact: D. Wade Walke , Ph.D. info@ionis.com 760-603-2331 Ionis Media Contact: Hayley Soffer media@ionis.com 760-603-4679 View original content: https://www.prnewswire.com/news-releases/tryngolza-olezarsen-approved-in-us-as-first-ever-treatment-for-adults-living-with-familial-chylomicronemia-syndrome-as-an-adjunct-to-diet-302336747.html SOURCE Ionis Pharmaceuticals, Inc.
"Vandersaw: Everything is Connected" is a compelling exploration of the complexities of human nature, the power of secrets and lies, and the interconnectedness of all things. Through the character of Teng Haige, author Chen Xin invites readers to ponder the fragility of truth, the elusiveness of justice, and the unpredictable nature of fate. In a world where everything is connected, Teng Haige must navigate the treacherous waters of mystery and deceit, knowing that not every outcome is within his grasp.Micah Richards was 'banned' from discussing Brest on Tuesday night, leading to a hilariously immature conversation about the French side. Brest were facing Barcelona in the Champions League and as part of CBS Sport's coverage of the night's action, Kate Abdo , Thierry Henry , Jamie Carragher and Richards were set to take a look at the side. CBS Sports have built a reputation for combining sports content with comedy and entertainment, leading to a number of memorable moments in their recent coverage. Knowing that ex- Manchester City star Richards has a somewhat immature sense of humour, Abdo took the opportunity to have some fun and try to make him laugh when discussing the unfortunately-named French side. “We are going to do a segment about Brest, but unfortunately you’ve consistently proven that you can’t stay professional when talking about Brest so production would ask are you comfortable just staying silent?” Richards responded: “Come on, Kate. I can do this! You can’t trust me?," to which Abdo replied: “No, we can’t. Experience has taught us not to trust you.” Beginning the segment, Abdo asked: “So after four games, who here likes Brest?," to which Carragher immediately raised his hand. “You like Brest?” asked Abdo, with Carragher replying: “I like the shape of them.” This led Richards to burst out laughing as he watched on in disbelief. Abdo continued: “You look at the setup that the manager has got – do you think he’s going with a front two tonight?” Henry replied: “Yeah, two big – a big pair up front who will try to...” “work off each other,” interrupted Carragher. Abdo then asked: “I’m interested to know how much you like to watch them, would you pay to watch them?” Carragher then replied: “I have done,” which led to hysterical laughter from Henry and Richards. Henry then added: “One thing you have to say is that you don’t have to be big, you can be small to compete,” with Abdo replying: “Hmm, that’s interesting.” The anchor then asked: “Do you think Brest could get exposed tonight?” with Carragher cheekily replying: “I hope so!” With a look of disbelief on his face, Richards asked: “What is this? What is this? Nonsense! HR? Wow!” Abdo then asked: “What do you think Micah? Do you think Barcelona could come a bit quickly for Brest tonight?,” to which Carragher replied: “Oooh, I think we might have crossed the line.” Richards then responded: “You’re trying to get me sacked! I’m taking the fifth (amendment),” with a big exhale. The panel then went on to properly analyse the French side, before Abdo wrapped up the segment. She said: "Daydreaming about Brest, I'm sure you can all relate," to which Richards replied: "What is going on here?" Brest ended up losing the clash 3-0, with Robert Lewandowski helping himself to a double.
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Moreover, the popularity of these cultural skins reflects a broader trend among young people to explore and appreciate their cultural heritage. In an age where trends come and go with lightning speed, the allure of ancient artifacts like those from Dunhuang and Sanxingdui lies in their timeless beauty and enduring significance. By incorporating these symbols into their daily lives, young people are adding layers of meaning and depth to their digital experiences.Despite the uncertainty surrounding the future of The Witcher series, one thing remains clear: the passionate fan base will continue to support and celebrate the world of Geralt of Rivia and the rich lore of The Witcher universe. Whether it's through the original video games, the popular Netflix series, or other forms of media, fans will always find ways to immerse themselves in the fantastical world created by Andrzej Sapkowski and brought to life by CD Projekt Red.
The fundamental principle behind Willow lies in its ability to detect and correct errors that inevitably arise in quantum computations due to environmental noise and other interference factors. By implementing a sophisticated system of error correction codes and fault-tolerant techniques, Willow effectively mitigates the impact of these errors, thereby improving the overall stability and accuracy of quantum computations.
Fans and critics alike have praised the artwork for its attention to detail, artistic flair, and imaginative concept. The seamless integration of Master Chief and Dr. Jones showcases the talent and skill of the artist, as well as the dedication of the Halo team to deliver exceptional content to their audience. The artwork has sparked a wave of excitement and speculation among fans, who eagerly await the release of "Treasure Hunter" to delve into this intriguing crossover.As the slideshow came to an end, a single, spotlighted chair was illuminated at the back of the room. On the chair was a beautiful, framed photo of Matthew's mother, surrounded by flowers and candles. It was a poignant tribute to her memory and a reminder that she was there in spirit, watching over her son on his special day.
‘I’m not a quitter’: Mettam responds to ‘catastrophic’ polling that suggests Zempilas should be Liberal leaderFurthermore, Atalanta's style of play under coach Gian Piero Gasperini has been instrumental in the team's success. Known for their high-tempo, attacking football, Atalanta has become synonymous with free-flowing, entertaining soccer. This proactive style of play not only puts pressure on their opponents but also allows players like Muriel to thrive and express themselves on the field.An on-field interaction between a UW-Madison Police officer and a Nebraska football assistant coach after Saturday's game was a "misunderstanding" that ended in an apology, a police spokesperson said. Lt. Adam Boardman, one of the UWPD officers escorting University of Wisconsin coach Luke Fickell to the locker room amid fans rushing the field after a 44-25 Huskers victory, turned away to grab Nebraska offensive line coach Donovan Raiola by the arm, video posted to social media showed. That followed an apparent exchange of words between Raiola and Fickell and Badgers assistant offensive line coach Casey Rabach, who were walking in opposite directions. The context of the discussion wasn't apparent from the video, but Fickell and Raiola both pointed at the other, and Rabach later pointed at Raiola. Boardman and Raiola talked for about 15 seconds after Boardman pried Raiola away from a hug with Nebraska running backs coach EJ Barthel. UWPD spokesperson Marc Lovicott said it was a "misunderstanding amid a pretty chaotic scene." He said Boardman made contact with an "unknown individual who had approached" Badgers coaches as they were leaving the field. "Once it was confirmed that the individual was a member of the Nebraska coaching staff, the UWPD officer apologized for the misunderstanding," Lovicott wrote in an email Tuesday. "The interaction concluded cordially with a handshake." Lovicott said UW Police has made contact with counterparts at Nebraska "and they're also considering it a misunderstanding." Raiola played for Wisconsin from 2002 to 2005. "I don't want speculate without knowing, obviously Donny went to Wisconsin, so I don't know if there was some history there with somebody or something," said Nebraska coach Matt Rhule, who said he was shown video of the incident Monday. "When I asked Donny about it, he was like, 'No big deal.' Things happen after games and people are emotional, but he seemed to kinda brush it off." Fickell said he didn't know much about the interaction when he was asked about it at his weekly news conference Monday. "I mean, I don't know if he was talking to Casey, somebody said something, I don't know," Fickell said. "I just said it looked like maybe he said something to me, but I had no idea. And I had no idea that that was even something. So if it was, I didn't spend a whole lot of time thinking about it." — Lincoln Journal Star reporter Luke Mullin contributed to this report. Get local news delivered to your inbox!
NoneIn conclusion, Zhou Changqiang's appointment as the Secretary of the Qionghai City Committee of Hainan Province and his promotion to the level of Deputy Director are significant milestones in his career. As a dedicated and experienced leader, Zhou is well-equipped to lead Qionghai City to new heights and contribute to the overall development of Hainan Province. With his vision, determination, and leadership, Zhou Changqiang is sure to make a positive impact on the people and the region he serves.In a touching farewell ceremony, Mr. Li bid a tearful goodbye to his beloved companion, expressing gratitude for all the years of faithful companionship and unwavering support. The emotional farewell served as a poignant reminder of the special relationship between humans and animals, showcasing the profound impact that a furry friend can have on someone's life.
As the sedan driver drove away from the scene, his expression reflected a mix of remorse and gratitude for the understanding and forgiveness extended to him. The drivers and parents, on the other hand, felt a sense of relief and satisfaction in knowing that justice had been served in a peaceful and harmonious manner.Pakistan developing missiles that eventually could hit US, top US official says
What Black Friday's history tells us about holiday shopping in 2024Fans of table tennis can look forward to witnessing some of the sport's biggest stars in action, as well as up-and-coming talents vying for their chance to make a name for themselves on the international stage. From intense singles matches to thrilling doubles showdowns, the tournament promises to deliver excitement and drama at every turn.
It also highlights the challenges faced by many young people today, who are grappling with issues of identity, belonging, and purpose in a rapidly changing global landscape. As we mourn the loss of this young life, we must also reflect on the broader societal implications of intolerance and extremism, and redouble our efforts to promote dialogue, compassion, and understanding across borders and cultures.