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Kenny Pickett says he'll 'be OK' after rib injury knocks him out of dream start for Eagles
India's exports to Australia grew 14% since the signing of the India-Australia Economic Cooperation and Trade Agreement (ECTA) with textiles, chemicals, and agriculture growing substantially, and new lines, including gold studded with diamonds and turbojets highlighting the diversification enabled by the agreement, the government said Sunday. ET Year-end Special Reads What kept India's stock market investors on toes in 2024? India's car race: How far EVs went in 2024 Investing in 2025: Six wealth management trends to watch out for Total trade, however, moderated in FY24 to $24 billion although since its signing, bilateral merchandise trade has more than doubled to $26 billion in FY23 from $12.2 billion in FY21. The current fiscal continues to reflect strong momentum. Total merchandise bilateral trade in April-November 2024 reached $16.3 billion, according to a statement issued by the commerce and industry ministry. "This landmark agreement has brought with it increased market access for Indian exporters, expanded opportunities for MSMEs and farmers, and generated several employment avenues," commerce and industry minister Piyush Goyal said in a post on X, adding that it has also enabled a notable boost in IT/ITeS, business & travel services, and post-study work & work holiday visas. "We are committed to building on the momentum that the Ind-Aus ECTA has generated and achieve the AUD 100 billion trade target by 2030. Together, we are shaping a prosperous and resilient future," Goyal said. Exchange of preferential import data has commenced between both countries, highlighting the effective implementation of the agreement in 2023. 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Imports of essential raw materials, such as metalliferous ores, cotton, wood and wood products have fuelled India's industries, contributing to the win-win nature of this partnership. Sectors such as electronics and engineering have room for growth. Nominations for ET MSME Awards are now open. The last day to apply is December 31, 2024. Click here to submit your entry for any one or more of the 22 categories and stand a chance to win a prestigious award. (You can now subscribe to our Economic Times WhatsApp channel )
Dy CM assesses concerns of local residents in Katra
SAN ANTONIO (AP) — Damari Monsanto's 22 points helped UTSA defeat Southwestern Adventist 117-58 on Thursday. Monsanto added six rebounds for the Roadrunners (6-5). Sky Wicks scored 20 points while shooting 8 for 12, including 4 for 7 from beyond the arc and added eight rebounds and three steals. Amir "Primo" Spears shot 5 of 10 from the field, including 1 for 5 from 3-point range, and went 5 for 6 from the line to finish with 16 points. Domonique Wilkins and Orlando Gooden each scored 19 points for Southwestern Adventist. Jason Garcia had 13 points, four assists and two steals. Monsanto led his team in scoring with 16 points in the first half to help put them up 61-24 at the break. UTSA extended its lead to 87-38 during the second half, fueled by a 13-3 scoring run. Wicks scored a team-high 10 points in the second half. ___ The Associated Press created this story using technology provided by and data from . The Associated PressJockey Club Multiple Pathways Initiative - CLAP-TECH Pathway Reveals Latest Talent Survey Results In Information And Communications Technology And Creative Media Industries Media Outreach Newswire APAC
The holiday season is a time for family gatherings, festive celebrations and trips back home. However, with the hustle and bustle of this busy time of year, holiday travel can dampen the festive spirit. Whether it’s a canceled flight, unexpected traffic jams or lengthy layovers, these disruptions can lead to stress and frustration for the whole family. Keeping spirits high during travel is essential to ensure everyone enjoys the holiday season to its fullest. This article offers twelve practical tools to help families navigate the challenges of holiday travel while maintaining a positive atmosphere. From staying connected with kids through specialized phones to engaging in fun games that bring laughter and joy, there are plenty of ways to turn a frustrating situation into an opportunity for connection and creativity. Holiday travel doesn’t have to mean breaking the bank, especially for a budget-friendly ride. CoPilot offers an excellent solution for finding used cars for sale that meet your quality and affordability standards. Leveraging advanced AI technology, CoPilot scours thousands of dealerships and listings to provide a personalized selection of used cars based on your preferences. Unlike traditional car shopping platforms, CoPilot is designed to work for you, highlighting the best deals while ensuring you avoid overpaying or falling into common buying traps. Plus, CoPilot’s app continuously monitors the market for price changes, notifying you of the best time to buy. Whether you’re hitting the road for a winter getaway or simply looking for a dependable vehicle, CoPilot helps you find the perfect fit at a price that will keep your spirits soaring. Keeping kids connected during travel delays and while they’re on the move is essential for maintaining a positive atmosphere. Bark Technologies' kids phones , the Bark Phone, offer a safer way for children to stay in touch with their parents and friends. These devices are designed with built-in safety features that help children communicate without the distractions and dangers associated with other smartphones. The Bark Phone is a state-of-the-art Samsung phone that allows parents to set limits on screen time, monitor usage and more. This ensures that children can enjoy their devices without the worry of exposure to inappropriate content. With features like GPS-powered location tracking and contact approval, parents can feel secure knowing they can introduce their children to the online world without putting their safety at risk. Using the Bark Phone during travel encourages families to stay engaged with one another by sharing updates about their location, playing games or simply chatting. Staying connected helps alleviate boredom and contributes to a sense of togetherness, making the wait more manageable and enjoyable for all. Travel can be stressful for pets, especially when they are away from their familiar environment. Keeping dogs happy during long car rides or extended travel days is a necessity. Thankfully, giving them the best dental chews for dogs from Yummy Combs is an effective way to promote their comfort and overall well-being. These dental chews are designed to satisfy dogs' natural chewing instincts while also promoting oral health. Yummy Combs dental chews are made from high-quality ingredients that are delicious and beneficial for dogs' teeth and gums. They help reduce plaque and tartar buildup so pets can maintain good oral hygiene while they wait for plans to resume. Plus, rewarding dogs with these chews can help alleviate boredom and provide a soothing distraction in unfamiliar settings. Keeping pets entertained with Yummy Combs dental chews during travel contributes to a more relaxed atmosphere and a happier pup. Effective communication is key during travel, especially when dealing with changes. A cloud phone from Zoom helps families stay connected, regardless of location. This technology provides reliable voice and video communication that allows family members to coordinate plans and share updates easily. Using a cloud phone will guarantee that everyone remains in the loop during unexpected hiccups. With the ability to extract tasks from voicemails, send post-call summaries, and more family members can always stay on the same page. This flexibility is crucial for coordinating arrangements and maintaining peace of mind during busy holiday journeys. The user-friendly interface of Zoom’s cloud phone system simplifies communication for all ages. When checking in with loved ones or accessing flight information, a cloud phone keeps families organized and informed, helping to keep spirits high. Transit can take a toll on your body, whether you’re getting stuck in traffic on a long car ride or waiting for your flight to board. To help maintain healthy joints, hair, skin and more, consider incorporating collagen peptides from BUBS Naturals into your daily routine. These peptides provide essential amino acids that support overall vitality, making them a helpful addition to the family’s wellness plan. BUBS Naturals' tasteless collagen peptides powder is derived from high-quality bovine collagen. It can easily be added to smoothies, coffee or even water to boost your overall wellness while enjoying your favorite beverages. This versatility allows everyone, from kids to adults, to enjoy the benefits while on the go. With a little boost from BUBS Naturals, families can keep their spirits high and enjoy their journeys more fully. All pet parents know that traveling can also be stressful for pets, and staying cooped up in a car or crate can lead to joint stiffness, aches and more. Antinol Plus is a premium solution designed to support your dog’s joint health. This product features a proprietary blend of green-lipped mussel oil and Antarctic Krill to boost your pup’s mobility and help them maintain a healthy inflammatory response. This daily supplement is ideal for normal days at home and travel days alike, keeping your pets comfortable no matter what life throws at them. Traveling can often lead to discomfort, and extended periods in planes, trains and automobiles can do a number on your circulation. 2XU’s mens compression pants provide a solution by supporting your circulation and muscle recovery. These pants are designed with advanced technology to reduce injury, speed up recovery and keep you at your best. Plus, the high-quality fabric used in 2XU’s compression pants is quick-drying and moisture-wicking, keeping you dry and comfortable. The ergonomic design allows for ease of movement, ensuring family members can stretch and shift comfortably during their journeys. Packing a pair of 2XU compression pants will help everyone stay relaxed and ready to enjoy their holiday plans. During holiday transit, maintaining a polished look can boost confidence and keep spirits high. Lip gloss from SHEGLAM is the perfect accessory to add a touch of pampering while on the go. Easy to apply and reapply, this product ensures family members look their best when waiting in an airport or embarking on a road trip. SHEGLAM offers a variety of lip gloss shades and formulas, allowing individuals to express their personal styles. From bold colors to subtle nudes, there is a perfect option for every personality. For winter trips, look towards moisturizing options to keep lips hydrated so they stay soft and smooth throughout the experience. This is especially important during the dry winter months when skin can become parched. With just a swipe, family members can refresh their looks and boost their confidence throughout the day. For families with little ones, Hero Journey Club offers a special way to keep kids entertained and engaged. This innovative subscription service provides weekly subclinical group sessions inside popular video games that assist with anger management for kids . These sessions encourage healthy coping mechanisms, helping children manage big emotions while developing problem-solving skills. Each Hero Journey Club session is limited to a small group of participants, keeping the experience intimate and interactive. Because only usernames and avatars are shared, children can enjoy a safe, anonymous space for social engagement and growth. This structured virtual gaming option provides an outlet for kids during long wait times and downtime. Hero Journey Club can help children dive into exciting adventures and make long-haul trips or delays feel like an opportunity for learning and personal growth. Finding the right clothing while on the move is essential for comfort and style. Search through Editorialist’s recommendations for types of jeans to find options that suit any occasion, from casual outings to festive parties to long days in transit. With a focus on fit and quality, Editorialist provides a selection that caters to diverse preferences. Editorialist's platform offers a seamless experience, allowing users to explore various styles and cuts, including skinny, straight-leg and bootcut jeans. The guidance from expert stylists ensures family members can find the perfect fit for their personal aesthetic, which makes it easier to feel confident during your journeys. Also, having the right jeans can enhance comfort during long hours of waiting. With their combination of style and practicality, the jeans recommended by Editorialist can help you maintain a chic look and feel great, too. Long journeys can make it hard to stay comfortable, but a travel neck pillow from Trtl is an easy solution. This innovative pillow provides strong but flexible neck support and is ideal for family members of all ages who need a rest while on the go. Its compact design ensures it’s easy to carry and pack, even in a stuffed carry-on. Unlike traditional bulky neck pillows, Trtl’s model has a design that offers maximum support without sacrificing comfort. The soft fleece wrap keeps the pillow snug against the neck to provide gentle, ergonomic support that mimics the comfort of a cozy scarf. This makes it perfect for flights, train rides or even long car trips. Keeping spirits high during winter travel can be as simple as breaking out a game of Dobble . This fast-paced matching game is easy to learn and perfect for all ages. The compact tin makes Dobble an ideal game on the go because it fits neatly into bags or backpacks. Dobble’s quick rounds and interactive play make it an instant favorite for family bonding. Players race to find the matching symbol between any two cards, making for a lively competition that keeps everyone engaged. Plus, the variety of ways to play means it never gets repetitive, even after multiple rounds. Holiday travel doesn’t have to dampen the festive spirit. With a little planning and these thoughtful tips, each family member can stay entertained, comfortable and happy. By prioritizing connection, fun, and relaxation, travel can become a cherished part of the experience — no matter what the season throws at you. Receive the latest in local entertainment news in your inbox weekly!
Buffalo Next: Per Scholas finds strong demand for tech trainingThe dynamics of the germ cell tumors market are anticipated to change in the coming years owing to the approval of specialized therapies for GCT and anticipated greater patients getting access to treatment across the world. Some key players such as Exelixis (Cabozantinib), Daiichi Sankyo (DS-9606), and HiFiBiO Therapeutics (HFB200301) are investigating their candidates to treat GCT in the 7MM. LAS VEGAS , Dec. 18, 2024 /PRNewswire/ -- DelveInsight's Germ Cell Tumors Market Insights report includes a comprehensive understanding of current treatment practices, germ cell tumors emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [ the United States , the EU4 ( Germany , France , Italy , and Spain ) and the United Kingdom , and Japan]. Key Takeaways from the Germ Cell Tumors Market Report According to DelveInsight's analysis, the market size for germ cell tumors in the 7MM is expected to reach ~ USD 630 million by 2034. Cabozantinib is expected to garner the largest market share of USD 129 million in the US by 2034, followed closely by DS-9606a , with a market share of USD 63 million . The incidence of GCT is around 26,000 cases in the 7MM in 2023. Leading germ cell tumors companies such as AstraZeneca, Exelixis, Pfizer, Xencor, Inc., Daiichi Sankyo, HiFiBiO Therapeutics, and others are developing novel germ cell tumors drugs that can be available in the germ cell tumors market in the coming years. The promising germ cell tumor therapies in the pipeline include Cabozantinib, Talazoparib, XmAb541, DS-9606a, and HFB200301, among others. Discover which therapies are expected to grab the major Germ Cell Tumors market share @ Germ Cell Tumors Market Report Germ Cell Tumors Overview Germ cell tumors are a rare type of growth that originates from germ cells, the cells responsible for developing into sperm in males and eggs in females. These tumors can be benign or malignant and often develop in the gonads, but they can also arise in other areas of the body, such as the abdomen, chest, or brain. The exact cause of germ cell tumors is not always clear, but genetic and environmental factors may play a role. Some known risk factors include abnormal development of the gonads, family history of similar conditions, and certain inherited syndromes. Germ cell tumor symptoms depend on the tumor's location and size. Common signs include swelling or a mass in the affected area, abdominal or chest pain, difficulty breathing (in cases of tumors in the chest), or hormonal changes. In some cases, the tumors may cause symptoms such as fatigue or unexplained weight loss. Germ cell tumor diagnosis typically involves a combination of imaging studies, blood tests to measure tumor markers like alpha-fetoprotein (AFP) or beta-human chorionic gonadotropin (β-hCG), and biopsy or surgical removal of the tumor to determine its nature. Early detection and treatment are crucial for improving outcomes, with therapies including surgery, chemotherapy, radiation, or a combination of these approaches. Germ Cell Tumors Epidemiology Segmentation The germ cell tumors epidemiology section provides insights into the historical and current germ cell tumors patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The germ cell tumors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of GCT Type-specific Incident Cases of GCT Sub-type specific Cases of Gonadal GCT Age-specific Cases of GCT Gender-specific Incident Cases of GCTs Total Incident Cases of GCTs by Stage Total Treatable Cases of GCT Line-wise Treatable Cases of GCT Germ Cell Tumors Treatment Market The treatment approach for germ cell tumors depends on the tumor type, whether ovarian or testicular. Surgery, followed by chemotherapy and sometimes radiation therapy, forms the cornerstone of GCT management. For recurrent testicular cancer, a chemotherapy combination of ifosfamide (Ifex), paclitaxel (Taxol), and cisplatin (Platinol) has proven highly effective. Notably, testicular cancers were among the first cancers successfully treated with radiation or chemotherapy. Over 80% of patients with metastatic germ cell tumors achieve a cure with cisplatin-based chemotherapy, typically the bleomycin, etoposide, and cisplatin (BEP) regimen, combined with surgery for residual disease. However, only about 25% of patients who relapse attain long-term survival after second-line cisplatin-based therapy, often using the vinblastine, ifosfamide, and cisplatin (VeIP) regimen. BEP remains the standard first-line chemotherapy for GCTs, effective in both seminomas and nonseminomas. This regimen capitalizes on cisplatin's DNA-damaging properties, etoposide's inhibition of DNA synthesis, and bleomycin's ability to induce DNA strand breaks, resulting in high cure rates. Treatment typically involves 3 to 4 cycles, tailored to disease stage and risk factors. Advancements in surgical techniques, rising incidence rates, and improved post-surgical outcomes have increased the demand for surgical interventions, driving growth in the broader GCT treatment market. To know more about germ cell tumor treatment guidelines, visit @ Germ Cell Tumors Management Germ Cell Tumors Pipeline Therapies and Key Companies Durvalumab + Tremelimumab: AstraZeneca Cabozantinib: Exelixis Talazoparib: Pfizer XmAb541: Xencor, Inc. DS-9606a: Daiichi Sankyo HFB200301: HiFiBiO Therapeutics Discover more about germ cell tumor drugs in development @ Germ Cell Tumors Clinical Trials Germ Cell Tumors Market Dynamics The germ cell tumors market dynamics are expected to change in the coming years. Platinum-based chemotherapy , such as the BEP regimen, is highly effective in treating both early and advanced-stage germ cell tumors, while surgical interventions like orchiectomy or oophorectomy also contribute significantly to successful outcomes. Biomarkers such as AFP, hCG, and LDH play a crucial role in diagnosis, staging, and monitoring treatment response, facilitating enhanced clinical decision-making and personalized care. Ongoing research into the genetic and molecular drivers of GCTs holds promise for developing highly effective, less toxic therapies, particularly for refractory or relapsed cases. Furthermore, identifying and validating new biomarkers could improve diagnosis, risk stratification, and relapse detection , advancing personalized treatment approaches for patients, including those with non-secretory tumors. Furthermore, potential therapies are being investigated for the treatment of germ cell tumors, and it is safe to predict that the treatment space will significantly impact the germ cell tumors market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the germ cell tumors market in the 7MM. However several factors may impede the growth of the germ cell tumors market. Platinum-based chemotherapy is highly effective but is associated with significant acute toxicities , such as nephrotoxicity and ototoxicity, as well as long-term effects like secondary malignancies, which can severely impact the quality of life, particularly for young survivors. Additionally, approximately 10–15% of patients develop resistance to first-line therapies , leaving them with few effective options, as salvage treatments are often toxic and have limited success rates. The emergence of resistance to platinum-based chemotherapy, especially in advanced or metastatic cases, poses a significant challenge, threatening the high cure rates associated with GCTs . Furthermore, the cost of advanced therapies , including novel drugs and long-term survivorship care, places a substantial financial burden on patients and healthcare systems, potentially limiting access to effective treatments. Moreover, germ cell tumor treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, germ cell tumors market growth may be offset by failures and discontinuation of emerging therapies , unaffordable pricing , market access and reimbursement issues , and a shortage of healthcare specialists . In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact germ cell tumors market growth. Scope of the Germ Cell Tumors Market Report Therapeutic Assessment: Germ Cell Tumors current marketed and emerging therapies Germ Cell Tumors Market Dynamics: Key Market Forecast Assumptions of Emerging Germ Cell Tumors Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Germ Cell Tumors Market Access and Reimbursement Download the report to understand which factors are driving germ cell tumors market trends @ Germ Cell Tumors Market Trends Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma , among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NSCLC companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang , Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre , Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. Small Cell Lung Cancer Market Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key advanced small cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, Advanced Accelerator Applications, Trillium Therapeutics, Wigen Biomedicine, Linton Pharm , Carrick Therapeutics, among others. Small-cell Lung Cancer Pipeline Small-cell Lung Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key small-cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm , Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 www.delveinsight.com Logo: https://mma.prnewswire.com/media/1082265/DelveInsight_Logo.jpg SOURCE DelveInsight Business Research, LLP
MAI Capital Management Reduces Stock Position in Canadian National Railway (NYSE:CNI)
China's getting a big electric car battery swapping boost in 2025. Would that work across the globe?Beat the freeze: These fleece-lined leggings are 'amazingly flattering' — and down to $18CARLSBAD, 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.
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