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Novartis twice-yearly* Leqvio® (inclisiran) receives FDA approval for new indication enabling first-line use
Novartis twice-yearly* Leqvio® (inclisiran) receives FDA approval for new indication enabling first-line use

Yahoo

time4 hours ago

  • Health
  • Yahoo

Novartis twice-yearly* Leqvio® (inclisiran) receives FDA approval for new indication enabling first-line use

Leqvio can now be used alone, without addition of statin therapy, as adjunct to diet and exercise for LDL-C reduction in patients with hypercholesterolemia (high LDL-C)1 4 out of 5 atherosclerotic cardiovascular disease (ASCVD) patients do not reach guideline-recommended LDL-C target, reinforcing urgent need for more aggressive LDL-C lowering2-5 Twice-yearly Leqvio is uniquely positioned to help support patient adherence and long-term LDL-C management, including goal attainment EAST HANOVER, N.J., July 31, 2025 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia1. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. "This first-line label update reinforces Leqvio's proven ability to effectively lower LDL-C, a critical risk factor for heart disease," said Victor Bultó, President, US, Novartis. "With this new indication enabling Leqvio's use as monotherapy along with diet and exercise, we now have the potential to help even more patients achieve their LDL-C lowering goals earlier in their treatment journey." With its twice-yearly, health care provider-administered dosing, Leqvio is uniquely positioned to help support patient adherence and long-term LDL-C management, including goal attainment. This is a critical unmet need, as up to 80% of ASCVD patients in the US struggle to reach the LDL-C guideline-recommended target of <70 mg/dL2-5. This need is heightened by the latest 2025 ACC/AHA Joint Committee Clinical Practice Guideline for the Management of Patients with Acute Coronary Syndromes, which recommends more aggressive treatment to achieve LDL-C targets6. The updated label removes the requirement for Leqvio to be used on top of or in combination with statin therapy1. Other updates include revising "primary hyperlipidemia" to the more specific term of "hypercholesterolemia" throughout the label, to more accurately focus on LDL-C reduction1. *After an initial dose and another at three months. About LeqvioLeqvio is an injectable prescription medicine indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics. Important Safety InformationDo not use if you have had an allergic reaction to Leqvio or any of its ingredients. The most common side effects of Leqvio were injection site reaction (including pain, redness, and rash), arthralgia (joint pain), bronchitis (chest cold). These are not all the possible side effects of Leqvio. Ask your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for Leqvio full Prescribing Information. About Atherosclerotic Cardiovascular Disease (ASCVD)Cardiovascular disease (CVD) affects hundreds of millions of people and claims more lives globally than cancer, chronic lung disease and diabetes combined7. Around 80% of premature cardiovascular deaths can be prevented by addressing factors that cause or worsen accounts for 85% of all CV deaths5,9-11. Its burden in the US is greater than that of any other chronic diseases5,9-11. ASCVD is caused by the development and growth of plaques in the inner lining of the arteries12. The atherosclerotic plaque is mainly composed of low-density lipoprotein cholesterol (LDL-C) that accumulates over time13. Cumulative exposure to LDL-C can increase one's risk of cardiovascular events such as a heart attack or stroke12,13. About Novartis in Cardiovascular DiseaseAt Novartis, our mission is to ensure no heart is lost too soon. We envision a world where preventable CV deaths are no longer part of our lives. We're proud of the positive impact we've made over the past 40 years and remain dedicated to tackling the most challenging problems in CVD. Through cutting-edge science and technology, we are focusing on areas of high unmet need, including scaling our xRNA platform across multiple risk factors and pioneering breakthroughs for genetically driven CVD risk factors and common heart conditions, including atrial fibrillation. We also work with patients, healthcare professionals, and organizations around the world to improve CV care beyond medicine alone. Together, we can help people with CVD enjoy longer, healthier lives and more time with their loved ones. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About NovartisNovartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn US, X/Twitter US and Instagram. References Leqvio. Prescribing information. Novartis Pharmaceuticals Corp Cannon CP, de Lemos JA, Rosenson RS, et al. Use of lipid-lowering therapies over 2 years in GOULD, a registry of patients with atherosclerotic cardiovascular disease in the US. JAMA Cardiol. 2021;6(9):1060-1068. doi:10.1001/jamacardio.2021.1810 Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011-2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/ Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1016/ Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI guideline for the management of patients with acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2025;85(22):2135-2237. doi:10.1016/ American Heart Association. More than half of U.S. adults don't know heart disease is leading cause of death, despite 100-year reign. Published January 24, 2024. Accessed July 25, 2025. World Heart Federation. World Heart Report 2023: confronting the world's number one killer. Published May 20, 2023. Accessed July 25, 2025. World Health Organization. Cardiovascular diseases (CVDs). Published June 11, 2021. Accessed July 25, 2025. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2012 update: a report from the American Heart Association. Circulation. 2012;125(1):e2-e220. doi:10.1161/CIR.0b013e31823ac046 Kim H, Kim S, Han S, et al. Prevalence and incidence of atherosclerotic cardiovascular disease and its risk factors in Korea: a nationwide population-based study. BMC Public Health. 2019;19(1):1112. doi:10.1186/s12889-019-7439-0 Goldstein JL, Brown MS. A century of cholesterol and coronaries: from plaques to genes to statins. Cell. 2015;161(1):161-172. doi:10.1016/ Ference BA, Graham I, Tokgozoglu L, Catapano AL. Impact of lipids on cardiovascular health: JACC Health Promotion Series. J Am Coll Cardiol. 2018;72(10):1141-1156. doi:10.1016/ ### Novartis Media Relations E-mail: Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: original content: SOURCE Novartis Pharmaceuticals Corporation Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Bag of animal organs found in Morris County town, police say as investigation continues
Bag of animal organs found in Morris County town, police say as investigation continues

Yahoo

time14 hours ago

  • Yahoo

Bag of animal organs found in Morris County town, police say as investigation continues

A suspicious garbage bag found at a car wash in East Hanover contained animal organs, not human remains, authorities said July 30. Police were called to The Finish Line Car Wash at 84 Route 10 around 9:33 a.m. July 29 after employees discovered the bag inside a trash can, according to a statement from East Hanover Police Chief Christopher F. Cannizzo. The Morris County Medical Examiner's Office examined the contents and confirmed the bag contained animal remains. No human tissue was found, Cannizzo said. The investigation into how the remains ended up at the car wash is ongoing. Authorities have not said what kind of animal the organs belonged to. This article originally appeared on East Hanover NJ police report bag of animal organs found at car wash Solve the daily Crossword

CHIPS AHOY! Enters the Upside Down for the Most Anticipated Netflix Release Yet: Stranger Things 5!
CHIPS AHOY! Enters the Upside Down for the Most Anticipated Netflix Release Yet: Stranger Things 5!

Yahoo

time21-07-2025

  • Entertainment
  • Yahoo

CHIPS AHOY! Enters the Upside Down for the Most Anticipated Netflix Release Yet: Stranger Things 5!

CHIPS AHOY! celebrates the final season of Stranger Things by introducing nostalgic 1980s packaging, limited-edition chocolatey cookies with red filling that are inspired by the Upside Down, an augmented reality game to save the cookies, and a chance to win prizes, including a Stranger Things Eddie Munson-inspired guitar! EAST HANOVER, N.J., July 21, 2025 /PRNewswire/ -- Flavor meets fandom as CHIPS AHOY!, America's favorite chocolate chip cookie brand, and Netflix's hit series Stranger Things collaborate to create the new CHIPS AHOY! x Stranger Things Limited-Edition Cookie. A treat that is as otherworldly as it is delicious, the cookie blends the flavors of CHIPS AHOY! with the world of Stranger Things. Available in stores nationwide starting on August 11, fans can get early access now through the inaugural CHIPS AHOY! pre-sale. CHIPS AHOY! is also releasing retro-inspired Original CHIPS AHOY! packs that harken back to the look and feel of the 1980s CHIPS AHOY! packaging when Stranger Things takes place. The CHIPS AHOY! x Stranger Things Limited-Edition Cookie is inspired by the Upside Down, a dark alternate dimension that has played a key role throughout every season of Stranger Things. The cookies feature a new CHIPS AHOY! chocolatey base, fudge chips and a red strawberry-flavored filling. The brand's first-ever fruit-flavored filling peeks through the chocolatey cookie to represent the Rifts that are the entrance to the Upside Down. Before they even taste the delectable cookies, Stranger Things buffs will be drawn to the unique packaging that incorporates quintessential design elements from the show and a special glow-in-the-dark feature. CHIPS AHOY! is also inviting fans to step into the Upside Down. Starting on August 11, consumers can scan an on-pack QR code or visit to be transported into an immersive augmented-reality game. The brand that is Here for Happy is asking fans to find CHIPS AHOY! cookies hidden throughout different levels of the game to increase their happy meter while in the Upside Down. In-game achievements will translate into the chance to win exclusive prizes – most notably, a Stranger Things Eddie Munson-inspired guitar – plus limited edition Stranger Things merchandise*. "This isn't just any product launch – it's a cultural moment that joins two beloved brands together in an exciting and captivating way," said CHIPS AHOY! Senior Director, Sabrina Sierant. "Our collaboration with Stranger Things appeals to both long-time lovers of CHIPS AHOY! cookies and Stranger Things fans who have loved every episode. Through experiential components and elements of nostalgia, we are delivering unforgettable experiences for different generations of fans – whether they grew up in the 80s or are experiencing that awesome decade through the show." Created by the Duffer Brothers, Stranger Things debuted in July 2016 and quickly became one of Netflix's most popular shows ever with its fourth season alone amassing over 140.7 Million views globally. Stranger Things is produced by Upside Down Pictures & 21 Laps Entertainment with The Duffer Brothers serving as executive producers, alongside Shawn Levy of 21 Laps Entertainment and Dan Cohen. This fall, the award-winning series returns with its eagerly awaited fifth and final season. Stranger Things 5 will release on Netflix across three premiere dates with four episodes on November 26, three episodes on Christmas and the finale episode on New Year's Eve. Each volume releases at 5 PM PT. In the official season 5 synopsis: It's the fall of 1987. Hawkins is scarred by the opening of the Rifts, and our heroes are united by a single goal: find and kill Vecna. But he has vanished — his whereabouts and plans unknown. Complicating their mission, the government has placed the town under military quarantine and intensified its hunt for Eleven, forcing her back into hiding. As the anniversary of Will's disappearance approaches, so does a heavy, familiar dread. The final battle is looming — and with it, a darkness more powerful and more deadly than anything they've faced before. To end this nightmare, they'll need everyone — the full party — standing together, one last time. Registration to pre-order the CHIPS AHOY! x Stranger Things Limited-Edition Cookie is now open at and limited to the first 1,500 people. Beginning on August 11, fans can find the CHIPS AHOY! x Stranger Things Limited-Edition Cookie at retailers nationwide, starting at $5.79. In addition to the traditional tray, the cookies will also be available in 2-count portion packs that are ideal for on-the-go snacking or distributing for Halloween. Whether fans purchase Stranger Things Limited-Edition Cookies or Original CHIPS AHOY! 1980s retro packs, they will be sure to enhance their watching experience with delicious cookies that make each moment happier. *NO PURCHASE OR SCAN NECESSARY. Std. msg&data rates apply to scans. Open to residents of the 50 United States, D.C., & Puerto Rico 18 and older. Ends: 12/31/25. Void where prohibited. Visit for Official Rules including alternate method of entry About Mondelēz International Mondelēz International, Inc. (Nasdaq: MDLZ) empowers people to snack right in over 150 countries around the world. With 2024 net revenues of approximately $36.4 billion, MDLZ is leading the future of snacking with iconic global and local brands such as OREO, RITZ, LU, CLIF Bar and TATE'S BAKE SHOP biscuits and baked snacks, as well as CADBURY DAIRY MILK, MILKA and TOBLERONE chocolate. Mondelēz International is a proud member of the Standard and Poor's 500, Nasdaq 100 and Dow Jones Sustainability Index. Visit or follow the company on X at About Stranger Things Created by the Duffer Brothers, Stranger Things debuted in July 2016 and quickly became one of Netflix's most popular shows ever with its fourth season alone amassing over 140.7 Million views globally. Rooted in '80s nostalgia, it revived interest in pop culture items and fashion, as well as boosted Kate Bush's track "Running Up That Hill" into the Billboard Hot 100 chart for the first time in its 38-year history. The series has also garnered over 70 awards worldwide including Emmys® and the Screen Actors Guild Award for Outstanding Performance by an Ensemble in a Drama Series, and has been nominated for over 230 awards. This fall, it returns with its eagerly awaited fifth and final season;, and in the meantime, offering fans can various ways to engage with the cultural phenomenon through various experiences and offerings year-round, including: the most Tony Award-winning stage play of 2025, Stranger Things: The First Shadow which made its Broadway debut in April; an upcoming animated series; a collection of books; the touring Stranger Things Experience which expanded to Brazil and Australia this year; and a global assortment of lifestyle products and brand collaborations. Fans also celebrate November 6 - the day Will Byers went missing - as 'Stranger Things Day,' a special day to share their love for the world of Stranger Things. View original content to download multimedia: SOURCE Mondelēz International, Inc.

The Zbar Bake Sale Collection Features Two New Flavors and Helps Raise Awareness of KABOOM! Partnership Focusing on Kids' Access to Outdoor Play
The Zbar Bake Sale Collection Features Two New Flavors and Helps Raise Awareness of KABOOM! Partnership Focusing on Kids' Access to Outdoor Play

Associated Press

time14-05-2025

  • Business
  • Associated Press

The Zbar Bake Sale Collection Features Two New Flavors and Helps Raise Awareness of KABOOM! Partnership Focusing on Kids' Access to Outdoor Play

Approximately 30 million kids in the United States lack nearby outdoor places to play, inspiring the Zbar brand partnership with KABOOM! EAST HANOVER, N.J., May 14, 2025 /PRNewswire/ -- Zbar, the energy snack bar for kids, is kicking off the Spring season with the launch of the Bake Sale Collection, featuring two delicious new flavors: Cinnamon Roll and Cookies 'n Creme. Inspired by home baking, Cinnamon Roll tastes like all the fun that Saturday mornings bring in a bar, while Cookies 'n Creme offers a delicious twist on a family favorite. With a soft-baked texture, Zbar energy snack bars are made for busy, adventure-fueled days—perfect for park outings and snack breaks before sports practice. The Zbar Bake Sale Collection also highlights the brand's partnership with KABOOM!, a nonprofit organization committed to ending playspace inequity. According to a study from the University of Michigan, kids in the U.S. get only 7 minutes of unstructured outdoor play time per day, on average.1 In addition, the Trust for Public Land found that nearly 30 million kids live more than a 10-minute walk from the nearest park.2 As the brand that believes in helping fuel kids to discover their world, Zbar announced a two-year, $1 million partnership with KABOOM! in July 2024 to help build nature-based, sustainable playgrounds for communities nationwide. The initiative supports KABOOM!'s climate-forward playground design by incorporating natural elements like trees and shade structures, and replacing heat-retaining materials with cooler, sustainable alternatives. Together, the Zbar brand and KABOOM! want to create new nature-friendly playgrounds in communities where they're needed most to help give more kids the opportunity to spend time playing outdoors–even as the summer starts to heat up. 'At Zbar, we're committed to crafting quality snacks for kids that help fuel active exploration,' said Valerie Van Arkel, Director of Marketing for Zbar at Mondelēz International. 'The delicious new Cinnamon Roll and Cookies 'n Creme flavors in our Bake Sale Collection deliver the delightful taste kids want for their warm-weather adventures, while highlighting the work we are doing with KABOOM! to help connect more kids to nature and outdoor play.' 'The joy of outdoor play is something that every child needs to experience,' said Lysa Ratliff, Chief Executive Officer of KABOOM!. 'In partnership with Zbar, we will create eight new playgrounds that are nature exploration areas, helping more than 15,000 kids develop lasting memories outdoors. Together, we're making great progress toward our goals of fostering a more sustainable playground industry and helping increase the number of kids who can get outside to play.' Designed to provide parents with fuel their kids will love, Zbar energy snack bars are non-GMO, USDA Organic certified and a good source of fiber with 11g-13g whole grains per bar. Zbar Cinnamon Roll and Cookies 'n Creme flavors are available at all major national retailers in packs of 6 and 12. References About CLIF For more than 30 years, CLIF has crafted delicious food with organic whole grain oats under its CLIF BAR, Zbar, Nut Butter Bar, and LUNA brands. In 2022, CLIF became part of the Mondelēz International, Inc. (Nasdaq: MDLZ), portfolio of brands empowering people to snack right in over 150 countries around the world. With 2024 net revenue of approximately $36.4 billion, Mondelēz is leading the future of snacking with other iconic global and local brands such as OREO, RITZ, belVita, LU, and TATE'S BAKE SHOP biscuits and baked snacks, as well as CADBURY DAIRY MILK, MILKA and TOBLERONE chocolate. Mondelēz International is a proud member of the Standard and Poor's 500, Nasdaq 100, and Dow Jones Sustainability Index. For more information about CLIF BAR, please visit CLIF | Mondelēz International, Inc. ( About KABOOM! KABOOM! is the national nonprofit committed to ending playspace inequity – the reality that quality places to play are not available to every child, especially in communities of color. Since 1996, KABOOM! has partnered with kids and communities to create or transform 17,000+ playspaces and ensure that more than 12 million kids have equitable access to the critical benefits and opportunities that playspaces offer. KABOOM! continues to make progress on its 25 in 5 Initiative to End Playspace Inequity through new partnerships with a goal of accelerating efforts in 25 municipal systems toward achieving their mission at scale across the United States. Learn more at or join the conversation on Facebook, Instagram, and LinkedIn. View original content to download multimedia: SOURCE Mondelēz International

School bus safety bill focused on special education students clears NJ Senate
School bus safety bill focused on special education students clears NJ Senate

Yahoo

time24-03-2025

  • Politics
  • Yahoo

School bus safety bill focused on special education students clears NJ Senate

For the second time in a week, New Jersey lawmakers pushed forward legislation aimed at increasing school bus safety for students with disabilities. The state Senate on Monday unanimously approved S-3447, a bill that would create a 22-member Special Education Transportation Task Force to study reforms. The vote follows a trio of deaths and other safety complaints involving special-education students commuting to and from school in New Jersey, and it comes a week after a Senate committee advanced a separate measure to require video cameras and GPS tracking on buses that transport disabled students. Monday's legislation, approved by a 39-0 vote, is sponsored by senators Kristin Corrado, a Bergen County Republican, and Patrick Diegnan, a Democrat from Middlesex County. It would create a panel of parents, educators, state officials and advocates who will have one year to examine a system that disability groups say is failing New Jersey students and to come up with recommendations for improvements. 'Today's vote represents a big, important step forward in our effort to ensure the safety of students with disabilities. Among other things, this task force would provide a platform for a much-needed conversation about special education transportation – a conversation that should be student-centered and family-driven,' said Paul Aronsohn, the state's ombudsman for people with intellectual or developmental disabilities. Among other subjects, the task force would examine the training school bus drivers and aides receive and how they handle emergency situations. It would also study whether the education plans drafted for students with disabilities adequately lay out their transportation needs. This legislation follows tragedies like that of East Hanover's Matthew Rossi, a 19-year-old with muscular dystrophy and autism, who was put on a school bus in 2023 and returned home unresponsive. Rossi was pronounced dead at his home soon after that ride. His family spoke out about the tragedy in an effort to spark a public debate on accountability and safety. "I am pleased that the state Senate unanimously passed this bill, which supports our family's core mission of prioritizing the personal safety of our most vulnerable students during transport to and from school, including their unique medical and behavioral needs," Matthew's mother, Anabela Rossi, said in an email. More: Hundreds from NJ disability community rally in Trenton against GOP Medicaid cuts The legislation also "aims to establish greater accountability for the local school boards," she said. "We are grateful to Senators Corrado and Diegnan for their sponsorship on this bill and commitment to this issue." Groups like Disability Rights New Jersey and the New Jersey Education Association, which represents special education teachers, would also have a seat at the table on the new task force. An identical version of the legislation, Assembly bill 4607 will need to pass that chamber before heading to the governor's desk for a signature. This article originally appeared on Special education school bus safety bill clears NJ Senate

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