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Wednesday, November 27, 2024</div></section><div id="section-2" class="main-body"> <script src="/javascripts/pages/article.js?v=1732723395"></script> <div id="breadcrumbs" class="breadcrumbs"><a class="" href="/">Home</a> » <a class="" href="/topics">Topics</a> » Clinical</div> <div class="box1 article-topic"> <div class="records"> <h1 class="page-title"> Clinical <div class="rss"> <a href="/rss/topic/153-clinical"> <img alt="Clinical RSS Feed" height="16" width="16" loading="lazy" src="/images/icons/rss.gif" /> RSS </a> </div> </h1> <article class="record article-summary "> <div class="image"><a title="No plateau: Street level-sets obesity on Amgen Maritide phase II" class="url" rel="" target="" href="https://www.bioworld.com/articles/714682-no-plateau-street-level-sets-obesity-on-amgen-maritide-phase-ii"><img width="650" height="488" alt="Tape measure wrapped around scale" title="Tape measure wrapped around scale" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Obesity/Tape-measure-wrapped-around-scale.jpg?height=488&t=1698353901&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714682-no-plateau-street-level-sets-obesity-on-amgen-maritide-phase-ii">No plateau: Street level-sets obesity on Amgen Maritide phase II</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 26, 2024</div> <div class="author article-summary__author">By <a href="/authors/17-randy-osborne">Randy Osborne</a></div> <div class="comment-count article-summary__comment-count"><a title="No plateau: Street level-sets obesity on Amgen Maritide phase II" class="more" href="https://www.bioworld.com/articles/714682-no-plateau-street-level-sets-obesity-on-amgen-maritide-phase-ii#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">Wall Street began comparing and contrasting what’s available after Amgen Inc. rolled out phase II data with weight loss candidate Maritide – a disclosure that led shares of the biotech heavyweight (NASDAQ:AMGN) to close Nov. 26 at $280.01, down $13.99.<br /></div><a title="No plateau: Street level-sets obesity on Amgen Maritide phase II" class="more" href="https://www.bioworld.com/articles/714682-no-plateau-street-level-sets-obesity-on-amgen-maritide-phase-ii">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Edwards reveals superior outcomes with Sapien 3 Ultra Resilia" class="url" rel="" target="" href="https://www.bioworld.com/articles/714489-edwards-reveals-superior-outcomes-with-sapien-3-ultra-resilia"><img width="650" height="488" alt="Device in heart" title="Device in heart" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/BMT-source/2020/2-7-TAVR-edwards-sapien3.png?height=488&t=1724185362&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714489-edwards-reveals-superior-outcomes-with-sapien-3-ultra-resilia">Edwards reveals superior outcomes with Sapien 3 Ultra Resilia</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 25, 2024</div> <div class="author article-summary__author">By <a href="/authors/599-shani-alexander">Shani Alexander</a></div> <div class="comment-count article-summary__comment-count"><a title="Edwards reveals superior outcomes with Sapien 3 Ultra Resilia" class="more" href="https://www.bioworld.com/articles/714489-edwards-reveals-superior-outcomes-with-sapien-3-ultra-resilia#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">Edwards Lifesciences Corp. revealed excellent one-year data highlighting the performance of its newest generation Sapien 3 Ultra Resilia valve. Patients treated with the transcatheter aortic valve replacement system experienced lower rates of mortality and reintervention compared to its predecessors.<br /></div><a title="Edwards reveals superior outcomes with Sapien 3 Ultra Resilia" class="more" href="https://www.bioworld.com/articles/714489-edwards-reveals-superior-outcomes-with-sapien-3-ultra-resilia">Read More</a> </div> </article> <article class="record article-summary "> <div class="article-summary__details "> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714663-cassava-phase-iii-with-simufilam-fails-in-alzheimers">Cassava phase III with simufilam fails in Alzheimer’s</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 25, 2024</div> <div class="author article-summary__author">By <a href="/authors/17-randy-osborne">Randy Osborne</a></div> <div class="comment-count article-summary__comment-count"><a title="Cassava phase III with simufilam fails in Alzheimer’s" class="more" href="https://www.bioworld.com/articles/714663-cassava-phase-iii-with-simufilam-fails-in-alzheimers#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">The Alzheimer’s disease (AD) space took another blow along with the shares of Cassava Sciences Inc. (NASDAQ:SAVA), which plummeted by 83.8%, or $22.19, to end Nov. 25 at $4.30 after the firm unveiled top-line data from the phase III Rethink-Alz study with simufilam. The study tested simufilam in mild to moderate AD, where results fell short of each of the prespecified co-primary, secondary and exploratory biomarker endpoints.<br /></div><a title="Cassava phase III with simufilam fails in Alzheimer’s" class="more" href="https://www.bioworld.com/articles/714663-cassava-phase-iii-with-simufilam-fails-in-alzheimers">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Researchers develop first SDMA-based biosensor for kidney disease" class="url" rel="" target="" href="https://www.bioworld.com/articles/714296-researchers-develop-first-sdma-based-biosensor-for-kidney-disease"><img width="650" height="488" alt="SDMA kidney" title="SDMA kidney" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/BMT-source/2024/SDMA-kidney-22nov24.jpg?height=488&t=1732311884&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714296-researchers-develop-first-sdma-based-biosensor-for-kidney-disease">Researchers develop first SDMA-based biosensor for kidney disease</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 22, 2024</div> <div class="author article-summary__author">By <a href="/authors/603-marian-yoonjee-chu">Marian (YoonJee) Chu</a></div> <div class="comment-count article-summary__comment-count"><a title="Researchers develop first SDMA-based biosensor for kidney disease" class="more" href="https://www.bioworld.com/articles/714296-researchers-develop-first-sdma-based-biosensor-for-kidney-disease#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">Researchers developed a novel electrochemical biosensor technology capable of assessing symmetric dimethylarginine to detect early kidney disease, which could be adapted to detect other biomarkers for conditions like cancer.<br /></div><a title="Researchers develop first SDMA-based biosensor for kidney disease" class="more" href="https://www.bioworld.com/articles/714296-researchers-develop-first-sdma-based-biosensor-for-kidney-disease">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Medtronic, Tempus ALERT to disparities in valve replacement" class="url" rel="" target="" href="https://www.bioworld.com/articles/714288-medtronic-tempus-alert-to-disparities-in-valve-replacement"><img width="650" height="488" alt="Medtronic CoreValve" title="Medtronic CoreValve" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/BMT-source/2023/Medtronic-CoreValve.jpg?height=488&t=1693521331&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714288-medtronic-tempus-alert-to-disparities-in-valve-replacement">Medtronic, Tempus ALERT to disparities in valve replacement</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 21, 2024</div> <div class="author article-summary__author">By <a href="/authors/126-annette-boyle">Annette Boyle</a></div> <div class="comment-count article-summary__comment-count"><a title="Medtronic, Tempus ALERT to disparities in valve replacement" class="more" href="https://www.bioworld.com/articles/714288-medtronic-tempus-alert-to-disparities-in-valve-replacement#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">Medtronic plc and Tempus AI Inc. launched the ALERT study to better understand and address the racial, ethnic, gender and geographic disparities associated with guideline-recommended treatments for aortic stenosis and mitral valve regurgitation. Currently, white patients represent 91% of people who receive TAVR procedures, a minimally invasive procedure that sharply reduces complications and improves quality of life in patients with narrowed heart valves.<br /></div><a title="Medtronic, Tempus ALERT to disparities in valve replacement" class="more" href="https://www.bioworld.com/articles/714288-medtronic-tempus-alert-to-disparities-in-valve-replacement">Read More</a> </div> </article> <article class="record article-summary "> <div class="article-summary__details "> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714728-sage-shuts-down-huntingtons-program-after-phase-ii-failure">Sage shuts down Huntington’s program after phase II failure</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 20, 2024</div> <div class="author article-summary__author">By <a href="/authors/64-lee-landenberger">Lee Landenberger</a></div> <div class="comment-count article-summary__comment-count"><a title="Sage shuts down Huntington’s program after phase II failure" class="more" href="https://www.bioworld.com/articles/714728-sage-shuts-down-huntingtons-program-after-phase-ii-failure#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">The bad news keeps piling up for Sage Therapeutics Inc. Having absorbed other study stumbles in the past few months, the company now has halted development of dalzanemdor in treating Huntington’s disease after top-line phase II data showed it missed a statistically significant difference compared to placebo on the primary endpoint.<br /></div><a title="Sage shuts down Huntington’s program after phase II failure" class="more" href="https://www.bioworld.com/articles/714728-sage-shuts-down-huntingtons-program-after-phase-ii-failure">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Newamsterdam’s obicetrapib combo nails phase III LDL-C endpoints" class="url" rel="" target="" href="https://www.bioworld.com/articles/714724-newamsterdams-obicetrapib-combo-nails-phase-iii-ldl-c-endpoints"><img width="650" height="488" alt="Cholesterol plaque in artery" title="Cholesterol plaque in artery" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Cardiovascular/Cholesterol.png?height=488&t=1667944246&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714724-newamsterdams-obicetrapib-combo-nails-phase-iii-ldl-c-endpoints">Newamsterdam’s obicetrapib combo nails phase III LDL-C endpoints</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 20, 2024</div> <div class="author article-summary__author">By <a href="/authors/3-jennifer-boggs">Jennifer Boggs</a></div> <div class="comment-count article-summary__comment-count"><a title="Newamsterdam’s obicetrapib combo nails phase III LDL-C endpoints" class="more" href="https://www.bioworld.com/articles/714724-newamsterdams-obicetrapib-combo-nails-phase-iii-ldl-c-endpoints#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">“It all comes down to outcomes,” said Michael Davidson, CEO of Newamsterdam Pharma Co. NV, which hailed “robust” and “consistent” data from its phase III study testing a fixed-dose combination of CETP inhibitor obicetrapib plus established anti-cholesterol drug ezetimibe, even as investors focused on a couple of findings that turned up lower than expected, sending shares of the company (NASDAQ:NAMS) down 15.5% to close Nov. 20 at $20.01.<br /></div><a title="Newamsterdam’s obicetrapib combo nails phase III LDL-C endpoints" class="more" href="https://www.bioworld.com/articles/714724-newamsterdams-obicetrapib-combo-nails-phase-iii-ldl-c-endpoints">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="New diagnostics, trials address deadly disparities in women’s cardiac care" class="url" rel="" target="" href="https://www.bioworld.com/articles/714721-new-diagnostics-trials-address-deadly-disparities-in-womens-cardiac-care"><img width="650" height="488" alt="Female hands holding heart on cardiogram" title="Female hands holding heart on cardiogram" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Cardiovascular/Female-hands-holding-heart-on-cardiogram.jpg?height=488&t=1732138584&width=650" /></a></div> <div class="article-summary__details has-image"> <div class="kicker article-summary__kicker">Healing the health divide</div> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714721-new-diagnostics-trials-address-deadly-disparities-in-womens-cardiac-care">New diagnostics, trials address deadly disparities in women’s cardiac care</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 20, 2024</div> <div class="author article-summary__author">By <a href="/authors/126-annette-boyle">Annette Boyle</a></div> <div class="comment-count article-summary__comment-count"><a title="New diagnostics, trials address deadly disparities in women’s cardiac care" class="more" href="https://www.bioworld.com/articles/714721-new-diagnostics-trials-address-deadly-disparities-in-womens-cardiac-care#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials.<br /></div><a title="New diagnostics, trials address deadly disparities in women’s cardiac care" class="more" href="https://www.bioworld.com/articles/714721-new-diagnostics-trials-address-deadly-disparities-in-womens-cardiac-care">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="The Liver Meeting: A mashup of MASH data" class="url" rel="" target="" href="https://www.bioworld.com/articles/714647-the-liver-meeting-a-mashup-of-mash-data"><img width="650" height="488" alt="Liver " title="Liver " border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Gastrointestinal/Liver-7-7.png?height=488&t=1657229334&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714647-the-liver-meeting-a-mashup-of-mash-data">The Liver Meeting: A mashup of MASH data</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 19, 2024</div> <div class="author article-summary__author">By <a href="/authors/29-brian-orelli">Brian Orelli</a></div> <div class="comment-count article-summary__comment-count"><a title="The Liver Meeting: A mashup of MASH data" class="more" href="https://www.bioworld.com/articles/714647-the-liver-meeting-a-mashup-of-mash-data#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">Advertisements for Rezdiffra (resmetirom, Madrigal Pharmaceuticals Inc.), which was approved by the U.S. FDA in March 2024, adorned the lobby of The Liver Meeting 2024 being held at the San Diego Convention Center as well as the trolley stop across the street and other areas that doctors attending the meeting might be swayed. But inside the ballrooms of the convention center, companies were making presentations of data from clinical trials testing their drugs in patients with metabolic dysfunction-associated steatohepatitis (MASH) in hopes of potentially competing with Rezdiffra in a few years.<br /></div><a title="The Liver Meeting: A mashup of MASH data" class="more" href="https://www.bioworld.com/articles/714647-the-liver-meeting-a-mashup-of-mash-data">Read More</a> </div> </article> <article class="record article-summary "> <div class="article-summary__details "> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/articles/714646-escient-buys-prescience-queried-as-incyte-pauses-urticaria-work">Escient buy’s prescience queried as Incyte pauses urticaria work</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Nov. 19, 2024</div> <div class="comment-count article-summary__comment-count"><a title="Escient buy’s prescience queried as Incyte pauses urticaria work" class="more" href="https://www.bioworld.com/articles/714646-escient-buys-prescience-queried-as-incyte-pauses-urticaria-work#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">Incyte Corp.’s mention of would-be “backup molecules” could bode well for findings yet to roll out with Mas-related G protein-coupled receptor X2 antagonist INCB-000262 in chronic spontaneous urticaria. Meanwhile, though, the news is not good, as Incyte said in a terse press release that it will pause enrollment in the ongoing phase II study with the drug because of in vivo preclinical toxicology findings.<br /></div><a title="Escient buy’s prescience queried as Incyte pauses urticaria work" class="more" href="https://www.bioworld.com/articles/714646-escient-buys-prescience-queried-as-incyte-pauses-urticaria-work">Read More</a> </div> </article> </div> <div class="pager"> <div role="navigation" aria-label="Pagination" class="pagination"><span class="previous_page disabled" aria-disabled="true">Previous</span> <em class="current" aria-label="Page 1" aria-current="page">1</em> <a rel="next" aria-label="Page 2" href="/articles/topic/153-clinical-bioworld-medtech?page=2">2</a> <a aria-label="Page 3" href="/articles/topic/153-clinical-bioworld-medtech?page=3">3</a> <a aria-label="Page 4" href="/articles/topic/153-clinical-bioworld-medtech?page=4">4</a> <a aria-label="Page 5" href="/articles/topic/153-clinical-bioworld-medtech?page=5">5</a> <a aria-label="Page 6" href="/articles/topic/153-clinical-bioworld-medtech?page=6">6</a> <a aria-label="Page 7" href="/articles/topic/153-clinical-bioworld-medtech?page=7">7</a> <a aria-label="Page 8" href="/articles/topic/153-clinical-bioworld-medtech?page=8">8</a> <a aria-label="Page 9" href="/articles/topic/153-clinical-bioworld-medtech?page=9">9</a> <span class="gap">…</span> <a aria-label="Page 362" href="/articles/topic/153-clinical-bioworld-medtech?page=362">362</a> <a aria-label="Page 363" href="/articles/topic/153-clinical-bioworld-medtech?page=363">363</a> <a class="next_page" rel="next" href="/articles/topic/153-clinical-bioworld-medtech?page=2">Next</a></div> </div> </div> </div><aside class="main-interior-sidebar"><div class="main-interior-sidebar__column"><div id="article-recommendations"></div> </div><div class="main-interior-sidebar__column"><section class="popular-stories "> <h1 class="popular-stories__title">Popular Stories</h1><ul class="popular-stories__items"> <li class="popular-stories__item"> <article class="popular-stories__article popular-stories--article"><div class="popular-stories__details popular-stories__details-1"><h1 class="popular-stories__headline"><a class="popular-stories__article-title-link" href="https://www.bioworld.com/articles/432891-todays-news-in-brief">Today's news in brief</a></h1><div class="popular-stories__topics"><a class="popular-stories__topic-link" href="/topics/84-bioworld">BioWorld</a></div><div class="popular-stories__teaser"><em>BioWorld</em> briefs for Nov. 26, 2024.</div></div></article> </li> <li class="popular-stories__item"> <article class="popular-stories__article popular-stories--article"><div class="popular-stories__details popular-stories__details-1"><h1 class="popular-stories__headline"><a class="popular-stories__article-title-link" href="https://www.bioworld.com/articles/699574-todays-news-in-brief">Today's news in brief</a></h1><div class="popular-stories__topics"><a class="popular-stories__topic-link" href="/topics/85-bioworld-medtech">BioWorld MedTech</a></div><div class="popular-stories__teaser"><em>BioWorld MedTech</em> briefs for November 26, 2024.</div></div></article> </li> <li class="popular-stories__item"> <article class="popular-stories__article -has-image popular-stories--article"><figure class="popular-stories__image"><a class="popular-stories__thumbnail-link" data-eventname="popular-stories" data-eventcategory="click" data-eventaction="popular-stories-image" data-eventlabel="https://www.bioworld.com/articles/714048-j-and-js-ottava-robotic-system-approved-for-us-pivotal-trial" href="https://www.bioworld.com/articles/714048-j-and-js-ottava-robotic-system-approved-for-us-pivotal-trial"><img class="popular-stories__image-thumb" alt="Da Vinci Xi robot - Intuitive Surgical" title="Da Vinci Xi robot - Intuitive Surgical" width="640" height="355" loading="lazy" src="https://www.bioworld.com/ext/resources/BMT-source/2023/1-26--Da-Vinci-Xi-robot-Intuitive-Surgical.png?height=355&t=1699482891&width=640" /></a></figure><div class="popular-stories__details popular-stories__details-1"><h1 class="popular-stories__headline"><a class="popular-stories__article-title-link" href="https://www.bioworld.com/articles/714048-j-and-js-ottava-robotic-system-approved-for-us-pivotal-trial">J&J’s Ottava robotic system approved for US pivotal trial</a></h1><div class="popular-stories__topics"><a class="popular-stories__topic-link" href="/topics/85-bioworld-medtech">BioWorld MedTech</a></div><div class="popular-stories__teaser">Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. 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