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Sunday, November 24, 2024</div></section><div id="section-2" class="main-body page-newsletters-show"> <div id="breadcrumbs" class="breadcrumbs"><a class="" href="/">Home</a> » <a class="" href="https://www.bioworld.com/newsletters">Newsletters</a> » BioWorld</div> <div class="box1 article newsletters-show"> <h1 class="page-title">BioWorld</h1> <h2 class="newsletters-show__post-date">Nov. 22, 2024</h2> <a class="newsletters-show__view-issues" href="https://www.bioworld.com/newsletters/1-bioworld/archive">View Archived Issues</a> <div class="records issue-articles-list"> <div class="record issue-articles-list__article"> <div class="image issue-articles-list__image"> <img width="650" height="487" alt="China U.S. deal" title="China U.S. deal" border="0" loading="lazy" src="//www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Asia/thumb/china-us-deal.png?1591119468" /> </div> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714648-zai-lab-pfizer-team-up-to-widen-china-access-to-antibacterial-xacduro">Zai Lab, Pfizer team up to widen China access to antibacterial Xacduro</a> </h2> <div class="abstract issue-articles-list__teaser">Zai Lab and Pfizer Inc. are teaming up in China to fight the deadly carbapenem-resistant <em>Acinetobacter baumannii</em> (CRAB) infection with novel antibacterial drug Xacduro (sulbactam-durlobactam). Through the collaboration, Zai Lab will leverage Pfizer’s commercial infrastructure in the anti-infective space to widen access to Xacduro in mainland China. Terms of the deal were not released. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714648-zai-lab-pfizer-team-up-to-widen-china-access-to-antibacterial-xacduro">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714649-celltrion-wins-korea-approvals-of-prolia-xgeva-biosimilars">Celltrion wins Korea approvals of Prolia, Xgeva biosimilars</a> </h2> <div class="abstract issue-articles-list__teaser">The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714649-celltrion-wins-korea-approvals-of-prolia-xgeva-biosimilars">Read More</a></div> </div> <div class="record issue-articles-list__article"> <div class="image issue-articles-list__image"> <img width="650" height="487" alt="Regulatory-US-FDA-HQ.png" title="Regulatory-US-FDA-HQ.png" border="0" loading="lazy" src="//www.bioworld.com/ext/resources/Stock-images/Regulatory/thumb/Regulatory-US-FDA-HQ.png?1587508313" /> </div> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714650-former-fda-chief-hamburg-notes-challenging-times-post-trump-win">Former FDA chief Hamburg notes ‘challenging’ times post-Trump win</a> </h2> <div class="abstract issue-articles-list__teaser">Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714650-former-fda-chief-hamburg-notes-challenging-times-post-trump-win">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714651-two-stelara-biosimilars-among-15-us-fda-approvals-in-october">Two Stelara biosimilars among 15 US FDA approvals in October</a> </h2> <div class="abstract issue-articles-list__teaser">The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714651-two-stelara-biosimilars-among-15-us-fda-approvals-in-october">Read More</a></div> </div> <div class="record issue-articles-list__article"> <div class="image issue-articles-list__image"> <img width="650" height="487" alt="Illustration of gut bacteria on scales being evaluated by AI chip" title="Illustration of gut bacteria on scales being evaluated by AI chip" border="0" loading="lazy" src="//www.bioworld.com/ext/resources/BWS/BWS-source/thumb/EMBL-Bork-Gut-hero.jpg?1731686299" /> </div> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714819-machine-learning-links-microbiome-composition-to-bacterial-load">Machine learning links microbiome composition to bacterial load</a> </h2> <div class="abstract issue-articles-list__teaser">Many studies have linked the presence of specific bacteria to various diseases. But a general overgrowth of gut bacteria can be a symptom of different conditions, including colorectal cancer and inflammatory bowel disease. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714819-machine-learning-links-microbiome-composition-to-bacterial-load">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714815">Healing the health divide: BioWorld reports on women’s health space</a> </h2> <div class="abstract issue-articles-list__teaser">It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. Women’s health has traditionally focused on what Seema Kumar, the CEO of Cure, coined as the “bikini zone.” However, reproduction and breast health are a drop in the bucket when it comes to women’s health. In this multipart, in-depth series, BioWorld provides insight into the oft-overlooked space of women’s health, exposing the disparities in research and funding while looking toward future opportunities for bridging the gender gap in health care. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714815">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714818-bioworld-insider-podcast-healing-the-health-divide-for-women">BioWorld Insider Podcast: Healing the health divide for women</a> </h2> <div class="abstract issue-articles-list__teaser">As a new <em>BioWorld</em> <a href="https://www.bioworld.com/womens_health">investigative report shows</a>, decades of research excluding women from clinical trials and investment decisions made in male-dominated boardrooms have led to half the world’s health needs being underserved. Karen Carey, <em>BioWorld</em>’s managing editor and chief analyst, and the managing editor of <em>Bioworld Science</em>, Anette Breindl, join <a href="https://www.bioworld.com/media/podcasts/532-bioworld-insider-podcast/play/53-healing-the-health-divide-for-women" id>this episode of the BioWorld Insider podcast</a> to talk about the business and the science of women’s health. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714818-bioworld-insider-podcast-healing-the-health-divide-for-women">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714816-money-raised-by-biopharma">Money raised by biopharma</a> </h2> <div class="abstract issue-articles-list__teaser">Total raised in public, private and other financings of biopharma companies, comparing 2019-2024. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714816-money-raised-by-biopharma">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714817-biopharma-money-raised-jan-1-nov-21-2024">Biopharma money raised: Jan. 1-Nov. 21, 2024</a> </h2> <div class="abstract issue-articles-list__teaser">Year-to-date money raised in public, private and other financings of biopharma companies. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714817-biopharma-money-raised-jan-1-nov-21-2024">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714656-appointments-and-advancements-for-nov-22-2024">Appointments and advancements for Nov. 22, 2024</a> </h2> <div class="abstract issue-articles-list__teaser">New hires and promotions in the biopharma industry, including: Paragon, Realta. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714656-appointments-and-advancements-for-nov-22-2024">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714657-financings-for-nov-22-2024">Financings for Nov. 22, 2024</a> </h2> <div class="abstract issue-articles-list__teaser">Biopharmas raising money in public or private financings, including: Cidara, Intensity, Tearsolutions, Verrica. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714657-financings-for-nov-22-2024">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714658-in-the-clinic-for-nov-22-2024">In the clinic for Nov. 22, 2024</a> </h2> <div class="abstract issue-articles-list__teaser">Clinical updates, including trial initiations, enrollment status and data readouts and publications: Lapix, Lumos, Pyxis. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714658-in-the-clinic-for-nov-22-2024">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714659-other-news-to-note-for-nov-22-2024">Other news to note for Nov. 22, 2024</a> </h2> <div class="abstract issue-articles-list__teaser">Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alloy, Ayrmid, Biolinerx, Gamida, Pep2tango, Primefour, Takeda, Transposon. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714659-other-news-to-note-for-nov-22-2024">Read More</a></div> </div> <div class="record issue-articles-list__article"> <h2 class="headline issue-articles-list__headline"> <a href="https://www.bioworld.com/articles/714660-regulatory-actions-for-nov-22-2024">Regulatory actions for Nov. 22, 2024</a> </h2> <div class="abstract issue-articles-list__teaser">Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Inxmed, Jazz, Nurix. <a class="issue-articles-list__more-link more" href="https://www.bioworld.com/articles/714660-regulatory-actions-for-nov-22-2024">Read More</a></div> </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 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