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A roundup of the most newsworthy healthcare press releases from PR Newswire, including Zimmer Biomet's acquisition of Paragon 28, Icy Hot's partnership with Unrivaled and three major health news trends from January. NEW YORK, Feb. 7, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, January 2025. Photos provided by Icy Hot, March of Dimes Inc. and BD (Becton, Dickinson and Company). Zimmer Biomet Announces Definitive Agreement to Acquire Paragon 28 "This proposed transaction further diversifies Zimmer Biomet's portfolio outside of core orthopedics and positions us well in one of the highest growth specialized segments in musculoskeletal care…," said Ivan Tornos, President and Chief Executive Officer of Zimmer Biomet. Icy Hot Signs on as Official Recovery Partner of Unrivaled Icy Hot will serve as the Official Recovery Partner of the groundbreaking professional women's basketball league. Icy Hot will provide topical pain relief products to players during games and practice sessions, and in recovery and training facilities throughout the nine-week season. AbbVie and Neomorph Announce Collaboration to Develop Molecular Glue Degraders for Oncology and Immunology "We are excited to collaborate with Neomorph to develop novel molecular glue degraders which could pave the way for new, effective therapies in the treatment of immune disorders and cancer," said Steven Elmore, vice president, small molecule therapeutics and platform technologies at AbbVie. Michael J. Fox Honored with Presidential Medal of Freedom The nation's highest civilian honor recognizes his tireless advocacy and dedication to speeding a cure for Parkinson's disease. "I'm grateful for this recognition, which I share with the patients, families and researchers who have brought us closer than ever to ending Parkinson's disease once and for all," said Fox. Ginkgo Bioworks Partners with Universal Cells, an Astellas Company, to Advance Next-Generation iPSC-Derived Cell Therapies for Solid Tumors iPSC-derived cell therapies have the potential to transform cancer care by offering scalable, 'off-the-shelf' treatment options. The companies aim to accelerate the development of more potent and durable cell therapies while maintaining manufacturability at scale. Eirion Therapeutics Announces Potential Breakthrough Treatment for Hair Loss Based on First-in-Man Clinical Trial Results "We believe that ET-02 has the potential to not only treat but prevent androgenic alopecia. The results of this clinical trial show we are an important step closer to potentially having a solution for hair loss," said Jon Edelson, MD, CEO and President of Eirion. Variant Bio Announces Multi-Year Research Partnership with Novo Nordisk to Discover Novel Targets for Metabolic Disease "Metabolic disease - including obesity - affects people all over the world, yet newer targets with genetic evidence are primarily based on studies with European-ancestry populations. As a result, there is still an unmet need in this space," said David Moller, Chief Scientific Officer at Variant Bio. Panasonic Well Sets the Stage for the Future of Family Wellness in Opening Keynote at CES 2025 Families are at their breaking point as chronic stress, disconnection, and fragmented wellness solutions are taking a toll, and the call for help is loud and clear. To confront the mounting wellness imperatives families face in their daily lives, Panasonic Well CEO Yoky Matsuoka, took the stage to introduce the next step in building a comprehensive wellness ecosystem to support families. SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression This approval, which was granted following FDA Priority Review, is supported by positive results from the randomized, double-blind, multicenter, placebo-controlled study in which SPRAVATO® alone showed a rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours. GORTEC Announces New Trial Success for Head and Neck Cancer Treatment "This is the first time in decades where a therapy demonstrated superiority over standard of care cisplatin-radiotherapy in high-risk patients with [locally advanced squamous cell carcinoma of head and neck] LA-SCCHN," said Prof Jean Bourhis, Principal Investigator of the study and Medical Director of the GORTEC. Viking Therapeutics Announces Initiation of Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity Company announced the initiation of a 13-week study to evaluate the safety and efficacy of oral VK2735 dosed once daily. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity. Boston Scientific Announces Agreement to Acquire Bolt Medical, Inc. The acquisition is expected to further Boston Scientific's strategy to address coronary and peripheral disease. "Bolt Medical is developing a next-generation technology that is highly complementary to our existing portfolio. The addition of this system to our offerings can help us better serve physicians and their patients," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer. For maintenance treatment, once every four weeks dosing regimen may be easier than once every two weeks dosing for patients and care partners to continue treatment for early Alzheimer's Disease. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Trending Topics Among the health news that was distributed in January, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. Cervical Cancer Awareness Month: January saw an increased focus on women's health, with our team noting a surge in new medical guidelines and concerning research findings. The American Cancer Society released data showing cancer mortality continues to decline despite rising incidence in women. New ASCCP guidelines introduced more precise screening methods, while survey results revealed many women are skipping critical OB-GYN exams - highlighting ongoing challenges in cervical cancer prevention and detection. Maternal Health Awareness Day: The maternal health crisis generated significant wire activity surrounding Maternal Health Awareness Day, which was observed on Jan. 23. March of Dimes celebrated historical White House engagement on the issue and healthcare providers shared promising results from innovative programs, including MedStar Health's Safe Babies Safe Moms initiative and Preeclampsia Foundation's creative intervention targeting Black maternal health. California Wildfires Response: As wildfires devastated the Los Angeles area, PR Newswire distributed a wave of announcements as organizations across sectors mobilized support for affected communities. Healthcare providers like CVS Health, DaVita and Magellan Health ensured continued care and crisis support. Fitness chains including 24 Hour Fitness and Crunch opened their facilities to displaced residents. Specialized assistance came from organizations like Braille Institute supporting visually impaired individuals, while companies donated air purifiers and other relief supplies to vulnerable populations. All news releases related to severe storms and extreme weather events across the U.S. can be found here. Looking ahead: PR Newswire anticipates significant wire activity in February around American Heart Month, with releases spotlighting cardiovascular health innovations and awareness campaigns. Early February announcements are expected to focus on cancer research breakthroughs around World Cancer Day (Feb. 4), while health equity themes will likely dominate coverage of National Black HIV/AIDS Awareness Day (Feb. 7). Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

全球药物批准/研发动态 01 全球新药批准情况 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）全球（不含中国）共有6个新药获批上市。其中，NDA批准2个，新适应症批准3个，新制剂批准1个。本次统计周期新药批准数量与上次持平。 1月21日，Arctic Vision宣布TGA已正式批准其用于治疗葡萄膜炎性黄斑水肿（UME）的ARCTUS®的新药申请。ARCTUS®是皮质类固醇曲安奈德的专有混悬液，用于脉络膜上腔给药，使药物能够快速、充分地分散到眼睛后部，使药物的作用时间更长，并最大限度地减少对眼睛周围健康部位的伤害，已在美国和新加坡被批准用于治疗葡萄膜炎相关黄斑水肿（UME），目前正在研究糖尿病性黄斑水肿（DME）和其他眼底疾病。 1月21日，强生公司宣布，FDA批准了SPRAVATO CIII鼻喷雾剂的补充新药申请，使这种创新疗法成为首个针对至少两种口服抗抑郁药均反应不足的患有重度抑郁症（MDD）的成年人的单一疗法。研究显示单独使用SPRAVATO显示出蒙哥马利-阿斯伯格抑郁量表总分的快速和优越改善。在事后分析中，SPRAVATO在第28天展示了所有10个MADRS项目的数值改进，第4周时，服用SPRAVATO的患者中有22.5%达到缓解。SPRAVATO作为独立治疗的安全性与现有的临床和真实世界数据一致。 全球（不含中国）新药批准情况 02 全球新药申报进展 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）全球（不含中国）共有7个新药申报上市。其中，NDA申报6个，BLA申报1个。与上次统计周期相比，本次增加2个NDA/BLA申报。 1月20日，Arrowhead宣布FDA已接受Plozasiran用于治疗家族性乳糜微粒血症综合征（FCS）的新药申请。研究数据显示，在PALISADE中，Plozasiran实现了甘油三酯的深度和持久降低，Plozasiran 25 mg组的基线变化中位数为80%，发生急性胰腺炎的风险统计学显着降低了83%，耐受性普遍良好。 NDA/BLA申报 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）全球（不含中国）共有4个药物药物获监管机构特殊资格认定。其中，生物药4个。与上次统计周期相比，本次增加2个获监管机构特殊资格认定的药物。 1月22日，Replimune Group宣布FDA已受理RP1（Vusolimogene oderparepvec）与抗PD-1抗体Nivolumab联用，治疗晚期黑色素瘤患者的生物制品许可申请（BLA），FDA同时授予该BLA优先审评资格。IGNYTE试验的主要分析结果显示根据RECIST v1.1标准评估，患者的ORR为32.9%，根据mRECIST v1.1评估的CR率为15%。在既往接受过抗PD-1和抗CTLA-4疗法的患者中，ORR为27.7%，在对抗PD-1初始耐药的患者中，ORR为35.9%。患者的中位DOR为21.6个月。 1月23日，再鼎医药宣布FDA已授予ZL-1310孤儿药资格认定（ODD），用于治疗小细胞肺癌（SCLC）。ZL-1310包含人源化抗DLL3单克隆抗体，该抗体与新型喜树碱衍生物（一种拓扑异构酶1抑制剂）连接作为其有效载荷。由新型连接子有效载荷平台TMALIN®设计，该平台能够利用肿瘤微环境克服第一代ADC疗法遇到的相关挑战，包括脱靶有效载荷毒性。 全球获监管机构特殊资格认定药物（部分） 03 全球新药研发进展 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）全球（不含中国）新药临床研发状态更新共计27条，涉及肿瘤、血液和淋巴系统疾病、神经疾病以及心血管疾病等共计9个领域。 其中，肿瘤领域临床进展更新居各领域之首，为7条：化学药3条，生物药3条，疫苗1条。 1月23日，Coherus BioSciences公布其白细胞介素-27（IL-27）靶向抗体Casdozokitug（Casdozo）与PD-L1靶向抗体Atezolizumab（Atezo）和VEGF靶向抗体Bevacizumab（Bev）联合，治疗无法切除的局部晚期或转移性肝细胞癌（HCC）初治患者的II期试验最新数据。分析显示，患者的ORR达38%，CR率为17.2%，PFS为8.1个月，DCR达58.6%，其中有部分患者的肿瘤在接受治疗后完全消退。 1月24日，SELLAS宣布IDMC已完成关键性III期临床试验REGAL的预定中期分析，该试验评估了在研多肽免疫疗法Galinpepimut-S（GPS）治疗急性髓系白血病（AML）的疗效和安全性。分析结果显示，试验参与者的中位总生存期超过12个月，而类似患者群体的预期生存期约为6个月，80%的患者产生了特异性免疫反应。 全球新药研发进展详情（部分） 04 全球医药交易事件 本次统计周期（2025.01.18-01.24）全球（含中国）医药交易时间共计28起，涉及药物权益转让、公司并购等多起交易事件。 全球医药交易时间汇总表（部分） 国内药物批准/研发动态 01 国内新药批准情况 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）国内共有3个新药获NMPA批准上市。其中，BLA批准1个，新适应症批准2个。与上次统计周期相比，本次减少2个NMPA批准新药。 1月20日，科伦博泰宣布联合顺铂和吉西他滨用于一线治疗复发或转移性鼻咽癌（NPC）患者的靶向程序性细胞死亡配体1（PD-L1）的创新人源化单克隆抗体塔戈利单抗（科泰莱®）已获NMPA批准上市。研究结果显示，塔戈利单抗联合顺铂和吉西他滨可获得更优的PFS、更高的ORR和更长的DoR，且无论患者PD-L1表达如何，均可获益，疾病进展或死亡风险降低了53%，ORR为81.7% vs 74.5%，中位DoR为11.7 vs 5.8个月。 1月26日，CDE官网最新公示显示，银诺医药1类新药依苏帕格鲁肽α上市申请已获得批准：用于单药治疗在饮食和运动干预后血糖控制不佳的2型糖尿病以及联合治疗二甲双胍治疗后血糖控制不佳的2型糖尿病。临床研究结果显示，经过24周治疗，3mg剂量组单药治疗较基线的糖化血红蛋白（HbA1c）降幅高达2.2%，联合二甲双胍治疗较基线降幅高达1.8%，单用及联合二甲双胍治疗24周HbA1c达标率为60%~70%。其中，针对于基线HbA1c<8.5%的患者，依苏帕格鲁肽α单用治疗24周HbA1c达标率为81.5%。 国内新药批准情况（部分） 02 国内新药临床默示许可进展 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）国内共有23个新药获临床默示许可，涉及35个受理号。其中，化学药19个，治疗用生物制品4个。与上次统计周期相比，本次减少9个临床默示许可获批受理号。 本周国内新药临床默示许可进展（部分） 03 国内新药申报进展 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）国内共有18个新药申报上市，涉及27个受理号。其中，化药11个，治疗用生物制品6个，预防用是生物制品1个。与上次统计周期相比，本次增加21个新药申报上市受理号。 国内新药申报上市情况（部分） 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）国内共有47个新药申报临床，涉及63个受理号。其中，化学药18个，治疗用生物制品26个，预防用生物制品3个。与上次统计周期相比，本次增加13个临床申报受理号。 国内新药临床申报情况（部分） 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）国内共有1个药物获NMPA特殊资格认定，其中，疫苗1个。与上次统计周期相比，本次减少3个获监管机构特殊资格认定的药物。 1月22日，CDE官网最新公示，康希诺生物申报的吸附无细胞百（三组分）白破联合疫苗上市申请拟纳入优先审评。公开资料显示，这是康希诺生物研发的婴幼儿用吸附无细胞百白破联合疫苗（简称“婴幼儿用DTcP”）。婴幼儿用DTcP的3期临床试验方案中，基础免疫从2月龄开始，接种3剂，每剂之间间隔1或2个月，加强免疫于18～24月龄进行，每人接种1剂。目前婴幼儿用DTcP的III期临床仍在进行中，已完成了基础免疫的接种及数据收集工作，同时取得了基础免疫的临床试验总结报告。 获NMPA特殊资格认定药物 04 国内新药研发进展 根据药渡数据统计分析，本次统计周期（2025.01.18-01.24）国内新药临床研发状态更新共计5条，涉及肿瘤、血液和淋巴系统疾病以及消化系统疾病领域。其中，化学药1条，生物药3条，细胞疗法1条。与上次统计周期相比，本次增加1条国内新药临床研发状态更新。 1月19日，海创药业宣布其自主研发的HP515片用于治疗非酒精性脂肪性肝炎（NASH）的临床试验于近日完成首例受试者入组。HP515片是一种口服高选择性THR-β（甲状腺激素受体β亚型）激动剂，HP515片能直接作用于THR-β激活下游基因转录，通过增强肝细胞脂质代谢活性、提高肝脏脂肪代谢、降低脂毒性达到对非酒精性脂肪性肝炎的改善效果。 1月20日，科济生物宣布靶向CD38的同种异体CAR T细胞疗法KJ-C2320已在研究者发起的试验（IIT）中为一名患者进行了首剂给药。KJ-C2320是基于THANK-uCAR平台开发的，该平台通过修饰供体来源的T细胞来生成具有更好扩增和持久性的同种异体CAR-T细胞。临床研究表明，在THANK-uCAR平台上开发的BCMA CAR-T疗法可以在达到与自体CAR-T相当的完全反应水平的患者中扩展，初步显示出可控的安全性和良好的疗效。 国内新药研发进展（部分） 05 国内新药研发领域政策法规动态 国家药监局药审中心关于发布《预防用mRNA疫苗非临床研究技术指导原则》的通告（2025年第7号） 为规范和指导预防用mRNA疫苗非临床研究与评价，在国家药品监督管理局的部署下，药审中心组织制定了《预防用mRNA疫苗非临床研究技术指导原则》。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。特此通告。 06 国内新药研发领域热点新闻 百济神州，也要上岸了 第43届JPM摩根大通年度医疗健康年会（JPM 2025）虽已落幕，但会上亮相的MNC巨头和中国创新药企并未停下脚步，继续在各自的赛道上奔跑。 回看JPM大会，制药巨头纷纷披露了新战略：强生斥资146亿美元收购Intra-Cellular，强化神经科学领域的布局；默沙东计划在未来几年推出20个“重磅炸弹”；百时美施贵宝（BMS）预计未来五年内推出10款新药，弥补专利悬崖；吉利德表示适当进行并购及合作…… 中国创新药企在大会上奏响了“中国之声”：百济神州表示将实现2025年全年经营利润为正（即营业收入大于营业成本、销售费用、管理费用及研发费用之和）；再鼎医药预计到2028年将有超过15款产品上市，实现20亿美元的营收；传奇生物手握11个在研项目，并与强生一起……更多资讯，请阅读原文 强势来袭：翰森ADC药物全梳理 创立于1995年的翰森制药，几乎伴随了整个中国现代生物医药的发展步伐。90年代到21世纪初期，其以仿制药的首仿起家，奠定了在多个治疗领域的领军地位。随后逐步转向仿创结合的阶段，特别在抗体偶联药物ADC领域，翰森更是通过全面自主创新加速转型，基于BD交易推动实现盈利拐点。短短几年时间内，其已经成为中国乃至全球ADC药物领域的强势力量，本文简要梳理其ADC药物研发管线。 2024年1月，翰森制药在CDE药物临床试验登记与信息公示平台网站上，登记了一项CDH17 ADC药物HS-20110，在多种晚期实体瘤患者中启动一项I期临床试验CTR20250100，这也是公司启动的第五项ADC药物临床试验。更多资讯，请阅读原文 咨询、合作请联系作者 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