VYVGARTⓇ is the first-and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada Approval based on the positive Phase 3 ADAPT trial (p001) showing 68% of VYVGART-treated patients were responders on the MG-ADL scale compared to 30% of placebo patients after one treatment cycle argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Health Canada has issued a Notice o

Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to Humira® (adalimumab). The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted A

- Research study demonstrates regulation of chromatin structure and cancer gene expression – - Findings to augment clinical trial in liver cancer - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced new research findings uncover

Klebsiella pneumoniae is responsible for severe infections and stands out for its high resistance to antibiotics PHAXIAM's anti-Klebsiella pneumoniae phages to enter pre-clinical development to assess their efficacy in lung, blood and urinary tract infections, in addition to the three major targets already developed (S. aureus, P. aeruginosa, E. coli) PHAXIAM Therapeutics (Nasdaq & Euronext: FR0011471135), today announces the launch of a new preclinical development targeting a strong antimicrobi

非酒精性脂肪性肝病(NAFLD)从非酒精性脂肪肝(NAFL)发展到非酒精性脂肪性肝炎(NASH)，NASH是NAFLD的进行性亚型，肝细胞死亡引发炎症，导致纤维化。NASH发生在约20%-30%的NAFLD患者中，其特征是慢性脂质堆积、肝损伤(肝细胞肿胀、细胞凋亡和灶性坏死)以及涉及免疫细胞招募和激活的小叶和/或门脉炎症。 慢性肝细胞死亡会触发修复性反应，最终导致纤维化。NASH是导致肝移植和肝细胞癌的主要原因。据估计，NAFLD发生在大约25%的人口中，NASH的患病率估计为~20%。从NAFL到NASH的转变机制是复杂的，大约15%的NASH患者进展为肝硬变，这些人发展为肝细胞癌的易感性增加。 近日，来自耶鲁大学医学院的研究者们在Nature Communications杂志上发表了题为“MKP1 promotes nonalcoholic steatohepatitis by suppressing AMPK activity through LKB1 nuclear retention”的文章，该研究揭示了MKp1通过LKB1核滞留抑制AMPK活性促进非酒精性脂肪性肝炎。 非酒

来自长庚大学的陈锦宏团队进行了一项大规模队列研究，探讨了抗抑郁药物与HCC预后之间的关联。研究发现，确诊HCC后使用抗抑郁药物与总体死亡风险降低31%有关，与癌症特异性死亡风险降低37%有关。 研究发表在JAMA Network Open上。 研究数据来自台湾健康保险计划。抗抑郁药物分为SSRIs、SNRIs和TCA 3类。诊断前使用抗抑郁药物定义为在确诊HCC前1年内至少服用1种抗抑郁药物，诊断后使用抗抑郁药物定义为首次确诊HCC至2017年底或患者死亡期间服用至少1种抗抑郁药物。主要研究结果为患者总死亡率和癌症特异性死亡率。 1999年至2017年间，共308938名患者确诊HCC；其中诊断前使用抗抑郁药物的患者21202名，对照组为287736人；诊断后使用抗抑郁药物的患者66211名，对照组235083人。大多数确诊HCC患者为老年人，诊断前后使用抗抑郁药物的65岁以上患者比例分别为53.4%和40.8%，男性患者比例分别为42.7%和57.9%。 在诊断前使用抗抑郁药物的患者中，抗抑郁药物使用组的总体死亡率为15.68人/100人年，未使用组为12.14人/100人年。在HC

LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS). The clinical tria

– Preliminary Data Support Progression to Phase 2a Proof of Concept Trials in T cell-mediated Autoimmune Diseases – Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138. Preliminary data from the MAD trial demonstrated: that ATI-2138 was general

欧盟委员会（EC）已批准替雷利珠单抗用于经治晚期或转移性食管鳞状细胞癌（ESCC）患者 美国食品药品监督管理局（FDA）已受理用于一线晚期ESCC患者的上市许可申请 百济神州（纳斯达克代码：BGNE；香港联交所代码：06160；上交所代码：688235）是一家全球性生物科技公司。公司今日宣布，欧盟委员会（EC）已批准替雷利珠单抗（中文商品名：百泽安®；英文商品名：TEVIMBRA®）作为单药用于治疗既往接受过含铂化疗的不可切除、局部晚期或转移性食管鳞状细胞癌（ESCC）的成人患者。美国食品药品监督管理局（FDA）也已经受理替雷利珠单抗的一项上市许可申请，用于一线治疗不可切除的局部晚期、复发或转移性的ESCC患者。 百济神州实体瘤首席医学官Mark Lanasa医学博士表示："我们无比兴奋，替雷利珠单抗获得了EC的上市批准和FDA的上市申请受理，且公司最近也收回了这一重要药物在全球的完整权益。这对于晚期或转移性ESCC患者而言是重大里程碑，无论单药使用还是化免联合，替雷利珠单抗已为全球患者带来深具临床意义的生存获益。我们很自豪能将这一开创性的疗法带给欧洲患者，并可能惠及美国患者。我们将继

2017年美国FDA批准首个基因疗法Kymriah（tisagenlecleucel）用以急性淋巴细胞白血病（ALL）治疗以来，基因疗法领域在近年不断有所突破。然而尽管该领域持续进展，关于如何将基因载体有效率地递送至肝脏以外的器官与组织以扩大基因疗法的应用范围，一直是产业面对的挑战也是基因疗法领域突破的关键。对此，再生元（Regeneron）发现一项简单的方式——将抗体与病毒载体相连以靶向目标器官——或许是战胜递送挑战直接、有效的方式。 无论是直接使用病毒还是脂质纳米颗粒，基因载体在体内的递送最终多聚集在人体的清除器官——肝脏——当中。若是为了增加抵达肝脏以外靶器官的基因载体数量而提高剂量，常常会导致肝脏负荷过重而造成病患因肝毒性而死亡。因此基因疗法的开发目前多集中于那些肝细胞中异常表达的基因，例如靶向PCSK9以降低胆固醇。又例如目前美国FDA正在审评的镰状细胞CRISPR基因编辑疗法，通过使用接近移植手术的离体过程来避免递送问题。 凭着其在抗体领域多年来累积的专业知识与经验，再生元正在进行早期研究，打算将抗体连接于标准病毒载体之上，以促进载体专一性地进入特定细胞当中。目前该公司专注