July 24, 2024 -- ConSynance Therapeutics, Inc., a clinical-stage biopharmaceutical company developing first-in-class therapies for rare central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to its investigational drug CSTI-500 for the treatment of Prader-Willi Syndrome (PWS) in children and adolescents. “Receiving RPDD from the FDA is a significant regulatory milestone for ConSynance as we

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Sandoz launches biosimilar Pyzchiva® (ustekinumab) across Europe, to treat chronic inflammatory diseases Launch across Europe, starting today, strengthens well-established Sandoz immunology portfolio in Europe, leveraging existing footprint Pyzchiva® first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130mg vial initiation dose for Crohn’s disease Pyzchiva® to treat adults with

July 23, 2024 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) resubmission for Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). FDA considers the resubmission to be a complete response and Mesoblast anticipates a decision on or before

July 24, 2024 -- Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), announced today the issuance of a U.S. patent for methods of treating acute traumatic brain injuries (TBI) with its lead drug candidate, buntanetap. In 2016, the Company filed a patent covering the treatment of various nerve insults, including TB

July 24, 2024 -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor cell growth and improved survival in a mouse model. “Therapeutic Anti-Tumor Efficacy of DC-Ba

July 23, 2024 -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to pushing the boundaries of neuroscience, today announced that the first patient has been dosed in the RECONNECT Phase 2 clinical trial of RE104 for the treatment of postpartum depression (PPD). RE104 was designed to be a safe, fast-acting, single-dose therapy to benefit patients suffering from underserved mental health disorders, including PPD. “Dosing the first patient in our RECONNECT Phase 2 t

July 24, 2024 -- Beacon Biosignals, a leader in at-home sleep monitoring and computational neurodiagnostics, today announced a strategic collaboration with Skye Bioscience, Inc. (Nasdaq: SKYE), a pharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, to enhance its upcoming CBEYOND™ Phase 2 clinical trial of Nimacimab. This partnership will incorporate sleep quality and sleep apnea endpoints via the Beacon Platform and the FDA 510(k)-cleared Dreem 3S EEG devi

RC28-E注射液是荣昌生物开发的用于治疗眼科疾病的全球首创VEGF/FGF双靶标融合蛋白药物。7月20日，一项RC28-E治疗湿性年龄相关性黄斑变性（wAMD）的Ib期临床研究，发表于国际眼科权威期刊《眼科和治疗》（Ophthalmology and Therapy） 《眼科和治疗》是一本专注于医学眼科学领域的国际权威期刊，致力于发表最新眼科治疗、临床实践指南和创新技术等研究成果，该刊被SCI、SCIE等多个国际数据库摘要和索引收录。 本次发表的是RC28-E注射液多次玻璃体腔给药治疗wAMD的非随机、开放、多中心临床研究。该研究由北京医院戴虹教授牵头完成，为期48周，旨在评估RC28-E多次给药的安全性，初步评价有效性。 研究结果显示，RC28-E（0.5mg~2.0mg）治疗wAMD患者表现出良好的安全性及耐受性，试验中发生的不良事件（AE）大多为轻度或中度，最常见的是轻微的注射相关结膜下出血（16.2%）。第48周时，RC28-E注射液0.5、1.0和2.0mg组的最佳矫正视力（BCVA）和黄斑中心区视网膜厚度（CST）在治疗1年后均能得到明显改善。此外，本研究纳入了46%的

Transposon Therapeutics今天宣布其在研逆转录酶抑制剂TPN-101治疗肌萎缩侧索硬化（ALS）患者2期试验的最终结果，这些患者的C9orf72基因具有六核苷酸重复扩增（C9orf72相关的ALS）。分析显示，TPN-101治疗可显著降低ALS疾病进展，并减缓患者的肺活量（VC）下降情形。Transposon计划将TPN-101推进至用以治疗C9orf72相关ALS患者的3期研究。 ALS是一种进行性且普遍致命的神经退行性疾病。呼吸衰竭是ALS患者最常见的死亡原因之一。肺活量是评估呼吸功能的客观指标，与ALS患者的死亡率相关。分析显示，在试验24周，接受TPN-101治疗的ALS患者的VC下降约为对照组的一半（最小二乘[LS]平均值变化为-8.4% vs -16.5%）。当对照组患者在开放标签期转换为TPN-101治疗时，随后的24周内VC下降（-7.2%）不到他们在双盲期的一半，并且与双盲期中TPN-101组的下降率相当。 在24周的双盲期内，TPN-101组和对照组之间在修订的ALS功能评分量表（ALSFRS-R）上的下降相当（LS均值为-7.2分vs -6.

近日，中国国家药监局药品审评中心（CDE）官网公示，3.1类新药罗莫佐单抗注射液上市申请已获得受理，根据临床试验进展，推测此次申报的适应症为骨质疏松症。 罗莫佐单抗是优时比和安进（Amgen）共同开发的骨硬化蛋白 (sclerostin)单克隆抗体，通过特异性抑制骨硬化蛋白，提高骨形成并降低骨吸收从而降低骨折风险。2019年1月，罗莫佐单抗首次在日本获批，用于治疗高骨折风险的骨质疏松症。2019年4月，罗莫佐单抗获得美国FDA批准，用于治疗具有高骨折风险的绝经后妇女的骨质疏松症。 根据中国药物临床试验登记与信息公示官网，在中国，安进和优时比公司已经完成一项3期临床研究，该研究旨在中国绝经后骨质疏松症女性中评价罗莫佐单抗的疗效、安全性和耐受性。该研究实际入组总人数为327人。罗莫佐单抗的给药途径为皮下注射，每次两支 （210mg），每月一次，共计给药12个月。 Wnt信号通路对骨骼发育和骨量调节都至关重要。正常情况下，Wnt蛋白与七跨膜受体（Frizzled）、低密度脂蛋白受体相关蛋白5/6（LRP5/6）结合，形成多聚体，从而导致LRP5或LRP6的细胞质尾部磷酸化，从而使蛋白A