Jan. 07, 2025 -- Cyclarity Therapeutics is pleased to announce regulatory approval to begin its first-in-human clinical trial. The trial will be conducted at CMAX, one of Australia’s leading clinical research centers, in partnership with Monash University. This effort will be led by Dr. Stephen Nicholls of the Victorian Heart Institute (VHI), a distinguished leader in cardiovascular medicine. In addition to a traditional SAD/MAD phase 1 trial, the authorization includes an allowance to enroll

The Acquired Portfolio of Infectious Disease Assets Includes a Class of Potential Broad Spectrum Oral Antiviral Agents, TNX-3900 with a Host-Directed Mechanism Tonix Plans to Develop the TNX-3900 Series of Molecules as Oral Antivirals Either as Monotherapy or in Combination with Other Antivirals The TNX-3900 Class of Antivirals Has a Novel Mechanism of Action Based on Inhibition of Certain Cathepsin Proteases which are Required for Cell Infection by Many Viruses like SARS-CoV-2 Sina Bavari, Ph.D

Feb. 06, 2025 -- Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today announced that safety and efficacy data on ATSN-201 for the treatment of X-linked retinoschisis (XLRS) will be presented during a panel discussion at The Macula Society’s 48th Annual Meeting taking place February 12-15, 2025, in Charlotte Harbor, Florida. ATSN-201, a best-in-class gene therapy product candidate, levera

Feb. 05, 2025 -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic and genomic tumor testing and precision medicine, and Lumea Inc., a leader in digital pathology solutions, have signed an agreement to integrate Myriad’s advanced molecular diagnostic tests — Prolaris® Prostate Cancer Test and MyRisk® Hereditary Cancer Test – into Lumea’s digital pathology platform, BxLink™. This collaboration will streamline the ordering and delivery of molecular tests, enabling healthcare providers t

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales of the antifungal Cresemba® (isavuconazole) in Japan exceeded the threshold triggering the first sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to approximately CHF 1.2 million. David Veitch, Chief Executive Officer of Basilea, said: “Japan is a key market

2月8日，中国国家药监局药品审评中心（CDE）官网最新公示，赛诺菲（Sanofi）申报的盐酸非索非那定口服混悬液上市申请获得受理。公开资料显示，非索非那定是一款二代新型抗组胺药。此前非索非那定片已经在中国获批，治疗过敏性鼻炎及慢性特发性荨麻疹。本次申报上市的为口服混悬液剂型。 在人的心血管系统、皮肤、平滑肌及胃部的靶细胞中至少有着4种亚型的组胺受体（H1受体、H2受体、H3受体和H4受体）。其中组胺H1受体主要分布于血管内皮、气道平滑肌等多种细胞，与过敏反应的关系非常密切。靶向组胺H1受体的抗组胺药可将被组胺激活的受体下调至未激活的状态，下调过敏性炎症，减少促炎症细胞因子和细胞黏附分子的表达，并减弱嗜酸性粒细胞等的趋化作用，进而发挥生物学效应。 根据赛诺菲此前新闻稿介绍，非索非那定是二代新型抗组胺药，具有起效快、24小时长效，且不引起嗜睡，脑部受体占有率低等特点。其对H1受体的亲和力较高，表明其较好的心脏安全性。 2021年，赛诺菲研发的盐酸非索非那定片剂剂型获NMPA批准上市，用于过敏性鼻炎及慢性特发性荨麻疹的治疗。目前，赛诺菲已经针对该产品开发了胶囊、片剂、复方制剂等多种剂型

1. 华润双鹤改良型新药获批上市 2月7日，NMPA官网最新公示，华润双鹤申报的改良型新药巯嘌呤微片的上市申请已获得批准。根据CDE优先审评公示，这是一款可精准计量的创新剂型巯嘌呤微片（5mg规格），“体型”缩至芝麻大小。该药本次获批的适应症为：绒毛膜上皮癌，恶性葡萄胎，成人和儿童急性淋巴细胞白血病及急性非淋巴细胞白血病，慢性粒细胞白血病的急变期。巯嘌呤属于抑制嘌呤合成途径的细胞周期特异性药物，是一种硫嘌呤类化疗药物。然而，巯嘌呤的药物相关骨髓抑制和肝毒性可威胁患儿生命，由此导致的化疗中断或停止增加疾病复发风险。实施个体化给药将提高巯嘌呤的疗效和安全性。目前临床已有的巯嘌呤规格为50mg片剂，直径约1厘米，儿童需按每公斤体重计算服用剂。2022年4月，华润双鹤与北京儿童医院达成巯嘌呤微片合作开发共识，开发适合儿童的直径不超过4mm的微型片剂。 2. 科伦博泰「西妥昔单抗」生物类似药获批上市 2月7日，NMPA官网显示，科伦博泰的生物类似药EGFR单抗西妥昔单抗N01注射液（A140）的上市申请已获得批准。根据科伦博泰此前的新闻稿披露，该药的拟定适应症为：本品用于治疗RAS基因野生型的转

2月7日，中国国家药监局（NMPA）官网最新公示，华润双鹤申报的改良型新药巯嘌呤微片的上市申请已获得批准。根据中国国家药监局药品审评中心（CDE）优先审评公示，这是一款可精准计量的创新剂型巯嘌呤微片（5mg规格），“体型”缩至芝麻大小。该药本次获批的适应症为：绒毛膜上皮癌，恶性葡萄胎，成人和儿童急性淋巴细胞白血病及急性非淋巴细胞白血病，慢性粒细胞白血病的急变期。 巯嘌呤属于抑制嘌呤合成途径的细胞周期特异性药物，是一种硫嘌呤类化疗药物。据文献报道，巯嘌呤是儿童急性淋巴细胞白血病、绒毛膜上皮癌、恶性葡萄胎等疾病的重要治疗药物。然而，巯嘌呤的药物相关骨髓抑制和肝毒性可威胁患儿生命，由此导致的化疗中断或停止增加疾病复发风险。实施个体化给药将提高巯嘌呤的疗效和安全性。 根据华润双鹤此前公开资料介绍，目前临床已有的巯嘌呤规格为50mg片剂，直径约1厘米，儿童需按每公斤体重计算服用剂。儿童应用巯嘌呤面临着“吃药靠掰、剂量靠猜”的困境，用药剂量精准度和用药安全难以保证。 2022年4月，华润双鹤与北京儿童医院达成巯嘌呤微片合作开发共识。微片是指直径不超过4mm的微型片剂，是世界卫生组织和中国儿童

中国国家药监局药品审评中心（CDE）官网近日公示，金赛药业申报的1类新药GenSci120注射液获得一项新的临床试验默示许可，拟开发治疗炎症性肠病（IBD），包括溃疡性结肠炎（UC）和克罗恩病（CD）。公开资料显示，GenSci120注射液是一款PD-1激动剂抗体新药，该产品已于今年1月首次在中国获批临床，用于开展治疗成人系统性红斑狼疮、成人原发性干燥综合征的临床试验。 程序性细胞死亡蛋白受体1（PD-1）在肿瘤治疗中已经发挥了极其重要的作用，但这一靶点在自身免疫疾病治疗中的潜力还远远未被发掘。动物模型中已有研究显示，PD-1/L1与多种自身免疫性疾病的发生有关，包括系统性红斑狼疮、心肌炎、类风湿关节炎和炎症性肠病等。该信号通路通过调节淋巴结细胞激活，调节T细胞功能，影响免疫耐受发挥作用。 根据金赛药业此前新闻稿介绍，GenSci120是该公司研发的人源化抗PD-1单克隆抗体，抗体类型为IgG1，通过和PD-1结合并激活PD-1抑制性信号通路以及ADCC效应，从而抑制或杀伤致病性T细胞，发挥相对特异的靶向免疫抑制作用。临床前试验表明，GenSci120注射液能发挥相对特异的靶向免疫

- Primary endpoint achieved by both DURAVYU doses (1.34mg and 2.7mg) with extended time to first supplemental injection versus aflibercept control – - DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a 24-week gain of +7.1 letters and anatomical improvement of 76 microns reduction in CST paired with reduction in treatment burden of two-thirds – Favorable safety profile continues with no DURAVYU-related ocular or systemic SAEs – – Phase 3 non-inferiority pivotal program