SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, which are the same type of cells and process used for the pro

April 17, 2024 (GLOBE NEWSWIRE) -- The rates of precancerous skin conditions and skin cancers are soaring in many parts of the world. Actinic keratosis (AK) is the most common form of precancer, with over 40 million Americans a year developing this condition. Treating AKs before the cells become cancerous and spread to other parts of the body is crucial. For those patients with multiple AKs, common treatment options are chemotherapy creams and photodynamic therapy. Although effective, these tr

Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks The twice-yearly, 10-minute SC injection has the potential to expand the usage of OCREVUS to treatment centres without IV infrastructure or with IV capacity limitations U.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S.

New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis Data support frexalimab as a potential first-in-class, high-efficacy, non-lymphocyte depleting treatment for relapsing multiple sclerosis 96% of participants receiving high-dose intravenous frexalimab had no new Gd+ T1 lesions and an annualized relapse rate of 0.04 after 48 weeks Sanofi has initiated global phase 3 studies of frexalimab in relapsing MS and non-relapsing secondary progressive M

Long term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p Significantly improved clinical outcomes associated with long-term daily oral CNM-Au8® 30 mg treatment (change from original baseline; p Long-term CNM-Au8 treatment, encompassing up to three years, was well-tolerated; no significant safety findings were observed First Phase 2 clinical MS tr

April 16, 2024 -- Jaya Biosciences, Inc. (“JayaBio” or “the Company”), a privately held early-stage life-sciences company developing CNS-directed gene therapies for unmet needs in the neurodegenerative diseases, reported preclinical data at the 45th Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD), a leading research conference on inherited metabolic diseases, including lysosomal diseases. During a podium presentation, Jaya Biosciences’ scientific founder and science adv

April 16, 2024 -- Sentia Medical Sciences Inc. today announced that they have further extended a research collaboration with Neurocrine Biosciences, Inc. (Nasdaq: NBIX) aimed at discovering novel, long-acting corticotropin-releasing factor (CRF) receptor antagonist peptide therapeutics. The collaboration will continue to leverage Sentia’s proprietary peptide-based platform and Neurocrine’s drug development expertise in CRF biology to develop and commercialize medicines with the potential to tre

IGC Pharma公司今天宣布，2期临床试验的中期数据显示，其在研疗法IGC-AD1在治疗阿尔茨海默病患者的激越症状时，与安慰剂相比，在治疗第二周已显示出具有临床意义的症状减轻。 IGC-AD1是一种基于THC的复方配方，THC是大麻中具有精神活性的大麻素。IGC-AD1旨在针对神经炎症和CB1受体功能障碍，目前正在2期临床试验中接受检验，治疗阿尔茨海默病。 这一结果采用Cohen Mansfield激越量表（CMAI）评估基线和第2周测量的激越症状变化，显示出效应值（effect size）为0.79（p=0.071），表明疗法组与安慰剂组之间存在大幅度差异。新闻稿指出，在2023年获批治疗阿尔茨海默病激越症状的疗法在3期临床试验中，治疗12周后的CMAI效应值为0.5。这一结果显示了IGC-AD1作为一种治疗选择的潜力。2003年发表的一项研究表示，效应值超过0.5意味着患者的变化对细心的观察者来说是明显的。 这项正在进行的临床试验是一项多中心、随机双盲、安慰剂对照研究（n=146），旨在评估IGC-AD1治疗阿尔茨海默病相关痴呆症患者的激越症状的安全性和有效性。迄今为止，患者已

4月15日，中国国家药监局药品审评中心（CDE）官网公示，信达生物1类新药IBI133获批临床，拟开发治疗不可切除的局部晚期或转移性实体瘤。根据信达生物公开资料，这是一款靶向HER3的抗体偶联药物（ADC）。 HER3是受体酪氨酸激酶EGFR家族的成员之一，其在实体瘤中广泛表达，与肿瘤生长扩散、耐药和不良预后相关。研究显示，HER3可能在高达75%的非小细胞肺癌（NSCLC）患者中表达，因此它也成为治疗NSCLC的潜在靶点。靶向HER3的各种药物的研发已在EGFR突变/TKI耐药的肿瘤治疗中开始展现出一定前景。 根据ClinicalTrials官网，信达生物已经在澳大利亚启动了IBI133治疗晚期或转移性实体瘤的1/2期、首次人体临床研究。该研究将探索IBI133单药治疗的最大耐受剂量（MTD）和推荐扩展剂量，以及该产品单药治疗在特定肿瘤人群中的疗效、安全性和耐受性。 近期，信达生物的ADC管线迎来较为密集的进展：今年4月，信达生物在美国癌症研究协会（AACR）会议上展示了靶向Claudin18.2的ADC（IBI343）的临床前发现及特征；今年3月，信达生物两款ADC产品在中国获批临

4月16日，中国国家药监局（NMPA）官网最新公示，康泰生物全资子公司民海生物申报的水痘减毒活疫苗上市申请已获得批准。根据康泰生物此前公告，该疫苗适用于12月龄以上健康水痘易感人群，接种后可刺激机体产生抗水痘-带状疱疹病毒的免疫力，用于预防水痘。 水痘是水痘-带状疱疹病毒原发感染的临床表现，是儿童时期常见的一种急性、高传染性疾病，通常表现为轻症自限性疾病，伴有发热和特征性皮肤疱疹，偶尔会出现严重的并发症。成人发生水痘虽然比较少见，但出现严重并发症的概率明显增加。水痘病毒的主要传播途径为呼吸道飞沫传播、直接接触传播、母婴垂直传播，也可通过污染的用具传播。儿童与带状疱疹患者接触亦可发生水痘。 目前接种水痘疫苗已成为有效的水痘预防措施。根据民海生物此前新闻稿，该公司于2022年3月收到《冻干水痘减毒活疫苗1、3期临床试验总结报告》，其研发的冻干水痘减毒活疫苗的临床研究阶段工作已经顺利完成。研究结果显示，该公司研制的冻干水痘减毒活疫苗对1岁至55岁健康水痘易感人群具有良好的免疫原性及安全性。 减毒活疫苗是指病原体经过处理减弱了毒性，但还有一定繁殖能力的疫苗。它能使人体产生类似自然感染的过程，但