Lucy Scientific Discovery Inc. (“Lucy” or “the Company”) (NASDAQ: LSDI), a Nasdaq-listed licensed producer of compounds for medicinal products, is pleased to announce a partnership with TheraPsil to advance medical psilocybin access and research. TheraPsil is a prominent non-profit organization that advocates for legal, compassionate access to psilocybin therapy for Canadians in medical need. TheraPsil supports patients with their applications for ministerial approval of psilocybin for medical

Sania emerges from stealth mode and presents key proof-of-concept data at ASGCT 2023 Launching core technology platforms which enable the precision delivery of proteins for neuromodulation Team combines world-leading scientific pioneers with industry drug development expertise 17 May 2023, Sania Therapeutics (the “Company”), focused on developing genetic medicines for neural circuit dysfunction, launches today by unveiling its suite of proprietary patented platforms at the American Society of Ge

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that England’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia® for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis. The decision follows authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022. “The recommendation of Kapruvia® by NICE is a key step on our journe

- Geographic atrophy (GA) program introduced with complement Factor I (CFI), a key component of the complement cascade, as a payload and utilizing two intravitreal (IVT) capsids, 7m8 and LSV1 - - IVT administration of AAV-CFI using either the 7m8 or LSV1 capsid resulted in high expression levels and was well tolerated in non-human primates (NHPs) - - Presented data on an optogenetics program utilizing an engineered melanopsin mutant that could serve as a therapeutic transgene for optogenetic vis

2023年5月18日，礼来PD-1激动剂抗体Peresolimab治疗类风关2a期临床数据发表在新英格兰医学杂志上。 Peresolimab为全球首款的PD-1激动剂抗体。 该2a期临床入组98例中至重度难治性类风关患者，按1:1:2分组，分别接受安慰剂、30mg Peresolimab、700mg Peresolimab治疗。 研究达到了主要终点，疾病活动指数DAS28-CRP显著低于安慰剂组，次要终点ACR20响应率、ACR50响应率等在高剂量组也得到显著提高。 安全性方面，治疗组与安慰剂组副作用发生率相当，表明Peresolimab有很好的耐受性。 总结 在PD-1抑制剂抗体围绕肿瘤领域展开激烈竞争的时候，礼来率先完成了PD-1激动剂抗体的初步临床概念验证，礼来还在探索系统性红斑狼疮等适应症。期待PD-1激动剂抗体在自身免疫病领域经过后期临床验证，续写PD-1的新传奇。 内容来源于网络，如有侵权，请联系删除。

中国国家药监局（NMPA）官网公示，卫材（Eisai）抗癫痫新药吡仑帕奈口服混悬液已获得批准。根据中国国家药监局药品审评中心（CDE）优先审评公示，该产品本次获批适应症为：成人和4岁及以上儿童癫痫部分性发作（伴有或不伴有继发全面性发作）的治疗。 癫痫是最为常见的神经疾病之一，极度影响了患者正常生活。其中，部分发作性癫痫患者占到了60%。癫痫的发作与大脑有关——大脑中充满了电信号，但当大脑内突然出现强烈的电信号爆发，就会影响大脑正常的功能，诱发癫痫发作。 卫材研发的吡仑帕奈（perampanel，商品名：卫克泰）是一款选择性、非竞争性的AMPA（α-氨基-3-羟基-5-甲基-4-异恶唑丙酸）受体拮抗剂，它通过靶向抑制突触后膜上AMPA受体的谷氨酸活性，从而降低与癫痫发作相关的神经元的过度兴奋。2020年1月，吡仑帕奈片在中国上市，用于加用治疗12岁及以上癫痫患者的部分性癫痫发作（伴或不伴继发性全面性癫痫发作）。2021年7月，吡仑帕奈片在中国获批新适应症，用于成人和4岁及以上儿童癫痫部分性发作（伴有或不伴有继发全面性发作）的治疗。 此次在中国获批上市的为吡仑帕奈的口服混悬液。据卫材早前发

药物研发进展 1.拜耳创新疗法非奈利酮在中国获批拓展适应症 5月17日，拜耳（Bayer）宣布，中国国家药品监督管理局（NMPA）批准非奈利酮（finerenone，英文商品名为Kerendia）的拓展适应症，以纳入3期FIGARO-DKD研究的心血管获益结果。该研究表明，非奈利酮降低了1-4期与2型糖尿病（T2D）相关慢性肾病（CKD）患者的心血管事件风险。此次批准也使得非奈利酮在中国的适应症扩展至与2型糖尿病相关的慢性肾脏病的早期阶段。非奈利酮是一种非甾体选择性盐皮质激素受体拮抗剂，在临床前研究中显示可阻断盐皮质激素受体过度激活造成的有害影响。在糖尿病患者中，盐皮质激素受体过度激活被认为会通过靶器官的炎症和纤维化，导致慢性肾病进展和心血管受损。在中国，非奈利酮于2022年6月获得NMPA首次批准，用于与2型糖尿病相关的慢性肾脏病成人患者（肾小球滤过率估计值[eGFR]≥25至<75mL/min/1.73㎡，伴白蛋白尿），可降低eGFR持续下降、终末期肾病的风险。根据拜耳公开资料，非奈利酮用于治疗与2型糖尿病相关的慢性肾脏病患者的3期临床项目纳入了全球13000多名患者，该项目

Elevar Therapeutics, Inc., a wholly owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresecta

Six abstracts to be presented demonstrating efficacy and tolerability of investigational Bylvay in select cholestatic liver diseases New data emphasizes the consistent benefit of Bylvay as an investigational drug in Alagille syndrome and an approved medicine in PFIC, with evidence of rapid, sustained, and significant improvements in pruritus and sleep, and reductions in serum bile acids (sBAs) Further data shows evidence of disease modification with longer-term native liver survival in PFIC pati

Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS) trials Phase II study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo The safety profile of fenebrutinib was consistent with previous and ong