Myriad’s Prolaris Test is the only biomarker test to quantify the benefits of adding androgen deprivation therapy to radiation therapy1 May 16, 2024 -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced that JCO Precision Oncology has published a study showing a clinical cell-cycle risk (CCR) score can accurately predict the benefit of adding androgen deprivation therapy (ADT) to radiation therapy (RT) in men with localized prostate cancer. Guid

May 17, 2024 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that topline and subgroup results from the ESLIM-01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association (“EHA”) Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online. ESLIM-01 is a randomized, do

近十年来，生物制药领域正兴起一种新颖的但极具发展前景的治疗方法，那就是微生物组疗法（Microbiome Therapy）。 研究表明，肠道微生物占人体微生物总数的将近80%，人体肠道微生物参与人体代谢，免疫等多种人体正常功能的运行。对于肠道微生态活菌药物的研发也将大有前景。 今天聚焦于肠道微生物治疗领域，呼吁中国肠道微生物组领域的公司们一起加强合作，推动这个领域一起健康持续的发展和壮大。 近十年来，生物制药领域正兴起一种新颖的但极具发展前景的治疗方法，那就是微生物组疗法（Microbiome Therapy）。 各种研究显示人体健康与微生物组有着密切的关系，人体内的微生物是人体不可或缺的重要组成部分。人体肠道微生物基因数量是人体基因数量的100倍以上，人体肠道微生物参与人体代谢，免疫等多种人体正常功能的运行。研究表明，肠道微生物占人体微生物总数的将近80%。 目前研究发现，肠道菌群紊乱会引起多种肠道和肠道外疾病，如炎症性肠病(IBD）、肠易激综合症（IBS）、肥胖（Obesity）、代谢综合症（Metabolic syndrome）、中枢神经系统疾病（CNS）、自身免疫系统疾病（Au

The Data Monitoring Committee recommended to continue the clinical trial without modification of the current protocol, based on the pre-planned review of safety data. The recommendation was based on the unblinded review by the DMC of safety data from more than 900 patients randomized in the main and exploratory cohorts, including more than 360 and 80 patients that have been treated for more than 48 and 72 weeks, respectively. The patient who experienced the adverse event of increased liver test

Development of BIIB105, an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), will be discontinued based on data from the Phase 1/2 ALSpire study Biogen and Ionis continue their long-standing commitment to developing therapies for ALS given the devastating impact of this progressive, fatal neurodegenerative condition May 16, 2024 -- Biogen Inc. (Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced the decision to terminate development of BIIB105

2024年5月13日，武田宣布与AC Immune就针对Aβ的疫苗产品ACI-24.060达成了一项全球独家选择权和许可协议。 根据协议，AC Immune将获得1亿美元预付款，若协议期完成所有里程碑，有资格获得高达约21亿美元的期权行使费和额外的潜在开发、商业和销售里程碑。商业化后，AC Immune将有权获得全球净销售额的两位数的分级特许权使用费。 AC Immune将负责完成ABATE试验。选择权行使后，武田将进行并资助所有进一步的临床开发，并负责所有全球监管活动以及全球商业化。 ACI-24.060是基于AC Immune公司SupraAntigen平台开发的抗Aβ疫苗，旨在激发针对Aβ寡聚体和焦谷氨酸Aβ的多克隆抗体反应。这些Aβ种类被认为是驱动淀粉样蛋白沉积和疾病进展的重要形态。这一在研候选疫苗具有抑制淀粉样蛋白斑块形成，提高斑块清除的潜力，可能延缓或预防疾病进展。 ACI-24.060目前正在1b/2期试验ABATE中受检视。这项随机、双盲、安慰剂对照的试验旨在评估该免疫疗法在早期AD患者和唐氏综合征成年人中的安全性、耐受性、免疫原性和药效。过往研究显示，唐氏综合征患者罹

5月16日，中国国家药监局药品审评中心（CDE）官网公示，优卡迪生物医药公司申报的具有沉默白介素6（IL-6）表达功能的靶向CD19基因工程化自体T细胞注射液拟纳入突破性治疗品种，针对难治/复发急性淋巴细胞白血病。 公开资料显示，这是优卡迪生物研发的一款具有IL-6敲减功能的CD19靶向CAR-T细胞（ssCART-19）。 白血病是常见的血液肿瘤之一，急性淋巴细胞白血病（ALL）约占所有白血病的15%，其中B细胞急性淋巴细胞白血病（B-ALL）约占ALL的75%。成人B-ALL患者较儿童B-ALL患者整体生存更差，初治后复发率高，约60%的患者最终会进展到复发或难治性B细胞急性淋巴细胞白血病（r/r B-ALL）。成人r/r B-ALL患者预后极差，严重危及生命，临床缺乏有效治疗手段。 根据优卡迪生物公开资料介绍，ssCART-19是其开发的第四代CAR-T产品，可同时表达CAR结构和IL-6沉默元件，可显著降低IL-6因子的释放水平，从而进一步降低单核细胞活化和促炎细胞因子的释放，从预防层面来减轻严重细胞因子释放综合征（CRS）和严重免疫效应细胞相关神经毒性综合征（ICANS）的发

Primary results of the Scemblix® ASC4FIRST pivotal Phase III study in first-line Ph+ CML-CP supporting third US FDA Breakthrough Therapy designation, to be detailed in the ASCO Press Program and the EHA Plenary Session Latest data from the Kisqali®* NATALEE trial, including efficacy endpoints for patients with node-negative stage II and III HR+/HER2- early breast cancer New radioligand therapy portfolio data supporting overall platform leadership and ongoing expansion in research infrastructure

Interim clinical data from APG777 Phase 1 healthy volunteers study exceeded all trial objectives and achieved a half-life of approximately 75 days with a potentially best-in-class profile 16-week proof-of-concept data from Part A of the Phase 2 trial expected in 2H 2025 Pipeline-in-a-product potential with a Phase 2 in asthma expected to initiate in 2025 and plans for additional indication expansion May 15, 2024 -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company

LIfT BioSciences Awarded Innovate UK Grant to Accelerate Product Development of New IMAN Cell Therapy Variants Groundbreaking in vivo studies will be progressed to explore the impact of IMAN cell therapies in solid tumour and immunology models uniquely available at the Saeb-Parsy Lab at the University of Cambridge 16 May 2024 – LIfT BioSciences, (‘LIfT’ or ‘the Company’), a rapidly emerging biotech company about to start clinical trials for its first-in-class allogeneic innate cell therapy, toda