Otitis

04月04日的《热心肠日报》，我们解读了 15 篇文献，关注：生命早期，肠道Treg，ILC3，IBD，肠脑轴，纳米医学，1型糖尿病，小檗碱，IPA，微生物生态学，FMT，迈维代谢，九源基因，Fractyl，甫康药业，欧世盛。 该篇日报由R·AI辅助创作生成，人工审核校对。 Cell：出生队列揭示婴儿肠道微生物和代谢物与神经发育障碍的关系 Cell——[64.5] ① 瑞典一项长达20年的前瞻性出生队列研究，通过分析调查问卷、HLA基因型、脐带血清代谢组和脂质组、粪便菌群和代谢组，揭示了生命早期因素与之后确诊为神经发育障碍（ND）的关系；② 未来ND个体在婴儿期（1岁）就存在菌群组成和代谢物的失调，例如，Akk菌和粪球菌属减少，伴随某些氨基酸、脂肪酸、维生素和神经递质前体等代谢物的紊乱，并与早期情绪和胃肠问题存在关联；③ 耳炎、早产、感染、家庭压力、父母吸烟以及特定HLA基因型（DR4-DQ8）与ND风险增加相关，其中，HLA、压力、感染/反复使用抗生素、剖宫产等因素与菌群的变化存在关联，耳炎可能通过减少粪球菌属、增加柠檬酸杆菌属，增加未来ND风险；④ 未来自闭症患者的脐带血清中，亚麻酸水平较低、全氟癸酸毒素水平较高；⑤ 这些发现支持了一种假说，即ND的早期起源是由肠道菌群介导的，可能与炎症调控等有关。 【原文信息】 Infant microbes and metabolites point to childhood neurodevelopmental disorders 2024-04-03 , doi: 10.1016/j.cell.2024.02.035 Nature：免疫微环境塑造肠道Treg功能 Nature——[64.8] ① 本研究对致病共生菌（肝螺杆菌）反应性的调节性T细胞（Treg）进行了时空追踪，揭示了肠道中的局部免疫微环境在塑造Treg功能方面的空间机制，为开发新一代促进免疫耐受的疗法提供了见解；② 发现固有层（LP）而非淋巴聚集体（LA），是支持效应Treg（eTreg）功能的关键微环境，eTreg在LP中最具功能，LP微环境中还存在多种抗原呈递细胞，是eTreg产生IL-10的主要靶标；③ 一旦这种微环境建立起来，eTreg就会稳定并在此增殖，但炎症状态下，这种空间上区室化的LP微环境被打破，使原本局限于LA的CD103+SIRPα+树突状细胞等被招募到LP；④ 该研究还识别了LP中CD206+巨噬细胞与eTreg之间的相互作用，并鉴定了可能调控这种互作的受体-配体对（如CCR2–CCL8、VCAM1-α4β7等）。 【原文信息】 Immune microniches shape intestinal Treg function 2024-04-03 , doi: 10.1038/s41586-024-07251-0 郭晓欢Nature子刊：Wnt/β-catenin信号通路调控ILC3s介导肠道炎症 Nature Communications——[16.6] ① 清华大学郭晓欢研究员团队最新揭示Wnt/β-catenin信号通路在调节肠道炎症中的关键作用，特别是具有影响3型天然淋巴细胞（ILC3s）的功能；② 在炎症性肠病和结直肠癌患者中，肠道ILC3s的β-catenin水平升高，与健康人群相比有显著差异；③ 激活的Wnt/β-catenin信号在ILC3s中抑制RORγt表达，阻碍其增殖和功能，导致小鼠ILC3s缺失并增加结肠炎易感性；④ ILC3中激活的Wnt/β-catenin信号通路通过表观遗传调控和TCF-1-JunB途径抑制RORγt表达，导致ILC3缺乏并加剧肠道炎症和癌症的发展；⑤ Wnt/β-catenin信号传导的激活对体外ILC3和T细胞有不同影响，表明该信号通路对先天性和适应性淋巴细胞具有不同的调节机制。 【原文信息】 Dysregulation of Wnt/β-catenin signaling contributes to intestinal inflammation through regulation of group 3 innate lymphoid cells 2024-04-01 , doi: 10.1038/s41467-024-45616-1 Nature子刊：肠炎病史会影响小鼠社交行为 Nature Communications——[16.6] ① 研究发现，即使结肠炎症状消失，反复患有结肠炎的小鼠在与外来小鼠互动时表现出社交参与能力下降的现象；② 将自闭症谱系障碍（ASD）患者的微生物群落移植到雄性无菌动物中，并诱导结肠炎，与家族神经典型（NT）对照组的微生物群落相比，携带ASD患者微生物群落的动物表现出更严重的肠道表型；③ 所有家族NT对照组中都富含Blautia属菌株，并观察到单形拟杆菌丰度升高与肠道损伤减少之间的关联；④ 通过口服Blautia属或单形拟杆菌，可以减轻小鼠的结肠损伤；⑤ 从NT对照组中分离出的Blautia菌株可以改善小鼠肠道损伤相关的社交参与能力下降。 【原文信息】 Colitis reduces active social engagement in mice and is ameliorated by supplementation with human microbiota members 2024-03-30 , doi: 10.1038/s41467-024-46733-7 黄鹤+曹晓沧+刘占举：开发新型双特异性纳米抗体或可治疗IBD Clinical and Translational Medicine——[10.6] ① 天津大学黄鹤团队、天津医科大学曹晓沧团队及同济大学刘占举团队联合开发了一种新型双特异性纳米抗体（BsNb-Fc），通过同时靶向TNF-α和IL-23p19，缓解小鼠实验性肠炎；② BsNb-Fc具有比单一抗体更优的血清半衰期、靶向能力和效应功能；③ 与抗TNF-α单抗（infliximab, IFX）和抗IL-12/IL-23p40单抗（ustekinumab, UST）组合相比，BsNb-Fc具有更强的抗炎效果；④ 在TNBS和DSS诱导的急性结肠炎小鼠模型中，BsNb-Fc可有效减轻结肠炎症程度，且优于IFX&UST组合治疗；⑤ 本研究表明BsNb-Fc具有更高的疗效和生物稳定性，为对TNF-α抑制反应不足的IBD患者提供了一种潜在的新疗法。 【原文信息】 Novel bispecific nanobody mitigates experimental intestinal inflammation in mice by targeting TNF-α and IL-23p19 bioactivities 2024-03-27 , doi: 10.1002/ctm2.1636 孙嘉+潘礼龙：SCFAs受体GPR41或为T1D防治靶点 Acta Pharmacologica Sinica——[8.2] ① 江南大学孙嘉教授、潘礼龙教授及团队发现短链脂肪酸受体G蛋白偶联受体41（GPR41）缺失会加剧小鼠1型糖尿病（T1D），揭示了GPR41在维持肠道和胰腺免疫稳态中的重要性；② 在非肥胖糖尿病小鼠（NOD）中，GPR41表达降低；③ Gpr41-/-小鼠在链脲佐菌素（STZ）诱导的T1D模型中表现出更严重的疾病症状，且肠道免疫失调更为明显，肠道激活的IFN-γ+ T细胞迁移到胰腺的数量增加；④ Gpr41-/-小鼠的骨髓来源树突状细胞（BMDC）中，SOCS表达显著降低，STAT3磷酸化显著增加，促进了树突细胞的成熟；⑤ 通过向受辐照的NOD小鼠移植Gpr41-/-小鼠的BMDC，可以加速T1D的发展，表明GPR41可能是T1D的潜在治疗靶点。 【原文信息】 GPR41 deficiency aggravates type 1 diabetes in streptozotocin-treated mice by promoting dendritic cell maturation 2024-03-21 , doi: 10.1038/s41401-024-01242-7 王琰+蒋建东：小檗碱调节肠道菌群防治血栓 Phytomedicine——[7.9] ① 近期中国医学科学院北京协和医学院医药生物技术研究所蒋建东和王琰作为共同通讯作者发表了一项研究，本研究揭示了小檗碱（黄连素）作为肠道微生物群的调节剂，能有效抑制小鼠血栓形成；② 小檗碱通过促进苯乙酸降解来限制苯乙酰甘氨酸的生物合成，后者是宿主-肠道菌群的一种促进血栓形成的共同产物；③ 小檗碱的抗血栓效果可以被腹腔注射的苯乙酰甘氨酸逆转，而粪菌移植实验确认了肠道菌群在血栓形成中的关键作用；④ 研究强调了肠道菌群在血栓发展中的重要性，并突出了小檗碱介导的肠道菌群调节作为预防血栓形成的有前景的治疗方法。 【原文信息】 Berberine promotes the degradation of phenylacetic acid to prevent thrombosis by modulating gut microbiota 2024-03-07 , doi: 10.1016/j.phymed.2024.155517 李宁宁/张雪松等：肠道代谢物IPA激活ERK1，改善小鼠自闭症 Microbiome——[15.5] ① 人染色体16p11.2微缺失（16p11.2+/−）与自闭症谱系障碍（ASD）和其他神经发育障碍普遍相关，但其与肠道菌群及肠道代谢物的关系尚未解析，中山大学七附院的李宁宁、英国伦敦大学学院Huiliang Li、美国罗格斯大学张雪松及发表研究，揭示了16p11.2微缺失小鼠模型中肠道代谢物吲哚-3-丙酸（IPA）对ASD相关症状的缓解及其机制；② 16p11.2微缺失小鼠模型显示出肠道菌群失调和血清/粪便中IPA水平显著下降，其中IPA产生途径相关基因丰度下降，表现出社交和认知记忆缺陷；③ 经口给予IPA能有效改善这些小鼠的社交和认知缺陷，恢复海马齿状回神经元的抑制性突触传输；④ IPA处理显著增加了16p11.2区域Mapk3基因编码的ERK1蛋白的磷酸化水平，但不影响Mapk3基因的转录和翻译；⑤ 研究揭示了肠道菌群代谢物在ASD发病机制中的关键作用，并为相关社交和认知记忆障碍的治疗提供了新的视角。 【原文信息】 The gut metabolite indole-3-propionic acid activates ERK1 to restore social function and hippocampal inhibitory synaptic transmission in a 16p11.2 microdeletion mouse model 2024-03-28 , doi: 10.1186/s40168-024-01755-7 Nature子刊：肠道共生菌适应性演化高分辨率定位追踪 Nature Communications——[16.6] ① 本研究通过对定植四种人类肠道拟杆菌的悉生小鼠中的400,000多个肠道菌群谱系进行了分析，揭示了肠道菌群通过快速新突变来适应宿主环境的微生态进化机制；② 研究发现了数千个隐性变异受到正向选择，而这些变异大多与原始基因敲除无关；③ 不同物种之间的适应性突变谱显示具有随时间和饮食条件变化的多样性权衡，提示其可能参与的潜在功能；④ 这些结果表明，宿主内适应是由众多竞争变异之间的激烈竞争进行的，这对肠道菌群的进化产生了重大影响。 【原文信息】 Quantifying the adaptive landscape of commensal gut bacteria using high-resolution lineage tracking 2024-02-21 , doi: 10.1038/s41467-024-45792-0 青少年肥胖症患者粪菌移植后的水平基因转移有何特征？ Microbiome——[15.5] ① 使用WAAFLE生信工具和宏基因组组装及基因聚类两种互补方法，分析了381个粪便样本中的水平基因转移（HGT）事件；② 两种方法均发现FMT和安慰剂受体的肠道微生物组中可能的HGT事件水平在干预后没有显著差异；③ 在FMT受体中，干预6周后识别出由供体物种引导的HGT事件，这些事件主要涉及拟杆菌门相关菌株；④ 依赖移植的水平转移基因在干预后12周和26周仍保留在受体微生物组中。 【原文信息】 Horizontal gene transfer after faecal microbiota transplantation in adolescents with obesity 2024-02-12 , doi: 10.1186/s40168-024-01748-6 多组学企业「迈维代谢」完成B轮融资，海达投资领投 ① 近日，国内多组学领先企业武汉迈维代谢生物科技股份有限公司宣布，完成B轮融资，由海达投资领投，具体金额未披露；② 融资将用于拓展业务布局、加大产品技术研发投入及推进重点项目自动化升级；③ 迈维代谢成立于2015年，专注于质谱多组学CRO和质谱体外诊断试剂产品开发；④ 首次开发了以“广泛靶向”专利技术为核的高通量、超灵敏、广覆盖代谢组检测技术，并构建了业内最全、最精细化、最准确的代谢组数据库，包括40000个植物内源性和220万医学代谢物数据库。 【原文信息】 迈维代谢完成B轮融资，海达投资领投！ 2024-04-03 , 单细胞测序网 九源基因「司美格鲁肽」生物类似药申报上市 ① 4月3日，九源基因的司美格鲁肽注射液生物类似药上市申请，获得国家药监局受理；② 该药物用于成人2型糖尿病患者的血糖控制，具有降糖、减重和心血管获益等多重作用；③ 司美格鲁肽原研产品由诺和诺德开发，2023年在中国销售额约49.40亿元人民币；④ 国内多家企业正在开发司美格鲁肽生物类似药，九源基因为首家递交上市申请的公司。 【原文信息】 首个！九源基因「司美格鲁肽」生物类似药申报上市 2024-04-03 , 医药魔方 Fractyl体重管理方案Revita Remain-1临床获批 ① 4月1日，Fractyl Health公司宣布，旗下针对肥胖患者停用GLP-1类药物后的体重管理疗法Revita，其Remain-1临床研究获得FDA批准；② Remain-1研究是一项随机、双盲试验，旨在评估Revita与安慰剂在替尔泊肽治疗至少减重15%患者中的体重维持效果；③ Revita一种十二指肠粘膜表面重修术，这种新型内镜手术能够使肠道异常的营养感知和信号机制得以恢复，可以从根源上治疗肥胖和2型糖尿病；④ 同时，Fractyl Health公司还宣布启动Reveal-1开放标签研究，将跟踪Revita在同类患者群体中的使用效果。 【原文信息】 Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs 2024-04-01 , Globe Newswire 甫康药业CVL237片2期临床完成首例患者给药 ① 近日，甫康药业宣布，针对PTEN基因缺失的晚期实体瘤一类新药CVL237片，其2期临床研究已完成首例患者给药；② 该2期临床研究是一项随机、单臂、开放、多中心国际多中心临床试验，旨在评估CVL237片的有效性和安全性；③ 研究针对七种肿瘤，包括胃癌、前列腺癌、结直肠癌、肺癌、乳腺癌、妇科肿瘤和黑色素瘤；④ CVL237片是全球首个针对PTEN缺失进行篮式研究的PI3Kβ/δ双重抑制剂，有望成为该领域首个靶向药物。 【原文信息】 一类新药CVL237片II期临床研究完成首例患者给药 2024-04-03 , 甫康Convalife 连续流研发制造企业「欧世盛」完成pre-B轮融资 ① 近日，欧世盛宣布完成数千万元的pre-B轮融资，融资由道彤投资领投，长岭资本跟投；② 融资将用于丰富欧世盛的产品矩阵，拓展其商业化网络并进军海外市场；③ 欧世盛是流动化学解决方案提供商，拥有行业领先的流动化学反应系统产品；④ 此外，欧世盛还同时能够为客户提供科研装备设计、研发外包、工艺优化、放大研究、设备工艺研究、精密制造和连续流工艺培训等多模块服务。 【原文信息】 欧世盛科技完成pre-B轮融资，加速打造流动化学连续智造平台 2024-04-03 , 动脉网 感谢本期日报的审核者：mildbreeze，RZN，章台柳，圆圈儿，注册营养师陈彬林，Johnson，Zhonghua，九卿臣，617，Richard 点击阅读过去10天的日报： 0403 | 今日Cell肠道研究双发：代谢胆固醇的肠菌+肠炎细胞图谱 0402 | 保肠护关节：高分研究揭示抵御关节炎的肠道因子 0401 | 3月，最值得关注的35篇肠道健康要闻！ 0331 | 聚焦特殊人群：老年人和孕妈妈的饮食新知 0330 | Akk菌或是免疫性肾病帮凶？Science子刊揭示机制 0329 | 33页综述纵论：超加工食品健康转型的新策略 0328 | Science子刊：锁定肠道中让病毒逃脱免疫的"避风港" 0327 | 10文聚焦菌群-肠-脑轴研究新进展 0326 | 100分综述详解：IBD细胞因子疗法最前沿 0325 | 大肠癌患病为何年轻化？遗传与生活方式的双重影响

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today that VIGPODER™ (vigabatrin) for oral solution, USP, a treatment for appropriate patients with infantile spasms (IS), is now available. As a therapeutically equivalent product, VIGPODER™ is anticipated to offer the same safety and efficacy pro SABRIL® (vigabatrin) for oral solution. Please see full Prescribing Information to view other approved indications, BOXED WARNINGS, and Important Safety Information. This press release features multimedia. View the full release here: VIGPODER™ (vigabatrin) for oral solution, USP (Photo: Business Wire) Infantile spasms, a rare but serious form of epilepsy, poses significant challenges for patients and their families. With VIGPODER™, Pyros aims to provide reliable services and an affordable treatment option, ensuring that families faced with an IS diagnosis, and whose children are prescribed vigabatrin, can rapidly obtain this essential therapy. Additionally, Pyros Total Care™, the Company’s personalized comprehensive support program, is available to assist families throughout the treatment journey. "The launch of VIGPODER™ and the Pyros Total Care™ program underscores our dedication to supporting families facing the challenges of infantile spasms," stated Michael Smith, Chief Executive Officer at Pyros. "We strive to elevate the overall treatment experience and offer comprehensive support to families navigating this challenging journey. Moreover, we are committed to initiatives aimed at accelerating symptom recognition and referrals to neurologists.” Pyros Total Care™ As part of the Company’s commitment to prioritizing patient access to treatments for those who need them most, Pyros is providing ongoing personalized support service to caregivers through Pyros Total Care™ for those prescribed VIGPODER™. The support program offers personal assistance and financial resources to caregivers whose child is starting or continuing therapy. Our dedicated support team includes a nurse educator, reimbursement support, and a clinical pharmacist. For more information, visit PyrosTotalCare.com or call 1-888-760-8330, Monday to Friday, 8 a.m. to 5 p.m. Central Time. About Infantile Spasms Infantile spasms (IS) is a rare, severe form of epilepsy that typically begins in children less than one year old.1 Infantile spasms can appear as subtle but repetitive movements that can often be overlooked or misdiagnosed. IS can lead to long-term permanent issues such as continued seizures, other forms of epilepsy, autism spectrum disorder, and developmental issues.2 The American Academy of Neurology conducted a systematic review of treatment for IS and concluded that successful treatment of IS can improve the long-term prognosis.3 About Vigabatrin Vigabatrin is a medication used in the treatment of infantile spasms and is designed to inhibit the enzyme GABA transaminase, consequently increasing gamma-aminobutyric acid (GABA) levels in the brain.4,5 This release is thought to enhance seizure control for patients by modulating neuronal excitability.6 Vigabatrin's mechanism of action underscores its importance in treating seizure disorders.7 Its impact may extend beyond seizure management, with emerging research indicating potential benefits in mitigating neurodevelopmental complications associated with certain epilepsy syndromes.8 Vigabatrin REMS Program The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated. Healthcare providers must be certified in the Vigabatrin REMS Program to prescribe VIGPODER™ and patients must be enrolled in the Vigabatrin REMS Program to receive VIGPODER™. Certified prescribers and patients enrolled in the Vigabatrin REMS Program remain in the Vigabatrin REMS Program and do not need to recertify or re-enroll.* INDICATION VIGPODER™ (vigabatrin) is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. Please refer to the full Prescribing Information to view other approved indications. IMPORTANT SAFETY INFORMATION FOR VIGPODER™ (vigabatrin) WARNING: PERMANENT VISION LOSS See full Prescribing Information for complete BOXED WARNING. VIGPODER™ can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGPODER™ may also decrease visual acuity. Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to VIGPODER™ known to be free of risk of vision loss. Risk of new and worsening vision loss continues as long as VIGPODER™ is used, and possibly after discontinuing VIGPODER™. Baseline and periodic vision assessment is recommended for patients on VIGPODER™. However, this assessment cannot always prevent vision damage. VIGPODER™ is available only through a restricted program called the Vigabatrin REMS Program. WARNINGS AND PRECAUTIONS Because of this risk and because VIGPODER™, when it is effective, provides an observable symptomatic benefit, patient response and continued need for treatment should be periodically assessed. Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is recommended. Because vision testing in infants is difficult, vision loss may not be detected until it is severe. Due to the risk of permanent vision loss, VIGPODER™ is only available through the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Further information is available at or 1-866-244-8175. Abnormal Magnetic Resonance Imaging (MRI) signal changes and Intramyelinic Edema (IME) in some infants and young children treated with vigabatrin have been observed. These changes generally resolved with discontinuation of treatment and resolved in a few patients despite continued use. VIGPODER™ should be withdrawn gradually to avoid withdrawal seizures. Patients and caregivers should be told not to suddenly discontinue VIGPODER™ therapy. Monitor for symptoms of anemia. VIGPODER™ causes somnolence and fatigue. In pediatric clinical trials (pooled data), the incidence of peripheral neuropathy and edema observed in pediatric patients was similar on vigabatrin and placebo. ADVERSE REACTIONS The most common (>5%) adverse reactions that occurred more frequently than placebo patients were somnolence, bronchitis, ear infection, and acute otitis media. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088 or Pyros at 1-855-406-1010. Please see full Prescribing Information, including BOXED WARNING, for additional Important Safety Information. About Pyros Pyros Pharmaceuticals is developing enhanced specialty pharmaceuticals for rare diseases. Our mission is to elevate the standard of care for infantile spasms, providing treatment options that significantly improve the lives of affected children. Through our enhanced therapies and comprehensive support services, we aim to assist providers and caregivers in navigating the complexities of the patient journey. For more information, please visit: Forward-Looking Statements The Company has made statements throughout this press release which constitute forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any results, levels of activity, performance or achievements expressed or implied by any such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “hopes,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “likely,” “potential,” or “continue” or the negative of these terms and similar words. Although management believe that the expectations reflected in these forward-looking statements are reasonable, management cannot guarantee future results, levels of activity, performance or achievements. Furthermore, management undertakes no obligation to update any forward-looking statements for any reason unless required to do so by law. References Mackay, M. T., Weiss, S. K., Adams-Webber, T., et al. (2004). Practice parameter: medical treatment of infantile spasms. Report of the American Academy of Neurology and the Child Neurology Society. Neurology, 62(10), 1668-1681. Lux, A. L., & Osborne, J. P. (2004). A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group. Epilepsia, 45(11), 1416-1428. Pellock, J. M., Hrachovy, R., Shinnar, S., et al. (2010). Infantile spasms: a U.S. consensus report. Epilepsia, 51(10), 2175-2189. Cilio, M. R., & Cross, H. J. (2011). Vigabatrin. Neurotherapeutics, 8(2), 330–337. Löscher, W., & Schmidt, D. (2004). New horizons in the development of antiepileptic drugs: innovative strategies. Epilepsy Research, 60(2–3), 77–159. Houston, S. M., & Smart, T. G. (2006). GABA pharmacology: the search for analgesics. Current Opinion in Investigational Drugs, 7(1), 48–55. Wheless, J. W. (2004). Vigabatrin: efficacy and safety in pediatric epilepsy. Journal of Child Neurology, 19(Suppl 1), S21–S29. Chiron, C. (2006). Vigabatrin in the treatment of epilepsy: literature review. Epileptic Disorders, 8(S1), S33–S38. *SABRIL® is a registered trademark of Lundbeck.

Amneal aims to develop an affordable, complex, high-value product for bacterial ear infections. Credits: goodlux/Shutterstock.com. Amneal Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) for its ciprofloxacin and dexamethasone otic suspension, a generic drug of Novartis ’ Ciprodex (ciprofloxacin/dexamethasone), for the treatment of ear infections. With the FDA approval, the New Jersey-based pharma company will develop an affordable, complex, and high-value product that reflects the “diversification of [the] business” and its evolving portfolio, said Amneal’s generics executive vice-president Andy Boyer in the 25 March press release. An approved ANDA allows a sponsor to manufacture and market a safe and effective generic product at a lower cost than the brand-name product it references. Ciprodex is designed to prevent bacterial DNA replication and the growth of new bacteria via the antibiotic ciprofloxacin. It suppresses inflammation by inhibiting the synthesis of cytokines associated with inflammation. As per its label, the drug is indicated to treat infections caused by susceptible isolates of the designated microorganisms in acute otitis media (AOM) and acute otitis externa (AOE) in patients aged six months and older. Novartis reported a 62% rise in net income in 2023, increasing from $6.04bn to $8.6bn on constant currencies. See Also: J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction Takeda’s ADZYNMA gains Japanese approval for cTTP treatment Amneal is among several companies marketing generics of Novartis’ combination ear drop medication. India-based Dr Reddy’s launched its Ciprodex generic after receiving FDA approval in August 2020.