STAT+: Cancer detection firm Freenome to go public via $330 million SPAC deal
Freenome，一家位于湾区的生物技术公司，计划通过与Perceptive Capital Solutions Corp合并，进行3.3亿美元的SPAC交易，以推动其血液癌症筛查技术的发展。该技术已在PREEMPT CRC研究中获得临床验证，并预计在2026年推出多项测试。此次交易还包括来自多家私人投资者的2.4亿美元投资，标志着Freenome在血液癌症筛查领域的关键时刻。
Unprecedented turmoil engulfing FDA threatens public health: mRNA coalition speaks out
mRNA联盟对FDA的领导层动荡表示担忧，认为这将影响公众健康和生物技术投资。联盟呼吁稳定的监管，以维护公众信任并促进生物医药创新。行业领导者指出，FDA的不稳定性可能会导致投资流失，影响美国在生物技术领域的领导地位。
CDC panel recommends delaying birth dose of hepatitis B vaccine
CDC's Advisory Committee on Immunization Practices voted to recommend delaying the hepatitis B vaccine for newborns, a move that could increase chronic infections and liver cancer cases. This decision, influenced by anti-vaccine sentiments, marks a significant shift in U.S. vaccine policy, as the committee's discussions were dominated by vaccine skeptics. A modeling study suggests that this delay could result in serious health consequences for infants, highlighting the ongoing debate over vaccine safety and efficacy.
Bruceine A protects nuclear receptor 4A1 from ubiquitin-degradation to alleviate mesangial proliferative glomerulonephritis
Bruceine A, a natural compound, has been identified as a potential therapeutic agent for mesangial proliferative glomerulonephritis (MsPGN) by stabilizing the nuclear receptor NR4A1. This stabilization inhibits NR4A1 degradation, leading to reduced inflammatory responses and mesangial cell proliferation. The study highlights the significant burden of MsPGN, particularly in China, and proposes a novel approach to treatment that could enhance therapeutic strategies in the biotechnology field.
BMS scores 5th indication for Breyanzi with FDA marginal zone lymphoma nod
Bristol Myers Squibb的Breyanzi获得FDA批准用于治疗边缘区淋巴瘤，成为首个针对该适应症的CAR-T疗法。该疗法在临床试验中表现出95%的总体反应率，62%的患者实现完全反应，显示出其在治疗中的潜力。BMS的销售额在第三季度增长58%，预计Breyanzi将成为重磅药物，进一步巩固其在血液癌症治疗领域的地位。
The biopharma dealmaking landscape and what to expect in 2026
文章分析了生物制药行业的交易环境，指出在经历了一段不确定性后，行业参与者对市场的把握逐渐增强，交易的风险降低，预计未来将出现更大规模的收购。同时，强调了人工智能投资的复兴和中国在创新领域的崛起。这些趋势为2026年的商业发展奠定了良好的基础。
Ethiopia eyes experimental Marburg vaccine after outbreak
埃塞俄比亚正在进行Marburg疫苗的二期临床试验，疫苗由Sabin Vaccine Institute提供，旨在保护高风险人群，包括医疗工作者和与病例接触的人。该国目前面临首次Marburg疫情，已确认13例病例，其中8例致死。此疫苗也在乌干达和肯尼亚进行二期试验，显示出早期投资潜力。
Mercks Keytruda SC launch in Germany faces new hurdle as Halozyme scores preliminary injunction
Merck与Halozyme之间的专利争议导致德国法院对Merck的Keytruda SC发出初步禁令，要求停止在德国的推出活动。Halozyme的技术经过多年研究，支持快速、高容量的皮下药物输送。尽管Merck对禁令表示强烈反对，并认为Halozyme的专利无效，但这一事件对癌症治疗领域的市场动态产生了重要影响。
Fierce Pharma Asia—FDA safety probe of Takeda drug; Otsuka kidney disease nod; ADC patent fight
FDA对Takeda的Adzynma进行调查，因报告儿童死亡事件；Otsuka获得IgA肾病的首个生物药Voyxact的加速批准。Crescent Biopharma与Kelun-Biotech达成8000万美元的ADC候选药物交易，显示出早期投资潜力。
Optimizing clinical monitoring and management guidelines for capivasertib in HR-positive/HER2-negative advanced breast cancer: expert opinion
Capivasertib是一种AKT抑制剂，已获批用于HR阳性/HER2阴性晚期乳腺癌的治疗。其在CAPItello-291 III期临床试验中显著改善了无进展生存期。文章提出了针对与Capivasertib相关的不良事件的管理建议，以优化患者的治疗效果和依从性，强调了在临床实践中的重要性。
Defective vascular smooth muscle cell tafazzin impairs mitochondrial function and promotes atherosclerosis in preclinical models
研究发现，tafazzin在动脉粥样硬化中发挥重要作用，其表达减少与平滑肌细胞的线粒体功能障碍和凋亡相关。miR-125a-5p通过NFκB途径上调，抑制tafazzin表达，导致心血管疾病的进展。SS-31小肽显示出改善线粒体功能的潜力，提示其作为动脉粥样硬化治疗的潜在靶点。
AI for dental imaging: impressive in vitro, but what about in practice?
该研究系统评审了AI在牙科成像中的应用，分析了九项体外研究，结果显示AI在成像任务中表现优于传统参考标准。尽管实验室环境下的结果令人印象深刻，但研究指出，临床应用的有效性仍需更多实证支持，以确保AI技术能够安全有效地转化为临床实践。
SATrans-Net: Sparse Attention Transformer for EEG-based motor imagery decoding
SATrans-Net是一种新型的脑机接口技术，旨在通过改进的深度学习框架提升电生理信号的解码能力。该模型通过引入稀疏注意力机制和二维深度可分离卷积，显著提高了对运动想象信号的分类准确性。研究结果表明，SATrans-Net在多个数据集上均超越了现有方法，展示了其在医疗健康领域的应用潜力。
His lab was humming with discovery. After one year under Trump, it’s almost silent
Quackenbush's lab at Harvard is facing significant challenges due to funding cuts, impacting its ability to conduct cutting-edge research in computational biology. The lab's tools, crucial for understanding gene interactions in diseases like cancer and autism, are at risk as staff numbers dwindle. The article highlights the broader implications of reduced funding for scientific research in the U.S. and Quackenbush's efforts to adapt by exploring technology startups.
Opinion: STAT+: Sandoz chief scientific officer: What is truly necessary to establish biosimilarity?
生物类似药在治疗癌症和自身免疫疾病方面具有重要意义，但其开发复杂且成本高昂。尽管生物类似药为患者提供了更实惠的选择，但市场上仍存在生物类似药候选者不足的现象。文章强调了生物类似药的市场需求及其对患者生活的积极影响，指出了投资机会。