Leptin therapy gains FDA approval

Leptin therapy gains FDA approval
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瘦素疗法获得 FDA 批准

DOI:
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发表时间:
2014
影响因子:
46.9
通讯作者:
G. Sinha
G. Sinha
中科院分区:
工程技术1区
文献类型:
--
作者:
G. Sinha

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加利福尼亚州山景城的专业公司爱迪生制药公司与日本大阪的Dainippon Sumitomo Pharma(DSP)达成了一项价值高达43亿美元的战略联盟,以开发治疗遗传性线粒体呼吸链疾病的药物。根据协议条款,两家公司将共同扩大爱迪生的流水线,在未来五年内将10种针对氧化还原途径的新化合物投入临床开发。波士顿的生物技术公司Mitokyne也在研究线粒体相关疾病,该公司于2013年10月与东京的Astellas Pharma达成了一项为期五年的协议,潜在价值7.3亿美元,以发现和开发调节线粒体功能的药物。在投资者几十年不感兴趣之后,这些交易证实,线粒体研究正在获得更多的吸引力。费城线粒体和表观基因组医学中心主任道格拉斯·华莱士指出,更广泛的接受是,线粒体突变引起的系统性细胞能量代谢缺陷可能会导致器官特有的症状和多系统疾病,如糖尿病和阿尔茨海默病。华莱士证明线粒体DNA完全是从母亲那里遗传来的,他说:“我希望我们能[说服其他制药公司]线粒体生物能学是一个很好的靶子。”今年2月,当美国食品和药物管理局(FDA)和英国政府讨论线粒体替代问题时,大西洋两岸都燃起了解决线粒体疾病的希望。这项体外受精技术包括将患有线粒体缺陷的女性的核DNA放入捐赠的卵子中,卵子的核DNA已被移除,其中包含健康的线粒体。在英国,这种疗法得到了广泛的支持,政府的卫生部于2月27日宣布,将对该技术的立法草案开启为期三个月的公众评议期。在美国食品和药物管理局,顾问小组讨论了临床试验中可能使用的对照措施,但没有做出决定。Emma Dorey瘦素疗法获得FDA批准
Specialty firm Edison Pharmaceuticals of Mountain View, California, has entered a strategic alliance worth up to $4.3 billon with Dainippon Sumitomo Pharma (DSP) of Osaka, Japan, to develop drugs for inherited respiratory chain diseases of the mitochondria. Under terms of the deal, the companies will jointly expand Edison’s pipeline, bringing ten new compounds targeting redox pathways into clinical development over the next five years. Also in pursuit of mitochondria-related diseases is biotech firm Mitokyne of Boston, which in October 2013 struck a five-year agreement with Astellas Pharma of Tokyo, potentially worth $730 million, to discover and develop drugs that modulate mitochondrial function. After decades of disinterest from investors, the deals confirm that mitochondrial research is gaining more traction. Douglas Wallace, director of the Center for Mitochondrial and Epigenomic Medicine in Philadelphia, points to a wider acceptance that systemic, cellular-energy metabolism defects caused by mitochondrial mutations can result in organ-specific symptoms and multisystem disorders, such as diabetes and Alzheimer’s disease. Wallace, who showed that mitochondrial DNA is inherited exclusively from the mother, says: “I’m hoping we can [persuade other pharmaceutical companies] that mitochondrial bioenergetics is a good target.” Hopes of tackling mitochondrial disease were raised on both sides of the Atlantic in February, when the US Food and Drug Administration and the UK government discussed mitochondrial replacement. This in vitro fertilization technique involves placing nuclear DNA from a woman with defective mitochondria into a donated egg that has had its nuclear DNA removed and contains healthy mitochondria. In the UK, where there is broad support for such a therapy, the government’s Department of Health announced on February 27 that it was opening a three-month public comment period on draft legislation on the technique. At the US Food and Drug Administration, advisory panels discussed what controls might be used in clinical trials, but no decisions were made. Emma Dorey Leptin therapy gains FDA approval
DOI: 10.1056/nejmoa012437
发表时间: 2002-02-21
影响因子: 158.5
作者:
Oral, EA;Simha, V;Garg, A
通讯作者: Garg, A
DOI: 10.1101/gad.12.20.3182
发表时间: 1998-10-15
影响因子: 10.5
作者:
Shimomura, I;Hammer, RE;Brown, MS
通讯作者: Brown, MS