2016年网约车最新消息
2016年网约车最新消息
来源：应届毕业生培训网分类：驾驶操作时间：编辑：少芬 已有人查看
　　网约车新规将从日起实施，如何影响你的日常出行?交通运输部、工信部、公安部等七部委共同在国新办举办发布会，介绍《关于深化改革推进出租汽车行业健康发展的指导意见》、《网络预约出租汽车经营管理暂行办法》相关情况。新规中，网约车的合法地位终于明确了!
　　小编梳理了10条干货：
　　🚖出租车部分
　　1、出租车分&巡游&和&预约&两种。鼓励巡游出租汽车企业转型提供网约车服务。
　　2、出租车经营权实行期限制。新增经营权一律实行期限制和无偿使用，并不得变更经营主体。
　　3、出租车&份子钱&各方平等协商、动态调整。通过改革经营模式、降低过高的承包费标准和抵押金等，降低驾驶员负担。
　　🚘网约车部分🚘
　　4、网约车有了合法身份证&&车辆登记为&预约出租客运&。
　　5、网约车司机可以兼职：驾驶员与网约车平台签订劳动合同或协议。并满足无交通肇事犯罪记录、无危险驾驶犯罪记录、无吸毒记录、无饮酒后驾驶记录、无暴力犯罪记录等条件。
　　6、私家车可以做网约车：应为7座及以下乘用车，安装具有行驶记录功能的车辆卫星定位装置、应急报警装置，且车辆技术性能符合运营安全相关标准要求。
　　7、网约车无需8年强制报废：行驶里程达到60万公里时强制报废;行驶里程未达到60万公里但使用年限达到8年时，退出网约车经营。
　　8、网约车平台要取得网络预约出租汽车经营许可证，并向企业注册地省级通信主管部门申请互联网信息服务备案后，方可开展相关服务。审批过程实现&两级工作、一级许可&，也就是对线上服务能力由注册地升级相关部门一次认定，全国有效。
　　9、专车不一定会更便宜：实行市场调节价，城市人民政府认为有必要实行政府指导价的除外。
　　10、鼓励拼车：城市人民政府应鼓励私人小客车合乘并制定相应规定，明确合乘服务提供者、合乘者及合乘信息服务平台等三方的权利和义务，规范其发展。
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看了本课程的人还看了日-11月13日全球申报情况
【新药汇讯】 RHB-103、Xtampza、AZD9291、Adynovate全球首次获批；SD-809获突破性疗法认定；CAM2038、XF-73获QIDP资格。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im text-decoration: color: rgb(0, 176, 80);"><strong style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im font-size: 18 font-family: 宋体;">一、新药批准
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">1.日消息，RHB-103（利扎曲普坦口服膜剂）在德国全球首次获得批准，由RedHill和IntelGenx共同开发，商品名RIZAPORT，用于治疗急性偏头痛。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">2.日消息，FDA临时批准Collegium滥用威慑性羟考酮缓释胶囊，商品名Xtampza，用于慢性疼痛镇痛。该药PDUFA日期为日。临时批准是由于与普渡制药专利纠纷，安全性和有效性无问题。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">3.日消息，FDA批准基因泰克MEK抑制剂Cobimetinib，与自家B-Raf激酶抑制剂威罗菲尼联用治疗BRAF(V600)突变晚期或不可切除黑色素瘤。该药PDUFA日期为日。Cobimetinib由Exelixis公司开发，2015年8月在瑞士获全球首批。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">4.日消息，2014年10月FDA批准Harvoni用于基因1型丙肝患者，FDA今天批准吉列德一日一次丙肝疗法Harvoni新适应症，现可用于基因3，4，5型丙肝以及丙肝并发HIV患者。另外FDA今天批准Harvoni+利巴韦林12周疗法，替代Harvoni 24周疗法用于二线治疗基因1型丙肝并发肝硬化患者。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">5.日消息，FDA批准阿斯利康EGFR抑制剂Osimertinib（AZD9291），二线治疗EGFR-T790M突变 NSCLC，商品名Tagrisso。FDA同时批准罗氏第二代cobaseGFR Mutation Test v2，相比第一代增加诊断EGFR-T790M耐药突变。Clovis同类药物Rociletinib已进入FDA审评，PDUFA日期为日。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">6.日消息，欧盟委员会批准Baxalta Obizur（Susoctocog alfa，重组抗血友病因子-猪序列）用于治疗获得性血友病A。该药最早于2014年10月在美国获批。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">7.日消息，FDA批准Baxalta长效血友病A药物Adynovate（Rurioctocog alfa pegol，PEG化重组抗血友病因子），该药是百因止（Advate，Rurioctocog alfa，重组抗血友病因子）的长效版，用于12岁以上血友病A患者控制和预防出血事件。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 text-indent: 0 line-height: 28 box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im text-decoration:"><strong style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; font-size: 18 font-family: 宋体; color: rgb(0, 176, 80); box-sizing: border-box !im word-wrap: break-word !im">二、突破性疗法认定
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">1.日消息，FDA授予Teva SD-809（Deutetrabenazine）突破性疗法认定，用于治疗迟发性运动障碍。该药为Teva 32亿美元收购Auspex所得，已提交治疗亨廷顿氏舞蹈症NDA。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 text-indent: 0 line-height: 28 box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im text-decoration:"><strong style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; font-size: 18 font-family: 宋体; color: rgb(0, 176, 80); box-sizing: border-box !im word-wrap: break-word !im">三、<strong style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; font-size: 18 color: rgb(0, 176, 80); box-sizing: border-box !im word-wrap: break-word !im">QIDP<strong style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; font-size: 18 font-family: 宋体; color: rgb(0, 176, 80); box-sizing: border-box !im word-wrap: break-word !im">资格
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">1.日消息，FDA授予Destiny制药XF-73 （Exeporfinium chloride）QIDP资格，XF-73是卟啉类化合物，用于治疗多重耐用性抗甲氧西林金黄色葡萄球菌感染，目前正处于II期临床阶段。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 text-indent: 0 line-height: 28 box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im text-decoration: color: rgb(0, 176, 80);"><strong style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; font-size: 18 font-family: 宋体; box-sizing: border-box !im word-wrap: break-word !im">四、孤儿药
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">1.日消息，FDA授予ArQule ARQ 092治疗变形综合征孤儿药资格。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">2.日消息，FDA授予Bone Therapeutics自体骨髓干细胞移植疗法Preob治疗成骨不全孤儿药资格。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">3.日消息，FDA授予杨森anti-CD38单抗Daratumumab治疗大B细胞淋巴瘤孤儿药资格。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">4.日消息，FDA授予Seattle Genetics公司Vadastuximab talirine治疗急性髓细胞白血病孤儿药资格。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">5.日消息，FDA和EMA已授予Genkyotex公司辅酶II氧化酶NOX1&4抑制剂GKT137831治疗系统性硬化病孤儿药资格，此前该药还获特发性肺纤维化孤儿药资格，目前该药处于糖尿病肾病II期临床阶段。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">6.日消息，FDA授予Arch Biopartners AB569（亚硝酸钠+乙二胺四乙酸）治疗囊性纤维化患者铜绿假单胞菌肺部感染孤儿药资格，目前AB569处于I期临床研究阶段。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 text-indent: 0 line-height: 28 box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im color: rgb(0, 176, 80);"><strong style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im"><span style="margin: 0 padding: 0 max-width: 100%; box-sizing: border-box !im word-wrap: break-word !im text-decoration: font-size: 18 font-family: 宋体;">五、上市申请及审评
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">1.日消息，Neos收到FDA关于Cotempla XR-ODT（哌甲酯缓释口腔崩解片）的完全回应函，FDA要求Neos进行生物等效性&桥接&临床研究，FDA未提出安全性有效性方面问题。Neos XR-ODT技术另一药物安非他明XR-ODT的PDUFA日期为日。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">2.日消息，由于出现严重的胃肠道不良反应，今年9月FORUM Pharmaceuticals &7烟碱型乙酰胆碱受体激动剂Encenicline被FDA临床搁置。FDA现已解除Encenicline治疗精神分裂症认知功能障碍临床搁置，但Encenicline治疗阿尔茨海默病仍未解除。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">3.日消息，今年10月29日FDA受理Lipocine一日两次睾酮替代疗法LPCN (b)(2)NDA，用于治疗成年男性性腺功能减退症，近期FDA公布PDUFA日期为日，且无需咨询委员会决议。2014年LPCN 1021完成SOAR三期临床研究（NCT），88%的治疗患者血清激素水平恢复正常，达研究主要终点。Lipocine还在开发一日一次口服睾酮替代疗法LPCN-1111，去年FDA咨询委员会曾反对Clarus口服睾酮替代疗法Rextoro的上市申请。
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">&
<p style="margin: 0 padding: 0 max-width: 100%; clear: min-height: 1 white-space: pre- color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans- font-size: 16 line-height: 25.7 text-indent: 0 box-sizing: border-box !im word-wrap: break-word !im">4.日消息，艾伯维和杨森向FDA提交依鲁替尼+BR（苯达莫司汀+利妥昔单抗）治疗复发/难治性慢性淋巴细胞白血病或小淋巴细胞性淋巴瘤sNDA，申请基于HELIOS研究（NCT）结果，相比安慰剂+BR对照，依鲁替尼+BR可降低80%疾病进展或死亡风险，且大幅提高客观缓解率。
新药汇是专业新药技术服务和成果转让平台，提供新药临床批件，新药证书转让，新药外包技术服务信息！,-新药汇
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