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FDA警告:Keytruda和Tecentriq疗效并不优于化疗:杨森精神分裂症药物获批上市..

2018-05-25 佚名 药研发

FDA对全美范围内的医生、试验调查人员和公众发出用药警告,称默克Keytruda和罗氏Tecentriq在最近的试验中出现危险信号。来自监督委员会的早期审查中的两项分别对两种药物的单独研究发现,接受低水平PD-L1抑制剂免疫疗法患者的生存几率低于选择正常铂化疗的患者。

FDA警告:Keytruda和Tecentriq疗效并不优于化疗。近日,FDA对全美范围内的医生、试验调查人员和公众发出用药警告,称默克Keytruda和罗氏Tecentriq在最近的试验中出现危险信号。来自监督委员会的早期审查中的两项分别对两种药物的单独研究发现,接受低水平PD-L1抑制剂免疫疗法患者的生存几率低于选择正常铂化疗的患者。FDA建议医务人员在开具处方时严格遵守已批准的该类药物的适应症及产品标签的适用范围。目前,Keytruda和Tecentriq都被限制性地批准用于某些未曾接受过治疗的膀胱癌患者。

国内药讯

1. 杨森精神分裂症药物获批上市。强生旗下杨森(Janssen)制药宣布,其治疗精神分裂症长效针剂善妥达?棕榈帕利哌酮酯注射液(3个月剂型)获国家药监局正式批准上市。善妥达?每年仅需注射四次,适用于接受过善思达?棕榈酸帕利哌酮注射液(1个月剂型)至少4个月充分治疗的精神分裂症患者。截止到2017年12月,善妥达?已在全球53个国家和地区获批。

2. 李氏大药厂抗癌药「吉马替康」获临床试验批件。李氏大药厂宣布其新型口服亲脂性喜树硷类药物吉马替康获国家药监局批准进行临床试验。其Ⅰ期临床试验将使用0.4mg/kg、0.6mg/kg和0.8mg/kg 3种剂量,以确定中国患者的最大耐受剂量(MTD)。在此前的一项评估吉马替康对复发性上皮性卵巢癌、输卵管癌或腹膜癌患者的疗效和毒性的前瞻性Ⅱ期研究中,其最佳总体疗效为17例患者(24.6%)显示部分缓解,22例患者(31.9%)显示病情稳定。

3. 温医大生物制品一类新药获临床试验批件。温州医科大学李校堃团队开发的治疗类生物制品一类新药 “重组人角质细胞生长因子-2(KGF-2)滴眼液”获国家药监局颁发的《药物临床试验批件》。重组人角质细胞生长因子-2(rhKGF-2)是一种对伤口愈合非常有治疗潜力的生长因子,用于角膜手术及糖尿病溃疡性角膜损伤治疗,目前尚无同类品种在国内外上市销售。

4. 华道生物HD CD19 CAR-T细胞临床试验申请正式获CDE受理。华道(上海)生物医药有限公司“HD CD19 CAR-T细胞”(CXSL1800061)临床试验申请正式被CDE受理,此次提交的CAR-T临床试验申请的适应症为急性淋巴细胞白血病(ALL)和非霍奇金淋巴瘤(NHL)。

5. 60亿元!南京新百获重磅抗癌药Provenge。南京新百宣布,以59.68亿元人民币的交易作价,通过向控股股东三胞集团非公开发行股份的方式,购买其持有的世鼎生物技术(香港)有限公司100%的股权,并募集配套资金。据悉,世鼎香港的主要经营性资产为美国生物医疗公司Dendreon的全部股权。而Dendreon的核心产品Provenge(普列威)是FDA批准上市的首个细胞免疫治疗药物,也是目前治疗前列腺癌的唯一细胞免疫治疗药物。

6. 药明康德市值已破千亿,股价赶超恒瑞。5月24日,药明康德开盘再度涨停,收盘价 97.6 元(恒瑞医药收盘价 94.09 元),市值已达 1016.98 亿元,自 2018 年 5 月 8 日上市起,公司股票已连续 13 个 交易日涨停,近期涨幅较大。IPO 日报此前曾报道,药明康德中签号共有 93779 个,每个中签号码只能认购 1000 股,药明康德发行价为 21.6 元,截至目前,中一签就能赚 76000 元。

国际药讯

1. Bluebird基因疗法获FDA授予突破性疗法认定。Bluebird bio宣布其基因疗法Lenti-D获FDA授予突破性疗法认定,用于治疗一类严重的遗传性神经疾病--脑肾上腺脑白质营养不良(CALD,目前唯一的治疗方法是异体干细胞移植)。在一项Ⅱ/Ⅲ期临床试验中,针对17例17岁以下、且无法找到干细胞供体的CALD患者,其中有15例(88%)在接受Lenti-D的治疗后依旧存活,且在2年之后依旧没有严重的功能性残疾,达到研究的主要终点。Lenti-D曾获FDA颁发孤儿药资格。

2. 辉瑞罕见病新药获FDA授予突破性疗法认定。辉瑞(Pfizer)公司宣布其在研新药tafamidis获FDA授予突破性疗法认定,用于治疗转甲状腺素蛋白心肌病(transthyretin cardiomyopathy,一种罕见病)患者。Ⅲ期临床试验结果表明,与安慰剂相比,接受tafamidis治疗的患者的全因死亡率和心血管事件相关的住院这两项指标均显着减少。Tafamidis于2012年在欧盟和美国被授予孤儿药资格,2015年获FDA颁发快速通道资格。

3. 赛 诺 菲 1 型 糖 尿 病 新 药 上 市 申 请 获 FDA 受 理。赛诺菲(Sanofi)宣布其在研新药Zynquista(sotagliflozin)的新药申请(NDA)已获FDA受理,用于联合胰岛素治疗,以改善1型糖尿病成人患者的血糖控制。此次新药申请是基于inTandem临床试验的良好数据,其中包括三项评估Zynquista在约3,000名单独使用胰岛素控制血糖效果不佳的成人患者中的安全性和疗效的Ⅲ期临床试验。Zynquista是一种小分子、研究性口服SGLT(钠依赖型葡萄糖共同运输蛋白,Sodium-glucose transport proteins)-1和SGLT-2双抑制剂。

4. 默沙东Keytruda组合疗法Ⅲ期临床达双重主要终点。默沙东(MSD)宣布其PD-L1抑制剂Keytruda(pembrolizumab)联合化疗(卡铂+紫杉醇或萘普生+紫杉醇)一线治疗转移性鳞状非小细胞肺癌NSCLC)的关键III期研究(KEYNOTE-407)达到总生存期(OS)和无进展生存期(PFS)的双重主要终点。默沙东还宣布,已向FDA提交了该组合疗法一线治疗移性鳞状NSCLC的生物制剂许可证补充申请(sBLA)。

5. Avenue减少术后疼痛药物Ⅲ期临床结果积极。Avenue Therapeutics宣布,曲马多静脉注射剂(iv tramadol)的第一项关键Ⅲ期临床试验达到主要终点。在手术后经历中度至重度疼痛的患者中,与安慰剂相比,曲马多显着改善了48小时总疼痛强度差(SPID48);且达到其它关键次要终点,并表现出明显的剂量反应。曲马多是一种合成阿片类药物,具有独特的双重作用机制。在美国,口服曲马多目前已获批治疗成人的中重度疼痛,但目前尚无获批的静脉注射制剂。

6. 武田变卖在华资产或是为改善因收购Shire而恶化的财务体质。近日,武田(Takeda)制药宣布,将以2.80亿美元的价格将其在天普51.34%的股权出售给上海医药,来缓解其因620亿美元收购Shire的部分债务压力。据了解,武田收购Shire使其有息负债膨胀至3万亿日元左右,从金融机构的贷款额也高达3万亿日元。此外,武田在多款主力药品专利即将到期、盈利能力下滑的背景下依然维持了高额分红。预计武田今后将进一步加速出售非核心业务。

医药热点

1. 国内首例经鼻内窥镜下儿童颅咽管瘤切除手术成功。日前,由国家儿童医学中心、复旦大学附属儿科医院神经外科主任李昊教授带领的团队成功完成国内首例神经内镜经鼻儿童颅咽管瘤切除术,经过两个多小时,患儿的颅内肿瘤被绝大部分切除,并最大程度的保护了患儿的视神经。术后患儿视力没受任何影响,且恢复迅速。

2. 《肺炎球菌性疾病免疫预防专家共识》发布。《肺炎球菌性疾病免疫预防专家共识》在京正式发布。《共识》较全面、系统地介绍了肺炎球菌性疾病和疫苗等相关的最新进展,促进公共卫生人员和预防接种人员系统地认识肺炎球菌相关疾病;同时,肺炎球菌性疾病可以通过规范、科学地接种疫苗来预防。据了解,全球5岁以下儿童疫苗可预防死因中,肺炎球菌性疾病位居首位。中国5岁以下儿童感染肺炎球菌的病例数位列全球第二,占全球总病例数的12%。

3. 有啤酒肚的人或存在维生素D缺乏。荷兰研究者在分析了参与荷兰肥胖症流行病学研究的年龄在45~65岁、平均维生素D浓度70.8 nmol/L的男性和女性受试者基线数据,通过使用线性回归分析了全身脂肪、腹部皮下脂肪组织、内脏脂肪组织、肝脂肪与血清25羟维生素D[25 -(OH)D]浓度的相关性。结果发现,腹部脂肪的堆积和维生素D水平的降低之间的密切关系,腰围较大的人发生维生素D缺乏的风险更大。

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    2018-08-04 shock_melon
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    2018-06-30 weiz
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    2018-05-27 lfyang
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    2018-05-27 陆成振
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    2018-05-25 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2018-05-25 1ddf0692m34(暂无匿称)

    学习了.长知识

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