下图为国家食药监总局公开信息，整理的7月21日重要新药受理信息，按注册类型排序，供参考。
Trimel制药获Shire公司绝经期综合征用药Estrace在加拿大的代理权
7月17日，Trimel制药很高兴宣布，获得了Shire公司妇科用药Estrace（17-β雌二醇）在加拿大的代理权，该产品用于缓解绝经期综合征症状。
7月17日，Trimel制药很高兴宣布，获得了Shire公司妇科用药Estrace（17-β雌二醇）在加拿大的代理权，该产品用于缓解绝经期综合征症状。Estrace已经在加拿大销售了39年，2013年的销售额为990万美元，同比增长6%。另外，Trimel已与Cormark证券公司达成协议，以私人配售的方式，以每股0.62美元的价格购买公司28,801,000股普通股票，款项总值17,856,620美元。受到需获得必要监管部门批准（包括多伦多证券交易所）等因素的影响，私募活动将于2014年7月30日前后才能结束。此次定向募集的资金将用于偿还上述提到的部分可兑换股票据。“对于Trimel公司而言，收购Estrace是从专注于产品研发到商业化转变的一个重要里程碑，未来将为公司提供巨大而稳定的年收入，”Trimel总裁兼首席执行官TomRossi说，“再者，我们相信，Estract将是对我们妇女健康特许经营权的重要补充，对Trimel的未来现金流有正面的影响。”
德国默克任命新研发主管 上一位仅在位6个月 发布日期：2014-07-22 来源：fiercebiotech
德国默克在其生物制药业务的改革中已找到一位新的研发主管，而其上一位研发主管仅在位6个月。
德国默克在其生物制药业务的改革中已找到一位新的研发主管，而其上一位研发主管仅在位6个月。Rossetti是一位资深的默沙东职员，他将于7月21日开始入职，管理该公司大约15亿美元的年研发预算，该公司将致力于将一些有前景的中期资产推进进入3期试验。Rossetti在默沙东最近的角色是作为高级副总裁负责后期药品的研发，他的新雇主称，他在备受关注的抗PD-1癌症药物Pembrolizumab (MK-3475)开发中曾扮有重要角色。他的前任是前百时美施贵宝的Jenkins，她于去年10月在广泛的重组中接受了这份工作，那次重组使前COO Garijo成为该生物制药业务的掌舵人。然而，据德国默克提供的信息，她决定于今年3月离开，德国默克对此几乎未提供细节内容。Rossetti介入的是一家致力于补充其研发线的制药商，此前，德国默克经历了几个昂贵的后期研发失败，目前只剩下几款3期候选药物。为了达到目标，德国默克反复寻求交易，今年该公司与MorphoSys、Mersana及辉瑞达成交易，为公司带来新的资产。该公司倚重的肿瘤研发线包括肿瘤疫苗、免疫治疗药物和多种激酶抑制剂，另为还有用于红斑狼疮、骨关节炎和多发性硬化症的治疗药物。Rosetti在默沙东的简历将帮助他在德国默克领导正在进行的改革，Garijo表示称。“丰富的经历及在两项研究及开发中的坚实记录，加之其明显的领导形象，将推动我们富有前景的研发线的发展，确保我们将达到我们的战略里程碑，向全球患者未满足的医疗需求输送创新药物，”Garijo在一份声明中称。信源地址：http://www.fiercebiotech.com/sto ... -rethink/2014-07-14
默沙东肿瘤免疫业务单元出现高管跳槽潮
7月16日，默沙东生物疫苗领域研发副总裁Richard Murray跳槽Jounce公司，出任CEO，领导肿瘤免疫疗法的开发。
7月16日，默沙东生物疫苗领域研发副总裁Richard Murray跳槽Jounce公司，出任CEO，领导肿瘤免疫疗法的开发。此前，Murray曾领导默沙东公司蛋白及疫苗业务，期间负责过期肿瘤免疫项目anti-PD1药物 pembrolizumab的开发。而位于马萨诸塞州的Jounce公司以肿瘤免疫疗法为主要研究领域。近来，默沙东肿瘤免疫业务单元频繁遭遇跳槽事件。6月3日，默沙东欧洲及加拿大研发总监Bruno Strigini跳槽诺华。对Strigini来说，也许因接手GSK肿瘤业务而实力增强的诺华肿瘤业务研发总监确是诱人的选择，但Murray则为其选择跳槽小公司找到了充分的理由：“加盟下一代肿瘤免疫药物的开发正当时。”
阿斯利康将在剑桥设立新全球生物医药研发中心
英国制药巨头阿斯利康公司最近公布了一项高达5亿美元的全球研发中心建设项目，公司表示这一新的阿斯利康全球生物医药研发中心将位于英国剑桥地区，公司希望能够依托该地区强大的科研实力来帮助公司的医药研发工作更上一层楼。
相关发言人表示这一研发中心预计将于2016年投入使用。这也是阿斯利康公司进行研发机构重组使研发部门全球化的一部分。据了解，这一研发中心在未来将主要承担阿斯利康公司小分子药物的研发。同时也将为公司研发部门与学术界交流起到重要作用。最近阿斯利康公司一直处于与辉瑞收购案的漩涡中。虽然公司最终拒绝了辉瑞公司的报价，但是有分析人士认为，阿斯利康公司如果无法证明其研发实力，很可能辉瑞公司会选择适当时机卷土重来。阿斯利康(AZ)正式公布其3.3亿欧元（5.64亿美元）剑桥新园区设计，该园区于2016年晚些时候开放时，届时将作为该公司研发中心及公司总部。园区预期于明年初开工，一旦完工，将容纳大约2000名人。建设项目显然是阿斯利康的一个旗舰投资项目，此外它对公司还有大的象征意义，因为它是政治的一个上触点，当时，阿斯利康为防御辉瑞年初690亿美元的收购而寻求动员支持。据公司提供的信息，新的场所将阿斯利康的小分子及生物研发团队放在一起，包括目前在其Medimmune子公司雇佣的研究人员，这将为开发合并治疗药物提供机会。阿斯利康已发布一系列园区艺术效果图，园区包含了大量开放空间和干道，这可激发公司内部及该区域更广泛的科学合作，同时，建筑的设计尽可能环境友好。设计公司Herzog & de Meuron表示称，该场所的外观旨在让人想起剑桥的大学建筑，所以主要建筑都不高，有中心庭院，锯齿形屋顶是为了统一建筑外观，使其具有鲜明的特点。主建筑被设计成三角形，当然它座落在英国生命科学“黄金三角”的一个角落，“黄金三角”将剑桥、牛津及伦敦联系在了一起。这项复杂计划的发布受到MedCity的热烈欢迎，MedCity今年初由伦敦市长Johnson发起，它旨在提升黄金三角的创新与投资。“新中心的设计证明了一种开放的、外向型方式，我希望这能够使黄金三角的研究社区促进合作，并坚定地植入公司当中，”伦敦副市长Malthouse表示称。除了剑桥项目，阿斯利康还对位于麦克莱斯菲尔德的生产设施投资1.2亿欧元，对位于斯皮克的疫苗工厂投资7500万欧元予以扩建。 信源地址：http://www.pmlive.com/pharma_new ... cambridge_hq_587792详细英文报道：AstraZeneca today revealed the proposed designs for its new Global R&D Centre and Corporate Headquarters in Cambridge in the UK. The plans for the new facility, which will be located on the Cambridge Biomedical Campus (CBC), include designs for the Global Centre, an R&D Enabling Building and an Energy Centre1.Key features of the site include:Science at the heart - the high technology labs on the site will be separated from other work spaces by glass walls to promote 'visible science', ensuring scientific innovation is the primary focus for all staff, both in R&D and other functions.Fostering collaboration -the site will feature a number of open spaces and thoroughfares to encourage collaboration not only within AstraZeneca, but also with the wider scientific community within the CBC and beyond.Reflecting the character of the City - the unique characteristics of Cambridge's historic centre have influenced the shape of the buildings. The site will be low rise and will include a central courtyard reflecting the colleges of Cambridge University. An environmental build -AstraZeneca is seeking Building Research Establishment Environmental Assessment Methodology (BREAAM) Excellent status for the site, which will feature labs that represent best practice in low energy design and the largest ground source heat pump in Europe. "Green Roofs" will also be installed across the majority of the site.Mene Pangalos, Executive Vice President, Innovative Medicines & Early Development at AstraZeneca said: "We are very excited to be able to reveal the plans for our new site in Cambridge today. Our aim is to create an open, welcoming and vibrant centre that will inspire our teams and partners to push the boundaries of scientific innovation."The new site will bring together AstraZeneca's small molecule and biologics research and development activity, opening up opportunities to exploit the promise of biologics and small molecule combinations. The CBC will be the new UK home for biologics research and protein engineering carried out by MedImmune, AstraZeneca's biologics arm. MedImmune already employs around 500 people at Granta Park, to the south east of the city."With our combined AstraZeneca and MedImmune portfolios we are already uniquely positioned to explore the promise of combination therapies in transforming the way patients are treated," said Dr. Bahija Jallal, Executive Vice President, MedImmune. "Our new Global Research Centre in Cambridge will see AstraZeneca and MedImmune scientists working side by side to advance science in our core therapeutic areas. This will support and strengthen our focus on combining the expertise across our business to develop new ways to treat patients and tackle the significant unmet need that exists in areas such as oncology."Stefan Marbach, Senior Partner at Herzog & de Meuron, the architects selected to design the new site in Cambridge, said: "In designing the new building we made reference to the historical colleges in central Cambridge, which are typically low-rise buildings enclosing a central courtyard. The building's proportions draw on this, as well as the open public access to the courtyard. The whole structure is connected in a single loop, providing short connections within the building and modern, innovative workspaces that support collaborative working. The 'saw-tooth' roof, which carries on through to the facade, aims to unify the appearance of the building and give it a distinctive character."In advance of the new site coming online in late 2016, around 70 AstraZeneca staff have already relocated to interim facilities in Cambridge, at the Melbourn Science Park, Cambridge Science Park and Granta Park. By the end of 2014 approximately 300-400 AstraZeneca staff will have relocated to the city, to cement important relationships with other members of the Cambridge life science community. Mene Pangalos continued: "As we carry on our work to get the new site up and running, our focus is on continuing to build important relationships with partners in the local bioscience community. With up to 400 staff relocating to the city by the end of the year, and with the range of exciting collaborations we have underway, Cambridge is already an important part of our innovation footprint here in the UK alongside our sites in the North West, which will continue to be important elements of our UK presence."Recent collaborations AstraZeneca has entered into in Cambridge include:In May 2014 AstraZeneca announced its intention to collaborate with the Medical Research Council (MRC) Laboratory of Molecular Biology to fund a range of pre-clinical research projects, aimed at better understanding the biology of disease.In March 2014 AstraZeneca and the MRC announced the creation of the AstraZeneca MRC UK Centre for Lead Discovery, which will sit within the new AstraZeneca site at the Cambridge Biomedical Campus and see AstraZeneca and MRC-supported researchers working side-by-side.In February 2014 AstraZeneca entered into a collaboration with the Cancer Research UK Cambridge Institute, to locate up to 60 of the Company's scientists in the Institute's state of the art labs on the CBC over the next three years. The first of AstraZeneca's scientists have already moved into the Cambridge Institute labs.Designs for AstraZeneca's new site are being made available today as part of a public consultation2 for the local community, ahead of submission of a detailed planning application in Autumn 2014. AstraZeneca expects to begin the build of the new site in early 2015.Hi-res images of the site plans are available at www.astrazeneca.com/Media/Photo-library and a broadcast quality animation is available at www.astrazeneca.com/Media/Broadcast-video.NOTES TO EDITORS1The R&D Enabling Building will house functions that support AstraZeneca's scientific work, including regulatory affairs and commercial units. The Energy Centre will support the entire site and will contain power generators, heating and cooling systems as well as other support systems such as IT and telecommunications.2The designs for the new site will be made available to the public at a viewing taking place between 15:30 on Friday 18 July and 20:30 on Saturday 19 July at the Long Road Sixth Form College on the Cambridge Biomedical Campus. AstraZeneca's presence in the UKAstraZeneca has a long history in the UK, and continues to contribute to the UK economy through employment, investment in the business and innovation in the life sciences sector:AstraZeneca directly employs 6,700 staff and supports 30,000 jobs through secondary employment in the UK.In 2011 AstraZeneca contributed ?3.8 billion total Gross Value Added to the UK economy and in 2012 the Company accounted for 1.8% (?5.4 billion) of the total UK export of goods.In March 2013 AstraZeneca announced the investment of approximately ?330 million in a purpose-built R&D centre and corporate headquarters in Cambridge in the UK.In November the Company announced an investment of ?120 million to continue production of Zoladex at its manufacturing facility in Macclesfield in the North West of England, which secured 300 existing jobs at the site and is expected to create over 200 temporary jobs between now and early 2017.AstraZeneca is investing more than ?75 million in its manufacturing site in Speke, Merseyside, to supply the UK Government's extended flu vaccination programme for children.AstraZeneca currently has 200 active collaborations with UK academic, research-funding and charitable organisations.Nearly 70% of AstraZeneca's pipeline was discovered in the UK, has its IP registered in the UK or is being developed by UK teams.
BMS和辉瑞开始为Eliquis的IV期临床研究招募受试者
百时美施贵宝（Bristol-Myers Squibb，BMS）公司和辉瑞公司近日宣布，已经开始招募IV期EMANATE临床试验的受试者。
百时美施贵宝（Bristol-Myers Squibb，BMS）公司和辉瑞公司近日宣布，已经开始招募IV期EMANATE临床试验的受试者，该临床试验旨在评估Eliquis（阿哌沙班）对正进行心脏整流术的非瓣膜性房颤（nonvalvularatrial fibrillation，NVAF）患者的有效性和安全性。目前Eliquis已被批准用于减少NVAF患者发生中风和全身性栓塞的风险。心脏整流术（又称心律转复术）是一种常用的、有效的把房颤转换到正常节律、并使心脏更有效泵血的方法，通常至少在手术前三周和手术后四周需进行抗凝治疗。对于某些NVAF新发患者，当通过影像检查确认心脏中没有预先存在的可在复律过程中脱落造成中风的血栓时，通常在发病当天或几天内就可进行心脏整流术。该临床试验预计在美国、加拿大、欧洲及亚洲招募1500名合格的受试者。BMS心血管全球临床研究副总裁Jack Lawrence说道，“这项IV期临床试验将为正在进行心脏整流术的NVAF患者使用Eliquis提供重要的参考数据。”
疗效显著 GSK提前终止黑色素瘤Mekinist+Tafinlar组合疗法III期COMBI-v试验
因疗效数据显著，葛兰素史克提前终止黑色素瘤组合疗法（Mekinist+Tafinlar）III期COMBI-v试验。完整的数据分析将于近几个月内完成并提交至未来的科学会议。
葛兰素史克（GSK）近日宣布，独立数据监测委员会（IDMC）已建议III期COMBI-v（MEK116513）提前终止。COMBI-v是一项III期研究，在BRAF V600E或V600K突变阳性不可切除性或转移性黑色素瘤患者中开展，调查了黑色素瘤药物Mekinist（trametinib）+Tafinlar（dabrafenib）组合疗法相对于vemurafenib的疗效。IDMC的积极建议，是基于COMBI-v的一项既定中期分析的积极数据。该分析数据证明，与vemurafenib相比，Mekinist+Tafinlar组合疗法在横跨既定疗效终止边界均表现出总生存期（OS）利益。进一步的疗效和安全性数据分析正在进行中，预计将在未来几个月内完成。该项研究中，vemurafenib治疗组的患者将被允许接受Mekinist+Tafinlar组合疗法治疗。关于COMBI-v：COMBI-v是一项随机、开放标签III期研究，在BRAF V600E或V600K突变阳性不可切除性或转移性皮肤黑色素瘤患者中开展，调查了Mekinist+Tafinlar组合疗法相对于vemurafenib的疗效。该项研究中所招募的704例患者来自美国、欧洲、加拿大、俄罗斯、乌克兰、以色列、阿根廷、巴西、韩国、新西兰、中国台湾和澳大利亚等地的研究中心。研究的主要目标是评估总生存期（OS），次要终点包括无进展生存期（PFS）、总缓解率（ORR）及缓解持续时间。关于Tafinlar和Mekinist：Tafinlar和Mekinist是GSK研发的2款黑色素瘤新药，均于2013年5月获FDA批准。Tafinlar为BRAF抑制剂，作为一种单药口服胶囊，适用于携带BRAF V600E突变的手术不可切除性黑色素瘤或转移性黑色素瘤成人患者的治疗。Mekinist为首个MEK抑制剂，作为一种单药口服片剂，适用于携带BRAF V600E或V600K突变的手术不可切除性黑色素瘤或转移性黑色素瘤成人患者的治疗。Tafinlar不适用于野生型BRAF黑色素瘤患者的治疗。Mekinist不适用于既往接受过BRAF抑制剂疗法的患者的治疗。转移性黑色素瘤中，约有一半携带BRAF突变，该异常突变能促使黑色素瘤生长和扩散。Tafinlar和Mekinist分别获批用于携带BRAF V600E突变的患者，该突变约占转移性黑色素瘤所有BRAF V600突变的85%。Mekinist同时获批用于携带BRAF V600K突变的患者，该突变约占转移性黑色素瘤所有BRAF V600突变的10%。英文原文：Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase III BRAF V600-mutant metastatic melanoma study stopped earlyGlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the Independent data Monitoring Committee (IDMC) recommended COMBI-v (MEK116513), a phase III study of its MEK inhibitor, trametinib (Mekinist™), in combination with its BRAF inhibitor, dabrafenib (Tafinlar™), compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma be stopped early. This IDMC recommendation is based on an interim analysis which demonstrated an overall survival benefit for the trametinib and dabrafenib combination compared to vemurafenib that crossed the pre-specified efficacy stopping boundary. The safety profile of the trametinib and dabrafenib arm was consistent with the safety profile of the combination observed to date.The IDMC recommendation today is based on headline data; further analysis of safety and efficacy data is underway and will be completed in the coming months. Eligible study patients who were randomised to the vemurafenib arm will be allowed to cross over to receive treatment with the trametinib and dabrafenib combination.Dr. Rafael Amado, Head of oncology R&D at GSK, said: “Today’s headline results for the combination of dabrafenib and trametinib add to the body of evidence our phase III program has provided thus far, which we hope will more fully characterise the efficacy and safety profile of this combination for patients with BRAF V600-mutant metastatic melanoma. We will continue to analyse this data versus vemurafenib over the coming months and look forward to sharing these with the scientific community once the analysis is complete.” about COMBI-vThis phase III, randomised, open-label study compared the combination of dabrafenib and trametinib to vemurafenib in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. COMBI-v enrolled 704 patients from investigative sites in the U.S., Europe, Canada, Russia, Ukraine, Israel, Argentina, Brazil, Korea, New Zealand, Taiwan, and Australia.The primary objective of the study was to evaluate dabrafenib and trametinib combination therapy vs. vemurafenib with respect to OS. Secondary objectives evaluated and compared dabrafenib and trametinib combination therapy versus vemurafenib with respect to progression-free survival, overall response rate, and duration of response. The safety of dabrafenib and trametinib combination therapy, including incidences of squamous cell carcinoma and other proliferative skin diseases, was also evaluated.about cutaneous melanomaCutaneous melanoma is the most aggressive form of all skin cancers. Worldwide, it is expected that over 132,000 people will be diagnosed with melanoma each year and more than 37,000 people are expected to die of this tumour disease annually. In the U.S. and most countries of the Western World including Australia, the incidence of melanoma continues to rise faster than any other type of cancer in men and the annual increase in the incidence of melanoma in women is second only to lung cancer.about trametinib (Mekinist™) and dabrafenib (Tafinlar™)Combination use of trametinib and dabrafenib in patients with unresectable or metastatic melanoma who have BRAF V600E or K mutation is approved only in the U.S. and Australia.Trametinib was in-licensed by GSK in 2006 from Japan Tobacco Inc. (JTI). GSK holds the worldwide exclusive rights to develop, manufacture, and commercialise trametinib, while JTI retains co-promotion rights in Japan.Tafinlar and Mekinist are registered trademarks of the GSK group of companies.
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