Pages

Thursday, August 30, 2012

中裕新藥 委 藥明康得(WUXI PHARMATECH) 生產愛滋抗體新藥 ibalizumab (TMB-355)!!!

WuXi PharmaTech to Manufacture Ibalizumab for TaiMed Biologics By WuXi PharmaTech (Cayman) Inc. Published: Tuesday, Aug. 28, 2012 - 5:17 am SHANGHAI and TAIPEI, Aug. 28, 2012 -- /PRNewswire-Asia/ -- WuXi PharmaTech (NYSE: WX) today announced that it has a contract manufacturing agreement with TaiMed Biologics Inc. for the manufacture of ibalizumab (TMB-355) in support of Phase 2 and Phase 3 clinical trials globally.Ibalizumab is a humanized monoclonal antibody and a member of an emerging class of HIV therapies known as viral-entry inhibitors.This work will be completed at WuXi's biologics manufacturing facilities in China and its biologics testing facilities in the United States. "We are pleased that TaiMed Biologics has selected WuXi to manufacture ibalizumab for its global clinical trials because of WuXi's strong technical capabilities and high quality standards," said Edward Hu, Chief Operating Officer of WuXi PharmaTech."WuXi's integrated biological drug discovery, development, manufacturing and testing service platform provides our customers with a seamless solution to bring their biologics products to the market globally and in China.""TaiMed looks forward to working with WuXi to produce clinical-trial supplies of this important new medicine for patients," said James Chang, Chief Executive Officer of TaiMed Biologics. "We are delighted to have such a skilled and reputable partner in WuXi for late-stage manufacturing as we further develop the subcutaneous formulation of our lead product, ibalizumab."
About WuXi PharmaTechWuXi PharmaTech is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States.As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process.WuXi PharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D.WuXi PharmaTech's operating subsidiaries are known as WuXi AppTec.For more information, please visit http://www.wuxiapptec.com.
About TaiMed BiologicsTaiMed Biologics, Inc. is a publicly held Taiwanese biotechnology company with the mission to discover, develop and deliver for the global market innovative medicines that help patients prevail over serious infectious diseases. For more information, please visit http://www.taimedbiologics.com.

創源 往Bio-bank 模式建構 !!

基因 健康 醫療 醫界推出健康雲 2012-08-29 中國時報 李盛雯/台北報導 雲端時代,醫界也推出「個人健康雲」。台灣第一家幹細胞銀行訊聯生技,轉投資國內首家基因應用公司創源生技,成為全球首創的生技雙軌銀行,將推出從受孕開始就進行健康照護的個人健康雲計劃。創源董事長蔡政憲表示,2012年上半年全台5成以上新生兒都是創源客戶,高滲透率是創源得以掌握個人健康雲計畫的重要基礎。每個新生命從受精卵、胚胎到懷孕發展成長為完整個體,這是大家熟悉的「實體生命」,在資訊與生醫科技發達時代,伴隨實體生命成長,另一個重要的「資訊生命」也同時成形。資訊生命最重要的起點是每個生命體獨一無二的基因密碼,所有檢測、醫療、用藥乃至家族病史的資訊,都會隨著實體生命成長而累積豐富資訊生命。這些資訊需要得到妥善保存、加值及運用,不但和個人的健康息息相關,也助於全家族的健康管理。蔡政憲的父親住院時,面對漫長的診斷、治療過程與複雜的用藥處置,加上家人不同時間照顧、探訪與對病情資訊的掌握需求,他想到若能將這些資訊都送上雲端,讓醫護人員與家屬可以分享,治療將更有效率且更安全,這也促使他加入推展個人健康雲計劃。生命資訊的三大領域是基因資訊、健康資訊和醫療資訊,以雲端科技做完整儲存,以基因醫學新知持續加值,再以行動通訊科技作利用,個人、親族和醫護人員可透過這片雲,即時正確地提供必需的健康資訊。創源也將經營觸角由基因產業延伸到藥品產業,引進世界前20大藥廠使用多種先進專業軟體與資料庫,並迎向全球最新伴隨式診斷(Companion Diagnostics)趨勢,以基因檢測協助藥商開發個人化藥物市場,成為藥品產業鏈中不可或缺的成員。整合基因科技、資訊科技與健康照護,明年將推出新生兒用藥過敏性基因篩檢、流產物質晶片篩檢並完成新生兒全基因定序。

北京宝岛妇产医院 1st Cross-Straits hospital in trial operation

Updated: 2012-08-28 19:58 BEIJING - A maternity hospital built jointly by medical institutions from the Chinese mainland and Taiwan went into trial operation in Beijing on Tuesday.Baodao Healthcare has 226 medical staff and provides 50 beds for expectant mothers at first.Jin Dapeng, head of the Beijing Medical Association, said at the hospital's opening ceremony that Baodao Healthcare has passed the association's assessment and is operating in accordance with national standards."We hope Baodao Healthcare will bring advanced hospital management experience from Taiwan and become a leading figure in international maternity care," Jin said.According to statistics given at the ceremony, 11 expecting mothers have already registered at the hospital before the trial operation.Baodao Healthcare is the first mainland-Taiwan joint hospital to be registered in Beijing since the signing of the landmark Cross-Straits Economic Cooperation Framework Agreement (ECFA) in 2010. The hospital is scheduled to go into official operation in October, providing 100 beds.

热烈祝贺北京宝岛妇产医院新闻发布会胜利召开 ,我院首场新闻发布会在北京钓鱼台国宾馆胜利召开。此次新闻发布会以“两岸携手孕育生命”为主题。全国人大常委会委员,台盟中央名誉主席,第九届、十届全国政协副主席张克辉;中国国民党第一副主席、海峡交流基金会董事长江丙坤;海峡两岸关系协会会长陈云林;国家卫生部、北京市各级领导,以及来自台湾的领导和嘉宾出席了会议并发表重要讲话。参加新闻发布会的还有来自首都医科大学附属妇产医院、北京协和医院、北京大学第三医院等二十余位著名专家学者。大会吸引了中央电视台、中央人民广播电台、中国国际广播电台、人民日报、新华社、台湾中天电视台、台湾TVBS电视台、台湾中央通讯社等70余家海内外媒体记者到访。中国网、新华网、搜弧微博三家媒体对发布会进行了现场直播。会上首先由我院院长、台湾高雄医师公会理事长庄维周介绍北京宝岛妇产医院项目背景。他表示,北京宝岛妇产医院是在《两岸经济合作框架协定》(简称ECFA)签署后,经国家卫生部、北京市卫生局、北京市商务委员会批准落户的北京首家与台湾合资的医疗企业。医院将秉持两岸医疗先驱者的重大责任,积极引进台湾先进技术及医疗管理理念,充分整合国际优势医疗资源,实现与国际妇婴保健医疗产业的全方位接轨,让京城女性同胞、海外侨胞及国际友人享受到更专业、更人性化的国际医疗保健服务。全国人大常委会委员,台盟中央名誉主席,第九届、十届全国政协副主席张克辉表示,这是北京首次引进台湾的医​​疗体系,两岸的合作也充分体现了两岸医疗产业的公益价值和人文关怀,更加促进了两岸在医疗产业方面的深入交流与合作,是两岸在新领域合作上的一次重大突破。中国妇幼保健协会副会长兼秘书长于小千在接受媒体采访时表示,宝岛妇产医院宣导绿色孕育,鼓励自然分娩、母乳喂养等自然孕育方式,对于提高我国出生人口品质有着十分重要的意义。

默沙東"精英養成計畫" PK 諾華Novartis "BioCamp Leadership" !!!

默沙東「精英養成計畫」跨界人才大比拼‧角逐「未來生醫 經理人」實習機會2012/08/31   台灣默沙東總經理劉思雅(左)頒發獎學金給獲得第二名的學員-陳昱庭。 MSD/提供 ■王慰祖/撰稿■ 未來生醫領域發展有多夯,從今年參加「默沙東精英養成計畫」,包括準司法官、醫師,以及國內外頂尖大學的碩博士生等各界精英,爭相競逐「未來生醫經理人」即可看出。近幾年幾家跨國藥廠陸續舉辦各種人才培育計畫,台灣默沙東藥廠今年也首度舉辦「默沙東精英養成計畫」,訊息一出,吸引近300名學生報名,除了台、成、清、交等大學生及碩士生,還有來自於全球排名71名的美國華盛頓大學Foster商學院的留學生及跨國僑生,正在攻讀碩、博士班的醫師、物理治療師、執業藥師,甚至連準司法官也紛紛加入這個競爭機會。台灣默沙東總經理劉思雅表示,為貫徹「病患優先」的核心使命,並將這個理念灌輸於想從事生醫領域的青年學子,今年首次嘗試以四天三夜的研習課程結合競賽方式,徵選出三位充滿憧憬與使命感的熱血青年,成為台灣默沙東的未來實習生。台灣默沙東為使學員了解身於生醫產業,無論是研發還是行銷,都應以「病患」為出發點,課程第一天就安排癌症病友與學員們的心靈對話,透過病友的觀點,讓學員在當下有不同的感受。除了給予學員心靈層面的洗禮,「默沙東精英養成計畫」也重視學員的專業長才,同時也很在乎他們的抗壓性。在研習活動規劃上,不但可以充實學員們的專業,也能著實的檢測出每位學員在高壓的狀況下,是否還能同心協力的完成新藥行銷企劃。課程內容包含,新藥臨床試驗與上市法規、生技製藥資產評價、新藥上市行銷企劃、藥品競爭之公平交易、健保藥價制定及全球藥業發展,步驟性的讓學員了解一顆藥的背後需要非常多的資源與人力,才能使藥品成功的行銷濟世。最後,在36位參賽學員中,由世新大學公共關係暨廣告所碩二的李俊賢、清華大學分子與細胞生物研究所博六的陳昱庭,以及陽明大學基因體科學所碩一許大信等三位同學,獲得至台灣默沙東的實習機會。劉思雅強調,默沙東藥廠希望藉由此次四天三夜的課程,跨領域傳遞生醫製藥的經營理念及人文關懷知識,以病人需求為導向,結合醫療政策,發展新藥上市計畫,透過研習營活動,網羅各領域菁英加入默沙東,透過研習營的舉辦,除了能讓學生們提早接觸,並了解生醫在業界的發展,也可以激發學生對於未來的規劃,這也是默沙東對於社會的回饋。

沒出生就無望...遠距照護 !!!

百略科技林金源:遠距照護已經沒希望    自蘋果推出iPhone,將智慧帶入手機後,智慧化的生活體驗已逐漸擴展到各個方面。為了更聚焦「智慧生活」的服務創新,資策會舉辦了「2012智慧生活服務創新系列論壇」,以「健康照護,零售創新」為主題,分析科技發展趨勢及智慧生活的落實與推動。其中,在智慧健康中,資策會打破過去醫療照護的傳統價值,以個人化、商業化、行動化、價值化等新思維重新建構智慧醫療價值。儘管根據許多研究數據顯示,移動醫療、遠距照護將在全球創造龐大的產值,但至今卻仍難以將健康資訊整合,消費市場中也難見單一服務成功的商業模式,百略醫學科技董事長林金源甚至在會中提出「遠距照護已經沒有希望」的觀點。林金源認為,遠距照護在一些地方有其需求,然而卻有更多的意見是,沒有人喜歡每天被監控,即使那是對健康有益處。過去業者在研發遠距醫療裝置時,常以醫院、醫生的角度切入,以藥為本,卻忘了「以人為本」。遠傳電信執行副總李浩正也表示,用戶端經常是發展智慧醫療中最大的挑戰。因此,資策會前瞻所提出,以個人化健康管理服務著手,將健康主權還之於民。在ICT的支援下發展個人化健康醫療,也可為醫療資源不足的問題解套,達到醫療、健康產業雙贏效益。林金源說到:「讓民眾當自己的主治醫師,健康只有自己能生產,」以個人為主體,進行跨服務、跨裝置、跨平台的資訊整合,才能突破過去圍繞在醫療照護的柯版印象及市場侷限。

再生医療: 治療用の細胞シート作成装置 開発

ようやく、再生医療の実用化に大きく近づいたよう。日立製作所は29日、働きが悪くなった組織や臓器を作り直す「再生医療」への利用が 期待される培養細胞「細胞シート」を自動的に作製する装置を開発したと発表。人体から採取した細胞を培養してつくった直径数センチの細胞シートを、 清潔に保たれた装置内に入れると、2週間程度で1人分の細胞シートを作製できるとのこと。装置で培養された細胞シートは、目の角膜の治療に利用できるほか、 内視鏡で食道がんを取り除いた後の粘膜再生などに使われます。これまで、細胞シートの作製は大半は手作業で行われており、 医療用に使うためには細菌やほこりなどの汚染がない環境が欠かせず、 衛生管理だけでも作業者1人当たり年間数百万円が必要でしたが、 今回の装置は衛生管理の手間が省けるうえ、作業者も不要なため、 これまでの10分の1以下のコストで済むとのこと。開発に携わった大和雅之教授曰く「これまで細胞シートの作成には専用の部屋が必要で、 1か月で1人分しか作れなかった。装置を使うと、低コストで数人、数十人分作れるようになり、 再生医療の普及に大きく貢献すると思う」とのことで。ようやく研究の成果を気軽に利用できるようになりそうです。


東京女子醫科大學等單位,合作研發出製造細胞片(cell-sheet)的全自動機器。細胞片是用患者細胞組織再生培養製成,可用在心臟移植等手術上,助於修復組織。細胞片全自動製造機若能普及,大型醫院便可自行製造細胞片,可望有助於再生醫療的普及。《日本經濟新聞》報導,細胞片全自動製造機是由東京女子醫大與日立製作所、日本光電公司等合作開發的,十三日在日本再生醫療學會上發表這項成果。過去製造細胞片須從患者口腔黏膜、腳部肌肉組織等採集細胞,經過分離、精製,再花兩周培養、增殖出所需細胞,將再生細胞重疊製成細胞片。若使用全自動製造機,這些過程就無需仰賴人工。這套全自動製造機價格未定,但已知可削減製造細胞片成本,計畫在一、二年之後即可臨床運用。

Nanoparticles Could Lead to Stronger Drugs, Fewer Side Effects for Cancer Patients

 A biotech company called Cerulean says its nanoparticle-delivered cancer drugs are better at attacking tumors.SUSAN YOUNG Thursday, August 30, 2012 One result of the side effects of cancer treatments is that patients often can't tolerate or survive a combination of different drugs at the same time—which can limit a doctor's ability to knock out the disease. The head of a Boston-area biotech called Cerulean Pharma thinks the solution is nanoparticle-delivered drugs, which have fewer and less severe side effects. They could make it easier for doctors to mount a multipronged attack on tumors and kill the cells before they can develop a resistance to any one compound.Cancer cells can develop resistance to individual drugs very quickly, says Oliver Fetzer, CEO of Cerulean. And he points to recent studies showing that different cells within the same tumor can have different genetic mutations. In some cases, that means that a drug that kills cancer cells in one part of a tumor may not work in other parts. This tumor diversity suggests that it would be best to hit cancer cells with multiple drugs at once to make it extremely difficult for the tumor to develop resistance to all therapies.Nanoparticles could help achieve this goal. The nanoparticles developed by Cerulean are too big to get out of blood vessels and into healthy tissue, but they are the right size to get into tumors because the blood vessels that grow around cancer tissue have pores or gaps that aren't found in healthy tissue. "These nanoparticles find their way into the tumor through the leaky [blood vessels], so they can't really escape out of your normal bloodstream in the healthy tissue," says Fetzer. Once inside the tumor tissue, cancer cells take them in.Cerulean's nanoparticle acts like time-release packaging—instead of dumping all the cancer drug into the tumor at one time, the nanoparticle slowly breaks down and releases the drug bit by bit. A feature of Cerulean's technology is that the nanoparticle and the drug are connected by a chemical bond. While drugs in other nanoparticles used in delivery are held by polymer meshes or inside a fatty capsule, drugs in Cerulean's nanoparticles are tethered by a chemical link. The drug is released as the chemical bond is broken, a process partly controlled by an unknown enzyme in the body. That rate of release can be tuned using different linkers, says Fetzer.Data from early clinical trials of Cerulean's lead compound—a nanoparticle containing a drug called Camptothecin that is too toxic to be administered on its own—suggests it is well-tolerated. Patients in the trial experienced fewer and milder side effects than do patients given available drugs.Another player in the nanoparticle-delivery space, BIND Biosciences, adds a layer of specificity to its delivery by affixing targeting molecules to the outside of its nanoparticles (see "Fine-tuning Nanotech to Target Cancer"). The targeting molecules recognize proteins on the outside of cancer cells and so help bring the nanopharmaceutical to its desired location.Fetzer says that while there may be applications where the targeting is helpful, his company does not think it is necessary. "When we look at the data we've generated with untargeted particles, we haven't seen the need to add another layer of complexity."
The company expects to have results from its human trials of its lead compound in treating lung cancers by the end of the 2012. It recently began testing the effectiveness of the same compound in ovarian cancer patients. To begin to explore the possibility of combining nanoparticle-based cancer drugs with other therapies, Cerulean is also enrolling patients with kidney cancer in a phase I trial that will combine the company's lead compound with bevacizumab, a commercially available cancer drug used in a variety of cancers.


FDA 510(k)许可: Covidien宣布其Nellcor床边SpO2患者监测系统获

 编辑:Sharon 来源:美国商业资讯20120806日全球领先的医疗产品供应商及患者监护与呼吸监护解决方案领域公认的创新企业Covidien (NYSE: COV)今日宣布,该公司的Nellcor床边SpO2患者监测系统已获得美国食品药品监督管理局(FDA)允许其上市的510(k)许可。新的患者监测系统现已在美国发售。搭载OxiMax技术的Nellcor床边SpO2仍将继续监测成人、儿童及新生儿患者的SpO2和脉律,使医生能够即时掌握患者呼吸综合走势信息,较早地发现那些不易察觉但却非常重要的心律和SpO2变化,从而及时应对呼吸系统并发症的发生。Covidien呼吸和监护解决方案总裁Robert J. White说:"我们很高兴地宣布,CovidienNellcor床边SpO2患者监测系统已获批在美国商业发售。医院综合护理及其他轻症科室的医护专业人员都需要及时获得重要的患者信息,这样他们便能够对危胁患者健康的状况作出迅速响应。该系统通过随时向他们提供患者的呼吸历史数据,使他们能够专注于提供高效率、高品质的医护服务,无需为搜集和处理数据而分心。"Nellcor床边SpO2患者监测系统还具有增强功能,加强的数据信号处理能够在低血流灌注或其他难于准确跟踪的挑战情况下给出精确的SpO2读数。其SatSeconds?警报管理技术可区分严重及轻微事件,从而减少了临床上不显著的血氧不足报警。而且,监测仪屏幕还提供了直观且多彩的画面,便于在任意光线下从不同角度观看。此外,医院技术人员还可自行设置专业默认,更换电池,执行诊断,并对监测仪进行普通维护,从而节省了时间和资源。Nellcor床边SpO2患者监测系统符合医用电气设备安全标准,如IEC 60601-1:2005,并遵从指导产品在欧洲经济区市场销售的《电子电气设备限用有害物指令(RoHS)》。
关于COVIDIEN Covidien是一家全球领先的健康保健产品公司,致力于为改善患者的用药效果提供创新的医疗解决方案,并通过在临床领域的领导地位及卓越表现创造价值。Covidien在三大业务领域制造和销售业界领先的产品线,并提供相应服务,这三大领域是:医疗设备、医药产品和医疗用品。2011年,Covidien公司的营业收入高达116亿美元,公司在全球65个国家拥有43,000多名员工,其产品销往140多个国家。免责声明:本公告之原文版本乃官方授权版本。译文仅供方便了解之用,烦请参照原文,原文版本乃唯一具法律效力之版本。