The BrainGate implantable microelectrode array When the participants thought of their arm performing a certain action, neurons adjacent to the array fired accordingly. Due to the subjects' paralysis, this did not result in the movement of their arm, which it would do in a non-handicapped person. The electrical activity of the neurons was, however, picked up by the electrodes. This data was fed (via the cable) to a linked external computer, which translated the activity into instructions for the robotic arm. Over the course of four days, the woman and man used this setup in a series of exercises. Some of these involved trying to grab foam targets, within 30 seconds of their popping up in different locations. When using the DEKA arm and hand, which has a wider grasp, the woman was successful 66.7 percent of the time, while the man managed a figure of 62.2 percent. Both subjects experienced much higher success rates when it came to simply touching the targets. According to a press release from Rhode Island's Brown University, where BrainGate was developed, "The study represents the first demonstration and the first peer-reviewed report of people with tetraplegia [also known as quadriplegia] using brain signals to control a robotic arm in three-dimensional space to complete a task usually performed by their arm." As mentioned, the woman went a step further than grabbing the foam targets, and used the arm to grasp a bottle of coffee from a table, move it over to her face, and then tilt it so she could sip the coffee through a straw. She subsequently had the arm return the bottle to the table. The researchers were impressed both that the motor neurons in her brain were still active after 15 years of essentially being "disconnected," and that her microelectrode array still functioned properly five years after being implanted. The system still needs to refined – it would definitely be preferable to make it wireless, for instance, so that users didn't have to be hard-wired to a computer through the top of their head. Nonetheless, the scientists are enthusiastic about what has been accomplished so far. "Our goal in this research is to develop technology that will restore independence and mobility for people with paralysis or limb loss," said lead author of the report, Dr. Leigh Hochberg. "We have much more work to do, but the encouraging progress of this research is demonstrated not only in the reach-and-grasp data, but even more so in S3's smile when she served herself coffee of her own volition for the first time in almost 15 years."
Pages
Thursday, May 17, 2012
Mind-controlled robotic arm!!
The BrainGate implantable microelectrode array When the participants thought of their arm performing a certain action, neurons adjacent to the array fired accordingly. Due to the subjects' paralysis, this did not result in the movement of their arm, which it would do in a non-handicapped person. The electrical activity of the neurons was, however, picked up by the electrodes. This data was fed (via the cable) to a linked external computer, which translated the activity into instructions for the robotic arm. Over the course of four days, the woman and man used this setup in a series of exercises. Some of these involved trying to grab foam targets, within 30 seconds of their popping up in different locations. When using the DEKA arm and hand, which has a wider grasp, the woman was successful 66.7 percent of the time, while the man managed a figure of 62.2 percent. Both subjects experienced much higher success rates when it came to simply touching the targets. According to a press release from Rhode Island's Brown University, where BrainGate was developed, "The study represents the first demonstration and the first peer-reviewed report of people with tetraplegia [also known as quadriplegia] using brain signals to control a robotic arm in three-dimensional space to complete a task usually performed by their arm." As mentioned, the woman went a step further than grabbing the foam targets, and used the arm to grasp a bottle of coffee from a table, move it over to her face, and then tilt it so she could sip the coffee through a straw. She subsequently had the arm return the bottle to the table. The researchers were impressed both that the motor neurons in her brain were still active after 15 years of essentially being "disconnected," and that her microelectrode array still functioned properly five years after being implanted. The system still needs to refined – it would definitely be preferable to make it wireless, for instance, so that users didn't have to be hard-wired to a computer through the top of their head. Nonetheless, the scientists are enthusiastic about what has been accomplished so far. "Our goal in this research is to develop technology that will restore independence and mobility for people with paralysis or limb loss," said lead author of the report, Dr. Leigh Hochberg. "We have much more work to do, but the encouraging progress of this research is demonstrated not only in the reach-and-grasp data, but even more so in S3's smile when she served herself coffee of her own volition for the first time in almost 15 years."
松山湖高新区不作產業孵化器 而是”加速器” !!
松山湖为首批6名"高参"发聘书 2012年05月18日南方日报[ 南方日报讯 (记者/彭子英)昨日,松山湖高新区举办经济社会发展顾问聘任仪式暨高新区建设交流座谈会,为首批6位专家学者和企业高管顾问颁发了聘书,这些"高参"在各自行业都颇有建树,涉及经济、规划、法制、文化等领域。松山湖智囊团已引进19名顾问。松山湖高新区管委会常务副主任、工委书记刘宁、副主任蒋亚军、李航、蓝启章等参加活动。 此次聘任的顾问包括深圳市科技企业孵化器协会副会长、副秘书长吕勇,广东省文化促进会主席王业群,华特迪士尼公司(中国)董事总经理、大中华区行政总裁张志忠,中国国际金融学会理事田秋生,中国城市规划设计研究院副总规划师,深圳分院副院长、教授级高级城市规划师朱荣远,深圳市原政协副主席刘家琛。 蒋亚军对智囊团提出两点希望:一是希望顾问们紧紧围绕松山湖高新区重大的经济社会发展问题积极建言献策;二是希望顾问们积极发挥桥梁纽带作用,为松山湖招商引资、招才引智工作扩展思路。他说,松山湖在发展取得一定成绩的同时,与国内现金园区相比还存在一定差距,松山湖作为东莞当前推进"三重"建设的前沿阵地,任务艰巨,"如今国际国内的经济形势不明朗,城市与城市之间的竞争也十分激烈,大项目、龙头企业、上市公司或者上市后备企业都不好找,希望顾问团主动发挥自身影响力,帮助松山湖拓宽与重大项目、高层次人才之间的对接渠道,为松山湖招商择资、招才引智发挥桥梁纽带作用。"聘任仪式结束后,顾问团围绕松山湖经济社会发展进行了交流座谈,提出了许多有建设性的意见。松山湖管委会相关负责人表示,松山湖智囊团目前已邀请19名顾问,除了第一批聘任6人以外,近期内还将举行第二批顾问聘任仪式。昨天,首批受聘的6位专家都畅所欲言,谈了不少有关松山湖高新区的发展的想法和建议。
"不要只做简单的投融资平台" 深圳市科技企业孵化器协会副会长、副秘书长吕勇说,在当前的经济环境下,一定是政府引导产业发展的。在吕勇看来,松山湖更需要的是加速器。孵化器时间过长,对企业项目的孵化时间就要3—5年,等再出成果就要7—9年,周期长,对产业拉动不明显。孵化器要做,但重点要从加速器开始做,提供合适的载体,提升创新能力,很快就能见成效,紧要的是先把产业带动起来,孵化器也就更容易出成果。另外,无论怎样起步,没有金融资本的强力介入是一定做不起来的,松山湖不要只做简单的投融资平台,也应当考虑发行产业基金,撬动并形成百亿元的资金规模时,整个产业只需3—5年时间就能做成。
"金融业发展要看准城市定位"中国国际金融学会理事、华南理工大学区域经济研究中心主任田秋生说,要找准松山湖金融业发展的定位,可以学习别人的经验。比如说,看看纽约、伦敦等国际金融中心和周边城市是什么样的关系;再看看北京、上海两大国内金融中心和周边城市天津、南京以及无锡杭州是怎样的关系。再回到珠三角,看看香港、深圳和广州与东莞应该是怎样的关系,松山湖又该在这样的关系中扮演怎样的角色。可以说,给松山湖金融服务业定位不是容易事。中心会聚集更多的资源,这在金融业上表现的尤为突出,周边城市是无法抗衡的。金融业的发展不仅是自身的发展,也是服务于实体经济的发展,金融资产起到资源配置的作用。作为松山湖的顾问,接下来会专门研究这方面的问题。
"生物医药要从科研入手" 协和医科大学教授、深圳市原政协副主席刘家琛说,松山湖是东莞经济发展的一块宝地,自然资源条件非常好,可以说深圳都不见得能比得上。广东又是中医药大省,中医药是我国的瑰宝,一个王老吉的品牌就值上千亿元,王老吉也就是一个处方啊!松山湖要搞生物医药,就要从科研入手,做科技、做医疗器械都可以,做生物工程也是对的,深圳华大基因的模式就很适合松山湖,而且要引进一流的医学院搞合作松山湖要是想办医院,办高端的会员制医院,有急诊和体检再设置几个主要科室就足够了。
生技月…設立兩岸生技專區
研華強力佈局中國智慧醫療商機!!
细胞治疗技术研讨会将于6月在广州召开
訊映建立台灣第一血糖儀品牌: OKmeter (歐克)!!
進階CRO訂單成長??
院所醫療設備競爭 台廠獲利多少??
白藜芦醇国际出口价暴跌!!
天然白藜芦醇国际市场前路扑朔迷离 2012/5/17药品资讯网信息中心 市场监测显示,白藜芦醇国际消费热度明显在降低,新品推出数量和频率逐年下降,今年国际市场新增白藜芦醇新品企业远少于往年。白藜芦醇是国际保健品市场上的畅销产品之一。过去10年里,西方研究人员发现白藜芦醇具有多种抗病保健作用,如抗机体衰老、抗癌、减肥和治疗糖尿病等。过去10年里白藜芦醇类保健产品的上市总量可反映出该产品在国际市场上的受欢迎程度。不过,在合成白藜芦醇产品上市之后,我国的天然白藜芦醇出口多少遭遇到了阻力。
终端用途成熟稳定 据欧洲Datamonitor咨询公司的统计数据,在2002~2010年间,全球共计开发上市98只含白藜芦醇的保健食品,尤其在2007年高峰期间,全球共计上市24只白藜芦醇类保健新产品;2006年这一数字仅为8只;到2008年,各国厂商开发白藜芦醇保健品的热度有所下降,当年仅上市18只白藜芦醇保健品;2009年下降为16只;2010年为15只。但国外有人认为,全球白藜芦醇保健品上市数量减少并不代表该产品总体销量的下降,因为自2005年以后,白藜芦醇的一些新用途被陆续发现,根据这些新用途开发的食品类产品已占据了一定的市场。另外,化妆品也是白藜芦醇的一大用户。Datamonitor数据显示,护肤类化妆品每年消耗的白藜芦醇约占全球白藜芦醇总销量的12%~15%,且增势十分强劲。从附表可清楚看出,国际市场上白藜芦醇原料的销量并未减少而是缓慢上升。这一情况很大程度上与功能食品等新用途推高白藜芦醇的销量有关。 目前全球使用白藜芦醇原料的药品、保健品、化妆品及各种功能食品已达上千种之多,而服用或使用含白藜芦醇成分终端产品的人数每年有2亿人左右,估算白藜芦醇终端产品的全球销售额高达几亿至十几亿美元。
2010年出口下行 目前天然白藜芦醇主要来源于葡萄皮和中药材虎杖。我国厂商生产的白藜芦醇主要从虎杖中提取,欧洲产的主要从葡萄皮中提取。由于虎杖资源集中分布在我国西南诸省,以四川、重庆、湖北等省的白藜芦醇产量为最高,其他省次之。白藜芦醇国际市场长期以来销量增长平平,但自2008年以后国际白藜芦醇保健品市场突然红火起来,造成国外厂商纷纷向我国追加白藜芦醇订单。白藜芦醇的外销价猛涨至4800元/公斤,这一高价引起国内众多厂商纷纷投入到白藜芦醇生产中,最多时国内生产白藜芦醇的厂家超过了60家,但多数厂家的产量仅几十到几百公斤。由于国内迄今尚未形成白藜芦醇类保健品市场,因此大量白藜芦醇只能向海外出口。但受到经济危机冲击和欧洲厂商开发出人工合成白藜芦醇等因素的影响,2010年后我国出口白藜芦醇开始受阻,出口价猛跌至2300~2400元/公斤。如此低价对多数厂家来说肯定要亏本,所以去年绝大多数白藜芦醇生产商都停产,仅剩十来家企业仍在坚持生产白藜芦醇,国内白藜芦醇粗品产品已从前几年的近30吨猛跌至十几吨。
难见突围之机 近据国外媒体报道,美国辉瑞公司已投资7亿多美元用于白藜芦醇及其衍生物新产品的开发研究工作。而有消息说,美国FDA将在今后几年内批准白藜芦醇作为抗衰老药品上市。辉瑞公司之所以将白藜芦醇列入今后新品开发重点,很大程度上是看好今后10年全球抗衰老产品市场的前景,预计明年全球抗衰老产品市场总销售额将达2740亿美元。另外,近年来以荷兰DSM公司为首的西方厂商已研制出合成白藜芦醇产品,并已有产品投放市场。由于合成白藜芦醇的售价至少比天然来源白藜芦醇低1/3,且其纯度可达99%(目前最好的植物提取白藜芦醇的纯度仅98%,且含一定量的大黄酸等杂质),因此欧洲不少保健品厂商纷纷购买合成白藜芦醇,以代替天然白藜芦醇。因而有推测认为,2010年后我国出口天然白藜芦醇数量急剧减少,或主要与荷兰DSM公司合成白藜芦醇产品大量上市有关。美国和英国等西方国家近年来又陆续开发出多只白藜芦醇新功能食品,其中最引人注目的是"抗衰老水"。据介绍,"抗衰老水"是一种含白藜芦醇的等渗水,可将体内的自由基排出体外,从而减缓细胞或组织的衰老进程。而白藜芦醇最主要的新用途是除皱霜等皮肤化妆品。有关部门预计上述新用途将大大拓展白藜芦醇的全球销量。白藜芦醇市场经过十几年的发展,在国外已形成高度成熟的市场,预期今后几年我国白藜芦醇出口量仍将继续保持目前的现状。由于荷兰等国已开发出全合成白藜芦醇产品,再加上印度、阿根廷等国均加入天然白藜芦醇出口国行列并与我国天然白藜芦醇产品形成竞争之势,今后几年我国天然白藜芦醇的出口前景并不十分明朗。不过,我国在合成白藜芦醇上也取得了一些成果,杭州广林生物医药公司已成功合成出白藜芦醇及氧化白藜芦醇和紫檀芪等保健品新原料,并已有产品出口。美得康 佈局醫療光碟燒印市場!!
美得康引進醫療光碟系統 全自動輸出醫療影像光碟 2012-05-18 打造醫院、健檢中心、民眾三贏局面 國內醫療軟體研發領導廠商美得康科技股份有限公司,日前宣布引進美商Rimage研發之「醫療影像專業燒錄管理系統」(Medical Disk System, MDS)。MDS是一軟體搭配硬體之整體解決方案,軟體為網頁式操作介面(web-based),用戶可以隨時隨地至管控頁面執行燒錄醫療光碟的動作,完成的光碟亦內建醫療影像瀏覽程式(DICOM-Viewer),非醫療專業儀器亦可瀏覽;硬體則搭配Rimage專業機種,能全自動燒印、不需人為介入,有效避免醫療疏失。MDS軟體搭配硬體的特色,具備高可用性及方便性,成為醫療院所及健檢中心醫療影像光碟輸出的完整解決方案。 衛生署於2010年推動電子病歷及醫療光碟收費標準化,民眾如需至其他醫院看診或尋求第二意見協助,可以自費請醫院燒製病歷及醫療影像光碟,但拿到的光碟卻可能因為格式相容性問題,攜至其他醫院後卻無法讀取。醫院在此傳統的燒製過程中,則需要耗費時間及人力處理這非必要的事務,更遑論光碟圓標在手寫過程中,可能因人為疏失造成無可彌補的醫療疏失。而在健檢中心部分,高階健檢中心如雨後春筍般成立,精密的檢驗設備已經滿足不了消費者與外賓,轉而更強調服務品質與賓至如歸的感覺,在周邊配套的健檢光碟亦不能採用易掉色的噴墨光碟。有鑑於此,美得康科技與美商Rimage技術合作,引進「醫療影像專業燒錄管理系統」(MDS),希望能以人性化、易管理的軟體操作介面,搭配Rimage光碟燒印機器與熱轉印圓標技術,搶進醫療光碟燒印的藍海市場。 「MDS支援權限設定,不同科室的使用者可依各自權限,在任何時間以web登入系統,並且可自動接收遠端醫療儀器傳送來的DICOM影像,或經由院內PACS伺服器查詢下載醫療影像,再燒錄成標準DICOM光碟,」美得康科技資深副總李建宏表示。「有好的軟體還不夠,硬體我們也有獨特的規格。Rimage的光碟燒印機器,除了具備機械手臂,不需人力操作外,特殊的熱轉印技術,能讓圓標防刮、防水、防褪色。對醫院而言可以進行權限控管、避免不必要的醫療疏失;對健檢中心的客戶而言,高品質、可客製化的光碟能提升對中心的觀感;對需要醫療光碟的人而言,更便利攜帶且不易毀損。MDS就是要提供這樣三贏的局面!」
【關於美得康】 美得康科技股份有限公司成立於2009年初,是由一群在醫療資訊領域有多年經驗的專業人員所組成,該組團隊人員在醫院資訊系統(HIS)、醫療影像儲傳系統(PACS)、放射部門資訊系統(RIS)、電子病歷交換系統(EMR)及資料通訊技術(ICT)照護的全方位醫療資訊系統專業領域上,具有多年開發整合的實務經驗,擁有優良的醫療Know-How與研發實力,也有與全台最多區域級規模醫院客戶的合作經驗,亦是台灣最大資訊服務企業精誠集團成員之一。
【關於美商RIMAGE®】 美商RIMAGE®(www.rimage.com)是整合性數位發行解決方案的領導廠商,提供CD/DVD/Blu-ray光碟燒錄及多色/單色封面列印服務。主要市場及應用包括影音產業、零售經銷通路、醫療影像及警政執法機構等等。近年積極強化核心價值,不僅是硬體供應商,更要以提供客戶完整解決方案為目標邁進。總部位於美國明尼蘇達(Minnesota),在北美、歐洲及亞洲均有據點,1992年在NASDAQ上市。新英格蘭醫學期刊: 喝咖啡降低死亡機率!!
奇美基因健檢專案 搶國際醫療業務!!
護理荒vs國際醫療 !! (醫護人力有限、健保自顧不暇 ??!!)
佳醫於中國的第一家上海醫美中心!!
杏昌事業集團…杏泰洗腎/ 杏華呼吸治療/ 臺萃生技
張上淳將分享台灣防疫經驗
WHO矮化國名 邱文達:會提抗議
泰宗TCM-700C 進入兩岸臨床合作試行專案!!
東宇生技:本公司董事會通過重要議案
2012/5/17 鉅亨網 第三十四條 第39款1.事實發生日:101/05/172.公司名稱:東宇生物科技股份有限公司3.與公司關係(請輸入本公司或聯屬公司): 本公司4.相互持股比例(若前項為本公司,請填不適用):不適用5.發生緣由:本公司董事會通過重要議案:1、松昂商貿(上海)有限公司總經理任命案2、修訂本公司「公司章程」案3、修訂本公司「取得或處分資產處理程序」案4、修訂本公司「股東會議事規則」案5、修訂本公司「背書保證作業程序案」案6、修訂本公司「董事及監察人選舉辦法」案7、修訂本公司「董事會議事規範」案6.因應措施:無7.其他應敘明事項:無
World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal
BusinessWire COLUMBIA, Md. Osiris Therapeutics Inc. (NASDAQ: OSIR) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal® (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the world's first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD — a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis. "I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope," said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. "As a result of Health Canada's comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine." Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing. "Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies," said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. "Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last." Health Canada's authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal's safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy. "Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses," said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. "I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD." Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year. "Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research," said Peter Friedli, Chairman and Co-founder of Osiris. "It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission." In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada's decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.
Webcast and Conference Call A webcast and conference call is scheduled for tomorrow, May 18, 2012 at 9:00 a.m. ET. To access the webcast, visit the Investor Relations section of the company's website at http://investor.osiris.com/events.cfm. Alternatively, callers may participate in the conference call by dialing (877) 303-6133 (U.S. participants) or (970) 315-0493 (international participants). A replay of the conference call will be available approximately two hours after the completion of the call through May 24, 2012. Callers can access the replay by dialing (855) 859-2056 (U.S. participants) or (404) 537-3406 (international participants). The audio replay confirmation code is 82905846. To access a replay of the webcast, visit the Investor Relations section of the company's website at http://investor.osiris.com/events.cfm.
About GvHD GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.
About Prochymal (remestemcel-L) Prochymal is the world's first approved drug which has a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of mesenchymal stem cells (MSCs), which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is currently approved in Canada for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in Phase 3 trials for refractory Crohn's disease and also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack) and type 1 diabetes.
About Notice of Compliance with Conditions An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Products approved under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. Such products have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to such products on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.
About Osiris Therapeutics Osiris Therapeutics, Inc. is the leading stem cell company, having developed the world's first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic areas and wound healing areas. Osiris currently markets Prochymal for refractory GvHD, Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. The company's pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign patents. Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com. (OSIR-G)NIH study: coffee drinkers with lower risk of death
China to Approve its First Non-animal Testing Method for Cosmetics Ingredients
- May 17, 2012 Following to guidance from PETA-funded scientists, Chinese officials are now in the final stages of approving the country's first non-animal testing method for cosmetics ingredients. According to PETA, the 3T3 Neutral Red Uptake Phototoxicity Assay, which tests chemicals for their potential toxicity when they come into contact with sunlight-and which is already in widespread use in the U.S. and the E.U.-is expected to be accepted in China by late summer. Last year, when Chinese Officials discovered that China was requiring animal tests for cosmetics to be funded by cosmetics companies-including Avon, Estée Lauder, and Mary Kay, which for years had been on PETA's list of companies that don't test cosmetics on animals-PETA awarded a grant to scientists at the Institute for In Vitro Sciences. These scientists traveled to China several times to offer their expertise and guidance in replacing animal-based tests-which are cruel and unreliable-with non-animal alternatives. PETA is delighted to have helped jump-start the acceptance of non-animal tests in China and congratulates Chinese officials for acting swiftly to implement the first in a wide range of non-animal tests. About People for the Ethical Treatment of Animals People for the Ethical Treatment of Animals (PETA) is an American animal rights organization based in Norfolk, Virginia, and led by Ingrid Newkirk, its international president. A non-profit corporation with 300 employees and two million members and supporters, it says it is the largest animal rights group in the world. Its slogan is "animals are not ours to eat, wear, experiment on, or use for entertainment."
Source: PETAMany Primary Care Docs Don't Know Long-Term Effects of Chemo: Survey
Wednesday, May 16, 2012 WEDNESDAY, May 16 (HealthDay News) -- Many primary care doctors don't know the long-term side effects of the chemotherapy treatments that cancer survivors under their care may have been given, a new survey found. On the other hand, most oncologists -- though not all -- are familiar with the side effects of four common treatments used to treat breast and colon cancer, according to the results of the survey being presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. "While oncologists commonly identify the main late effects of four common cancer drugs, primary care providers did not," study author Dr. Larissa Nekhlyudov said during a Wednesday news conference. "This is not surprising in that primary care providers have different training and exposure to chemotherapy drugs," she noted. "However, these findings emphasize that in the transition of patients from oncology to primary care settings, primary care providers should be informed of late effects of cancer treatments so they are better prepared to recognize and address these effects," added Nekhlyudov, who is an assistant professor of population medicine at Harvard Medical School. Advances in cancer treatment have pushed the number of cancer survivors in the United States from 3 million in the 1970s to 12 million today. Once cancer treatments -- such as chemotherapy or radiation -- are complete, primary care physicians become a critical part of continuing care for cancer survivors. The new findings are based on a 2009 survey of more than 1,100 primary care doctors and more than 1,100 oncologists (doctors who specialize in cancer) across the United States. Both types of doctors were asked to identify side effects of four commonly used chemotherapy drugs for breast and colon cancer: Adriamycin (doxorubicin); Eloxatin (oxaliplatin); Cytoxan (cyclophosphamide); and Taxol (paclitaxel). Fifty-five percent of primary care doctors identified heart problems as a late-occurring effect of Adriamycin, while only 27 percent and 22 percent identified peripheral neuropathy (nerve damage to the arms and legs) as a possible result of Taxol and Eloxatin, respectively. Only 15 percent to 17 percent of primary care doctors knew that early menopause and second cancers could result from Cytoxan. Oncologists performed better on the survey, with 62 percent to 97 percent aware of these late effects. It was "surprising that oncologists were not more aware of late effects," Nekhlyudov said. But she also pointed out that the area of cancer survivorship is relatively new. "As more and more attention is placed on survivorship, oncologists will become more equipped with that information," she said. The findings highlight the need for more communication between the different doctors involved in a patient's care, one expert stressed. The burden of that communication lies not only with doctors (oncologists and primary care physicians) but also with patients, said Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City. "This study just highlights the importance of communication on everyone's part, including the patient, including the doctors in trying to get that information across," she added. "If an oncologist is discharging a patient, they should make it clear what they need to be looking for in the future and that they need to convey this to their doctor." The knowledge rates shown here make "a good case for electronic medical records . . . which would allow primary care providers to access patients' cancer care," said ASCO spokesman Dr. Nicholas Vogelzang. A second study being presented at the ASCO meeting in June found that the antipsychotic drug Zyprexa (olanzapine), used to treat schizophrenia and bipolar disorder, reduced post-chemotherapy nausea and vomiting among patients who had not responded to other therapies. Eighty patients with chemotherapy-related nausea and vomiting were randomized to receive either Zyprexa or the heartburn drug Reglan (metoclopramide), often used to treat nausea and vomiting in cancer patients. Over the next three days, 71 percent of patients taking Zyprexa did not vomit, compared with 32 percent of patients receiving Reglan. About two-thirds of patients on Zyprexa experienced no nausea, compared with only one-quarter of Reglan patients, the study found. Zyprexa can cause side effects if used for six months or longer, but did not cause significant side effects for the short duration used in this study. Generally, those getting chemotherapy would not need to take Zyprexa for longer than three days. The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.
SOURCES: May 16, 2012 press conference with: Nicholas Vogelzang, M.D., ASCO spokesman, and Larissa Nekhlyudov, M.D., assistant professor, population medicine, Harvard Medical School, Boston; Stephanie Bernik, M.D., chief, surgical oncology, Lenox Hill Hospital, New York City; study abstractsOutpatient trial for Smartphone Glucose Monitor
Smartphone Turned Into Glucose Monitor May 17, 2012 By Dale McGeehon Medical researchers have started an outpatient trial on a medical device built by reconfiguring a smartphone that will allow patients with type 1 diabetes to more easily monitor their condition. The smartphone-turned-into-medical-device is handheld and can continuously monitor a patient's glucose level, reports ScienceDaily. The device automates much of the work to maintain safe blood sugar levels in diabetics, according to the researchers at the University of Virginia School of Medicine, where the device was created. The first outpatient, Justin Wood, started his trial in April and says that "the device automates a lot of the tracking and monitoring I do now." Before the trial started, he used an insulin pump but had to prick his finger five times a day to check his blood sugar level. The device should reduce that need to no more than two times per day. The machine is "a step forward in technology that could change my view and outlook on life," he says. Before the trial, Wood had to precisely estimate his food consumption, particularly with carbohydrates, to help properly adjust his insulin supply. But the device automatically read and balanced his blood sugar level. At mealtimes, he entered what he ate to help balance his blood sugar more quickly. "The operating interface was very slick and very fast," he says. "The extra second or two you save pressing buttons adds up when you have to do it every day." Outpatient testing will continue through 2013 at the University of Virginia and three other locations. Researchers plan to enroll 120 patients in the trial.
Source: "Artificial Pancreas Gets First U.S. Outpatient Test," ScienceDaily, 5/14/12