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Thursday, July 19, 2012

松山湖台湾高科技园 硬體規劃!

广东东莞:完善配套加快推进台湾高科技园建设   华夏经纬网 2012-07-19 09:34:41广东东莞市松山湖台湾高科技园(以下称"台湾高科技园")由广东省省委书记汪洋倡导成立,是松山湖专门承接我国台湾地区高端产业项目的高科技主题园区,是松山湖20128个重大项目之一。为加快推动台湾高科技园完善配套,促进新一轮招商引资和产业聚集,今年以来,松山湖高新区财政安排69,038元,重点推进台湾高科技园的土方平整、水利及综合配套设施建设,进一步提高和优化台湾高科技园的产业承接能力和科技创新环境。其中:计划投入22,500万元,开展台湾高科技园的场地平整工程,为项目入园建设打好基础。包括东部出口加工区土方平整工程及竖向工程、松山湖先进IT制造业区启动区土方平整工程、台湾高科技园北部区土方平整及竖向工程、台湾园南部D-C07-05地块土方平整工程、台湾高科技园土方平整工程。计划投入19,126万元,整治台湾高科技园排渠系统及兴建污水处理厂,完善台湾高科技园环保配套。包括投入10,000万元,启动台湾高科技园南排渠整治工程,畅顺台湾高科技园的排水系统;投入9,126万元,建设大型工业污水处理厂,为高端科技项目入园解决环保之忧。计划投入27,412万元,进一步完善台湾高科技园综合配套,优化科技创新环境。包括投入25,000万元,启动胜华科技厂区供电设施工程,满足胜华等企业的用电需求;投入1,140万元,建设台湾高科技园警务室工程、台湾高科技园消防站,优化治安配套。投入1,272万元,对台湾高科技园绿化景观进行改造,美化台湾高科技园生态环境。另据了解,台湾高科技园自2010年开园至2011年年底,松山湖高新区财政已累计投入38,650万元,建成全长约13公里路网,包括台中路、基隆路等11条主干道(含道路、照明、绿化及人行道等),为台湾高科技园营造了良好的招商引资环境。 (财政部)

台灣醫療環境惡化? 監察院糾正行政院 !

醫療環境五大皆空 糾正行政院 中央商情網-20120717 下午18:27 (中央社記者葉素萍台北2012717日電)監察院調查發現,健保實施10多年來,行政院未能營造有利醫療環境,造成內、外、婦、兒、急診科,五大科醫師出現嚴重「五大皆空」出走潮,今天糾正行政院。監察院財政及經濟委員會通過監委黃煌雄、沈美真、劉興善提案,糾正行政院。黃煌雄、沈美真指出,大多數醫院內、外、婦、兒四大科的住院醫師人力不足,一個月工時有人超過300小時;有些完全缺乏住院醫師的醫院,四大科主治醫師更要代替值班,加上on call,一個月工時有時竟然多達400小時。監委說,相對醫美的「錢多、事少、離家近」,四大科則「錢少、事多、離監(獄)近」,急診科也不例外,從台大到長庚,都已很難招到醫師,有些醫院更掛零,所以「四大皆空」其實已成為「五大皆空」。黃煌雄、沈美真說,調查此案過程,與醫師訪談,有醫師感嘆外科是即將消失的行業,擔心「現在我幫人開刀,等我老了,恐怕沒有人幫我開刀」;有醫師說,急診科醫師能待上3年,已算是奇人了,急診是四大科的縮影,同時是醫院的第一線,民粹氾濫,急診科醫師幾乎成為驚弓之鳥;還有醫師提醒,要同時處理護理人員,「不然將會出現六大皆空」。黃煌雄、沈美真指出,醫療糾紛和支付制度已成為扼殺五大科發展的「緊箍咒」,加上醫院評鑑制度的不勝其煩,台灣已失去合理的醫療環境,這是健保問題的最大根源。監委們說,希望糾正案文及調查報告能夠喚起政府注意此問題,儘速導正醫療體系的問題。1010717

中国生物仿制药行业扩容仍存在阻力

 发布时间:2012-7-19 来源:药品资讯网信息中心到2015年,将有30多种价值510亿美元的品牌药专利期满,从而掀起一波生物仿制药浪潮。生物仿制药已经在制药行业引起巨大关注,不过,对于那些欲进入生物仿制药领域的跃跃欲试者来说,所面临的挑战同样巨大,因为相关的科学问题和监管的不确定性限制了其增长潜力。但不管怎样,全球生物仿制药的市场规模在2011年已到达25亿美元左右,而且未来市场肯定将会保持持续增长。高速率增长据相关市场调研机构发表的一份报告估计,2012~2016年,全球对生物仿制药的需求年复合增长率预计将约为8%。其中,2011年低分子量肝素(LMWH)生物仿制药销量将占全球生物仿制药市场的44%。虽然低分子量肝素并非重组治疗性产品,但由于该类产品的高度复杂性,欧洲药监局(EMA)在其制定的《生物仿制药指导原则》中还是纳入了该类产品。其他具有显著市场潜力的产品包括促红细胞生成素、生长激素和非格司亭生物仿制药。合作和投资是推动全球生物仿制药市场的主要动力。在亚太地区,生物仿制药的开发和商品化更为活跃。在有利的监管条件下,生物仿制药的安全性和有效性问题能积极得以解决。在2013~2020年,市场对生物仿制药的需求可能迎来一轮高潮。调研机构预测,一些"重磅炸弹"级生物药品专利到期的影响是有限的,这主要是由于原研生物品牌药的专利到期与生物仿制药被人们接受之间存在着较长的时间差。尽管生物仿制药的开发看起来很有希望,但许多处于晚期阶段的高附加值产品如单克隆抗体仿制药的开发数量还很有限。到2016年,几类重组治疗产品生物仿制药的安全性和疗效将会影响到生物仿制药市场的增长。全球单克隆抗体生物仿制药需求预计在2012~2016年的年复合增长率达到17%。随着单克隆抗体专利到期促使更多的生物仿制药入市和市场接受程度提高,这些产品的市场需求预计将在2016年后以更高的速率增长。
审批政策呼之欲出 在美国,早在2010323日,奥巴马就签署了《保护患者与廉价医疗服务法案》(PatientProtectionandAffordableCareAct),通过《生物制剂的价格竞争和创新法案》(BPCIA)为生物仿制药提供监管途径。欧盟在2005年也发布了"类似的生物医药产品(即仿制药)"指导原则,为生物仿制药研发提供支持。此外,日本于2009年发布了"后续生物制剂"指导方针。其他国家也紧随其后,包括巴西、澳大利亚、土耳其、中国台湾、马来西亚等国家和地区,都建立了以欧盟模式为基础的生物仿制药监管模式。前不久,国家食品药品监督管理局(SFDA)启动了生物仿制药指南制定的前期工作。据了解,目前生物仿制药指南制定工作处在调研阶段,符合中国实际的生物仿制药简化审批程序在不久的将来就会出台。此前曾有企业人士指出:"企业需要新的利润增长点,政府致力于降低患者医疗开支,生物仿制药正在全球形成一个新的磁场,中国市场更诱人。但不管是原创还是仿制,在中国所有生物药必须按新药程序进行审批,这是企业的一块心病。"
开发困境   我国制药行业似乎已经嗅到生物仿制药开发带来的利润机会,但是对于已经习惯于进行化学药仿制的中国企业来说,生物仿制药开发所面临的难题要远高于化学药。首先,巨额的开发成本将使国内企业望而却步。据《国际生物制药》杂志报道,生物仿制药的开发和商业化平均需要投入1000~4000万美元,传统的小分子仿制药仅需要100~200万美元。而据美国投资公司CollinsStewart估计,开发一种适应症的单克隆抗体生物仿制药花费甚至高达1亿美元。因此,对于一向研发投入不足而又缺乏经验的国内企业来说,如果开发生物仿制药,将会投入巨额资金,而且面临更高风险,也许只有少数公司能承担得起。其次,生物仿制药成本和投资收益低。生物仿制药尤其是抗体生物仿制药并不如小分子或较简单的生物制品节约成本。据分析师预测,与小分子药物的仿制药价格平均下降90%相比,生物仿制药价格将会下降20%~30%。不过生物仿制药开发者可以在开发和生产投资中寻找最大回报率,如通过缩短临床前和临床试验等。再次,患者和医生短期内对生物仿制药的接受程度比较低。社会对专利生物制品的认知度已经形成,再加上有实力的国际巨头如辉瑞、诺华等纷纷进军生物仿制药,更加剧了这一领域的竞争。对于国内企业来说,如何开发出让患者和医生接受的产品,将面临更大困难。另外,生物仿制药的开发还面临着参比制剂等技术上的难题。正如默沙东生物投资业务负责生物仿制药经营战略的运行部总裁迈克尔·卡马克(MichaelKamarck)博士所说:"至少在可预见的未来,生物仿制药将不可能成为专利生物制品可互换或替代的产品。"

"假發票"引討論 國科會"鬆綁與課責"

教育廣播電台 (2012-07-19 18:44)4個月前爆發的「假發票事件」,對台灣學術界造成極大衝擊,引發科研經費制度面的討論,經過國科會分區座談與內部檢討,對於有學者反應「國科會對科研經費的規定是否過嚴」這點,國科會19號修訂兩項行政規則,這次修訂「鬆綁與課責並重」,希望能塑造更友善的學研環境!行政院國家科學委員會主委朱敬一表示,這次修正主要包括「放寬專題研究計畫業務費、研究設備費與國外差旅費大項目間流用比例,由現行各大項流入20%、流出30%放寬至流入流出皆50%,超過這個比例才須報國科會核准,與歐美國家大致相當」、「國科會只管主經費項目的新增與流用,其餘主項目內細項與經費調整,由校方認定合理性,計畫結束後學校需繳交變更報表,方得結案」。由於給予學者與各管理的大學更大的調配自主空間,因此將來若有向國科會申請研究經費的「個案」涉及浮報、虛報或浮濫認定,計畫主持人除了會受到向國科會申請研究的停權處分,國科會也會視情況減扣申請機構(也就是大學)的管理費,幅度可為浮報、虛報總額的13倍。而在通案部分,也就是大學若對校內各學者申請到的研究經費核銷整體的認定、管理都很鬆散,將降低撥給學校的管理費比例,情節嚴重者,將移送法辦。

兩性奧秘:性夢背後的真實想法

 20120713 09:47:50 來源: 生命時報 在很多人的夢境裏,情愛之夢是經常出現但難與人分享的一種,在它背後,其實隱藏著許多真實想法。近日,美國《悅己》雜志刊出了8種最常見的性夢,並請多位心理專家和性學家對此進行了解讀。
夢境一:夢見與上級、同事有親密行為。26歲單身女教師萊斯莉平時與同事交往並不多,但她卻經常夢見一位男同事帶她去戶外騎馬。夢中,馬鞍的刺激讓她享受到快感,甚至發出呻吟。萊斯莉常因此感到難為情。 英國倫敦人際關係心理學專家帕姆‧斯帕爾博士表示,夢見上級領導、同事並不表明你潛意識中想與其發生關係,大多說明你欽佩此人的能力,希望他(她)給你指引和幫助。馬在女性性夢中經常出現,喜歡自慰的女性可能會夢到撫摸馬兒。
夢境二:夢見當眾性愛。29歲的迪娜夢見她在機場遇到一名陌生男子,男子搭訕後便拉她入懷,兩人在眾目睽睽之下開始做愛。讓迪娜感到最滑稽的是,夢中壓根沒看清男子的臉。 美國亞利桑那州夢境分析專家卡羅爾‧L‧庫明斯表示,這類性夢揭示了一種開放性的心態,說明你在期待新的戀情,對一段新的感情生活充滿熱情。"看不清男子的臉"是一種自我保護,說明內心還在為新感情的到來做準備。
夢境三:夢見與同性親熱。37歲的護士簡茵夢見自己在咖啡廳遇到一名女子。當她喝咖啡時,咖啡泡沫濺到嘴上,那女子笑著親吻她的嘴唇和脖子。現實中簡茵並沒有同性戀傾向。 斯帕爾博士表示,夢見跟同性纏綿,並不意味著你的性取向有所改變,只是說明你期望在性方面得到更多關心與體貼,你渴望伴侶動作更溫柔些。同時也說明你在生活中期望得到同性的理解。
夢境四:夢見與名人性愛。34歲的凱茜說,在《泰坦尼克號》熱播的那段時間,她多次夢到與男主演萊昂納多‧迪卡普裏奧在光天化日之下瘋狂做愛,即使被家人發現也沒有停下來。 經常有人做跟名人有關的性夢,女人尤其多。夢見與明星做愛,其實是期望自己的另一半有明星所體現的某種特質,如勇敢或浪漫等。夢中有家人出現都不停下來,說明她在性方面很自信。
夢境五:夢見在兒時家中性愛。39歲的瑪麗夢見自己在母親的房子裏與一男子發生關係,但她並不喜歡那個男子,甚至很反感。她的很多性夢都是在兒時的家中發生的。 霍洛維博士表示,夢見兒時的家,說明目前的性觀念受到家庭影響較大,也表明希望回到童年更簡單的生活中。夢見與厭惡的人做愛,說明現實中可能遇到了一些不得不面對的困難,需要與周圍人交流。
夢境六:夢見偷情。31歲的莉絲多次夢見與丈夫的弟弟或好友偷情。夢境中,性愛十分自然,莉絲也極度享受。但是如此直白和真實的性夢也讓她感到"出軌的罪惡感"。 斯帕爾博士表示,這種夢並不意味著你想出軌。可能只是你的生活太過平淡。反復做這樣的夢,說明你對婚姻中的某部分(不見得一定是性生活)感到厭倦,這時應採取措施,重新燃起夫妻激情。
夢境七:夢見舊愛復燃。37歲的斯蒂芬妮已是兩個孩子的母親。她經常夢見與自己大學時暗戀的導師狂熱激情,導師的淵博與內涵徵服了她。 庫明斯博士表示,如果我們與某人有強烈的情感聯係,那麼就可能在性夢中夢見此人。夢見昔日的舊愛很常見,可能是象徵你與他(她)有關聯的某樣東西,斯蒂芬妮夢見導師,說明她很懷念那個階段所擁有的青春、自由和對知識的渴望。
夢境八:夢到性愛被迫中斷。39歲的凱蒂夢見與一個喜歡的男人性愛,但她還沒達到性高潮就結束了。她經常做諸如此類的性夢,前戲極佳,但總是在快臨近高潮時被打斷。 庫明斯博士表示,一方面這可能表明,凱蒂的性需求沒有得到滿足,另一方面,她對生活現狀感到不滿。如果總是夢見性愛被打斷或無法達到高潮,可能表明對愛人缺乏信任或者對親密性愛存在恐懼感。(陳宗倫)

長期背痛可能和腦有關

 2012-7-09 21:10 作者:PanSci 泛科學網 作者:逆旅(PanSci主編) 大多數的成年人都有背部無名疼痛的經歷,幸運的是,幾天之後疼痛會漸漸消去。不過有些人就沒這麼幸運,一開始他們的疼痛和其他人一樣,差別在於疼痛卻持續了數年之久。科學家發現這兩種不同疼痛經歷的成人在腦部掃描上的差異,不僅能鑑定出慢性疼痛的好發患者,還可能設計新療程解決慢性疼痛。 「這是首次我們可以區分出兩位同樣飽受疼痛的病患中,誰的疼痛會發展成慢性疼痛。」主持這項研究,西北大學(Northwestern University)的神經科學家凡尼亞‧亞帕林(Vania Apkarian)表示。 過去二十年來,亞帕林的研究室進行了許多實驗,比較慢性疼痛患者和健康成人的腦部掃描,發現兩者在構造和腦功能區域都有差異。不過實驗設計較難指出是什麼腦部差異造成慢性疼痛,或者由止痛劑、生活模式,或者其實是疼痛引起這些差異。 因此,亞帕林的研究團隊改追蹤背痛患者的腦部掃描變化,而非像過去一樣和健康人士的腦部掃描結果比較。研究團隊找來了39位在自我量表上顯示中等疼痛(十級量表中填寫56級)持續一至四個月長的患者,往後一年內進行四次腦部掃描,並追蹤背痛。年末,有20位患者痊癒,另外19位則持續受疼痛之苦。 然後研究團隊檢視多處腦部特徵,包括伏隔核(nucleus accumbens)和腦島(insula)間神經傳遞訊息量的改變,這改變出現在背痛患者上。伏隔核和腦島與人類學習、對環境的情緒反應有關,慢性疼痛患者不僅在這兩區域間的訊息傳遞量增加,且這增加從研究初期就發生,顯示一開始便能預期患者將持續經歷疼痛,不過仍需要更多的資料才能確定腦部掃描結果能作為預測的依據。 研究成果發表於《自然‧神經科學》(Nature Neuroscience),能應用於檢查出慢性疼痛的好發族群,也能根據這項結果,開發出減緩伏隔核和腦島之間神經訊號的止痛藥物。除此之外,研究結果也顯示不僅痛覺功能區和慢性疼痛有關,調控情緒有關的腦功能區也參與其中。 並未參與這項研究,哈佛大學的神經科學家 David Borsook 認為,研究結果僅是謎團中的一條線索,還需要更多的研究找出是什麼原因使疼痛成為慢性,而且還需要針對其他族群進行研究,才能擬出治療方法。另一方面這項研究是一項突破,相較過去僅由患者自評疼痛程度,現在可以藉由腦部掃描診斷。 資料來源:ScienceNow: Blaming the Brain for Chronic Back Pain [1 July 2012] 

医药联盟创新促制药行业整合升级

 2012071909:08医药经济报作者:马飞【慧聪制药工业网】自主创新逐渐成为主流制药企业的核心价值观。718日,厦门,在一年一度的全国制药工业百强榜揭榜盛会上,由SFDA南方医药经济研究所联合天士力集团、康缘药业、石药集团、先声药业、步长制药、齐鲁制药、绿叶制药、誉衡药业和悦康药业共9家国内主流创新型药企倡议、发起的"中国创新药物企业发展联盟"将在此宣布正式成立。"区别于其他性质联盟的是,我们组建的联盟要真正通过调查研究,对医药创新领域遇到的共性问题展开全面、务实的研究分析,为医药行业的创新搭建与政府主管部门沟通的平台,并整合成员间的优势资源,带动更多的创新企业发展。"该联盟发起人之一、天士力集团董事长闫希军一语切中肯綮,道出首批制药企业结盟的初衷。
集体呼声显弱 对于自主创新,先声药业董事长任晋生感受颇深。从他们的实践来看,这几年有7个专利药获批,但其中只有2个药品真正属于自主研发,其余5个药品都是通过合作,特别是国际合作来完成的。由于本土企业体量较小,他们选择了联合研发,并先后和施贵宝、默沙东建立了合作,甚至与一些具有源头性创新的中小公司合作,寻找受国家政策鼓励的me-betterme-new产品。可见,制药技术合作已渐入佳境。然而,创新已不仅仅表现在技术层面,政策法规、企业管理、市场转化等环节的创新才是这类创新企业真正感到困惑的短板。"当前的定价机制、各地的招标采购政策,以及进医保目录等市场转化方面的因素,让很多立志创新的企业很受伤。但遗憾的是,当前产业界真实的现状、困惑和呼声尚缺乏有效而高端的发声平台。"对此,步长制药总裁赵超直言不讳地指出了产业界的集体困惑。他认为,单个企业的力量有限,步长制药虽拥有以脑心通胶囊为代表的具有自主知识产权的新药72个,且98%以上的产值来自于自主研发的产品,但在市场化过程中也深受政策法规所累,建立政府沟通机制相当必要。一旦有新政策调整,RDPAC就会集体向政策制定者发出自己的声音。相比而言,国内企业尚未形成真正的行业诉求意识。
联盟雏形初现 记者了解到,目前主流创新企业普遍有一种改变松散结构的愿望,试图通过联合组织为产业的发展助力。闫希军分析指出:"中国目前主流的创新型企业尚未形成一个强有力的办事机构,专门研究具体的技术问题,专门和政府部门勾通如何来扶持中国的民族制药工业创新升级,如何来借鉴国外的先进科技为我所用,为政府有关部门作相关决策提供咨询参考。"在这种背景下,中国创新药物企业发展联盟应运而生。赵超指出,创新联盟就是为了积极参与行业的相关政策制定,进而推动我国创新药物的发展和产业的健康发展。"新联盟要注重研究国外企业成功的路径以及社会医药管理发展的主流模式,再结合中国的产业形势研究,依托南方所和医药经济报的技术体系、信息体系和传媒体系,为政策部门提供一线的改革评价,并给出我们的意见。真正做到外有RDPAC,内有创新联盟。"赵超建言。在采访中,绿叶制药、齐鲁制药等首批发起单位的相关负责人也对此深表赞同。前述企业认为,健康的联盟为组织成员创造的价值是可持续的,而不是短视的,他们对即将成立的联盟抱有很高的期盼。记者还了解到,该联盟拟在正式成立之后,着手行业热点问题的研究,并形成产业发展白皮书直接提交给国务院相关部委,为行业政策制定者提供评价依据,以唤醒各界对民族药企在创新链条上所遇到的困惑给予足够重视。

工作狂 可能與大腦的多巴胺分泌量和位置有關 ?

大腦的多巴胺分泌位置 決定工作意願   鉅亨網新聞中心 (來源:華人健康網) 2012-07-13 15:34:19  華人健康網 記者張雅雯/台北報導 有些人工作如同拼命三郎,有些人卻像懶惰蟲般,這種差別可能與大腦的多巴胺分泌量有關。范德堡科學團隊發表一篇腦成像研究於《神經科學期刊》,指出大腦中3個特定區域的多巴胺愈多,努力工作賺錢的意願愈高。
研究顯示一個人的工作意願,可能與大腦的多巴胺分泌量和位置有關。 這項研究包含了25位年齡在1829歲之間的健康受試者,為了瞭解他們贏得金錢酬賞的工作意願,受試者被要求進行一項按鍵任務。首先,受試者自行選擇任務的難易程度,最簡單的任務酬賞是1美金、最困難的任務報酬是4美金,當他們做了選擇後會被告知獲得酬賞的機率,每個任務進行的時間約30秒, 受試者必須重複這些任務約20分鐘。 研究者透過正子斷層掃描發現,有強烈意願工作贏得報酬的「拼命三郎」,其大腦裡掌管酬賞和動機有關的紋狀體和腹內側前額葉區所,分泌較多的多巴胺;而較無工作意願的「懶惰蟲」,則是在掌管情緒和危機感的前腦島區,分泌出較多的多巴胺 研究者指出,過去以老鼠進行的實驗發現,多巴胺對酬賞動機有著重要的影響,然而他們的研究則解釋了,多巴胺如何決定人類在尋求酬賞行為上的個別差異。研究結果顯示,前腦島分泌出較多的多巴胺與工作意願的減低有關,且多巴胺對於不同腦區可能造成完全不同的效果。 董氏基金會心理衛生組主任葉雅馨表示,如何在促進工作意願的大腦部位分泌較多的多巴胺,是研究人員的目標,但找方法讓自己降低負面憂鬱情緒、增加愉快感,則是民眾現在就可努力的,建議透過運動增加體內的多巴胺,即便未必提升工作意願,但也有紓壓的效果。

台灣API 廠因產業鏈改變 進入國際供應商行列!!

原料藥族群Q3營收估成長 中化生今除息表現佳 2012/07/19 13:31 精實新聞 2012-07-19 13:30:59 記者 蕭燕翔 報導 原料藥族群永日(4102)及中化生(1762)19日除息,在龍頭神隆(1789)傳出客戶新藥獲FDA核准上市及整體族群第3季營收可望穩定成長下,逐步邁向填息路。法人指出,今年原料藥營運差距拉大,相對具有國際接單能力的廠商可望優先勝出。原料藥族群今年填權息行情表現各異。已除權息的個股包括旭富(4119)及台耀(4746),目前都還處於貼息狀態,19日則有永日及中化生同步除息,每股分別配發1.8元及1.5元,在類股龍頭傳出客戶新藥上市佳音及大盤大漲百點下,逐步邁向填息路,其中,中化生盤中漲至47.3元,填息近8成,表現相對較優。而原料藥族群未來將跟進除權息的還有生泰(1777),預計下月2日除權息,每股將配發1.5元股利,其中含1元現金及0.5元股票;神隆今年則將配發1.3元股利,含1元現金及0.3元股票,除權息基準日還待董事會定案。法人指出,在神隆客戶的減肥新藥通過FDA核准上市下,第3季可望開始拉貨,本季營收將較上季有較明顯成長,帶動整體族群第3季營收走強。根據康和證預估,在神隆營收唱旺帶動下,主要原料藥個股中的神隆、中化生、台耀及旭富等4家公司第3季營收可望平均有18.6%的增幅,其中神隆營收季增幅度最大,中化生預估也將有個位數的成長,連2季創歷史新高。旭富則因上半年基期較高,第3季營收預估逆勢較上季減少近5%。不過,法人指出,近年原料藥族群的營運表現差距拉大,受到全球景氣成長趨緩及醫療保險體系財源壓力,不少藥廠都限縮研發成本,影響新藥上市進度;另方面在產業併購潮下,也加速了供應鏈訂單的移轉,未來在美國、日本及中國市場接單能力可勝出的廠商,可望有較優表現。

科研經費審查放寬浮報重罰

2012-07-19 21:30:504個月前爆發科研經費核銷用假發票,行政院國科會主委朱敬一19日表示,科研經費8月起將實施新作法,審查彈性放寬;若浮報,對個人停權、扣浮報額的13倍經費。中央社19日報導,朱敬一指出,國科會今天修訂完成「補助專題研究計畫作業要點」與「補助專題研究計畫經費處理原則」部分規定修正案,8月起實施。他強調,這次修正有4大重點,首先是放寬專題研究計畫業務費、研究設備費與國外差旅費3大項目的流用比例,將從現行各大項流入20%、流出30%,放寬至流入及流出都50%,超過此新制比例,才需要報國科會核准;此彈性度參考德國、美國、日本等國,與歐美國家大致相當。其次,國科會只管上述3大主經費項目的新增與流用,其餘主項目內細項與經費調整,由校方認定合理性。他舉例,像是耗材、人力等細項的合理性認定;但是計畫結束後,學校必須繳交變更報表,方得結案。第3點,取消經費細目例示,以免誤導僵化認定內容;將來與研究相關的支出,授權學研機構認定。第4點為新增規範,基於前述要點彈性已經放寬,若涉及浮報虛報或浮鑑認定,國科會得視情況減扣申請機構管理費,幅度得為浮報虛報總額的13倍。朱敬一強調,第4點的扣款是新制。他說,假如浮報一只單價新台幣2000元的訂書機,並買了30只,則會扣款機構管理費;若是浮報購買一顆鑽石,則會對當事人停權(不再獲研究經費補助),並要送檢調偵辦。朱敬一重申,「我們是勇敢的!新訂定的作法,不一定就是最好的,若彈性要再放寬,會放寬,需要更嚴格,會更嚴格,要先試用。」【中央網路報】

遠距雲端照護 日夜監控糖尿病

 【中央社╱台北15日電】 2012.07.15 04:20 pm 羅東聖母醫院和保全業者合作,遠距照護糖尿病患,健康資訊上雲端,有的病患免於低血糖昏倒危險,也有病患被捉到竄改血糖數值,進而調整藥物及平日飲食,成效良好。 羅東聖母醫院新陳代謝科主任陳白蓮指出,有位病人連續多日量測,早上空腹血糖值約100,晚上飆到300400,如果日夜維持相同的藥量,很容易白天血糖太低而昏迷或休克。透過雲端報表,醫師調整病人的藥量,更有效控制血糖。 另一名患者今年3月報表顯示,多日處於低血糖,但是保全客服紀錄發現病患並無不適且食慾正常,醫師推斷患者可能是降血糖藥過量,主動聯繫病患家屬,建議將血糖藥減量,並增加血糖量測次數,有需要時也可以提早回診。 陳白蓮指出,慢性病友最麻煩的就是難以定期記錄血糖指數,甚至會造假。常遇到老人家,回診前竄改血糖紀錄,或平時不注意飲食,回診前幾天才做個樣子。雲端健康照護搭起醫院與病友的橋梁,能幫助醫師診斷,也幫病人監控病情。 這套「醫療照護雲」遠距醫療照護系統,由保全業者聘請的合格護理師與醫院社工組成服務中心,創新糖尿病照護模式,24小時全年無休提供諮詢與關懷,目標是促進病友自我健康管理,降低糖尿病合併症,減少住院及門診次數。 據中興保全表示,當雲端數據顯示患者血糖量測或其他生理指數出現異常指數時,會立即聯繫病人,病人到門診時,想不起當時異常狀況的原因也無妨,因為護理客服人員的紀錄,可協助醫師診斷病情。 2012/07/15 中央社】

腦死判定擬放寬 足月嬰可器捐

 【聯合晚報╱記者黃玉芳/台北報導】 2012.07.15 02:28 pm 衛生署自93年公布「腦死判定準則」以來,3歲以下嬰幼兒沒有納入,引發爭議。最近衛生署委託器官捐贈移植登錄中心,邀集專家學者再度開會,終於對解除腦死判定年齡限制有了共識,只要是足月生產的新生兒,經過一定程序,也可以執行腦死判定。 衛生署醫事處科長呂念慈表示,衛生署擬放寬限制,未來只要是經媽媽懷孕滿37周、足月生產的新生兒,不幸陷入深度昏迷、或是腦部結構損壞無法復原,可由小兒專科醫師執行腦死判定。不過昏迷原因需排除藥物中毒、體溫過低等因素。 同時考量嬰幼兒的潛在修復能力較強,雖然嬰幼兒腦定判定跟成人一樣,也需經兩次的腦死判定,但成人兩次腦死判定只需間隔4小時,嬰幼兒的觀察時間拉長、更為嚴謹,學者專家討論共識,13歲需間隔12小時、1歲以下更需間隔24小時,才能做第二次腦死判定。 衛生署表示,「腦死判定準則」修正草案,預計將於8月定案,正式對外預告、公告修正草案內容,完成相關的立法程序。 器官捐贈移植登錄中心統計,國內等待心、肝等各種器官移植的小小孩,一年雖不到10人,但受限腦死判定才能摘取器官的法令限制,3歲以下嬰幼兒幾乎等不到器捐。 前台灣小兒神經醫學會理事長、國泰醫院副院長洪焜隆表示,過去擔心嬰幼兒對腦部缺氧的耐受性較高,近十年來雖有討論,但一直不敢替嬰幼兒進行腦死判定。但臨床上遇到明明已經腦死,卻苦無法源依據,不僅可能流失器官捐贈的契機,小小孩只能繼續住在加護病房一到兩個月後過世,期間也衍生無效醫療。 去年美國已同意將新生兒納入腦死判定,國內也終於達成共識。洪焜隆說,每個孩子都是父母的心頭肉,可能捨不得判定腦死的小寶貝捐出器官,但至少勸募人員可以試著介入,讓腦死小孩的器官延續其他孩子的生命。 亞東醫院外科部主任陳芸也說,除了心、肝等器官外,小腸移植已被衛生署列為常規手術,由於短腸症患者六成是幼兒,一出生就只能靠著靜脈注射攝取營養,長期注射容易造成感染、肝脾腫大、黃疸、出血,若要移植救命,必須要有尺寸、長度適合的腸子,放寬法令後,小小患者有機會重拾生機。 2012/07/15 聯合晚報】

常常莫名焦慮 老化速度恐加快

 2012-07-13 【台灣醒報/陳珮瑜】 你身旁的朋友是否常莫名焦慮?研究指出,恐懼型焦慮障礙,也就是眾人熟知的其中一種焦慮症,將會引發細胞損傷,使人老化的速度加快。研究員表示,有焦慮症的人,其細胞內「端粒」通常都較短,且罹患癌症、心臟疾病、老年痴呆症的機率都比正常人還要高。 「端粒」位於細胞染色體的末端,功能在於確保染色體DNA能被完整複製,防止遺傳物質遭受損害。「端粒」的長度某種程度上是一種生物學的年齡標記,因此又被稱為是細胞的生命時鐘。 美國布里格姆婦女醫院的研究團隊匯集5,000名年齡介於4269歲女性的血液樣本,並請受試者填寫問卷,調查其是否受焦慮症所苦。研究發現,有著高度焦慮傾向的受試者,其細胞內的端粒都較短;且比較相同年齡者,有著較短端粒的受試者看起來比原本年紀還老了6歲。 研究員表示,年紀較長的女性如果會恐懼人權或是較高的地方,其細胞內的「端粒」通常都較短;而「端粒」較短的人,其罹患癌症、心臟疾病、老年痴呆症的機率都比正常人還要高。 研究員歐克瑞克醫師表示,從研究得知,心理壓力的確會加速人的老化;但目前還不確定究竟是過度焦慮使得端粒變短,或是較短的端粒引發焦慮,一切還需查明。此研究也被刊登於《PLoS ONE》期

醫院人力失衡 3年300億解決

 【聯合報╱記者李順德/台北報導】 2012.07.14 02:54 am 行政院長陳冲昨天原則同意衛生署長邱文達所提三年三百億預算,解決醫界五大科人力失衡問題。另外,將於二○一四年實施的公費醫學生返偏鄉服務新制,未來可由衛生署指定科別執業,以因應各科醫師人力需求。 邱文達昨天是提出「提高五大科執業意願、降低醫療糾紛風險策略」報告。衛生署建議,提高內外婦兒及急診等五科全民健保給付標準、增加住院醫師津貼、調整五科醫師訓練員額、充實五科輔助醫療人力、強化畢業後全科及五科訓練方向。 財源來自公務預算、醫發基金、健保總額成長,陳冲請衛生署整合醫療資源,提減少浪費的具體方法。 邱文達說,衛生署將於十月一日試辦生育事故救濟制度,提供最高新台幣二百萬元救濟給付補助。衛生署也研議修醫療法,使醫療過失刑責合理化。台灣醫生因醫療過失被判刑責是世界上罕見,這也是國內醫生最大的壓力。 邱文達說,二○一四年將實施偏遠地區公費醫學生新制(不限落籍地),有限制選科;陳冲指示,未來可由衛生署視社會當時各科醫師人力分布狀況,指定公費生選擇國家需要的科別執業。 2012/07/14 聯合報】

China Biotech In Review: Deals, Trials And Regulations

July 15, 2012|includes: ALNY, OCLS Deals and TransactionsAscletis Pharma, a US-China JV that made headlines one year ago when it announced $100 million in initial startup capital, in-licensed China rights to its first drug candidate, an innovative RNAi molecule from Alnylam Pharma (NSDQ: ALNY) (see story). ALN-VSP is being developed for liver cancers including hepatocellular carcinoma (HC)). Ascletis will have exclusive rights for ALN-VSP in China, Hong Kong, Macau and Taiwan. Alnylam will retain rights to the drug for the rest of the world.Yunnan Walvax Biotech (SHE: 300142) obtained a 51% stake in Shanghai Fengmao Biotech. Walvax, previously known as a vaccine maker, will establish subsidiaries of Fengmao to produce five monoclonal antibodies and a sustained-release version of the anemia treatment EPO. Walvax will invest $16 million in cash, while other investors will contribute a monoclonal technology valued at $14.6 million.HAO Capital, a Beijing-headquartered private equity firm, teamed up with TCL Group, a consumer electronics company that has a medical device subsidiary, to form a JV called TCL Healthcare. The JV will target the high-end diagnostic imaging market in China. The capitalization of the JV was not disclosed.Siegfried Holding (SIX: SFZN), a Swiss CMO, is building an API and intermediates production facility in Nantong. The construction is being supported by the Nantong Economic and Technological Development Area (NETDA). Siegfried said additional land at the site may be used in the future for building a finished drug facility.

Trials and ApprovalsOculus Innovative Sciences (NSDQ: OCLS) of California received SFDA approval for Microcyn Hydrogel, a topical treatment for moistening, repairing and healing of acute and chronic wounds (see story). With the approval in hand, Shanghai Sunvic, the China partner of Oculus, will launch the product in Q3 of 2012, marketing Microcyn Hydrogel in both the OTC and professional healthcare markets in China.

Government and RegulatoryThe SFDA has issued new regulations governing the purity and safety of excipients, the pharmacologically inactive substances that drugmakers add to stabilize or deliver a drug's active ingredients. The new rules, which go into effect on October 1, place responsibility for the safety of the excipient on the drug company that uses it. The regulations also require excipient makers to test their products and prove they meet all specifications.

Disclosure: none. 

海外就醫問題多 大陸就醫最怕「門診黃牛」

時間:2012/7/19 17:59 撰稿‧編輯:沈雅雯 新聞引據: 採訪暑假來到,民眾出國旅遊人數大增,在海外遇到醫療問題的情況也不少。根據國際SOS緊急救援組織統計,去年共接獲125千通求援電話。其中,最常發生就醫問題是「不知道如何溝通陳述病況」;而民眾最害怕生病求醫的國家則是中國大陸,最擔心碰上「門診黃牛」。每個國家的醫療情況與就醫規定大不相同,如果在海外生病,更是令人感到困擾無助。根據國際SOS緊急救援組織統計,去年一年共接到125千通海外醫療案件求援電話,其中,民眾最常碰到的問題是「不知道如何溝通陳述病況」」、「不放心醫療環境衛生」以及「不知道該找哪家醫院或專科」。調查也指出,民眾最怕生病就醫的國家,前5名分別是中國大陸、越南、印尼、美國和東歐,除了害怕環境衛生不良、醫療設備不佳外,部分國家的醫療費用太高也是主因。國際SOS協調醫師陳婉琳則說,每個國家情況不同,民眾可能因為不知情而花了冤枉錢,甚至引發嚴重糾紛。例如在越南流行塞紅包賄賂醫護人員;在大陸,則常常有「門診黃牛」搶掛號,再以高價叫賣。她說:『(原音)叫賣的價碼常常是門診掛號費的56倍,假設是名醫、專家甚至會高到10倍、20倍,這個門診黃牛叫賣號碼牌會影響到很多人在當地就醫的權益。』國際SOS總經理陳楷植建議,在海外就醫最好尋求能溝通的醫師,不要因為心急,什麼都說「YES」,出國前也要先準備好急難救助電話,遇到問題時可以隨時尋求協助。

 

科技大老攻雲端 上天下海

【經濟日報╱黃晶琳)】 2012.07.19 05:26 am 要從虛無的雲端中,找到商機,可不是一般人能做得到的,行政院政務委員張善政昨(18)日打趣說,來參加雲端大未來高峰會的人都是身懷絕技,才能做雲端。就像廣達董事長林百里透露才剛取得潛水執照,趨勢科技共同創辦人暨執行長陳怡樺最近在美國開過戰鬥機,她打趣說因為要上天攻雲端商機;呂學錦則分享自己當兵的時候是傘兵。大家笑稱,未來攜手合作上天、下海找出雲端的商機。張善政是未來政府發展雲端的重要舵手,呂學錦則是積極推廣雲端產業,更號召其他業者,成立台灣雲端運算產業協會,擔任首屆理事長。林百里昨日一上台演講,就跟張善政說「長官好」,更直稱呂學錦是「雲端總司令」。張善政則期許,中華電信肩負重要任務,要帶台灣產業一塊走出去。【2012/07/19 經濟日報】

Choosing Sunscreen?

 How to Decode the Labels Dermatologist explains what SPF numbers really mean, how much protection to use and when By Robert Preidt Saturday, July 14, 2012 SATURDAY, July 14 (HealthDay News) -- You may know that it's important to protect your skin when you're outdoors this summer, but you need to know how to pick the correct sunscreen and how to apply it, the American Academy of Dermatology says. "Consumers can be overwhelmed by the large number of sunscreen products available and because of that they avoid using sunscreen all together, resulting in sunburn and overexposure to the sun's ultraviolet (UV) radiation," dermatologist Dr. Henry Lim said in an AAD news release. "Dermatologists can provide the public with the information they need to make smart choices when it comes to sun protection, which can help reduce their risk for skin cancer, and keep their skin looking healthy and youthful," he added. The AAD says you should read the label on sunscreen products and use only those that offer: Broad-spectrum coverage (label may say "broad spectrum," "protects against UVA/UVB" or "UVA/UVB protection"). SPF of 30 or higher. The AAD also recommends that you: re-apply sunscreen every two hours when outdoors; find shade whenever your shadow appears to be shorter than you are; wear protective clothing, including long sleeves, pants, wide-brimmed hat and sunglasses. An AAD online survey found that many people are still confused about SPF numbers and how to use sunscreen correctly. Only 18 percent of respondents knew that a sunscreen with SPF 30 does not provide twice the protection of an SPF 15, and only 28 percent of respondents who said they sometimes or always use sunscreen reapplied sunscreen every two hours. UV protection does not increased proportionately with a designated SPF number, Lim said. An SPF 30 screens out 97 percent of UV rays, an SPF 15 screens 93 percent of UV rays, and an SPF 2 screens 50 percent of UV rays, he explained. Lim also noted that not applying enough sunscreen or not covering all exposed areas may result in a lower SPF than a sunscreen offers. "For adequate protection, sunscreens are best applied 15 minutes prior to going outside, and re-applied every two hours or immediately after swimming or sweating," Lim said. "Research demonstrates that most people only apply 25 to 50 percent of the recommended amount of sunscreen, which is one ounce for the entire body or enough to fill a shot glass. The relationship between SPF and amount applied is not a linear one. For example, if only half the proper amount of SPF 15 is applied, the actual in-use SPF would be approximately 5, which is then inadequate protection." SOURCE: American Academy of Dermatology, news release, June 14, 2012 HealthDay  

冬蟲夏草培養基 變降低憂鬱保健品!

海大教授開發「忘憂飲」 廢米飯變保健品2012/07/19   ■徐谷楨■ 現代人失眠問題普遍,台灣海洋大學食品科學系教授蔡國珍利用廢棄米飯培養基,研發一款乳酸菌發酵飲品「忘憂飲」,效果號稱媲美知名抗憂鬱藥物百憂解,而且經動物實驗,不會產生食欲不佳的副作用,正申請專利中。蔡國珍表示,一般業者「收割」冬蟲夏草之後,剩下的米飯培養基通常沒有什麼價值,但是它含有少許冬蟲夏草菌絲,加入特殊乳酸菌發酵,可產生高量的胺基丁酸(GABA,藉此研發抗憂鬱活性的乳酸發酵飲品,讓廢棄米基變身高價的保健食品。蔡國珍採用的特殊乳酸菌是來自從魚的腸道中分離出來的乳酸菌株,具有耐低溫儲存、耐胃酸與腸胃道環境的特性,解決了一般乳酸菌不耐低溫與人體胃酸與膽鹽的缺點,同時這株乳酸菌也是人體的益生菌,在攝氏20度到37度可生長良好,可生產高量的GABA。蔡國珍指出,GABA是人類中樞神經系統所分泌的抑制神經傳導物質,根據過去研究顯示,GABA對於血壓、血糖的調節,以及精神安撫、降低憂鬱程度等有幫助。她的研究團隊已經開發出添加桂圓、紅棗的高GABA乳酸飲品,風味不錯

台灣百靈佳殷格翰 也賣保健品!! (人蔘維他命)

台灣百靈佳殷格翰藥廠引進 歐洲暢銷品牌福馬康人蔘維他命2012/07/19   【台北訊】全球前20大藥廠百靈佳殷格翰,為讓消費者能更方便地補充完整營養素,特自歐洲引進暢銷品牌福馬康 人蔘維他命,在全省屈臣氏、康是美通路藥局上市。 福馬康人蔘維他命產品經理羅芝青表示,蔘製品中的人蔘皂 含量若不足夠,不但無法達到預期補充效果,不良的人蔘品種、過度噴灑農藥、快速收成或不精密的萃取製程,反而暗藏傷害人體健康的風險。有鑑於此,福馬康人蔘維他命在製程中制定嚴格的選種、種植、萃取等SOP步驟:嚴選有機栽種六年以上的上選高麗蔘種Panax Ginseng C.A. Meyer,以真空冷凍技術乾燥蔘根水分,再加上專利「定性定量」製成技術(Standardized Ginseng Extract),讓每一顆福馬康? 人蔘維他命活力膠囊都含有一定劑量的人蔘精華,為消費者的健康嚴密把關,此產品為軟膠囊形態,不僅好吞服,也易被吸收。 (陳碧雲)

台灣第一"合法"魚類疫苗(石斑魚疫苗)!!!

石斑魚疫苗問世 有注有保庇2012/07/19【台北訊】針對石斑魚養殖產業的剋星「石斑虹彩病毒感染症」所研發的首支疫苗,經廣泛試用結果,可讓龍膽石斑在免疫後5個月活存率可達9成以上,青斑則可達75以上,可提高我國石斑魚產業的出口競爭力 農委會家畜衛生試驗所助理研究員黃淑敏表示,針對好發於吋苗到後段成魚養成階段的石斑魚虹彩病毒,所研發的石斑魚虹彩病毒不活化疫苗,去年已成為國內首支合法登記使用的魚類疫苗26日將在生物科技大展農業科技主題館展出。農委會指出,我國水產養殖業的技術先進,產值高,尤其近年石斑魚等高經濟價值的魚種因為政府的政策推動及ECFA的簽訂而擴大市場,前景看好。不過,石斑魚養殖產業有二大剋星,分別為石班虹彩病毒感染症、神經壞死病毒,可成高達八成的損失,發展疫苗是現今最好的防疫對策。黃淑敏透露,有個知名科技公司的工程師放棄高薪工作,轉而投入石斑魚養殖業,還為了幫石斑施打疫苗,研發一台可以自動為魚類施打疫苗的機器,共同守護我國石班魚養殖產業,這台機器也將同步於生技展展出。

台灣創新生技? 何謂創新???

台灣創新生技 提升產業競爭力2012/07/19 2012 論壇主題:台灣創新生技提升產業競爭力指導單位:經濟部工業局主辦單位:經濟部生物技術與醫藥工業發展推動小組執行單位:威力顧問股份有限公司記錄:沈安玨 全球人口老化加遽,特別是台灣老化程度已趕上已開發先進國家,所以台灣對於生技醫藥的需求是與日漸增。如何以有限資源鼓勵生技醫藥業者,進一步突破台灣長期在學名藥產業的發展階段或代工窠臼,鼓勵台灣生技醫藥業者從事高階醫材及新藥的研究與開發、品牌經營和國際行銷或未來具有競爭性的利基產品。如何讓中上游學研界的研發項目順利被產業承接且發展出商業價值,使產、學、研無縫接軌是當前重要的課題。
議題一:在未來全球人口老化趨勢及各國醫療支出管控下,台灣生技醫藥業者在利基產品研發方向及未來市場佈局為何蘇東茂(中華民國製藥發展協會理事長):台灣未來必須要加入PIC/S(國際醫藥品稽查協約組織),目前台灣不是會員國,因此在外銷產品時,須經過查廠的程序,必然延緩國際貿易的速度。這部分是目前TFDA(行政院衛生署食品藥物管理局)、立法院與行政院正在努力的方向。在法規完善後,才能夠進而談其他部分,及健保如何配合。法規化已是現在全球的趨勢,連落後國家的法規訂定也越來越嚴謹。產品品質與法規是台灣目前保有的優勢,但必須要嚴格要求自己與國際接軌。目前提出申請PIC/S的業者有64 家,已通過的有40家,未來還會再增加,在10411日後沒有取得PIC/S認證的業者不得生產與銷售。目前健保對於有PIC/S認證的業者有給予藥價優惠,但隨著未來通過的業者越來越多,優惠不僅取消,取而代之的是砍價,這對於同業繼續投入研發的環境是相對不利的。朱懷祖(杏國生技總經理):民國80年代,在經濟部的推動與民間業者的資金贊助下成立了「藥技中心」。當時的目的就是要推動與解決台灣製藥產業面臨環境的種種問題,但到了現在民國101年,這些問題,如學名藥和原廠藥的藥價問題卻依然還是存在,正代表著台灣各項法規含衛生、財稅、獎勵等還有許多必須全面性整合、檢討和修正以符合現在產業環境的空間。近年衛生署TFDA對新藥研發採取專案輔導,希望台灣發展新藥能符合「創新程度」、「貢獻程度」、「早收程度」與「滿足法規程度」,但這其中有很大的困難,新藥必須要夠新,又要有貢獻度,但卻又要早收,這是新藥業者的挑戰。杏國生技在新藥,除了臨床一、二期的創新產品外,也有符合美國FDA Fast Track標準,安全性沒有疑慮可直接進入二、三期臨床試驗的「老藥新用」或「老藥新複方」,可以早收而且貢獻程度可期,完整的ppeline建置是我們投入的方向。直接進入二、三期臨床試驗的「老藥新用」產品屬眼藥水,可以早期偵測與治療乾式老年性黃斑部病變,將為老年化趨勢下的老年生活帶可期的光明。黃熹祥(旺北科技副總經理):旺北成立六年來,是以結合電子產業與生物科技為永續經營的目標,目前公司除PCR Machine產品外,醫療產品有血氧濃度監視器、心電圖監視器、多參數生理訊號監視設備等已獲得衛生署許可字號產品,並已成功銷入第一級大型醫療機構。在過往的經驗中,如多參數訊號監測器都僅是國外大廠如HPGE獨佔市場,如今旺北已能扮演供應者角色,並以台灣為基礎,漸次將產品導向國際市場。 銷售同時,在各大教學醫院中也發現,需長期照護的病人佔用很多資源,其實可轉鄰近的照護中心,但因沒健保補助以至意願不高。若健保開放補助,不僅可節省醫療資源,簡陋的照護中心也可引進先進設備,如此對病患、醫療資源、長照中心,及醫療器材業者,是多方均贏的政策,希望政府能考慮開放照護中心的健保給付。謝啟山(保生國際產品副總):目前觀察到醫療產業有全球人口老化、糖尿病及其併發症日益嚴重、自我健康管理觀念提升三大趨勢,並在2011WHO統計全球糖尿病人口已突破2.2億人,血糖檢驗試片為現今使用量最大的生化感測器,年使用量超過300億支試片。但全球血糖計現在卻面臨功能少及準確度不足的問題。多功能血液分析產品具有操作簡單,快速,高準確度,且具有價格競爭力的優勢,將會是目前居家照護產品的開發趨勢,新一代產品除了監控血糖外,還必須可量測肝、腎功能、血脂及心血管等各項生理指標,滿足居家照護需求。
議題二:如何利用政府資源加強行銷及推動許長山(因華生技製藥總經理):政府要推動生技醫藥產業,帶頭到國外參展時,力道卻明顯不足,各國設立的國家館每年規模越來越大,反觀台灣2個攤位擠了20幾家廠商,整體設計不夠完善,更不用說希望達到吸睛效果。台灣未來生技醫藥的市場絕不會是在國內,一定是在國際上,若政府有心要推動,則必須思考如何帶領產業國際化。
議題三:如何加強國內外醫療產業之產、學、研技術價值鏈之合作林瑩慧(美吾髮懷特生技集團董事長特助):在政府單位財務面、技術面、法規面上的協助下,集團透過醫藥產業的接力賽模式,承接學研界初步研發成果,從臨床實驗到取得NDA(新藥查驗登記-New Drug Application)後,進入設廠生產,落實在台技術深耕。懷特植物新藥是台灣第一件,從研發到臨床實驗到取得新藥核准,並在台灣設廠生產,到現在打入各大醫學中心進行銷售的案例。目前面臨學研合作狀況是,學研界舉辦的成果發表說明會,都已在技術成熟階段才讓業者參與,希望未來國科會可以提供產學合作管道讓廠商提早參與,並有設立機制保障廠商在前期與學界合作的權利。郭國華(德英生物科技總經理):韓國近年在新藥開發上的能量爆發,值得台灣反省思考,但國外的模式並不一定適合直接複製在台灣,台灣必須走出自己的一條路,才能突破國際的競爭。相較化學合成的西藥,植物藥沒有中間產物的問題,在安全性上是較穩定的。若植物藥的品質與療效能與西藥一樣能嚴謹管控,這會是台灣一大特色與利基。經濟部生技醫藥產業發展推動小組主任鄭建新表示,全球人口老化的影響,最直接的就是在醫療支出與需求上的增加。20081031日統計台灣生技相關產業上市櫃公司的市值有768億,到了20126月底,已達2800億,總計共有64家業者上市櫃。目前台灣的生技醫藥產業環境,吸引不少國外業者來台進行投資,這對台灣生技醫藥產業來說是很大的助力,廠商拿到資金,就可再往前推展,讓資本市場成長。

Seaweed toothpaste stops tooth decay ?

Saturday, July 14, 2012 by: PF Louis (NaturalNews) Brushing and flossing doesn't always keep you out of the dentist's chair, a chair we all need to avoid. Amalgams inserted into cavities are loaded with toxic mercury that leaks into our bodies. Root canals have been discovered to be the root of some chronic illnesses. (Natural News, source below). Of course, fluoride doesn't help prevent tooth decay. Instead, it contributes to bad physical and mental health and lowers I.Q. while diminishing will power. It's toxic and actually causes dental fluorosis, decaying tooth enamel that will put you back into that dental chair. So what to do to avoid the barbarism of modern dentistry? It appears that sea life may come to the rescue. A group of UK scientists are experimenting with enzymes extracted from seaweed microbes that may be able to remove the microbes in dental plaque. The Newcastle University research team had originally pursued this line of research into seaweed's Bacillus lichenifromis for the ship industry to see if these microbes would help clean ships' hulls without going into expensive dry dock maintenance that also takes a ship's time away from the sea. Actually, it's not the microbes themselves that deliver the cleansing. It's the enzymes they produce. This type of enzyme has to come from raw seaweed. Heat destroys enzymes.

From seawater to ship hulls to dental plaque Dr. Nick Jakubovics of the Newcastle University School of Dental Sciences discovered how these same enzymes produced by seaweed microbes could eliminate plaque on, between, and behind the teeth if utilized in an oral mouthwash or toothpaste. Dr. Jakubovics explained: "Plaque on your teeth is made up of bacteria which join together to colonize an area ... scrubbing off the plaque containing bacteria is not always effective ... We found this enzyme can remove some of these undesirable bacteria from plaque." Plaque is made up from lots of decaying bacteria. When those cells die, their DNA leaks out to form a biofilm that sticks to teeth. The dental research into seaweed enzyme producing microbes focuses on eliminating the need to eliminate plaque entirely. Instead, the idea is to simply remove the bacteria like Streptococcus mutans that actually cause tooth decay. Dr. Jakubovics and his team intend to present their findings to the UK's Society of Applied Microbiology. Dr. Jakubovics comes across in a radio interview as very conservative with how long it may take to go from research to market with his findings. Perhaps because he's familiar with the UK's process that rivals the USA's FDA hoops for approval. The short radio interview is available in the BBC Report below. Some of those hoops could be provided by dental profession groups' desire to not reduce office visits that require laborious plaque removal work. Worse yet, actually reducing cavities would eliminate a lot of dental business. In the UK's system of socialized medicine, that would logically reduce the national economic burden of health care. But logic isn't always worshiped by governments and egoistic medical groups, as evidenced by recent manic attempts to remove vastly less expensive homeopathy health care from England's medical system (http://www.naturalnews.co/034164_medical_monopoly_homeopathy.html). Here in the USA, that could result in even more opposition from the American Dental Association (AMA) bureaucrats who control the dental trade union to keep dentists in business. Even as the AMA publicly supports water fluoridation from industrial waste fluorides to prevent tooth decay, there is no evidence of less tooth decay from toxic public water fluoridation. Why should dentists even really want less tooth decay? How could they pay their staff, lease all that expensive dental apparatus, and buy more BMWs to park in their McMansions? 

中興新村高等研究園區 拼文化商機!!!!

大咖青睞睞中興新村成文創產業新星 2012-07-19 01:39 中國時報 【盧金足/台中報導】國際大導演侯孝賢、霹靂布袋戲、明華園歌仔戲,近來都到中興新村高等研究園區投石問路,七十二公頃用地,除卅五公頃規畫為科技園區,將釋出十五公頃作為全台灣最大規模文創園區,日月潭是中部明珠,中科發豪語,要讓中興新村成文創產業最閃亮的鑽石。中興新村轉型為高等研究園區,一般人都以為是中科的新科技重鎮,殊不知,這座園區也正在進行一場文創產業的大遷徙。「侯孝賢導演親自來中興新村,看到以前省政府留下的辦公廳舍、宿舍、綠樹扶蔭環境,很有興趣在這裡蓋片廠和電影中心,推動台灣大型影城」,中科管理局長楊文科說,為吸引文創業者進駐中興新村,提供十五公頃土地,每平方公尺土地、每月租金才六.三元,對影視業者很有誘因。楊文科說,台灣文創產業「大咖」,紛紛來中興新村考察,驚嘆這裡的風土人文,連知名史艷文霹靂布袋戲都有意來這裡興建攝影棚和博物館、明華園歌仔戲更展現進駐意願,3D動漫、遊戲集團也紛紛想來中興新村搶頭香。中科希望大陸觀光客來台遊覽日月潭、阿里山,一定要來中興新村欣賞台灣原汁原味的布袋戲和歌仔戲,人潮帶來錢潮,文創成為全台朝聖重鎮。為營造「文化是門好生意」商機,中科也正研擬開國際標,由國際級建築師來中興新村興建五星級大飯店,讓國內外觀光客遊寶島,會以在中興新村吃喝玩樂列為第一選擇。

Less time sitting can add two healthy years to your life

Saturday, July 14, 2012 by: John Phillip (NaturalNews) Many people believe they must engage in strenuous physical activity to achieve optimal fitness and prevent illness. While exercise is certainly important to health, new research provides a different perspective about the negative effects of sitting for extended periods and how we can make small changes to potentially increase our natural lifespan. Researchers gleaning data from the National Health and Nutrition Examination Survey (NHANES) have published the result of a study in the journal BMJ Open, that explains how restricting the amount of time spent seated every day to fewer than three hours might boost the life expectancy of US adults by an extra two years. Additionally, they have found that cutting down TV viewing to fewer than two hours every day might extend life by almost 1.4 years. In the past, studies have implicated sitting for extended periods and watching too much television with illnesses including diabetes, heart disease and stroke. This study is the first to directly link the sedentary lifestyle habits of more than 167,000 people with relative risk of developing or dying from a chronic illness. Researchers pooled data from five relevant studies to arrive at their startling conclusion.

Walking or standing a few minutes each hour may help extend lifespan in aging adults The scientists pooled all relevant data to develop a statistical tool known as a population attributable fraction (PAF). The PAF is an estimate of the theoretical effects of a risk factor on a population, rather than an individual marker, necessary to calculate the number of deaths associated with time spent sitting down. The researchers determined the PAFs for deaths from all causes linked to sitting time and TV viewing were 27 percent and 19 percent, respectively. By extrapolating the PAF statistics, the study team determined that cutting the amount of time spent sitting down every day to under three hours would add an extra two years to life expectancy. In a similar manner, restricting time spent watching TV to under two hours daily would extend life expectancy by an extra 1.38 years. These results are significant because many aging adults spend extended periods of time sitting or lying down as they watch television. Standing or walking for several minutes each hour may provide protection against vascular and metabolic dysfunction, the underlying processes behind the explosion in new cases of cardiovascular disease, stroke and diabetes in our aging population. 

你覺得自己臉太大嗎?

調查:整形最憂落差大 2012-07-19 新聞速報 中央社開業整形專科醫師張博全今天表示,傳統整形是民眾拿著藝人照要求醫師複製,往往會出現撞臉或整過頭,調查顯示8成不考慮整形手術的原因是,擔心術後落差。一份今年6157152012立體小顏大調查」顯示,透過網路問卷調查1321名民眾,超過7成民眾認為自己臉太大,超過5成表示外表會影響自信心,11%擔心影響求職,然而整形也非所有民眾都能接受,除考量醫療品質外,近8成不考慮手術的原因在於擔心術後落差大。張博全表示,許多民眾都以藝人臉形為範本到醫療院所聽聽專科醫師意見,自己想像術後可能會出現的樣貌,往往在手術結束時,期待又害怕的心情就在揭曉那一刻,一旦與原本想像有落差時,也無法再重來。拿藝人照的民眾對於整形有過度期望,開業整形專科醫師鄭紹隆表示,藝人照的訊息可使醫師知道患者個性,當作參考,不過每個人臉形不同,整形是要依個人條件去改造成比較好的,需配合整個臉的線條讓臉部和諧。1010719 

Aetna Upgrades iTriage Consumer Health Care App for the iPad

 Posted on Wednesday Jun 20th 2012 by Brian T. Horowitz. Aetna has announced that its health care app iTriage will run as a native application on the iPad, taking full advantage of its high-resolution Retina display. Aetna has announced that it has optimized the company's iTriage health resource for the Apple iPad with a new native app. iTriage is a Web-based service that allows consumers to research symptoms, look up medical providers and schedule appointments. It provides information on diseases and medical procedures, and uses GPS to direct patients to providers' facilities. The company redesigned the app to fit the full high-resolution display of the Apple tablet, said Dan Tucker, iTriage product manager, who blogged about the new iPad version.

The app can take full advantage of the iPad's Retina display, according to Aetna. iTriage is designed on the iPad in a "sweeping panel" format, in which one column lists a patient's condition, such as a puncture wound, and the middle column lists the definition. The third column shows a list of medications that can treat the problem, a location where patients can find treatment and an estimate of services for care. In addition, the iPhone iTriage version now allows consumers to search for providers by category, including Emergency Departments, Urgent Care, Retail Clinics, Physicians, Pharmacies and Additional Outpatient Clinics. Aetna acquired Healthagen, the developer of iTriage, Dec. 15, 2011, and relaunched iTriage March 5. The company announced the new iPad version June 19. The app's Symptom-to-Provider feature leads users through a question-and-answer process of connecting symptoms and causes as well as finding providers. iTriage is the first software tool on Aetna's open-data platform called CarePass, which allows consumers to share data and manage their health across applications using a single sign-on. CarePass is open to any insurance carrier, consumer or third party, Mark Bertolini, Aetna's chairman and CEO, announced at a March 5 relaunch event for iTriage. An iPhone app for iTriage launched in March 2009. Since then, the app has reached 6 million downloads, according to Aetna. "Our vision is to help the world make better health care decisions," Dr. Peter Hudson, co-founder and CEO of iTriage, said in a statement. "Expanding the availability and functionality of iTriage on the devices that consumers are increasingly using helps more people take control of and conveniently manage their health care decisions." iTriage allows patients to rate providers using technology from Vitals.com. The app also now features an ER Check-In feature for hospitals and an Early Check-In capability for urgent care clinics. Hudson and Dr. Wayne Guerra, iTriage's co-founder and chief medical officer, developed the service in 2008. On June 19, Aetna also announced that it would integrate its wellness platform Resources for Living with Consult A Doctor's telehealth platform, which allows patients to connect with doctors using video, phone or email. The combined platform, Consult A Doctor Plus, offers 24/7 phone consultations, patient advocacy bill review and mediation, electronic health record (EHR) access along with legal and financial consulting. "With Consult A Doctor Plus, we are able to work hand-in-hand with Aetna to reach beyond traditional, primary care settings and explore new opportunities within the telemedicine spectrum of health care," said Wolf Shlagman, founder and CEO of Consult A Doctor, in a statement. 

睾酮疗法可增强心衰患者运动能力 !!!

 发布时间:2012-7-19 来源:爱唯医学 低睾酮是心力衰竭(HF)患者运动能力降低和不良临床结果的一个独立的预测因子。研究者试图确定睾酮疗法是否能改善稳定性慢性心衰患者的运动能力。研究者检索了1980~2010年间MedlineEmbaseWeb of ScienceCochrane对照试验中心注册库的数据,纳入报道睾酮对心衰患者运动能力影响的随机对照试验(RCT)。最终确定了4项试验(n=198;男性占84%;平均年龄67)。试验采用6分钟步行测试(2RCT)、增量往返步行试验(2RCT)或峰值氧耗量(2RCT)来评估治疗52周后的运动能力。结果显示,相对于安慰剂,睾酮疗法与运动能力明显改善相关。睾酮组相对于安慰剂组在6分钟步行测试、增量往返步行试验和峰值氧耗量方面的平均增量分别是54.0(95%CI43.0~65.0)46.7(95%CI12.6~80.9)2.70 ml/kg·min(95%CI2.68~2.72)。采用汇总SDs单元检测,睾酮疗法与运动能力明显增强相关(净效应,0.52 SD95%CI0.10~0.94)。无明显心血管不良事件。研究者总结认为,睾酮似乎是改善心衰患者功能能力的一种有前途的疗法。睾酮对高危人群生活质量、临床事件和安全性的益处,还需更充分有力的随机对照试验来评估。

90 Percent of Patients Want to Self-Manage Health Online: Accenture Survey

By: Brian T. Horowitz 2012-07-03 Patients want to access health information online and fill prescriptions electronically. But they also want face-to-face time with their doctor, a survey by Accenture revealed. Patients are interested in accessing health information electronically, but they don't want to give up regular visits to the office, according to a recent survey by consulting firm Accenture. For its Connected Health Pulse Survey, Accenture interviewed 1,110 U.S. patients between March 30 and April 4 to find out their preferences regarding digital health. It announced the results of its survey on June 20. Accenture interviewed patients to see how they wanted to communicate with doctors. It also looked into how patients perceived electronic health records (EHRs), the company reported. Of patients interviewed, 90 percent want to self-manage their personal medical data online, refill prescriptions electronically and book appointments on the Web, according to the report. The survey also found that patients were interested in using their mobile devices to refill prescriptions. Mobile apps such as LowestMed allow consumers to compare drug prices at their local pharmacies. Still, 85 percent of respondents preferred to see doctors in person when needed rather than relying on alternatives such as telehealth consultations. These results show that patients simply want multiple options to access care, according to Dr. Kaveh Safavi, head of Accenture's North America health industry group. "The survey shows that patients don't want an either/or scenario [regarding] in-person vs. online," Safavi told eWEEK in an email. "Instead, patients want access to more entry points into the health care system and the ability to customize options to address their specific needs." Patients are increasingly seeking "anytime, anywhere" access to their personal medical data, said Safavi. "But they're not willing to give up the option of face time with their physicians." Despite a large amount of respondents being interested in managing their health online, only 46 percent knew if they're data was already accessible online for tasks such as refilling prescriptions. Meanwhile, patients were split on whether to let doctors manage their EHRs or maintain the information themselves. Patients are interested in accessing their own test results online in a personal health portal, said Safavi. To manage their own health data, patients would need to use a service such as Microsoft HealthVault, which is available on mobile devices such as Windows Phone 7 and integrates with EHR applications like those from Greenway Technologies. Patients are also interested in learning about their conditions by using online educational resources. These sites include Aetna's iTriage, WebMD and the National Library of Medicine's MedLinePlus. Of patients surveyed, 72 percent want to be able to book appointments online. Although patients prefer face time with doctors over virtual visits, they still want to be able to email with their doctors, according to Accenture. According to the survey, 88 percent of patients are interested in email reminders of appointments and 76 percent would like to consult with their physicians through email. In addition, 74 percent want to be able to reach their doctor by phone. As far as which device to use to connect with their data, 73 percent of patients preferred mobile devices. "They appreciate the immediacy and convenience of digital resources, such as email and mobile devices, but still value in-person exchanges when needed," said Safavi. 

美妝連鎖 不同的策略...寶雅

寶雅今年力拼總店數78家,全年獲利估增逾2 2012/07/12 18:21 精實新聞 2012-07-12 18:21:07 記者 楊舒晴 報導 即使今年百貨零售業飽受消費力衰退之苦,主打平價消費策略的寶雅(5904)今年上半年累計營收仍達31.92億元,年增7.46%。到6月底為止,寶雅全台共有68家門市,目標今年底前力拼78家,預計下半年將再展10家門市,法人估計,全年營收將較去年成長1成,全年獲利可望較去年3.36億元約成長超過20%寶雅為美妝及生活雜貨連鎖專賣店,產品包含括彩妝、服飾、雜貨、食品與藥品等,其中又以生活雜貨用品(服飾、雜貨、食品等)佔營收比重達68%,美妝佔29%、藥品佔3%,平均商品單價約70~80元間,客單價約370元,屬於平價消費,在目前經濟不景氣的環境下,營收還能維持成長。 截至6月底,全台總店數約68家,多以租金較低的大台北以外地區為展店區域,上半年只新展2家門市,下半年將會全力展店,力拼今年底前全台總店數達78家。 法人指出,寶雅展店地點大多不在精華區內,因此租金成本較低,再加上非精華區內百貨零售業較少,若寶雅開店都有相當的聚客力,新展門市約平均3個月即可轉盈,該公司今年目標新展12家門市,估計將帶動今年總營收較去年62.78億元約成長1成,全年獲利可望超過2成。 寶雅今(12)日進行除權息,每股配發現金股利3.28元、股票股利0.1元,除權息參考價為55.2元,市場看好該公司今年營收及獲利成長動能仍強,股價已經先行反應,昨日創下歷史新高達59元,但今日除權息後收在平盤55.2元。

Health-care apps for smartphones pit FDA against tech industry

 David Paul Morris/BLOOMBERG - Applications for smartphones that check on blood sugar or allergies may face the same scrutiny from U.S. regulators as heart stents and defibrillators. The Food and Drug Administration plans to issue draft guidelines this year classifying mobile health tools for handheld computers such as Apple Inc.'s iPhone as medical devices. Text Size PrintE-mailReprints By Dina ElBoghdady, Published: June 22 Three tries. More than two years. And roughly $150,000. That's what it took for MIM Software to get the Food and Drug Administration's clearance for a smartphone application that physicians can use to view MRIs and other medical images. Ron Gutman is the CEO and founder of HealthTap, which creates mobile and Web applications with the goal of connecting individuals with medical professionals. Gutman spoke with the Washington Post's Emi Kolawole about the power of turning doctors into health care information curators for the Web and on mobile. "It was 2008 when we first tried," said Mark Cain, the Ohio firm's chief technology officer. "They didn't know what questions to ask and neither did we. . . . But at some point, they had to be thinking, 'How many more people will be lined up behind these guys?' " His was, in fact, among the first apps cleared by the FDA. And since then, medical applications have flooded onto millions of smartphones, offering consumers the chance to check their heart rate, identify a pill in their medicine cabinet or even scan moles for skin cancer. Soon, if a firm called AliveCor gets its way, they may even be able to get an EKG by pressing iPhone to chest.

The gee-whiz factor can both astonish and alarm. A defect in apps that essentially turn your phone or tablet into a medical device could prove problematic or even life-threatening: The app may not work as it should. For instance, what if lighting or contrast issues distort an X-ray that's viewed on an iPhone or iPad? That's why federal regulators lurched into action a year ago, offering their thinking on how to police this vast new frontier. Just as they were putting the finishing touches on a plan, lawmakers intervened. The Senate agreed to put the plan on hold after technology firms argued that heightened oversight would stifle innovation and cost jobs. On Monday night, a compromise was struck. Congress gave the FDA the green light to proceed with its push to define exactly which apps require its attention. But they also ordered the Obama administration to come up with a strategy that balances public interest with innovation in the years to come. The task is daunting, given the warp speed of technology. It's a classic showdown between Washington regulators charged with safeguarding the public's health and a free-wheeling tech industry that prizes agility and first-to-market bragging rights. "There are two completely different mind-sets," said Merrill Matthews, a resident scholar at the Innovative Policy Institute. "The app people think: Where is there a need and how do I fill it? And the FDA thinks: Where is there a problem and how can I control it?"

Cost-saving potential Mobile apps, with their extraordinary reach, have the power to transform health care. Half of cellphone users in the United States have smartphones such as the iPhone or Android software-based devices, which can deliver care to their hands and potentially do so at a lower cost. Using smartphones and wireless tablets as diagnostic tools or monitoring devices could also cut back on emergency room visits. For software developers, especially cash-strapped start-ups, there's an enormous amount riding on whether the FDA steps up enforcement — and exactly how it plans to do it, industry analysts said. "The FDA approval process adds months, if not years, and potentially millions of dollars to what it takes to bring a solution to the market," said Liz Boehm, a director at ExperiaHealth, a consulting firm. "That development process would put many of these guys out of business."Medical apps exploded onto the scene in 2010 and have grown by about 150 percent each year since, according to MobiHealth News, which tracks Apple's iTunes store, where many apps debut. Consumers can choose about 13,000 of these apps; 5,000 more are marketed to medical professionals. The offerings range from very basic — and free — apps that calculate body mass index to more sophisticated ones that make use of pricey supplemental devices. The pharmaceutical firm Sanofi has an app for diabetics that registers glucose levels with the help of a meter that attaches to iPhones. IHealth offers an app that records blood pressure using a cuff that plugs into an iPhone, and WiThing has one that tracks weight and body-fat percentage using the company's WiFi-enabled scale. Ron Gutman is the CEO and founder of HealthTap, which creates mobile and Web applications with the goal of connecting individuals with medical professionals. Gutman spoke with the Washington Post's Emi Kolawole about the power of turning doctors into health care information curators for the Web and on mobile. A survey by the Pew Internet Project found that 11 percent of adults with cellphones downloaded an app last year to help them manage their health. That same year, the mobile health-apps industry generated an estimated $718 million worldwide, seven times more than the previous year, according to Research2Guidance, a consulting firm.

The regulation debate While the FDA currently regulates certain medical software, the agency wants to update its thinking now that smartphones have juiced the apps market. A year ago, the agency proposed policing only a subset of those apps: ones that use supplemental attachments to transform a mobile platform into a medical device (such as AliveCor's EKG app) and others that act as accessories to an already regulated medical device (such as MIM Software's app). Rather than overseeing all medical apps, agency officials said they want to limit regulation to a slice of the market and take a pass on low-risk apps, such as calorie counters, according to Bakul Patel, an FDA policy adviser. "We are taking a proactive step by saying that from the FDA perspective," Patel said. "We're not concerned about all those other apps." Software makers, on the other hand, see an agency that currently regulates next to nothing in the mobile apps space taking a sudden interest in regulating more. The FDA proposal, they say, is vague and leaves many questions unanswered. For instance, given that apps can be updated daily, does a software developer have to seek FDA approval for each update? Among the critics is a group called the Health IT Now Coalition. It represents health-care providers, patient advocates and health insurance companies, including Aetna, which last year bought iTriage — an app that helps consumers evaluate medical symptoms and find the proper care. "The issue here is that they're really using a process for approval of these mobile apps that was basically created when the 5 ¼ floppy disk was the latest technology," said Joel White, the group's executive director. Dirk Hobbs, chief executive of Medical Voyce Sciences and Multimedia, said the FDA's plan is ambiguous and he doesn't know whether the apps his firm is developing would be regulated. The apps aim to speed communication among medical professionals in different facilities."This is just going to slam the brakes on an innovative sector that includes tons of small businesses like mine," said Hobbs, who expressed his concerns to Sen. Michael F. Bennet (D-Colo.). Bennet and Sen. Orrin G. Hatch (R-Utah) wrote a provision, inserted in a broader FDA funding bill, that would have delayed the FDA proposal by forcing the agency to first reach agreement with other regulators about how to handle these apps. This week, in a compromise reached by House and Senate lawmakers, Congress allowed the FDA to press ahead. But it also directed the agency to work on a report with other regulators that would lay out an appropriate framework to promote innovation and protect patient safety. Former FDA deputy commissioner Scott Gottlieb, who researches medical trends as a fellow at the American Enterprise Institute, said he's disappointed. If consumers can track their blood-sugar levels using pen and paper, he said, why should the government have to clear an app that does the same thing more reliably? Gottlieb said that software developers should be suspicious because regulators have a tendency to tighten their grip on industries as they develop. "If they perceive a power vacuum," he said, "they'll step in and regulate more and more."

Some seek guidance Some in the tech industry do not perceive a threat. They say they've been expecting the FDA to regulate some apps and are eager for the agency to reveal which ones. A group called the mHealth Regulatory Coalition — which represents established firms such as Qualcomm as well as start-up software developers — was formed in 2010 to deal with mobile health care regulatory issues. Its leaders argue that uncertainty breeds anxiety and drives away potential investors. "We started telling the FDA that they're going to stifle innovation if they don't start clarifying where the lines will be drawn," said Bradley Thompson, the group's general counsel. Other technology groups — including the West Wireless Health Institute and the Application Developers Alliance — have taken a similar position. In a recent meeting with industry representatives, Jeffrey E. Shuren, head of the FDA's Center for Devices and Radiological Health, assured the group that the final plan would include more details than the draft, some attendees said. The agency may even create a Web site with generic examples of apps that would be exempt, Shuren told them. In the end, the FDA's plan may indeed sink some software makers whose products can't withstand federal scrutiny, said Lisa Suennen, co-founder of Psilos Group, a health-care-focused venture capital firm. "But while regulation puts an extra burden on young companies, those that can get through it will have a huge competitive advantage," Suennen said. "You can't have every Tom, Dick and Harry claiming that their medical app adds value without having to prove it." 

化療新方向TMPK抑制劑可專殺癌細胞

 鉅亨網新聞中心(來源:華人健康網)2012-07-19 14:06:24華人健康網 記者張世傑/台北報導國內基礎醫學研究又有重大發現!陽明大學生物化學暨分子研究團隊,在大白鼠動物實驗中,找到攸關癌細胞生長的TMPK標靶酵素,且據此發展出一個小分子抑制劑YMU1,可達到只針對癌細胞有毒殺作用,不會對正常細胞造成影響,此研究提供未來降低副作用癌症化學治療的新方向,成果發表於今年710日的國際知名醫學期刊「CANCER CELL」。主導這項研究的陽明大學生物化學暨分子研究所教授張智芬指出,國內10大死因中,癌症高居不下,許多病友在癌症化療後,常因正常組織受到抗癌藥物的侵襲傷害,造成非常不適的副作用,例如噁心、嘔吐等。因此,發展一個溫和的化療藥物組合內容,只針對癌細胞有毒殺作用,而對正常分裂細胞的影響很小,將對病人的治療過程會有極大的益處。目前,有許多傳統的化療藥物,其作用機轉是透過造成DNA嚴重損害以達毒殺細胞的效果,但這種DNA損害作用,同時也會對正常組織中快速生長的正常細胞造成毒害,也可能促成細胞二度癌化。這些副作用當然可以藉著降低藥物劑量獲得改善,但癌細胞卻可藉著DNA修復得到喘息的機會,最後造成治療失效。張智芬表示,由於細胞在DNA修復時,需要去氧核醣核苷酸做為原料之供給,研究團隊分析癌細胞及正常分裂的細胞,在接受少量DNA損害後,細胞去氧核醣核苷酸代謝的分歧性,結果發現癌細胞在少量DNA受損後,其核醣核苷酸還原酶表現量增多,同時配合胸腺核苷酸激酶(TMPK)之作用,產生足夠且平衡的4種去氧核醣核苷酸,進行DNA修補,使細胞得以繼續生長。但在降低TMPK的酵素活性後,造成4種去氧核醣核苷酸不平衡,使得DNA修補不完整,而癌細胞由於DNA基因不正常,因此形成分裂死亡。張智芬教授強調,在大白鼠動物實驗中,找到能有效抑制癌細胞生長的TMPK標靶酵素,且不會對正常細胞造成影響的小分子抑制劑YMU1。˙相對地,正常分裂細胞在少量DNA遭受損傷後,其核苷酸還原酶表現量下降,細胞呈現休止狀態,即使在TMPK功能下降情況下,其4種去氧核醣核苷酸仍保持平衡,使得DNA修復仍可完善進行,直至DNA的受損修補完整,因此,不會形成分裂死亡。 張智芬強調,在這樣的研究基礎下,研究團隊以TMPK為新標靶,利用冷光快速篩選系統,發展出第一個TMPK抑制劑酵素,可以專一性降低胸腺核苷三磷酸(dTTP)之生成,配合低劑量的化療藥物─小紅莓(Doxorubicin),可以有效毒殺癌細胞,而不對正常分裂的細胞產生毒害。同時從21,120個化合物中,發現第一個可穿透細胞的人類胸腺嘧啶核酸激酶(hTMPK)小分子抑制劑,命名為YMU1;實驗證明發現,低劑量的小紅莓合併YMU1並不會對正常細胞或組織造成影響,但可以有效抑制多種癌細胞的生長,在小鼠身上也會顯著減緩腫瘤的形成。

Happtique Mobile Health App Draft Guidelines Are Available

By: Brian T. Horowitz 2012-07-13 Happtique has published a draft of its mobile health app guidelines and seeks feedback from the medical community. Happtique, which runs a marketplace for mobile health applications, has released its draft guidelines on medical app development. Described as a "Good Housekeeping" seal of mobile apps by Happtique CEO Ben Chodor, the App Certification Program specifies which types of apps satisfy standards on operability, privacy, security and content, the company reported. Happtique is a unit of GNYHA Ventures, the business arm of the Greater New York Hospital Association. It launched the App Certification Program Jan. 17 and released its draft on July 11.

The draft dictates that apps need to operate reliably, according to Chodor. "There are tens of thousands of medical, health and fitness apps on the market, and their sheer number makes it difficult for health care professionals and consumers to locate apps that operate reliably, are based on valid information and safeguard users' information," Chodor said in a statement. "Happtique's App Certification Program will address an important need in the m-health field by evaluating apps along these dimensions." In a similar process, the FDA published its guidelines on medical health apps in July 2011. The FDA plans to regulate apps that work as accessories to FDA-regulated devices or that turn smartphones into medical devices to monitor conditions such as abnormal heart rhythms. Happtique's operability standard would mandate that apps run effectively on mobile devices, and are able to connect properly to peripherals as well as WiFi or cellular networks. Speed would also fall under operability standards, though the document doesn't mention how fast an app would need to operate on a network. To satisfy the privacy standard, a mobile app would have to make clear who will receive a patient's information prior to the user downloading the software. The app also must disclose resources that would be used, including how many Short Message Service (SMS) or Multimedia Message Service (MMS) messages would be sent per month, how many emails would be sent and which Bluetooth profiles would be used. As far as security, mobile apps would need to ensure that they don't contain viruses, worms, spyware, adware, rootkits or other threats. The content standards would require that the app is current and gets its data and documentation from a "recognized source." In addition, content would be need to be written in layperson's terms, according to Happtique. A panel of experts made up of a doctor, nurse, biotechnology scientist and patient advocate developed the guidelines. Happtique is looking for feedback from the medical, health and fitness community, including app owners, developers and patients, according to Dr. David Lee Scher, chair of Happtique's App Certification Program Blue Ribbon Panel. "Our goal is to produce a set of rigorous standards that will give both health care professionals and consumers a solid basis for selecting apps," Scher said in a statement. "We believe the certification process will lead to the identification of truly high quality apps, thereby giving health care professionals and consumers alike the confidence they need in the apps they are recommending or using," said Chodor. 

南部生技醫材產業聚落 生技月搶眼!!

101年第十屆台灣生技月參展7/2629登場2012-07-19 17:15:52 蔡清欽/報導生技產業是南部科學園區重點發展的產業之一,南科管理局為了讓社會大眾能了解南科生技產業的發展現況,因此邀集區內生技產業廠商,包括金穎生物、和鑫生技、双美生物、皇亮生醫、東宇生物、美梭生技、京達醫材、鴻君科技等八家廠商,於72629日在台北世貿展覽一館舉辦的2012台灣生物科技大展中,設置南科主題館共同參展。近年來隨著社會邁向高齡化,對醫療器材的的相關需求也大幅成長,未來醫療器材產業將呈現高成長的發展趨勢。南科管理局發展重點,也由生技產業拓展至生技醫療器材的發展,98年起執行「南部生技醫療器材產業聚落發展計畫」,迄今已邁入第4年,不僅吸引國內外知名廠商進駐園區,同時亦展現了豐碩成果。除引進醫材廠商投資進駐南科外,目前已引進13所學校及研究機構於園區內設置研發中心,除可藉由整合學術量能來培育高階生技醫材產業專業人才,進而提升產業競爭力外,並可協助廠商開發高階醫材產品與技術,以建立國內醫療器材自有品牌產品,提升台灣醫療技術水平及國際形象,奠定台灣生技醫療器材產業穩固發展之基礎。秉持「立足亞太,放眼世界」的精神,南科將持續推動醫療器材產業聚落發展,預計計畫完成後將創造百億元商機,屆時必能藉由聚落綜效,加速與各國合作的機會,進而使南科成為世界級的生技醫療器材產業重鎮。【中央網路報】

醫藥新興市場區塊 3,000億美元市場規模!!!!!

生技醫療基金 題材多 2012/07/19 【經濟日報╱記者高佳菁/台北報導】 今年股市慘遭歐「傷」下挫,讓具備防禦色彩的生技醫療類股逆勢追漲,NBI生技指數今年以來上揚28.58%7月初甚至一度逼近1,400點大關,隨著7月下旬生技股季報公布進入高峰,9月接著進入醫學年會及傳統旺季,加上併購題材不斷,相關生技醫療基金漲勢可期。ING全球生技醫療基金經理人黃靜怡表示,美國進入第2季財報公布期,生技類股走勢難免受財報表現左右,如本周有包含製藥大廠嬌生、亞培,以及醫療設備大廠百特醫療等企業將公布財報,7月下旬則有Biogen IdecAmgenCelgene等生技權值股加入行列,財報表現值得關注。富蘭克林坦伯頓生技領航基金經理人麥可羅指出,根據花旗集團預估,美國大型生技股20122014年獲利年增率預估值介於13%15%,高於史坦普500大企業4%6%增幅。黃靜怡認為,全球生技醫療類股產業基本面與總體經濟環境連動性偏低,在系統性風險升高之際,反而易吸引資金青睞;其次,今年上半年釋出之新藥研發結果,高達75%為正面,更重要的是9月開始進入醫學會議密集召開期,且第4季向來為生醫傳統產業旺季,預期下半年該類股仍可望震盪走高。德盛安聯全球生技大壩基金經理人傅子平進一步指出,近期市場偏重在具被購併條件與藥物研發和上市時程接近後段的公司,目前較看好此波大型製藥公司購併中小型生技公司的趨勢,預期在專利藥專利到期的壓力與低利率環境下,購併案將延燒至2013年。著眼新興市場受惠於中產階級成長、醫療涵蓋範圍擴張、每人藥品支出水準仍低、生活型態改變和慢性病增加等結構性因素,對醫療的需求成長潛力相當龐大,麥可羅認為,涵蓋金磚四國、南韓、土耳其與墨西哥等7國的醫藥新興市場的藥物支出占全球市場的比重,於2010年已正式超越歐洲5大國(法國、德國、義大利、西班牙、英國),成為僅次於美國的全球第2大支出區域,預估2015年醫藥新興市場的藥物支出金額有機會突破3,000億美元,成長潛力相當雄厚。

REVOLUTIONARY DRY SKIN TREATMENT SUCCESSFULLY OVERCOMES THE PROBLEM OF ECZEMA

 Saturday, 14 July 2012 Revolutionary dry skin treatment protects your skin from the itch of eczema.

What is the underlying cause of eczema? Eczema is a chronic skin disease characterized by dry, itchy, inflamed skin caused by an allergic immune response with in the skin. While there is no cure for the condition, understanding the causes and finding the right dry skin treatment product can greatly reduce the occurrence of symptomatic outbreaks and how to rejuvenate skin.

Could you be suffering from a damaged skin barrier? Nearly 80 percent of eczema is due to contact with harsh chemicals and environmental irritants. If you have damaged dry skin your skin's barrier is impaired and no longer properly functions and an increase in water loss having dry and cracked skin. Besides an increase in water loss, a damaged skin barrier makes your skin more susceptible to irritants that create an increased risk for dry skin conditions such as eczema. "As a dermatologist with many years of experience treating skin problems, I can tell you what the major causes are," says Dr. Lisa Benest, "one of them is exposure to irritants and chemicals in the everyday environment. We live in a much more toxic environment today and our skin bears the brunt. When we are exposed to harsh conditions in the environment it can have a very negative effect on our skin."

Shielding Lotion: A Revolutionary New Dry Skin Treatment that is the Best Lotion for Dry Skin Traditional moisturizers are simply add artificial moisture to the surface layer of your skin and do very little to heal or protect your skin. Many even contain harsh chemical ingredients that damage the integrity of your skin's barrier leading to more skin problems for you. Realizing the need for an entirely new approach to skin care, 21st Century Formulations put together a team of leading doctors, dermatologists, and cosmetic chemists who spent six years working together in developing Skin MD Natural Shielding Lotion. Skin MD Natural Shielding Lotion duplicates your skin's own natural functions and strengthens your skin's ability to protect against toxins and irritants resulting in healthier softer skin. Dr. Lisa Benest explains: "The reason shielding lotions are so effective is that they replace the protective barrier and allow the skin to heal from within. A shielding lotion bonds with the outer layer of the skin and protects it from outside irritants and chemicals, so it will prevent skin conditions from developing or it will help an existing condition to heal." Join the millions throwing away their old creams and lotions for Skin MD Natural: It's the only lotion that can truly treat severe eczema and is a real dry skin treatment. Go to http://www.skinmdnatural.com or call 800-540-4790 for more information. 21st Century Formulations is a company dedicated to creating healthy skin care shielding lotions. For more information please contact 1-800-540-4790. 

講究 "就診秩序 "的日本醫療體系 !

國際SOS:中國醫療品質仍待改進 台灣醒報實際入稿日期: 2012-07-19【台灣醒報記者劉運台北報導】中國及日本是台灣人近2年最喜歡旅遊的國家,但國人還是不熟悉國外的醫療制度。國際SOS緊急救援組織指出,即使中國的醫療體系持續改善,但是其人口眾多,仍然無法負荷廣大的人口需求,造成醫療品質的下降。相較之下,日本的醫療體系完善,國人比較可以放心就醫國際SOS緊急救援組織指出,台灣人在國外就診主要是因為腸胃相關疾病、呼吸道相關疾病,及外傷(扭、挫、骨折);最常就診的年齡層依序為36-55歲(43%),56-75歲(41%),16-35歲(14%)。在過去2年,最多國人前往的國家分別為中國(約58%)及日本(約13%)。 國際SOS緊急救援組織指出,即使中國一直在努力改善提升醫療品質,但中國的醫療體系仍然追不上中國廣大的人口需求。醫師陳琬琳指出,因為人滿為患,中國的醫院甚至出現VIP病房移至走廊上、病人的病床座位相隔距離太近,造成容易傳染疾病、沒有隱私的問題。另外,病房內環境欠佳、燈光昏暗,也會讓國人心生恐懼。 陳琬琳指出,中國的3級醫院硬體規模大、有幾千個床位,醫療人員也有一定的醫療水準,但也有許多缺失:由於中國人口眾多,經常有醫院門診大廳擠得水洩不通的情況,甚至有「門診黃牛」的現象,亦即有人提早來排隊領取號碼牌再轉而販售,價格是掛號費的5-6倍,若是名醫價碼則更高。 相較於中國,日本的醫療品質就讓人放心許多,但是有別於國人的看病習慣,日本的醫療體系非常講究「就診秩序」,看診有一定的流程。國人常把在台灣不好的看病習慣帶到日本,例如催促醫生、亂跑診間等問題。陳琬琳指出,如果去日本的醫院,應該多多注意,遵守當地的看病流程。

Current development of regenerative medicine products!!


Leading the way Business Posted on 18/07/2012 by Lorraine O'Hanlon @galwayindoThe global market potential for regenerative medicine products could be as high as $118 billion by 2013 and innovative Galway company Orbsen Therapeutics is working to target part of this rapidly expanding market, CEO Brian Molloy tells Lorraine O'Hanlon Earlier this year, US company Osiris Therapeutics received authorisation from the Canadian department of health to market its stem cell therapy Prochymal for the treatment of acute graft-versus-host disease in children who have received bone marrow transplants, marking the world's first regulatory approval of a manufactured stem cell product. Referring to the move as an important domino in the acceptance and development of stem cell therapies, Orbsen Therapeutics CEO Brian Molloy explains that adult stem cells appear to display an ability to combat inflammation and to promote healing and the repair and regeneration of tissue. "What that means is that if you have an inflammatory disease, for example rheumatoid arthritis, or when there's an inflammation of a particular organ or area of the body, stem cells seem to help calm down that inflammation" he says, adding that there are hundreds of ongoing trials across the world where stem cells are being used to treat a wide range of different conditions currently not being adequately treated by traditional drugs. There are currently up to 400 regenerative medicine products on the international market, with more in development. At NUI Galway, Orbsen Therapeutics is working on the development of an extensive range of therapies for conditions including osteoarthritis, acute respiratory distress syndrome and diabetes. Formed in 2006 to develop and commercialise new intellectual property built up by researchers at the Regenerative Medicine Institute (REMEDI), Orbsen has developed a novel proprietary technology enabling them to isolate pure and defined stromal cells, which it is hoped will allow the development of a range of human therapies. Led by Head of R&D Dr Stephen Elliman, the company is currently expanding rapidly and the number of employees is expected to increase to around ten by the end of the year. It is also hoped the company will begin clinical trials in 2014. The development of spin out companies from universities can be difficult, according to NUI Galway MBA graduate Mr Molloy, as a marrying of both business and scientific skills is required. He believes, however, that Orbsen is proving to be a "very good model for how you can bring university generated research into a commercial field by partnering up with commercial experts in the private field". Mr Molloy is a Director of financial advisory firm HC Financial Advisers, based in Oranmore. HC provide a range of business consultancy services to start-up and established firms and Mr Molloy serves as Orbsen Therapeutic's interim CEO under a business consultancy arrangement. NUI Galway remains a shareholder in the company and Mr Molloy explains that the business model for the privately owned company is very lean compared to the old style model of commercialisation of university developed spin outs, which would have involved "a very significant amount of capital being spent on getting the company up to a certain level of critical mass". He adds that it's much more difficult at the moment to source money than it had been in previous years, and that the focus now for start-up biotech companies such as Orbsen Therapeutics is really on keeping the operational costs as low as possible and "focus on the science". Despite the difficult economic climate, Orbsen's bids to secure funding over the years have proven very successful. The company will shortly commence a new round of fundraising and is currently seeking High Potential Start-Up status from Enterprise Ireland. The company has also secured significant EU funding and is lead SME on a EU Seventh Framework Programme (FP7) research initiative on diabetic complications. €6 million has been allocated to bring Orbsen's novel therapy to clinical trial in collaboration with leading researchers within NUI Galway and across Europe and the US. "There are a huge number of illnesses and conditions where having an anti-inflammatory and immunomodulating product is of massive importance, that's why billions are being spent by 'Big Pharma' and international biotech companies to develop into this space. "Orbsen is ideally positioned because we are in the process of securing our IP [intellectual property] around our subpopulation of cells, we are in compliance with the emerging future regulatory requirements with regard to purity and definition of our cell product and we're doing it at a relatively low cost whilst leveraging the really high quality research coming out of NUI Galway," he says, adding that two of REMEDI's directors, Prof. Timothy O'Brien and Prof. Frank Barry, are also directors at Orbsen."As well as a multi-billion euro market potential there is also the added value of knowing that if our product delivers as we hope it will, it has the potential to improve and save people's lives," says Mr Molloy.