Wednesday, November 28, 2012

PIC/S includes Taiwan and New Zealand regulatory authority under its umbrella from Jan 2013

Nandita Vijay, Bengaluru Saturday, November 17, 2012, 08:00 Hrs[IST] Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) has now offered New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) as well as Chinese Taipei/ Taiwan Food and Drug Administration (TFDA) to join the Scheme fromJanuary 1, 2013. Medsafe will become PIC/S' 42nd Participating Authority and TFDA its 43rd Participating Authority.Medsafe applied for membership in April 2010. A documentation assessment was conducted in view of its accession to PIC/S, followed by an on-site visitin February 2012. The Audit team recommended to the Committee to accept the membership application of Medsafe.TFDA applied for membership back in June 2010 and is competent for modern medicines. A documentation assessment was conducted in view of its accession to PIC/S, followed by an on-site visit on June 4-8, 2012. The Audit team recommended to the Committee to accept the membership application of TFDA.Both delegations welcomed their accession by thanking PIC/S and the Audit teams for the help and support provided. The PIC/S Chairperson congratulated both Medsafe and TFDA on their new status.Further to the submission on July 16, 2012 of a pre-accession application request by Uganda's National Drug Authority (NDA), Members nominated the Rapporteur and Co-Rapporteurs in charge of pre-assessment.Further, the PIC/S Committee reached an important step for evaluation and re-evaluation of PIC/S Participating Authorities and future new Applicant Authorities by formally adopting the Revised PIC/S Audit Checklist in connection with the PIC/S Assessment & Joint Reassessment Programme. The document has been revised and updated, is set to come into force on January 1, 2013. The Audit Report template was successfully revised and is presently available. This report must be used to document any audit conducted within the assessment of new Applicant Authorities; and the Joint Reassessment Programme. It aims at defining how the audit report should provide a documented evidence of the audit process which has to be filled out by the audit team until completion of the audit.The Committee reviewed the most recent replies received from Heads of Agencies from PIC/S Participating Authorities in connection with the survey carried out earlier this year on PIC/S new projects. The Working Groups established at the last Committee Meeting on May 7-8, 2012 in Geneva (Switzerland) to ensure the successful development of these projects reported the following progress.With regards to the project of extending PIC/S' mandate to new activities such as Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP), discussions were carried out with the EMA Ad Hoc Working Groups on GCP and pharmacovigilance.

 

 

PAREXEL and NTUH collaboration !!


PAREXEL and National Taiwan University Hospital Enter Partnership to Support Clinical Research in Taiwan By PAREXEL International Corporation Published: Tuesday, Nov. 27, 2012 - 3:11 am BOSTON and TAIPEI CITY, Taiwan, Nov. 27, 2012 -- BOSTON and TAIPEI CITY, Taiwan, Nov. 27, 2012 /PRNewswire/ -- PAREXEL International Corporation (NASDAQ: PRXL) a leading global biopharmaceutical services provider, and the National Taiwan University Hospital (NTUH) announced today that they have established an alliance. Under the agreement, PAREXEL and NTUH will collaborate to provide drug development services in Taiwan."Partnering with National Taiwan University Hospital further enhances our ability to meet the increasing demand from our clients to provide a full scope of Phase I-IV clinical trials in a rapidly growing market," said Joe Avellone, M.D., Corporate Senior Vice President, Clinical Research Services, PAREXEL International. "The National Taiwan University Hospital is well-known and highly respected in Taiwan. We are pleased to have the opportunity to work together to advance our biopharmaceutical clients' programs in the region and help them to compete more effectively in the global marketplace.""We are delighted to collaborate with PAREXEL, a world-leading biopharmaceutical services provider" said Ming-Fong Chen, M.D., Ph.D., Superintendent at National Taiwan University Hospital. "PAREXEL has a wealth of experience in both local and global clinical development programs. This partnership will bring opportunities for both PAREXEL and NTUH to leverage our combined expertise in order to accelerate clinical development programs in Taiwan and meet patients' need for more effective treatments." The alliance will drive greater efficiency for biopharmaceutical sponsors worldwide. As a center of excellence for clinical trials in Taiwan and the Asia-Pacific region, the National Taiwan University Hospital is ideally positioned to support PAREXEL in delivering a superior clinical development service to local and global biopharmaceutical companies. The combined experience and development expertise of the two organizations will help to create innovative solutions for biopharmaceutical companies looking to develop or market their products within this important region.

About National Taiwan University Hospital (NTUH) NTUH started operations in 1895. NTUH's modern hospital was designed to support the concept of "patient-centered-care", by which treatment is delivered at the bedside whenever possible. The hospital endeavors to provide appropriate, effective, and compassionate care that is accessible, affordable, and culturally sensitive, and in all these respects it serves as a model to emulate for other hospitals and clinics across the nation. With more than 4,000 employees serving approximately 2,000 inpatient beds, 7,000 daily outpatient visits, and over 200 chemotherapy treatments per day, NTUH remains the best-known and highest-quality academic medical center in Taiwan. For more information, please visit http://www.ntuh.gov.tw/en/default.aspx.

About PAREXEL International PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 70 locations throughout 51 countries around the world, and has approximately 13,330 employees. For more information about PAREXEL International visit www.parexel.com.This release contains "forward-looking" statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements.Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "appears," "estimates," "projects," "will," "would," "could," "should,""targets," and similar expressions are also intended to identify forward-looking statements.The forward-looking statements in this release involve a number of risks and uncertainties.The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release.Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company's recognition of revenue included in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth and costs, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company's business of government regulation of the drug,medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 as filed with the SEC on November 8, 2012, which "Risk Factors" discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future.These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this press release.PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.

 

 

基亞跌停!興櫃新藥三雄台微體、醣聯、安成股價嚇到

 鉅亨網/鉅亨網記者張旭宏 台北-20121113 下午14:08 上櫃新藥廠基亞(3167-TW)因被市場質疑內線交易,今(13)日股價打入跌停,連帶拖累興櫃新藥三雄台微體(4152-TW)、醣聯(4168-TW)、安成藥(4180-TW)股價下殺,跌幅都有5%以上,其中台微體跌破220元,安成跌幅最大,超過1成以上,最低來到140元。基亞上周五股價漲停收151.5元,昨宣布處分上海浩原,出售給紐交所上市公司perkinelmer(珀金埃爾默)簽署策略聯盟合約暨股權交易合約,金額高達20億元,昨(12)日更一度攻上漲停來到161元新高價位,由於在重大利多發布前,股價就提早反應大漲,因此市場懷疑消息提早走漏,疑似有內線交易的情形,拖累今日股價盤中打到跌停。基亞日前股價大漲,激勵興櫃新藥三雄台微體、醣聯、安成股價狂飆,其中台微體股價更一度來到241元新高,有直接問鼎興櫃股王氣勢,另外醣聯股價最高來到185元,安成也有180元以上,因此今基亞跌停,也同步拖累興櫃新藥三雄股價同步走低。台微體及醣聯年底前將掛牌上櫃。

 

ExAblate, MRI+ focused ultrasound !!!


GE醫療集團亮相北美放射學會年會 20121127 14:55:19來源: 中國網 GE醫療集團在北美放射學會年會(RSNA)上推出四項創新技術,旨在幫助醫師改善醫療服務,加強患者關愛:靜音磁共振掃描技術(Silent Scan, 510(k) 申請中)——將磁共振係統噪音降低至前所未有的,接近于環境音的水平,從而提升患者的舒適感Universal Viewer全面支持Centricity PACSCentricity PACS-IW影像傳輸及歸檔解決方案,(510(k) 申請中)——放射科醫師可輕松獲取大量數據及臨床檢測結果,從而提高效率

乳腺癌篩查超聲技術——美國首個,也是唯一獲批的乳腺癌篩查超聲係統 磁共振引導超聲聚焦療法,用于治療那些不適合或不願接受放療的患者芝加哥(20121126)——在北美放射學會2012年年會上,GE醫療集團推出了四項醫療創新技術,這些技術的問世,將改變放射學當前的工作方式和未來的發展方向。首先,GE醫療集團推出了業界領先的靜音掃描技術,將大幅降低磁共振檢測中產生的噪音,整個係統的噪音可降低至接近環境噪音的水平,使患者在檢測時更感舒適。其次,Universal Viewer解決方案大大提高了醫師工作時的連通性,加快工作流程。該解決方案能同時將來自不同影像設備的圖像整合到一個創意性工作界面,提高工作效率。此外,GE醫療集團擁有一項獨特的乳腺超聲技術,該技術使該GE醫療成為全球擁有最多乳腺癌成像解決方案的公司,同時是美國唯一一家能夠提供借助超聲手段進行乳腺癌診斷及篩查解決法案的公司。InSightec Ltd.宣布其ExAblate磁共振引導超聲聚焦療法獲得美國食品及藥物管理局(FDA)批準,該療法可用于治療不適合或不願意接受放療的骨轉移疼痛患者。GE董事長兼首席執行官傑夫‧伊梅爾特(Jeffrey R. Immelt)指出,"大幅降低磁共振噪音,用超聲技術進行乳腺癌篩查以及幫助醫師更直觀地獲得大量患者診斷影像信息——這些都不僅僅是漸進式變化,而是在患者關愛方面的巨大進步。GE集團努力打造一個更加健康的世界,我們今天所公布的成果表明,我們正在努力提高醫療質量,降低成本,讓更多的人享受到醫療服務。"

靜音磁共振掃描 靜音磁共振掃描技術是一項革命性的創新技術,解決了影響患者舒適度的最大障礙之一,即在磁共振掃描過程中產生的巨大的噪音。傳統的磁共振掃描儀會產生110分貝以上的噪音,基本相當于搖滾音樂會水平。GE醫療集團獨家研發的靜音磁共振掃描技術將磁共振掃描儀噪音降低到相當于環境音的水平,從而改善患者在接受磁共振檢查時的體驗。此前的噪音消除技術主要著眼于隔離元器件,阻擋聲音,從而起到消音的作用。而靜音磁共振掃描技術則關注處理聲源的噪音。通過採用一項全新3D採集和重建技術--"Silenz",並結合GE醫療磁共振梯度和射頻係統電子設備的獨特設計,靜音磁共振掃描技術能夠消除聲源處的噪音,令患者在檢查時更加輕松舒適。

Universal Viewer GE醫療集團推出的Universal Viewer,旨在快速方便地為放射科及臨床醫師提供關鍵和重要的診療信息,極大地提高醫師的診療效果。Universal Viewer將先進的影像後處理成像工具,智能化功效提高工具、腫瘤和乳腺影像及工作流程,整合在同一個具有創意性的工作界面,並且在任何時間,從任何地點都可以使用。Universal Viewer全面支持Centricity PACSCentricity PACS-IWCentricity Clinical ArchiveCentricity PACSCentricity PACS-IW用戶在使用Universal Viewer時可以發現全新的獲取臨床信息的方式。它實現了包括預處理和後處理的工作流的無縫連接。駕馭于GE醫療AW技術的高級臨床應用也被完美整合到了Universal Viewer裏面,從而可實現腫瘤量化、自動去骨、血管分析及注冊等多項功能。作為行業首創產品,Universal Viewer還集成了用于篩查診斷的乳腺診斷工具,該工具能夠顯示來自于不同影像設備的圖像,支持CAD標記和IHE的乳腺規范,並可接入報告係統。

乳腺超聲 美國大約有40%-45%的女性乳腺組織致密,而乳腺組織致密的女性患乳腺癌的機率會更高。現在,GE醫療集團能夠將3D自動全乳腺超聲篩查技術與應用于臨床實踐中來彌補乳腺X線照相術對致密乳腺的不足,為幫助醫師找到之前無法檢測到的癌症提供一種強有力的工具。美國華盛頓喬治華盛頓大學醫院乳腺成像科主任Rachel Brem:"在乳腺組織致密的女性中,超過三分之一的乳腺癌無法被發現,所以我們需要其他技術和手段。使用3D超聲做乳腺癌篩查將能夠發現目前標準篩查中無法發現的癌症"。

InSightec 的骨痛超聲療法獲美國食品藥物管理局(FDA)批準InSightec公司的ExAblate 係統與GE醫療的係統完全匹配,包括Signa HDxt 1.5T, Signa HDxt 3.0T, Optima MR450 & 450wDiscovery MR750 & 750w 該係統將治療性超聲波與磁共振的持續性引導和監測相結合。這一獨特的技術被稱為磁共振引導超聲聚焦療法(MRgFUS)。醫師利用磁共振計劃和引導治療,檢測治療結果。聚焦超聲波的能量能夠破壞引起骨轉移疼痛的神經,迅速減輕患者疼痛。"ExAblate能夠獲得FDA批準令人振奮,"GE醫療係統部總裁兼首席執行官、InSightec董事Tom Gentile表示,"疼痛是骨癌患者最常見、最嚴重的症狀。我們相信,ExAblate能夠大大提高患者的生活質量。這是ExAblate第一個獲批的腫瘤療法。InSightec將繼續在這一領域的研究,不斷擴大該產品的應用。"* 510(k)正在向美國食品和藥物管理局申請,目前尚未在美國銷售。

The ExAblate (also known as ExAblate 2000) is a non-invasive medical device manufactured by InSightec, a company based in Haifa, Israel with its US office in Dallas, TX. The ExAblate uses MRI guided Focused Ultrasound Surgery (MRgFUS) technology, which combines magnetic resonance imaging (MRI) with focused ultrasound. The MRI is used to visualize anatomy, aid in planning the treatment, and monitoring temperatures and thermal dose in real time during the treatment. This thermal feedback allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. Focused ultrasound is capable of ablating tumors inside the body without the need for an incision.

 

 

Tuesday, November 27, 2012

取代TMF 成立 跨太平洋醫材創投基金TPM (張有德/ Peter J. Fitzgerald/ 林榮錦)


國發基金投資生技/權威背書 張有德牽線【經濟日報╱記者 黃文奇】 2012.11.27 03:39 am 台灣生技創投基金(TMF)破局後,首檔通過國發基金的投資的「跨太平洋醫材創投基金」(TPM),背後促成投資成功的要角,正是The Vertical Group創投公司執行長暨合夥人張有德,由他找來史丹佛大學教授彼得.費滋傑羅(Peter J. Fitzgerald)參與對台灣投資。據悉,費滋傑羅在美國創辦超過10家創新醫材公司、若干大型生技創投基金,他是大學教授,更是國際心血管醫材、醫學工程等領域的權威;另外,被國科會主委朱敬一尊為生技大和尚的張有德,和他則是師兄弟的關係。2008年國科會和史丹佛大學簽訂了5年的「醫療器材產業設計人才培訓」(STB)計畫,希望培育台灣高階醫材設計、產業化等跨領域人才,主要促成者之一即是費滋傑羅。也因為這層關係,費滋傑羅連續幾年和台灣生醫人才有深入互動,他發現台灣擁有很好的創新及育成環境,因此除了自行開發新技術外,也可以將國外的創新進一步育成。至於台灣東洋董事長林榮錦,因為耕耘藥業以久,去年開始多角化想尋求醫材方面的投資機會,就在某個機緣下,透過STB計畫負責人林美雪的牽線,促成了林榮錦和費滋傑羅合作,未來也將投資STB的潛力標的。【2012/11/27 經濟日報】

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