癌症孕婦化療 胎兒OK ??!!…..

懷孕癌症患者化療 對胎兒無影響  2011/9/27： 中央社　癌症專家26日在研究報告指出，罹癌懷孕婦女接受化療似對胎兒無害，為避免胎兒暴露於化療藥劑而進行的未足月引產反而對胎兒有害。　科學家研究母親在孕期曾受化療的孩童身心發展，發現化療並無影響，但早產反而有害，無論是自然產或引產都一樣。領導研究的比利時魯汶大學醫院(University Hospitals Leuven)婦癌專家艾曼(Frederic Amant)表示，懷孕3個月以上的癌患沒有必要墮胎或延後化療，並強調醫師應盡最大可能避免早產。這份研究在斯德哥爾摩舉辦的歐洲癌症聯合年會(EMCC)上提出。艾曼說，根據他以往的經驗，許多婦女推斷化療對胎兒有害，往往選擇墮胎；而醫師也通常建議婦女要不延後化療，要不就是在寶寶約32週大時提前引產。但根據這項研究，這個醫囑對孕期已超過12至14週的癌患並不適用，因為只有微量的化療藥物會透過胎盤傳遞給胎兒，而這些藥物似乎對寶寶的發展無不良影響。　這項研究的對象為68次分娩的70名兒童，其中約三分之二在孕期37週以前出生。研究團隊發現，在先天缺陷的比例與類型上，以及生長、整體健康與發展層面，都和普遍人口相似，在這些孩童之中，也未發現心臟方面異常。　但研究團隊發現，儘管許多兒童在智商與行為檢測上的認知發展正常，但那些低於正常智商的兒童以早產兒居多。

幹細胞治療 中國醫大__林欣榮

World-Class Stem Cell Pioneers Collaborate & Educate at Texans for Stem Cell Research 2nd Annual Symposium In Austin  PRNewswire Sep. 27, 2011 AUSTIN, Texas, Sept. 27, 2011 -- /PRNewswire/ -- (http://www.myprgenie.com) -- Texans for Stem Cell Research (TSCR), a non-partisan, non-profit 501(c)3 volunteer organization announces the panel of stem cell experts from Texas and around the globe that will convene in Austin at the TSCR Second Annual Educational Symposium with a welcome address by Dr. Kenneth I. Shine, Executive Vice Chancellor for Health Affairs for The University of Texas System. The symposium will be held on Sept. 30th at the AT&T Executive Education and Conference Center on The University of Texas at Austin campus. Roger Gammon, M.D., and Stanley Wang, M.D., J.D., M.P.H. with Austin Heart and Heart Hospital of Austin, will be moderating the event. The promising results of clinical trials from around the world will be shared by seven Texas luminaries, representing leading Texas-based research institutions and medical facilities, along with nine other esteemed researchers from all corners of the United States and around the globe, including California, Florida, New York, New Jersey, Arizona and Taiwan. TSCR's educational programs are designed to provide community leaders, patients and policymakers current updates from the most renowned doctors, researchers and scientists in the biomedical field who work daily to discover treatments and cures. The complexity of the science and rapid pace of discovery make it difficult for the public to stay current on best practices in stem cell applications. TSCR believes collaboration among researchers can expedite progress, and science education can inform the community on the current state of this emerging field. The expert panels will include stem cell leaders from diverse disciplines including cardiology, endocrinology, neurosurgery, neurology, immunology and oncology. "The scientific and technological research being conducted by the leaders we invited to speak this year is ensuring a brighter future, not only for our economy, but most importantly for the millions of people who stand to benefit from the potential cures," said Keri Kimler, TSCR's Vice Chair and organizer of the annual event. The use of stem cells in regenerative medicine and the treatment of disease holds promise for game-changing advances in medicine. The impact of treatments to correct what have previously been considered as "incurable conditions," such as diabetes, heart disease and spinal cord injury will be revolutionary for medicine and biotechnology. Based upon recent discoveries in cell labs across the globe, stem cell science is advancing rapidly and the interest in new therapies and cures has reached a new, overall high. TSCR advocates for adequate research, clinical trials and FDA approvals as prerequisites prior to using stem cell therapies on the public.The daylong symposium will also provide physicians with professional education hours, compliments of Austin Heart, PLLC. Austin Heart is accredited by the Texas Medical Association (TMA) to sponsor continuing medical education for physicians and has designated this educational activity for a maximum of six (6) AMA PRA Category 1 credits™."This symposium features world-class pioneers in stem cell research," said Dr. Gammon, director of research at Austin Heart and interventional cardiologist at Heart Hospital of Austin. "They are donating their time and expertise to provide a glimpse into the future of stem cell research and its potential to transform medicine."    Freely volunteering their time and expertise to educate fellow physicians and the public at this event will be the following notable speakers:

Texas•James T. Willerson, M.D. FACC, President and Medical Director: Texas Heart Institute, Professor and Edward Randall III Chair in Internal Medicine, The University of Texas Health Science Center at Houston•Darwin J. Prockop, M.D., Ph.D., Director of the Institute for Regenerative Medicine at Texas A&M Health Science Center College of Medicine at Scott & White•Eric N. Olson, Ph.D., Annie and Willie Nelson Professorship in Stem Cell Research at UT Southwestern Medical Center at Dallas •Jay W. Schneider, M.D., Ph.D., University of Texas Southwestern Medical Center at Dallas•Roger S. Gammon, M.D. Austin Heart •Stanley Wang, M.D., JD, M.P.H., Austin Heart•William K. Decker, Ph.D., Baylor College of Medicine

California•Jane S. Lebkowski Ph.D., Geron Corporation•Larry Goldstein, Ph.D., University of California San Diego Stem Cell Program•Don C. Reed, Vice President Public Policy, Americans for Cures Foundation and Californians for Cures•Roman Reed, Roman Reed Foundation and Stanford Partnership for Spinal Cord Injury Repair

New York•Denis Rodgerson, Ph.D., NeoStem, Inc.

Arizona•Ratan Bhardwaj, M.D., Ph.D., Barrow Neurological Institute at Phoenix Children's Hospital Arizona

Florida•Cesar V. Borlongan, Ph.D., University of South Florida

New Jersey•Wise Young, Ph.D., M.D., Director and Chair in Neuroscience of W M Keck Center for Collaborative Neuroscience at Rutgers University

Taiwan•SHINN-ZONG (John) L.I.N., M.D., Ph.D., Neurosurgeon from China Medical University Beigang Hospital and China Medical University Hospital in Taiwan.

Attendees will hear from these distinguished guest speakers who are currently investigating stem cell applications for some of our most devastating diseases and injuries, such as Alzheimer's, Parkinson's, multiple sclerosis, heart disease, diabetes, degenerative eye diseases, spinal cord injury, stroke and traumatic brain injury. In addition, new technologies and directions in cord blood and stem cell banking will be presented."Our hope is that the symposium will expand understanding and support for stem cell research here in Texas, and the world," said David L. Bales, Texans for Stem Cell Research Chairman. "Each day, we get closer to a breakthrough in this vital science, and through our supporters, we can keep that momentum going to find cures through stem cell therapies."

About Texans for Stem Cell Research  Texans for Stem Cell Research (TSCR) is a non-partisan, non-profit 501(c)3 volunteer organization dedicated to the advancement of stem cell clinical applications for the treatment of millions of Texans living with incurable disease and debilitating injury. TSCR hosts education events and provides advocacy support to industry leaders, partner organizations, researchers and physicians interested in stem cell research in Texas. TSCR remains current on the latest information about stem cell research and discoveries that hold great potential for developing new treatments. TSCR assists the Texas based research teams and institutions by fostering strategic funding collaborations with potential partners. Stem cell therapies are advancing with promising clinical trial results. TSCR will continue to promote safe, ethical and responsible research to accelerate translational efforts in Texas.

About Learn or Life The Texans for Stem Cell Research launched the Learn for Life Education Series in 2011 and hosts an Annual Stem Cell Symposium each year in Austin, Texas.  The education series provides the public the opportunity to learn about groundbreaking research in stem cell science with the assistance of volunteers, leading academicians, researchers, industry leaders and advocates from around the world.  The events attract highly respected stem cell research professionals who provide the most current findings in their field to promote awareness for important FDA approved clinical trials that have the potential to aid the development of new treatments for unmet medical needs. 

Prof. Shinn-Zong Lin, M.D., Ph.D. Chief Medical Officer, StemCyte Taiwan  Dr. Shinn-Zong (John) Lin is a Professor of Neurosurgery and Vice Superintendent of the Center of Neuropsychiatry at China Medical University Hospital in Taiwan. With an M.D. from National Defense Medical Center in Taipei, a Ph.D. in Physiology and Biophysics from State University of New York at Stony Brook and a Master's degree in Medical Management from Tulane University, he has served as a Professor of Neurosurgery at the National Defense Medical Center, Chairman of the Department of Neurosurgery at Tri-Service General Hospital, and a Professor of Neurosurgery and Chairman of NeuroMedical Scientific Center at Tzu-Chi General Hospital. He is the inventor of many patented treatment technologies for Brain Damage patients including the patentable technology entitled, "Treatment of Brain Damage using umbilical Cord Blood Cells". His background also includes: Membership of Editorial Boards Tzu-Chi Nursing Journal, Tzu-Chi Medical Journal, Formosan Journal of Surgery, Acta Neurologica Taiwanica, Surgical Neurology and Taiwan Neuroscience Alliance, Presidency of the International Neural Transplantation and Repair Meeting, Membership of 23 Professional Societies, 25 Distinguished Honors and Awards, 41 Research Programs, 3 Patents, 161 Publications in refereed journals, 25 Books and 178 Conference Papers and Invited Lectures. He is a highly accomplished neurosurgeon and applied neuroscientist for innovative therapies for stroke and neurodegenerative diseases. Dr. Lin is also a Member of the Advanced Therapeutics and Clinical Studies Committee

Japanese weekly highlights Taiwan role in tapping into China market

2011/09/27 Tokyo, Sept. 27 (CNA) Toyo Keizai, a well-known Japanese business magazine, has touted the advantages for Japanese enterprises of going through Taiwan to make inroads into China's market. The latest edition of the weekly devoted more than 50 pages to introducing Taiwan's economy and analyzing the approaches available to Japanese companies in trying to capture a share of the Chinese market. The magazine first analyzed major risks at the national, management and security levels Japanese businesses must overcome in trying to expand into China. At a national level, the risks involve general political, social and economic issues. Management risk refers to potential managerial problems such as exchange rate volatility, quality control issues, rampant counterfeiting and high staff turnover that Japanese businesses could face in China. Security risk refers to issues such as anti-Japanese demonstrations, worsening social order, security management of the staff, new contagious diseases and information security. Taiwan's economic strengths could be grouped into three major trends that could minimize those risks and be exploited by Japanese businesses as they look to China's market, the weekly said. They are: Japan-Taiwan cooperation is the key to success in tapping into China's market; Taiwan's three major food brands have satisfied 1.3 billion Chinese consumers; and Taiwanese businesses are no longer just downstream manufacturers. The reports said Japan has become more interested in Taiwan after the March 11 earthquake, partly because Taiwan donated more than 18 billion Japanese yen (US$235.77 million) for post-quake relief and reconstruction -- more than any other country -- leaving the Japanese both surprised and grateful. At the same time, many factories had their supply chains disrupted by earthquake and tsunami damage, prompting them to consider diversifying production of basic items overseas, with Taiwan a prime destination. Panasonic, Canon, Hitachi and Elpida have already begun to move some of their production to Taiwan or set up new plants in the country. The magazine also looked at President Ma Ying-jeou's economic policy, which revolves in part around making use of the growing Chinese market to expand Taiwan's economic strength. It pointed to other core policies, such as Taiwan's support for six emerging sectors -- tourism, health care, biotechnology, green energy, creative and cultural industries, and specialty agriculture -- and the signing of the Economic Cooperation Framework Agreement with China last year, that were also favorable for Japanese businesses. If Japanese businesses look at Taiwan's investment course and the ECFA, they will find considerable opportunities, the magazine said. The special feature also noted that foreign countries have mocked Japanese businesses for operating comfortably at home but being timid at venturing overseas and warned they could easily miss big opportunities because of their overly cautious attitude. For Japanese small- and medium enterprises that have the capability to produce value-added products, the magazine suggested that they find Taiwanese partners to help expand their marketing and distribution. Japanese businesses should not only view China's market from a two-way Japan-China perspective, but should also incorporate Taiwan in charting new strategies that could lead them to new opportunities for growth.

浩鼎偽膜性結腸炎新抗生素Fidaxomicin 明年上市!

浩鼎 明年新藥將上市 【2011/09/28 經濟日報】 合一生技（4743）轉投資新藥公司台灣浩鼎，執行長許友恭昨（27）日表示，台灣浩鼎旗下兩項新藥明年將有正面結果，包括抗生素新藥DIFCI在台上市；抗乳癌新藥OPT-8222015年可望上市。合一於9月23日掛牌上櫃，昨日股價以20.4元作收，下跌0.05元；合一雖為新藥公司，但連續四年獲利，今年上半年稅後純益約1,050萬元，每股稅後純益為0.11元。許友恭表示，抗生素新藥DIFCID已於今年中獲得美國食品暨藥物管理局（FDA）核准上市，推出後六個星期內銷售成績即達390萬美元（約新台幣1.18億元），後續潛力看漲。許友恭指出，目前DIFCID正積極在亞洲爭取上市，包括韓國、日本、台灣、大陸等，其中台灣已經通過食品暨藥物管理局（TFDA）快速審查認定，今年11月將送件審查，可望於明年中通過核准，保守估計每年有1億元到3億元的營收貢獻。此外，許友恭也表示，DIFCID歐洲已於近期通過上市核准，在各國文件轉譯後，明年初即可上市。台灣浩鼎自美國Optimer母公司技轉抗乳癌新藥OPT-822，目前在台灣展開第二／三期臨床試驗，預計投資4億元收取342名病患，預估明年底可進行期中分析，若順利則2015年上市。許友恭表示，OPT-822屬於全新的抗癌藥物，其運作機制特殊，是針對乳癌病人癌細胞global-H的抗原做標的，以訓練身體免疫系統，尋求標的來消滅癌細胞。

120 Taiwan enterprises will attend the 2nd Cross-Straits Medicine Expo

Updated: 2011-09-27  The 2nd Cross-Straits Medicine Expo, scheduled to take place in October in Fuzhou, has nearly completed exhibition enrollment. About 700 pharmaceutical enterprises have decided to attend the exhibition. The expo will open up a hall for 120 enterprises from Taiwan province. According to officials of the organizing committee, nearly 400 enterprises will attend the exhibition, with 65 percent of them coming from Fujian province. They include leading enterprises like Fukang Pharmaceutical and Fuzhou Neptunus Fuyao Pharmaceutical. There will be 120 enterprises from Taiwan participating in the exhibition, compared with 50 in the first session. A series of important activities will be held opening day. They include the Cross-Straits Pharmaceutical Health Product Trade Talk, New Medicine Promotion meetings, the Cross-Straits Pharmaceutical Health Industrial Development Forum and the Fuzhou Health Industry Investment Environment Policy Illustration Meeting. The exhibition will be held at the Fuzhou Wenquan Convention and Exhibition Center.

HIV Antibody Therapy Ibalizumab Inches Forward

September 27, 2011 Long-awaited results from a Phase II study of ibalizumab, an antibody-based therapy that has been in early stage development for several years, were reported at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on September 17 in Chicago. Though the results raise more questions than answers about the drug's efficacy, the presenting researchers conclude that ibalizumab holds potential for HIV treatment veterans in need of novel therapies. Ibalizumab is an experimental entry inhibitor being developed by TaiMed Biologics, a biotechnology company with research facilities in Taiwan and Irvine, California. The drug contains genetically engineered antibodies, known as monoclonal antibodies. These antibodies bind to the CD4 receptor on CD4 cells. Once ibalizumab binds to these receptors, HIV cannot successfully connect with the surface of CD4 cells, thus preventing the virus from infecting healthy cells. Because of ibalizumab's unique mechanism of action, researchers have long believed that the drug holds tremendous promise as an HIV treatment, particularly for people with multiple-drug-resistant strains of the virus. Ibalizumab is currently administered intravenously in an outpatient setting. To date, the drug has been given by researchers once weekly and every other week, using a dose that depends on body weight.  With the successful completion of a variety of early stage studies, including a 48-week Phase IIa study reported in 2006 demonstrating statistically significant viral load reductions compared with placebo, a Phase IIb study was started in August 2008. Twenty-four week data from the latest study were reported at ICAAC by Stanley Lewis, MD, PhD, of TaiMed. Unlike the weight-based dosing used previously, the Phase IIb study explored two fixed doses: 800 milligrams (mg) administered intravenously once every two weeks and 2,000 mg given every four weeks. The clinical trial enrolled 113 people living with HIV with resistance to multiple drugs, including at least one drug in the three major classes of antiretrovirals (the nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and the protease inhibitors). Both doses were combined with an optimized background regimen containing at least one drug the patients' viruses were sensitive to. Of note, no placebo for comparison purposes was used in the study. After 24 weeks, viral loads were reduced, on average, by 1.5 log in both treatment groups. Undetectable viral loads were documented in 44 percent of those in the 800 mg ibalizumab group and 28 percent in the 2,000 mg ibalizumab group. CD4 counts increased by 63 cells and 80 cells, respectively. Though these viral load reductions are notable, the lack of a placebo group in the study prevents firm conclusions about ibalizumab's potential. For example, it remains unclear how much of the viral load reductions seen in both treatment groups were attributed to the ARVs used in combination with ibalizumab. Encouragingly, Lewis reported that ibalizumab was well tolerated with no drug-related deaths, serious side effects or discontinuations. Though some laboratory abnormalities were reported, these were not associated with any "clinically meaningful" problems. The most common side effects were rash, diarrhea, headache and nausea, which appeared to be more common in the 2,000 mg dosing group. Going forward, TaiMed plans to use the lower dose of the drug to minimize the risk of side effects without compromising efficacy. The company is also experimenting with a subcutaneous version of the drug—administered using a hypodermic needle to deliver ibalizumab directly under the skin—to allow for once-weekly injections at home.

總經銷協議認定!!

美時與安生訟案將再上訴2011-09-27 【時報-台北電】美時製藥（1795）與大陸珠海安生公司訴訟案，美時昨（26）日收到大陸廣東省高級人民法院判決書，仍維持原判，美時應支付安生約470萬人民幣。美時副總經理洪堯樂表示，上述賠償金額，已在98年度財報中認列損失，且公司正與委任律師商議提起再審。　美時認為，安生公司違約拒付樂特仕推廣費，應對美時承擔違約責任，所以公司正與委任律師商議，將依法提起再審。　98年7月6日，廣東省珠海市中級人民法院判決美時應支付安生約470萬人民幣。經美時上訴後，廣東省高級人民法院，據「中華人民共和國合同法」及中華人民共和國民事訴訟法，認為安生拒付推廣費在一定程度上影響了「總經銷協議」，但未全部影響「總經銷協議」執行，因此維持原判。

台灣第4家藥品外銷美國 美時抗癲癇藥

美時打開美國市場，進補800萬元 2011-09-28 【時報-台北電】美時製藥（1795）接到美國知名藥品經銷商Trigen公司首批抗癲癇藥的訂單，昨（27）日正式出貨，成為公司第一張外銷美國的藥品訂單，也是繼永信、益邦、安成公司之後，台灣第4家藥品外銷美國市場的製藥業者。美時表示，已分別取得美國FDA查廠，及藥品查驗登記，是爭取到美商Trigen公司首批抗癲癇藥訂單的主因，首批訂單金額約800萬元。為乘勝追擊，美時主管昨晚在美國持續與Trigen公司洽談第2張採購訂單的價格與數量。美時說，等首批抗癲癇藥訂單，在美國鋪貨上市銷售後，若市場反應不錯，後續訂單粗估在今年底或明年初可發酵。此外，美時的抗癲癇藥，也將向台灣衛生署藥檢局申請藥品許可證，準備搶攻內銷市場。美時認為，美商藥廠在美國生產專利過期的學名藥因成本高，已沒有市場競爭力，不少美國學名藥大廠或知名藥品經銷商，分別赴台灣及印度等地，尋找合作藥廠，並釋出代工藥品訂單或採購案。尤其，台灣製藥業，因有原物料供應的優勢，加上製藥技術水準，遠比大陸及東南亞等地業者還高，使台灣製藥廠已成為美商製藥廠或藥品經銷商，釋出海外藥品訂單的首選。為抓住此商機，美時再向美國FDA送件，申請包括止痛藥的藥品許可證，最快明年可望有初步的成果。　總公司位於台中大甲的永信控股（3705），多年前也已進軍美國藥品市場。永信經理鍾威凱表示，台灣廠外銷美國的藥品清單，包括3種抗生素、1種止痛藥，及1種精神科用藥，1年訂單總金額約1億多元。為擴大產品上市的銷售規模，永信台灣廠最近已送件申請美國藥品許可證的藥品，還包括心血管用藥等產品。另永信旗下美國廠，生產約6種藥品在美國鋪貨上市銷售；旗下馬來西亞廠產製的藥品，則以銷往東協與中東市場為主，並沒有外銷美國市場。

洗腎與偽藥??!!

杜絕偽藥販售 吳揆：已有成效 中央社 2011-09-27 （中央社）行政院長吳敦義今天表示，各地方政府針對電台販賣偽劣禁藥都有進行勸導、處罰，已有一定成效。衛生署長邱文達說，電台廣告販賣偽藥的情形，近1年來違規減少了一半。中國國民黨籍立委林德福上午在立法院針對地下電台的查緝情形提出質詢。他說，地下電台販賣偽劣藥，有人誤信食用後造成必須洗腎，台灣變成洗腎王國，國內洗腎人口有6萬8000多人，健保給付洗腎1年高達新台幣500多億元，政府應強力掃蕩。吳敦義答詢時表示，播出偽藥廣告的不一定是地下電台，有的合法電台也有播出販賣偽藥廣告的情形，對此各地方政府都有進行勸導、處罰，情節嚴重的會將違法電台的發射器全部拆除。衛生署長邱文達指出，市面上販賣偽藥的情形已有改善，這1年來「違規的減少了一半」；至於腎臟病的防治方面，衛生署在前5年進行腎臟病末期防治；最近匡列新台幣4億元，將進一步做前期的防治，前期防治也就是還沒進入洗腎階段的預防。吳敦義補充說，目前還在播出偽藥廣告的不一定是地下電台，有的是合法電台，合法電台一般性節目基於尊重新聞自由，政府不能干擾，但如果合法電台廣告推銷的是違法偽劣禁藥，政府會加以取締。