紅電醫103年現增催繳

紅電醫：本公司103年現金增資股款催繳公告 鉅亨網新聞中心2015-03-06 18:48:19　 第二條　第51款1.事實發生日:104/03/06 2.公司名稱:紅電醫學科技股份有限公司3.與公司關係[請輸入本公司或子公司]:本公司4.相互持股比例:不適用5.傳播媒體名稱:不適用6.報導內容:不適用7.發生緣由:本公司103年現金增資認股繳款期限已於104年03月06日截止，尚有部分原股東及員工尚未繳納現金增資股款，特此催告。8.因應措施:(1)依公司法第142條及266條第三項之規定辦理，特此催告。自104年03月09日至104年04月09日為股款催繳期間。(2)尚未繳款之股東請於前述期間內，持原繳款書至玉山商業銀行新竹分行及全省各分行或依繳款書所載之繳款方式辦理繳款，逾期未繳款者，即喪失認購新股之權利。(3)催繳期間繳款之股東及員工，俟催繳期滿經集保公司作業後，依其認購股數撥入繳款股東之集保帳戶。9.其他應敘明事項:若貴股東有任何疑問，敬請向群益金鼎證券股份有限公司股務代理部(台北市大安區敦化南路二段97號地下二樓，電話：(02)2702-3999)洽詢。

中裕TMB-355 phase III 美FDA修正收案300人為30人 !!!

中裕抗愛滋藥 須補做小規模臨床 2015-03-04 經濟日報 記者黃文奇╱即時報導 中裕新藥（4147）今日宣布，有關旗下抗愛滋病新藥TMB-355（Ibalizumab）靜脈注射臨床三期事宜，美國食品藥物管理局（FDA）明確指示，該產品藥證申請前僅需補作一個小型三期臨床試驗。中裕說，經過兩個月與美國FDA數次會議討論之結論，茲考慮孤兒藥資格、突破性治療資格以及TMB-355(Ibalizumab)靜脈注射現行各項發展狀況（包括CMO生產製造），美國FDA決議在該產品申請藥證申請前須補作一個小型三期臨床試驗，招募受試人數不低於30人即可。在意義上，中裕認為，這將大幅降低原先2011年美國FDA之三期臨床試驗300人要求，且臨床試驗計畫提出申請後即可進行不需等待審核，未來並可滾動式方式提出藥證申請及審核，以加速相關作業流程。

中裕愛滋新藥 藥證進度加速 2015年03月05日 04:10 記者杜蕙蓉／台北報導 中裕（4147）愛滋新藥TMB-355（Ibalizumab）靜脈注射藥證進度大步。在取得美國FDA突破性治療資格（Breakthrough Therapy）後，FDA已同意僅需補作一個不低於30人的小型三期臨床試驗，是原本設計300個人數的十分之一，而且可採滾動式方式提出藥證申請及審核。

以時程推算，法人預估，TMB-355有機會力拚明年上半年取得藥證。 中裕表示，TMB-355靜脈注射臨床三期事宜，經過兩個月與美國食品藥物管理局（FDA）數次會議討論的結論，因考慮孤兒藥資格、突破性治療資格以及TMB-355行各項發展狀況（包括CMO生產製造），FDA明確指示TMB-355在申請藥證申請前僅需補做一個小型三期臨床試驗，招募受試人數不低於30人，大幅降低2011年FDA的三期臨床試驗300人要求。該臨床試驗計畫提出申請後即可進行不需等待審核，未來並可滾動式方式提出藥證申請及審核，以加速相關作業流程。有機會以台灣品牌拿下美國FDA第一張新藥藥證的中裕，去年稅後損失2億8,173萬元，每股淨損1.32元。中裕執行長張念原去年股東會時表示，美國愛滋病患接受治療的約80萬人，屬於後期族群約5～10萬人，可用藥物5～6種，初估若2～3萬人適合用TMB-355靜脈注射型，其中1/3患者使用TMB-355，以過去後期愛滋病用藥一年平均約花費2萬美元計算，TMB-355未來市場價值至少2億美元。TMB-355還發展肌肉及皮下注射劑型，並分別在台灣進行一／二期人體臨床試驗中。

IV TMB-355: A Phase 2b, Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected With HIV-1(Amended to 24-Weeks). Enrollment: 113/Study Start Date: August 2008/Study Completion Date:   April 2011

SC TMB-355: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Sequential Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Ibalizumab in HIV-Negative, At-Risk Volunteers. Enrollment: 25/ Study Start Date: February 2011/ Study Completion Date: September 2012

安成生物 跨入big data 掘金世代! (Medidata Rave/ Medidata Coder)

安成生物科技選擇 Medidata 技術 提升代謝性疾病創新臨床研究的效率和速度 中央社 (2015-02-17 09:00)擁有獨步全球的專利技術，擁有最先進之實驗室，是生物科技生活化之領航者 (中央社訊息服務20150217 09:00:29)全球領先的生命科學臨床研究領域雲解決方案供應商Medidata（那斯達克代號：MDSO）今日宣佈, 安成生物科技有限公司(TWi Biotechnology, Inc) 決定採用該公司領先業界的技術平台。作為臺灣一家領先的生物製藥公司，安成生物科技選擇 Medidata Clinical Cloud以提升公司新開展的代謝性疾病臨床研究的速度、品質和效率。安成生物科技總經理陳志光（Calvin Chen）博士表示：「Medidata平台已經在全球範圍內被廣泛採用，它不僅有助於安成生物科技提升效率，同時可以確保研究機構和臨床研究協調人員熟悉並使用此項技術。我們很高興能夠與 Medidata攜手合作，共同應對目前未獲滿足的醫療需求，並持續為全球患者提供創新且高品質的治療方案。」安成生物科技致力於為新陳代謝、罕見疾病和皮膚病學領域目前未獲滿足的醫療需求研發創新型療法。為了優化代謝性疾病第II階段的研究，安成生物科技採用 Medidata 雲技術進行電子資料的採集和管理 (Medidata Rave) 以及醫學編碼 (Medidata Coder)。除了可以通過實時數據輸入提升效率，Medidata 技術解決方案還可以為安成生物科技提供更有效的臨床試驗監督，從而能夠更早和掌握更多資訊以做出更明智的決策。Medidata 亞太地區董事總經理山本武（Takeru Yamamoto）先生表示：「亞太新興市場在生命科學行業未來的增長潛力巨大。對於安成生物科技選擇 Medidata 的技術為其重要研究提供支持，我們感到很振奮，這同時也讓我們有機會為臺灣乃至亞洲市場的藥物研發領域貢獻我們的力量，從而有可能推進目前未獲滿足的重要醫療需求領域的創新療法。」

關於安成生物科技 安成生物科技股份有限公司（TWi Biotechnology, Inc.）為安成國際藥業股份有限公司（TWi Pharmaceuticals, Inc.）的獨資子公司，是一家領先的臨床階段生物製藥公司，總部位於臺灣臺北市，專門從事用於無適當醫藥可滿足現有需求(unmet medical needs)之創新藥物的開發，尤其是先天免疫力有關疾病藥物的發展。安成生物科技的產品開發系列包括三個候選藥物用於治療二型糖尿病，關節炎和免疫性皮膚疾病。

關於 Medidata Medidata是全球領先的生命科學臨床研究領域雲解決方案供應商，通過其先進的應用程式和電子資料分析改善臨床開發。Medidata Clinical Cloud 為極具發展前景的藥物治療臨床試驗提升效率和品質，使研究的設計、規劃以及執行，管理和報告均得到提升。我們致力於協助全球客戶推進市場競爭與科學研究的目標。我們的客戶包括全球前25名的製藥公司中90%以上的企業，創新型生物技術、診斷和設備公司，以及領先的學術醫學中心和合同研究組織（CRO）。訊息來源：Medidata

Medidata 大數據 開發幼童關節炎Childhood Arthritis治療策略!!

Medidata's Cloud and Mobile Technology Selected to Drive Collaborative, 10-Year Research in Pediatric Rheumatology  February 23, 2015 08:30 AM Eastern Standard Time  NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it has been selected to support the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry, a 10-year project to collect comprehensive data on pediatric rheumatic diseases and their treatments. "This is a critical next step in understanding how to best apply available therapies and improve the systems for studying the safety and efficacy of treatment options for childhood-onset arthritis."  "While we've made huge progress in the last decade, 300,000 children and families in the US alone are affected by rheumatic diseases," said Laura Schanberg, MD, professor of pediatrics at Duke University and CARRA president and the principal investigator for the CARRA Registry, an observational study of children and adolescents with major rheumatic diseases. By powering data capture for the scalable informatics infrastructure of the CARRA Registry, the Medidata Clinical Cloud® will help CARRA develop a resource for patients, physicians and researchers seeking to learn more about pediatric rheumatic diseases, and, ultimately, drive better diagnostic and treatment approaches.  In support of its long-term research efforts, the registry is leveraging Medidata's cloud-based technology for electronic data capture and management (Medidata Rave®) and mobile solution for patient-direct data capture (Medidata Patient Cloud®). A mobile app unified with Medidata's platform, Patient Cloud brings new efficiencies to the administration of electronic patient-reported outcomes (ePROs) in clinical trials and registries. The mobile app provides electronic patient questionnaires and diaries in a model that simplifies the process for both patients and researchers.  "Using Medidata's platform in combination with the open-source, i2b2 federated clinical research data warehouse platform already in use for the CARRA Registry, this post-marketing surveillance network will collect at least 10 years of comprehensive information, including detailed safety and treatment data, on pediatric rheumatic disorders in the US and Canada," said Marc Natter, MD, the CARRA Registry's director of informatics development and instructor in the Boston Children's Hospital Informatics Program. "This is a critical next step in understanding how to best apply available therapies and improve the systems for studying the safety and efficacy of treatment options for childhood-onset arthritis." Dedicated to advancing the health and quality of life of children living with rheumatic disease and arthritis, CARRA was formed by pediatric rheumatologists seeking to answer critical clinical research questions. "Juvenile idiopathic arthritis and other pediatric inflammatory disorders result in persistent joint pain, swelling and stiffness of joints, decreased activity, and potentially growth and eye problems," Schanberg added. "Children lose days from school, parents lose days from work and quality of life suffers greatly. We believe that simplifying data capture and patient participation processes will catapult the field of pediatric rheumatology research to the level of performance necessary to realize dramatic improvements in outcomes and quality of life for all children with rheumatic disease."  Glen de Vries, Medidata's president, said: "We're excited to be partnering with CARRA on this observational study and proud that our technology platform is helping to further the alliance's important mission to prevent, treat and cure arthritis and other rheumatic diseases in children and adolescents. All of us at Medidata share CARRA's commitment to fostering, facilitating and conducting high-quality research that advances the development of new, enhanced diagnostic and treatment approaches."

About CARRA  CARRA is a North American non-profit research organization of more than 400 pediatric rheumatologists, researchers and research coordinators at more than 100 sites (95% of all pediatric rheumatologists/sites in North America) who are working together to find treatments for juvenile idiopathic arthritis and other pediatric rheumatic diseases in children.  The CARRA Registry is a cornerstone of CARRA and provides disease and treatment data on children with a variety of rheumatic diseases. CARRA aims to make it possible for all affected children in North America to have the opportunity to participate in meaningful and high quality clinical and translational research. CARRA researchers have been awarded over $40 million in research funding over the last 10 years. In addition to Dr. Schanberg, the CARRA Executive team includes Yukiko Kimura, MD, Hackensack University Medical Center, Norman Ilowite, MD, Montefiore Medical Center, and Robert Fuhlbrigge, MD, PhD, Boston Children's Hospital. 

About Medidata Solutions  Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

Juvenile rheumatoid arthritis (JRA)  Etiology and Pathophysiology  The etiology and pathogenesis of JIA are not completely understood. Genetic susceptibility plays a major role, but there is significant overlap between loci associated with JIA and those associated with other autoimmune diseases. JIA is a genetically complex disorder in which multiple genes are important for disease onset and manifestations. The IL2RA/CD25 gene has been implicated as a JIA susceptibility locus, as has the VTCN1 gene.[8] Associations have been found between specific HLA alleles and clinical subtypes of JIA (eg, HLA-A(*)02:06 with susceptibility to JIA accompanied by uveitis, and HLA-DRB1(*)04:05 with polyarticular JIA, in a Japanese cohort). Humoral and cell-mediated immunity are involved in the pathogenesis of JIA. T lymphocytes have a central role, releasing proinflammatory cytokines (eg, tumor necrosis factor–alpha [TNF-α], interleukin [IL]-6, IL-1) and favoring a type-1 helper T-lymphocyte response. A disordered interaction between type 1 and type 2 T-helper cells has been postulated. Studies of T-cell receptor expression confirm recruitment of T-lymphocytes specific for synovial nonself antigens. Evidence for abnormalities in the humoral immune system include the increased presence of autoantibodies (especially antinuclear antibodies), increased serum immunoglobulins, the presence of circulating immune complexes, and complement activation. Chronic inflammation of synovium is characterized by B-lymphocyte infiltration and expansion. Macrophages and T-cell invasion are associated with the release of cytokines, which evoke synoviocyte proliferation. A study by Scola et al found synovium to contain messenger ribonucleic acid (mRNA) for vascular endothelial growth factor and angiopoietin 1, as well as for their receptors, suggesting that induction of angiogenesis by products of lymphocytic infiltration may be involved in persistence of disease. Some pediatric rheumatologists view systemic-onset JIA as an autoinflammatory disorder, such as familial Mediterranean fever (FMF) or cryopyrin-associated periodic fever syndromes, rather than a subtype of JIA. This theory is supported by work demonstrating similar expression patterns of a phagocytic protein (S100A12) in systemic-onset JIA and FMF, as well as the same marked responsiveness to IL-1 receptor antagonists. FMF is associated with mutations in the MEFV gene; these mutations are associated with activation of the IL-1b pathway, resulting in inflammation. A study by Ayaz et al found an increased frequency of MEFV mutations in Turkish children who were diagnosed with systemic JIA[12] ; this study has not been replicated in other populations.

Source: Medscape

安成藥 購現增1.1億 (安成生技25元/股)

安成藥業：本公司董事會通過變更認購子公司安成生物科技股份有限公司現金增資發行新股案鉅亨網／鉅亨網新聞中心-2015年01月29日 下午19:08 第二條　第20款1. 原公告日期：103/03/112. 簡述原公告申報內容：本公司103/03/11董事會通過將以不逾新台幣100,000,000元，認購子公司安成生物科技股份有限公司現金增資發行新股案，以每股新台幣25元價格認購，預計認購4,000,000股為上限。3. 變動緣由及主要內容：因應安成生物科技股份有限公司變更其增資發行計畫。故本公司將依照安成生物科技股份有限公司所變更之現金增資發行計畫，將以不逾新台幣117,640,000元，認購子公司安成生物科技股份有限公司現金增資發行新股案，以每股新台幣10元價格認購。4. 變動後對公司財務業務之影響：無5. 其他應敘明事項：無