Wednesday, November 14, 2018
浩鼎 通過FDA 臨床醫材申請phase I: 腫瘤Globo H 免疫組織化學染色法
抗藥性結核病 曙光藥超貴: US$2,000 bedaquiline 18 months/ $9,000 bedaquiline + delamanid
治療抗藥性結核病露曙光 新藥治癒率逾90%（中央社巴黎22日綜合外電報導）在全球對抗結核病的戰役中，一項以新藥bedaquiline為主的新療法問世，成功治癒逾90%的抗藥性結核病患者。這項試驗結果獲讚為扭轉局勢的醫界成就。東歐內陸國家白俄羅斯是全球多重抗藥性結核病罹患率最高國家之一，當地醫生花了數月的時間，以bedaquiline搭配其他抗生素治療患者。根據世界衛生組織（World Health Organization）的數據，目前只有55%的多重抗藥性結核病患者治療成功。國際抗癆暨肺病聯盟（International Union Against Tuberculosis and Lung Disease）科學主任藤原（Paula Fujiwara）表示：「這項研究結果證實…像bedaquiline這樣的新藥不但能治癒患者，對多重抗藥性及極度抗藥性結核病患而言，也出現扭轉局勢的轉機。」藤原並未參與上述研究。（譯者：鍾佑貞/核稿：劉學源）1071023
'New TB drug too expensive for low and middle income countries'Namita Kohli By Namita Kohli October 24, 2018 16:42 IST High prices of drugs have put patients of drug-resistant tuberculosis (DR-TB) at a huge disadvantage, according to new report by MSF (Médecins Sans Frontières). In the report, titled DR-TB Drugs Under the Microscope, MSF has called out US pharmaceutical giant Johnson & Johnson (J&J) to cut the price of the newer TB drug bedaquiline in half, to ensure that more lives could be saved. MSF has been consistently making the demand for a reduction in prices of the new TB drug. In August, the World Health Organization (WHO) recommended expanding the use of bedaquiline (produced by J&J) by making it a 'core drug' for treating DR-TB. The announcement came as game-changer in the treatment for TB. The use of bedaquiline, experts say, reduces the need for injectable drugs (administered daily) — side effects include deafness, renal failure, among others — as a 'last-resort' option only. "This change dramatically increases the number of people who should receive bedaquiline, and requires national TB treatment programmes to scale it up as part of the DR-TB treatment they provide. Despite the expected benefits, high prices remain a significant barrier," activists from the MSF said in a press statement. The organisation's research shows that DR-TB treatment regimens containing the two newer drugs bedaquiline and delamanid represent a significant price increase over older, no-longer-recommended treatment regimens. People with DR-TB must receive individually tailored treatment consisting of at least five drugs for different durations, according to the type of drug-resistant TB that affects them. The estimated price of longer individualized treatment regimens could now reach more than US$2,000 for people who need at least 18 months of bedaquiline, which would represent a 50 per cent price increase over previous standard treatment. People who might need both bedaquiline and delamanid for as long as 20 months, the price increase could reach 500 per cent, with a treatment regimen priced at around $9,000."Our analysis clearly shows that the high price of the two newer TB drugs makes today's best-possible treatment much more expensive than previous treatment regimens," said Sharonann Lynch, HIV & TB advisor for MSF's Access Campaign. "These newer TB drugs will save more lives, benefit programmes and make this arduous treatment more tolerable for people, but if they remain priced out of reach, they will not serve their purpose and the expected gains will not be achieved. Unless pharmaceutical corporations lower their prices substantially, people will continue to suffer without access to safer and more effective treatment." J&J recently announced a price reduction for bedaquiline for some countries, but this falls short of making the drug affordable in countries hardest hit by the DR-TB epidemic, according to MSF. The reduced price of $400 for six months of treatment is still too high, as many people need the drug for significantly longer than six months, driving the price even higher, said MSF. To ensure the drug is accessible to all, the organisation has asked J&J to issue a non-exclusive license to the Medicines Patent Pool to allow for price-lowering competition among generic producers."The new treatment recommendations from WHO represent the best chance for a cure with fewer debilitating side effects for people with drug-resistant TB," said Dr. Naira Khachatryan, Medical Coordinator of MSF's project in Armenia. "If bedaquiline continues to be too expensive, countries will have limited opportunity to scale up treatment, and we'll be stuck with the deadly status quo where the majority of affected people will not have a chance to benefit from more effective treatment." An estimated 558,000 people developed DR-TB in 2017, but only 25 per cent of those estimated cases were treated. Standard DR-TB treatment used by most countries up to now has required people to take up to 14,000 pills for nearly two years, including up to eight months of painful daily injections, causing severe side effects. The cure rate is only 55 per cent."To save as many lives as possible and really scale up treatment, the price of a full DR-TB treatment regimen should be no higher than 500 dollars per person in all low- and middle-income countries, plus high-burden TB countries," said Lynch. India has the highest burden of tuberculosis in the world — each year, 29 lakh new cases of TB are reported; 4.20 lakh people, mostly poor, are known to die of the disease. Economic loss due to TB has been calculated to be 20,000 crore per annum.
科技部GLORIA聯盟 瑞士商務辦事處 交流 牙醫器材
GLORIA集結7所大學 開拓瑞士生醫產業合作 2018-10-19 15:14經濟日報 彭子豪 科技部國際產學聯盟（GLORIA）昨(18)日與歐洲台灣生物科技協會（ETBA）、瑞士商務辦事處（TOSI）、台灣生物產業發展協會（Taiwan Bio Industry Organization）、安永聯合會計師事務所共同舉辦的「2018 Switzerland Taiwan Biotech Leaders Forum」。GLORIA匯集7大生技醫療聯盟，首度與瑞士官方及相關產業代表，針對台灣人工智慧醫療科技、即時照護、生技研發等進行交流。出席代表陣容包括台灣大學GLORIA代表周邑宣醫師、陽明大學GLORIA執行長貝先芝、中山大學GLORIA執行長張世楠、中央大學GLORIA執行長朱念慈、清華大學GLORIA協理吳仁貴、成功大學GLORIA營運長洪偉仁、台北醫學大學GLORIA新創公司酷式基因執行長兼創辦人林淑娟，與在場五十多位生技產業領袖分享我國可變現的生技資源，讓台灣學術研究成果受到更多產業關注，促進國際產官學研實質互動，將台灣前瞻生技研發成果向產業應用化更推進一步。本次論壇由瑞士商務辦事處處長傅瑞（Rolf Frei）致詞揭開序幕，為台灣醫療器材、數位醫療、製藥企業、與學術研發界，展開台灣與瑞士跨國企業領袖促進高階生技產品市場互惠之對話，期待透過此次台瑞交流盛會，進一步開啟台灣和歐洲國家在生技醫療領域於產官學研界之國際合作契機。此次盛會焦點圍繞瑞士台灣牙醫醫療器材、數位醫療科技趨勢、生物科技新創生態圈三大主軸。瑞士新創企業Embion Technologies執行長Georgios Savoglidis運用其生科與化學工程的背景，投入生物再生能源事業超過10年，闡述外國人在瑞士創立生技公司的機會與挑戰。現任職於諾華藥廠全球藥品開發部、歐洲台灣生技協會會長高子翔博士，特地返台帶回第一手瑞士生技產業因應數位化浪潮轉型趨勢分享。瑞士跨國牙材領導品牌Straumann 的商務處長Rebecca Yeung博士亦由瑞士巴賽爾直奔台北論壇現場，簡報該企業在全球市場激烈競爭的環境下，如何持續投資新產品開發和品質管控並成功達到營收增長的經營哲學。會中雙邊座談由台灣生物產業發展協會秘書長黃博輝博士帶領與會貴賓包括HTC DeepQ健康醫療事業部總經理張智威、臺灣財團法人醫藥品查驗中心執行長高純琇博士和瑞士產官代表探討兩國數位醫療及其法規，和新創生態系建造等議題。安永聯合會計師事務所合夥人林宜賢會計師整合多年協助台商利用國際稅法優勢規劃海外商務營運的實戰經驗，向本次與會的生技企業領袖說明如何善用瑞士和歐盟國際企業稅法優勢，拓展歐洲高端市場。此次論壇跨界整合生技產業營運、企業法規稅務、創新研發能量等元素，深獲瑞士產官代表矚目，更匯聚全台生技醫療企業主相互交流，出席企業主來自新牙科技、逸達生技、國光生技、慕康生技醫藥、熙恩細胞科技、鐿鈦科技、百特醫療、原創生醫、杏國新藥、行動基因、仲恩生醫科技、安盛生科、柏登生醫，Merck Group、BenQ Medical Technology Group, Bio-Helix、新加坡商佰草生技醫藥、緯創生技等國際大廠。同時亦藉此交流盛會，提供有意赴歐洲或瑞士拓展市場的臺灣廠商第一手市場訊息，系統化了解瑞士生技投資環境，為擴展國際版圖做好資源分配。
科技部國際產學聯盟（GLORIA） 聯盟每年維持會員數至少十家，其中國際會員至少一家，國內會員每年會費至少20萬台幣，國際會員每年會費至少美金3萬元，金質會員每年會費20萬美元。藉由會費及促成產學等合作收入，引導學校自主營運之能力，經費補助亦逐年遞減，補助期間至多二期(每期三年)，每年補助上限為8,000萬。讓台灣的大學及企業創新研發能量與全球產業供應鏈接軌，科技部鼓勵大學結盟國內外一流廠商，組成具前瞻發展性的「國際產學聯盟」（Global Research & Industry Alliance, GLORIA），經由與國內外企業的合作，導入產業的資源至學界，在各領域中打造創新生態圈，讓學術研究達到加乘效果，並走出象牙塔，創造社會效益及產業價值。
易威 董事長 李世仁 辭/ 林翰飛 接
易威 發言日期 107/11/12 發言時間 17:36:04 發言人 許景琦 發言人職稱 營運長 發言人電話 (03)666-9596 主旨 公告本公司董事長異動 符合條款 第 6款 事實發生日 107/11/12 說明 1.董事會決議日期或發生變動日期:107/11/12 2.人員別（請輸入董事長或總經理）:董事長。3.舊任者姓名及簡歷:李世仁先生。4.新任者姓名及簡歷:林翰飛先生。5.異動情形（請輸入「辭職」、「解任」、「任期屆滿」、「職務調整」、「資遣」、「退休」、「逝世」或「新任」）:辭職。6.異動原因:原任董事長李世仁先生，因業務繁忙請辭董事長一職。7.新任生效日期:107/11/12 8.其他應敘明事項:本公司董事長李世仁請辭董事長後仍擔任董事職務。
易威執行長 李世仁 辭
易威 發言日期 107/11/12 發言時間 17:36:49 發言人 許景琦 發言人職稱 營運長 發言人電話 (03)666-9596 主旨 公告本公司執行長辭任 符合條款 第 8款 事實發生日 107/11/12 說明 1.人員變動別（請輸入發言人、代理發言人、重要營運主管之名稱、財務主管、會計主 管、研發主管、內部稽核主管或訴訟及非訟代理人）:執行長。2.發生變動日期:107/11/12 3.舊任者姓名、級職及簡歷:李世仁先生。 4.新任者姓名、級職及簡歷:不適用。5.異動情形（請輸入「辭職」、「職務調整」、「資遣」、「退休」、「死亡」、「新 任」或「解任」）:辭職。6.異動原因:原任執行長李世仁先生，因業務繁忙請辭執行長一職。7.生效日期:107/11/12 8.新任者聯絡電話:不適用。9.其他應敘明事項:該職缺待補，待需委任時再由董事會委任。
易威 法人董事Magnifica Inc. 改派: 許景琦 退/ 林翰飛 接
易威 發言日期 107/11/12 發言時間 17:40:22 發言人 許景琦 發言人職稱 營運長 發言人電話 (03)666-9596 主旨 代重要子公司Magnifica Inc.公告-法人董事改派代表人 符合條款 第 6款 事實發生日 107/11/12 說明 1.發生變動日期:107/11/12 2.法人名稱:易威生醫科技股份有限公司。3.舊任者姓名及簡歷:許景琦先生。4.新任者姓名及簡歷:林翰飛先生。5.異動原因:本公司改派子公司代表人。 6.原任期（例xx/xx/xx至xx/xx/xx）:NA 7.新任生效日期:107/11/12。 8.其他應敘明事項:無。