浩鼎內線交易案 投保即起受理投資人求償登記 2017-03-29 18:35經濟日報 記者王奐敏╱即時報導 投保中心表示,張念慈等人涉嫌於2015年至2016年間從事浩
Thursday, March 30, 2017
(浩鼎案) 辦理 民事求償 登記中….
環瑞醫 投資 瑞亞生醫7億 (累計投資)
環瑞醫:董事會通過對台灣子公司瑞亞生醫現金增資 鉅亨網新聞中心※來源:台灣證券交易所2017/03/29相關
花蓮慈濟醫院(林欣榮)+台灣粒線體公司(鄭漢中): 開發幹細胞新藥 (巴金森氏症)
活化幹細胞研究 花蓮慈濟盼三年後造福類巴金森氏症 2017-03-30 07:50聯合報 記者徐庭揚╱即時報導 醫療技術再突破!
Wednesday, March 29, 2017
印度CRO 學名藥BE 歐盟 質疑 (Micro Therapeutic Research Labs)
歐盟建議暫緩印度某藥廠測試藥品上市 2017-03-27 18:51經濟日報 記者易起宇╱即時報導 歐洲藥物管理局(EMA)在官網上表示,由於印度承包商微治療研
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs/ European Medicines Agency 24/03/2017 The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for approval of generic medicines. The list of medicines recommended for suspension can be found here. The suspensions can be lifted once alternative data establishing bioequivalence are provided. Alternative supporting data have already been provided for several of the medicines reviewed. Therefore, the CHMP recommended that these medicines can remain on the market. The list of medicines recommended to remain on the market is available here. The Agency also recommended that medicines not yet authorised but which are being evaluated on the basis of bioequivalence studies from these sites should not be authorised until bioequivalence is demonstrated using alternative data. Micro Therapeutic Research Labs is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU. The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016. The inspections identified several concerns at the company's sites regarding misrepresentation of study data and deficiencies in documentation and data handling. The review, by EMA's Committee for Medicinal Products for Human Use (CHMP), concluded that data from studies conducted at the sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorisation in the EU. However, there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of studies at the sites. Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in certain EU Member States. Therefore national authorities can temporarily postpone the suspension in the interest of patients. Member States should also decide whether recalls of the affected medicines are needed in their territories. The CHMP's recommendation concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU.
(台澳打造荔枝不落國) 台灣6種 特有荔枝 昆士蘭試種 (台農2/3/4/5/6/7號); 澳洲荔枝 162-185台幣/公斤
台灣荔枝征服「澳客」年底移民南半球 劉光瑩 2017-03-28 Web Only 最快今年底,4種台灣品種荔枝,即將出現在27歲澳洲昆士蘭農夫
澳洲荔枝賣得愈多,台灣就能收到愈多權利金 至於這對台灣有什麼好處呢?張哲瑋解釋,
亞裔移民日增荔枝價格會更好 原本今年1月台灣方面就送出300株荔枝果苗至澳洲要開始試種,