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Wednesday, June 25, 2014

Forest Laboratories 獲vilazodone PhaseIII 正面結果

Forest Labs Posts Positive Results for Anxiety Disorder Drug  By Dow Jones Business News,  June 23, 2014, 06:05:00 PM By Maria Armental  Forest Laboratories Inc. ( FRX ) reported positive top-line results from three Phase 3 trials of vilazodone in adult patients with generalized anxiety disorder. In two flexible-dose and one fixed-dose eight-week trials, patients who received vilazodone showed statistically significant improvement, the New York specialty pharmaceutical company said. Based on the results, the company said it will file a supplemental new drug application next year with the U.S. Food and Drug Administration. Generalized anxiety disorders affect about 6.8 million American adults, causing them to be filled with fearfulness and uncertainty, according to the National Institute of Mental Health. It affects twice as many women as men, and the average age of onset is 31 years old. Forest, which has been diversifying its product base in recent years, acquired the drug as part of its deal for Clinical Data Inc. in 2011, betting the then-newly approved vilazodone would help offset the loss of major products against looming generic competition. Forest Labs is being bought by Dublin-based Actavis PLC for about $25 billion in a deal expected to close midyear.

Vilazodone (United States trade name Viibryd) is a serotonergic antidepressant developed by Clinical Data for the treatment of major depressive disorder. The chemical compound was originally developed by Merck KGaA (Germany). Vilazodone was approved by the FDA for use in the United States to treat major depressive disorder in 2011.

 

Tristan Camp: 生技多頭 (NBI, NASDAQ Biotechnology)

生技多頭 至少再五年 2014/05/23 【經濟日報╱記者張瀞文/台北報導】 美國生技股創新不斷,基金業者指出,生技股多頭走勢仍可持續五到十年。除了生技類股以外,美國的能源類股也享有優勢,同樣值得留意。從20093月低點以來,美股已上漲130%,指數更在歷史高檔區徘徊,不少投資人擔心美股已貴,許多資金仍停留在現金及債市,仍未大舉移入美股。不過,美盛股票產品分析師坎普(Tristan Camp)指出,美國經濟復甦,企業獲利動能增強,本益比仍然合理,仍可以找到許多投資機會。坎普指出,美國家庭淨資產達歷史新高,國內生產毛額(GDP)成長率去年達1.9%,今年更上看2.9%,企業現金多,有利併購、配發現金股利及買回庫藏股。坎普說,以預期獲利來看,美股本益比1516倍,只略高於歷史平均值,雖然很多人士認為美股已比歐股貴,但十年來美股的本益比向來都高於歐股,不代表美股的表現會比歐股弱。坎普最看好美國生技股,認為生技創新能力強,許多新藥已到研發最後階段,包括治療多發性硬化症、白血病等疾病,預期多頭趨勢可持續五到十年,美盛凱利美國積極成長基金的生技醫療股比重高達33%。此外,坎普說,一些大型生技股的本益比仍低,與大型製藥廠差不多,這是過去沒有出現過的現象。這些大型生技股手上現金多,無負債,有能力進行併購,獲利能力也強。坎普還看好能源股,美國天然氣價格已達六年低點,是歐洲的二分之一、日本及北亞的四分之一。能源價格便宜,有利石化等能源密集產業,也激勵廠商在墨西哥灣等地進行相關投資。‧免責聲明:以上內容由各投資機構或媒體提供,純屬研究性質,僅作參考,使用者應明瞭其參考性,審慎考量本身之投資風險,使用者若依本資料投資發生損失須自行負責,聯合理財網對資料內容錯誤、更新延誤不負任何責任。

WuXi PharmaTech藥明康德 通過FDA查核 (執行過92 IND-enabling programs)

藥明康德為中裕新藥生產的艾滋病新藥Ibalizumab獲得美國FDA批准用於新藥臨床試驗 鉅亨網新聞中心(來源:美通社)2014-05-06 09:04:11 PR Newswire Asia上海和台北, 201456上海和台北201456 /美通社/ -- 藥明康德(NYSEWX)與中裕新藥今日宣佈,藥明康德無錫生物製藥研發生產基地為中裕新藥生產的首批艾滋病治療單克隆抗體藥物ibalizumabTMB-355)的原液及無菌生物製品獲得美國FDA批准,用於新藥臨床試驗中對艾滋病患者的持續治療。這是目前已知國內生產的無菌生物產品首次獲得美國FDA認可,用於經美國FDA批准的新藥臨床試驗,標誌著中國生物製藥發展的一個重要里程碑。Ibalizumab是中裕新藥開發的治療艾滋病毒/艾滋病感染的人源單克隆抗體藥物,是一種被稱為「病毒侵入抑制劑」的創新艾滋病療法。藥明康德無錫生物製藥研發生產基地是中國目前唯一一家同時符合美國、歐盟以及中國cGMP標準,採用國際最先進的生產技術和設備建成的生物製藥生產車間。該基地生產ibalizumab原液的細胞培養工廠日前剛獲得國際製藥工程師協會(ISPE)頒發的「2014年度cGMP廠房特別獎」。生產ibalizumab無菌生物製品的cGMP制劑生產工廠新近落成,與細胞培養工廠位於同一園區。該制劑線採用國際先進的自動化小容量無菌灌裝系統,可以生產2-50毫升液體和凍干瓶產品,靈活滿足全球臨床試驗及產品上市的生產需求。「我們祝賀中裕新藥ibalizumab的這一重大進展朝最終走向市場邁出了堅實的一步。」藥明康德董事長兼首席執行官李革博士表示。「藥明康德致力於通過公司一體化的生物醫藥發現、開發、製造和檢測服務平台為廣大客戶提供全方位的解決方案,幫助他們的創新生物製藥產品早日推向全球及中國市場。」中裕新藥首席執行官張念原博士表示,「中裕新藥非常滿意與藥明康德ibalizumab合作項目的推進速度與執行情況。我們非常期待雙方下一階段的合作,最終推動這一重要藥物成功獲批進入市場,服務廣大病患。」

WuXi PharmaTech Toxicology Facility in Suzhou Passes FDA Inspection June 20, 2014, 8:00 a.m. EDT  SHANGHAI, June 20, 2014 /PRNewswire/ -- WuXi PharmaTech (Cayman) Inc. WX -0.21%  , a leading pharmaceutical, biotechnology, and medical device R&D services company with operations in China and the United States, today announced that its toxicology facility in Suzhou recently passed a surveillance Good Laboratory Practice (GLP) inspection by the U.S. Food and Drug Administration (FDA) with no major observations. This was the first FDA GLP inspection in the facility's five years of operation. The inspection was extensive, lasting five days and including the review of numerous processes and the audit of four studies. WuXi's toxicology facility in Suzhou has completed 92 IND-enabling programs for global submissions."The outcome of the FDA inspection further demonstrates the consistency of our GLP compliance and quality services following the excellent results of earlier OECD and CFDA inspections," said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech.

About WuXi PharmaTech WuXi PharmaTech is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi PharmaTech's operating subsidiaries are known as WuXi AppTec. For more information, please visit http://www.wuxiapptec.com or contact:

 

 

中裕TMB-355查登案 (皮下及肌肉): 義大、高榮、三總

中裕:衛福部核准愛滋病新藥TMB-355第一/二期人體臨床試驗計畫書修正14513MoneyDJ 台灣行業分析 證交所重大訊息公告(4147)中裕-公告衛生福利部核准本公司愛滋病新藥TMB-355皮下及肌肉注射劑型預防及治療之第一/二期人體臨床試驗計畫書修正1.事實發生日:103/05/12 2.公司名稱:中裕新藥股份有限公司 3.與公司關係(請輸入本公司或聯屬公司):本公司 4.相互持股比例(若前項為本公司,請填不適用):不適用 5.發生緣由:本公司接獲衛生福利部公文通知,愛滋病新藥ibalizumab供查驗登記用藥品臨床試驗計畫書(計畫名稱:TMB-121)修正乙案,經核,同意試驗進行。6.因應措施: 7.其他應敘明事項試驗名稱為"一項使用Ibalizumab 皮下注射/肌肉注射於健康志願者比較其安全性、耐受性與藥物動力學,並於感染第一型人類免疫不全病毒(HIV-1)、且目前未接受抗反轉錄病毒治療之病患,比較其安全性、耐受性與療效的第一/二期、隨機分組、安慰劑對照臨床試驗" 本修正案主要內容為Cohort 1 Arm B採皮下注射方式於HIV感染者,第0天注射一次450mg,之後五週每週注射一次180mg,故共注射六次。Cohort 2 Arm A採肌肉注射方式於健康志願者, 0天、第7天、第35天及第63天分別注射900mg,故共注射4次;Cohort 2 Arm B劑量將由Cohort 2 Arm A結果決定。 試驗地點預計在義大醫院、高雄榮民總醫院、三軍總醫院等院區執行,預計包括預防及治療受試者人數合計為28(包含Cohort 1 Arm A已完成臨床試驗HIV感染者8)資料來源-MoneyDJ理財網