Tuesday, September 29, 2015

美夢成真國際集團: SPA連鎖加盟店逾42家

美夢成真擴大徵才 進軍國際醫美 2015-09-24 13:58:19 經濟日報 李憶伶 看好全球醫學美容生技市場的龐大發展商機,美夢成真國際集團積極拓展國際市場,即日起誠徵專業美容主管及美容師、教育講師、商品行銷業務及業務級主管等相關人才,協助拓展中國大陸大連、東南亞、緬甸和馬來西亞等市場。美夢成真國際集團成立10多年全台SPA連鎖加盟店逾42家,有200萬名忠實會員,還有3家醫美診所及生技事業,擁有強大行銷據點通路,近年來更積極進軍國際市場經營成效卓越,公司穩健成長,已成為國內醫美產業的領導品牌。美夢成真國際集團總裁余麗雪表示,美夢成真長期以來經營模式與精神是以專業管理連鎖制度,協助面臨經營瓶頸的單點店家能夠永續經營。美夢成真的經營理念是為顧客提供健康、美麗、自信的生活;為社會創造就業、創業、成功的機會。美夢成真的企業文化三真的女人:做人天真、做事認真、目標當真;以人為本、客戶至上、超越自我、追求卓越、團隊合作與資源分享。有貢獻就有所得,一分耕耘、一分收穫、堅持誠信、注重業績、認真工作負責任、創造真善美的社會! 在培育專業人才上,美夢成真國際集團為培育國內優秀人才,已與黎明科技大學、萬能科技大學、華夏技術學院、建國科技大學、吳鳳科技大學、台北城市大學、南華高中及耕莘健康管理學校等八所學校產學合作,提供優秀學子畢業後有更寬廣的舞台發所長。

美夢成真生技 /統一編號/  53091346 臺北市松山區南京東路33056     /核准設立日期 0990910最後核准變更日期       1031121董事長 余麗雪董事 余炳河董事 許麗華 監察人        余季芬

中裕 授權 拚數億美金&同步2015 11月上櫃

中裕愛滋病新藥 年底前申請美藥證 20150929日【潘姿吟╱台北報導】中裕(4147)將在11月下旬上櫃,預計在11月初舉辦上櫃前法說會。據悉,屆時將公開宣布愛滋病新藥TMB-355靜脈注射劑型第3期在美人體臨床試驗的初步結果,年底前申請藥證,且肌肉注射劑型的2期臨床結果,也會同步說明。 11月下旬上櫃 法人預估,中裕正與跨國大藥廠洽談的授權等合作事宜,順利的話,授權金總額可高達數億美元。中裕愛滋病新藥TMB-355備受市場關注,日前已取得美國FDA核准快速審查與孤兒藥兩項資格,11月初將說明臨床試驗的初步結果。法人預期,中裕有機會成為台灣自主完成臨床3期試驗,並成功申請美國藥證核准的第1家新藥公司。值得注意的是,中裕抗愛滋病用藥已在美試驗多年,不少患者持續使用中。業界認為,中裕現有在臨床3期、即將申請藥證的靜脈注射劑型,與皮下注射、LM52等多種產品,都是極具有競爭力的抗愛滋病用藥,幾乎寡占愛滋病用藥市場,且許多使用者已經倚賴該產品,未來上市後,將可加快銷售額、規模可觀。TMB-355是針對多重抗藥性(MDR)的愛滋病用藥,屬於後線用藥,由於病患需求強、有使用急迫性且沒有取代性產品,極具競爭力。目前,中裕主要鎖定美國,目標市場為3~5萬人,若以每年用藥額度4萬美元(132萬元台幣)估算,市場規模約1220億美元(398 ~663億元台幣)中裕主管表示,TMB-355靜脈注射劑型預計收案33人,美國最少收案30人,台灣則最少收案3人,第1個病人在8月收進來,而CMC委託無錫藥明康德,預計9月完成第3批次。外界也預期,中裕目前則還在收案中,目標是在年底以滾動方式,提出生物製劑許可證(BLA)的申請及審核,希望明年能取得藥證。

Saturday, September 26, 2015

肺癌肋膜侵犯(Pleural spread)治療: 台大李章銘/陳克誠發表光動力 PHOTOFRIN(R) 毒殺成效

肺癌肋膜擴散非絕症 光動力毒殺癌細胞 2015/09/24 12:25 (中央社記者龍珮寧台北24日電)肺癌晚期肋膜擴散不是絕症,台大光動力治療,打入致敏劑給癌細胞吸收後,在雷射光刺激下現形,釋出大量自由基及過氧化合物,讓肉眼看不到的癌細胞被「毒」殺。台大醫院上午舉辦「惡性腫瘤的肋膜擴散不再是絕症,光動力治療在肺癌合作肋膜擴散的成果發表」,刊登在知名期刊「公共科學圖書館期刊(PLOS  ONE),也在今年世界肺癌大會發表,是全台灣最先使用光動力治療的醫院,目前還有部立桃園醫院。據國健署最新癌症發生登記數據顯示,101年共有11692人罹患肺癌,是發生人數第二名,不過卻是國人癌症死因第一位,國人常發生的是肺腺癌,透過篩檢可以早期診斷、早期治療。台灣大學校長楊泮池表示,有時候肺癌喜歡長在旁邊的地方,雖然不大但已侵犯到肋膜,而這是肺腺癌晚期治療效果不佳的原因,但是台大醫院團隊引進光動力治療,改善處理患者的困境,提高存活率。台大醫院外科部胸腔外科主任李章銘說,肺腺癌肺膜擴散的治療方式在過去是用手術切除,不過很難完全清除擴散在肋膜間的腫瘤細胞,治療上以化療或標靶治療為主,但治療情況不理想,也會復發,5年存活率10%以下。腫瘤醫學部醫師陳若白說,肋膜的位置是在肺的邊緣,在第四期中有4成患者是在靠近肋膜處,透過化療縮小腫瘤後再以手術切除,再透過光動力療法(POT)後,還要再搭配化療等療法。胸腔外科醫師陳克誠說,台大醫院5年前引進美國的光動力治療,讓本來不能手術的可以手術,肉眼可以看見腫瘤切除後,對於擴散且肉眼看不到的腫瘤,以光動刀方式找到癌細胞治療,目前已累計29名個案。李章銘說,在治療中或手術前注入「光致敏劑」,這會停留在癌細胞內,而不會出現在正常細胞,再以雷射光讓癌細胞現形後,會釋放大量自由基及過氧化合物「毒」殺癌細胞。李章銘說,以光動力治療的肺癌患者,近6年已有19例,其他癌症有10例,成果是肺癌患者3年存活率逾70%5年存活率有56%,未來將持續應用在不同癌症,手術是自費,且僅對惡性有肋膜擴散患者。

Pleural Photodynamic Therapy and Surgery in Lung Cancer and Thymoma Patients with Pleural Spread

Ke-Cheng Chen , Yi-Shan Hsieh , Ying-Fan Tseng, Ming-Jium Shieh, Jin-Shing Chen, Hong-Shiee Lai, Jang-Ming Lee  Published: July 20, 2015

Pleural spread is difficult to treat in malignancies, especially in lung cancer and thymoma. Monotherapy with surgery fails to have a better survival benefit than palliative chemotherapy, the currently accepted treatment. Photodynamic therapy utilizes a photosensitizer to target the tumor site, and the tumor is exposed to light after performing a pleurectomy and tumor resection. However, the benefits of this procedure to lung cancer or thymoma patients are unknown. We retrospectively reviewed the clinical characteristics and treatment outcomes of patients with lung cancer or thymoma with pleural seeding who underwent pleural photodynamic therapy and surgery between 2005 and 2013. Eighteen patients enrolled in this study. The mean patient age was 52.9 ± 12.2 years. Lung cancer was the inciting cancer of pleural dissemination in 10 patients (55.6%), and thymoma in 8 (44.4%). There was no procedure-related mortality. Using Kaplan-Meier survival analysis, the 3-year survival rate and the 5-year survival rate were 68.9% and 57.4%, respectively. We compared the PDT lung cancer patients with those receiving chemotherapy or target therapy (n = 51) and found that the PDT group had better survival than non-PDT patients (mean survival time: 39.0 versus 17.6 months; P = .047). With proper patient selection, radical surgical resection combined with intrapleural photodynamic therapy for pleural spread in patients with non-small cell lung cancer or thymoma is feasible and may provide a survival benefit. Pleural spread without distant metastases in thoracic malignancy is difficult to manage. In non-small cell lung cancer (NSCLC), it was stage IIIb in the previous International System for Staging Lung Cancer . The International Association for the Study of Lung Cancer (IASLC) published the seventh edition of the TNM classification of NSCLC in 2009 and changed the sixth edition of this document. The current IASLC lung cancer staging project committee recommended that pleural spreads, either malignant pleural effusions or pleural nodules, be upgraded from T4 to M1a. In patients with pleural carcinomatosis, the median survival time ranged from 6 to 9 months . Currently, the management options for pleural spread include chemotherapy, surgery with pleurectomy, and photodynamic therapy. Thymoma is neoplasm arising from epithelial thymic cells. Distant metastasis is rare but it more frequently shows pleural implantation upon diagnosis or after primary treatment. Thymoma with pleural spread is a difficult clinical situation to manage, and the treatment is controversial. … In our study, we used Porfimer sodium (Photofrin; Axcan Pharma Inc, Birmingham, AL, USA), a first-generation photosensitizer. 630 nm red light can activate the photosensitizer. Successful treatment of malignant mesothelioma by photodynamic therapy has been reported as a new approach for pleural malignancy dissemination . Moreover, like mesothelioma, PDT could be one of the multimodality treatment for NSCLC with pleural disseminations. A phase II trial for pleural spread, patients underwent surgery with complete resection or tumor debulking, followed by intrapleural PDT or PDT alone. The overall survival was significantly better than similar patients of historical controls .

PHOTOFRIN®, Pinnacle Biologics™ and the logo of Pinnacle Biologics™ are trademarks of


Pinnacle Biologics, Inc. See more. The PHOTOFRIN® trademark is owned by Concordia Laboratories Inc. PHOTOFRIN® is manufactured for Concordia Laboratories Inc. and distributed in the United States by Pinnacle Biologics Inc.

The role of PDT with PHOTOFRIN®1  PHOTOFRIN® is indicated for treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated.Potential patient types include  Patients with microinvasive lung cancer, a tumor that invades beyond the basement membrane of the bronchial wall, but not into the cartilagePatients ineligible for surgery or radiotherapy due to: Prior high-dose radiotherapy /Poor pulmonary function/Multifocal multilobar disease/Poor medical condition Tumor response rate1,* In 3 noncomparative studies, PDT with PHOTOFRIN® was evaluated in 62 inoperable patients with microinvasive endobronchial tumors; 11 of them clearly documented as unsuitable for surgery or radiotherapy.

Source: http://www.photofrin.com/

 

About Concordia  Concordia is a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs. Concordia's legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of a portfolio of branded products and authorized generic contracts, including branded products such as Nilandron®, for the treatment of metastatic prostate cancer; Dibenzyline®, for the treatment of pheochromocytoma; Lanoxin®, for the treatment of mild-to-moderate heart failure and atrial fibrillation; Plaquenil®, for the treatment of lupus and rheumatoid arthritis, Donnatal® for the treatment of irritable bowel syndrome and Zonegran® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordia's orphan drugs division owns Photofrin®. Photofrin® is marketed by Pinnacle Biologics, Inc. in the United States. Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Roanoke, Virginia and has a specialty healthcare distribution (SHD) division that operates out of Kansas City, Missouri. Pinnacle Biologics, Inc. is located in Chicago, Illinois.

Forest Labs to Buy Aptalis for $2.9 Billion  Forest Seeks New Drugs to Replace Those Facing Generic Competition By MIKE SPECTOR And  JONATHAN D. ROCKOFF  Jan. 8, 2014 7:56 a.m. ETForest Laboratories Inc. agreed to buy specialty pharmaceutical company Aptalis Holdings Inc. for $2.9 billion in cash. Private-equity firm TPG purchased Aptalis, at the time called Axcan Pharma Inc., in 2008 for about $1.3 billion. Axcan later merged with Eurand NV to create a company that was renamed Aptalis. The Wall Street Journal had reported that Forest's board was meeting Tuesday night and was expected to approve the deal. Aptalis, which focuses on treatments for cystic fibrosis and gastrointestinal disorders, toward the end of December filed papers with regulators stating intentions to pursue an initial public offering. Private-equity-owned companies often run a so-called dual track process in which they prepare to take a company public while also soliciting an outright buyer. Aptalis has sales and marketing operations in the U.S., Canada, France and Germany and manufacturing operations in North America and Europe, according to regulatory filings. For the fiscal year ended Sept. 30, the company posted an $86.9 million profit, compared with a $12 million loss a year earlier. Sales rose 12% to $687.9 million. The deal, which requires antitrust review in the U.S. and Canada, is expected to add about 78 cents a share to Forest's adjusted earnings in 2015, along with nearly $700 million in revenue. The company also expects to see about $125 million in cost synergies as a result of the deal. Forest intends to use a combination of cash on hand and debt to fund the deal, which is expected to close in the first half. Forest, a midsize pharmaceutical company based in New York with a market capitalization exceeding $15 billion, develops, makes and sells a bevy of drugs, such as Linzess to treat irritable bowel syndrome. The company has been looking to find new drugs to replace blockbusters, such as the antidepressant Lexapro, that are facing competition from low-price generic versions. Some of the company's new drugs haven't met Wall Street expectations, and the Food and Drug Administration late last year delayed an approval decision on a schizophrenia treatment Forest is helping develop. Brent Saunders, the company's new chief executive, has outlined plans to cut $500 million in costs by 2016 while using Forest's cash to buy drugs it can fold into its portfolio. Mr. Saunders has said he wants to complement Linzess with other drugs treating gastrointestinal disorders with deals that boost earnings and cash flow. Aptalis provides such a fit. It sells gastrointestinal treatments such as ulcer therapy Carafate, and Canasa for a painful condition affecting the rectum called ulcerative proctitis.

Concordia Healthcare Announces Terms of US$520 Million Public Offering of Common Shares  Published: Sept 24, 2015 6:45 p.m. ET  TORONTO, Sept. 24, 2015 /PRNewswire/ - Concordia Healthcare Corp. ("Concordia" or the "Company") CXRX, -2.37% (CXR) today announced the size and pricing of its underwritten public offering (the "Offering") of 8,000,000 common shares of Concordia at a price of US$65.00 per common share (the "Offering Price"). The gross proceeds from the Offering are expected to be US$520 million. The Offering is being conducted by a syndicate of underwriters led by Goldman, Sachs & Co. and RBC Capital Markets, as lead book running managers, and Credit Suisse Securities (USA) LLC and Jefferies LLC, as additional book running managers (collectively and together with the Canadian affiliates of certain of the book running managers, the "Underwriters"). In addition, the Company has granted the Underwriters an option (the "Underwriters' Option") to purchase an additional 1,200,000 common shares of Concordia at the Offering Price per additional common share, exercisable at any time, and from time to time, in whole or in part, up to 30 days from the closing of the Offering. If the Underwriters' Option is exercised in full, the total gross proceeds to Concordia are expected to be US$598 million. The common shares will be sold pursuant to a final prospectus supplement (the "Supplement") to the short form base shelf prospectus dated July 16, 2015 to be filed with the securities regulatory authorities in each of the provinces of Canada and a final prospectus supplement (the "U.S. Supplement") to the corresponding registration statement on Form F-10 to be filed with the U.S. Securities and Exchange Commission. The net proceeds of the Offering will be used to fund, in part: (i) a portion of the purchase price for the previously announced acquisition by the Company of all of the outstanding shares in the capital of Amdipharm Mercury Limited (the "Acquisition"); and (ii) the fees and expenses incurred in connection with the Acquisition. In the event that the Acquisition is not completed, the net proceeds from the Offering will initially be added to the Company's working capital and will subsequently be used to fund future acquisitions in furtherance of the Company's business plan, for general corporate purposes and to potentially repay certain debt obligations of the Company. The Offering is expected to close on or about September 30, 2015 and is subject to the satisfaction of certain conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the Toronto Stock Exchange. A copy of the Supplement and the U.S. Supplement may be obtained from the Company upon written request to Concordia at 277 Lakeshore Rd. East, Suite 302, Oakville, Ontario, L6J 1H9, telephone (905) 842-5150, Attn: Corporate Secretary. The Supplement also will be available on SEDAR at www.sedar.com and the U.S. Supplement also will be available on EDGAR at www.sec.gov. No securities regulatory authority has either approved or disapproved the contents of this press release. This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer, solicitation or sale would be unlawful.

     
patients undergoing PDT vs. non-PDT for pleural spread (P = 0.047)


BTC股漲勢難擋! 安克/德英/醣聯 撮合限制降溫!!

安克漲太兇 勒令預收款券 2015-09-24 02:19:20 經濟日報 記者黃文奇/台北報導生技股近日漲太兇,多家生技股因連番漲停達到「關禁閉」標準,昨(22)日創新診斷軟體公司安克(4188)也繼德英、醣聯等新藥公司之後,被勒令預收款券、五分鐘撮合一次,以為過熱的交易降溫。櫃買中心生技股最近交易爆量,業界認為,這跟近期行政院生技產業策略諮議會議(BTC)的正面結論有關,再加上近期證所稅喊廢,雖然將遞延至11月再戰,但大勢所趨證所稅可望取消的期待下,受到綑綁的生技股,也有拿掉天花板的效應。安克(4188)、醣聯、德英等創新生技公司,近期均連日拉漲停,安克昨日繼續拉出第六根漲停後,股價收在33.45元,若從今年825日的14.2元之起漲點起算,安克的股價不到一個月已經飆逾倍。法人認為,這與BTC的政策做多有直接相關。近期BTC閉幕時,由中研院院長翁啟惠代表BTC委員們向行政院提出建議,應擴大生技產業資本市場規模,目標是三年總市值由目前7,200億元提升至1.1兆元,五年內要增一倍,總市值要達到1.4兆。此目標一出,生技股均應聲「股漲」通過。另外,為鼓勵人才投入生技,近期政府對生技新藥企業之技術股、員工認股權證、與現金增資的所得等問題,也積極研討變革措施,讓生技公司吸納人才更有力。更重要的是,BTC委員也關注生技產業資本市場發展,建議三年擴增50%、五年要增加一倍,打造全球矚目的生技資本市場。此外,BTC委員們建議允許永續型生技創投基金上市掛牌,透過資本市場加強對生技產業的投資;同時,協調國發基金、國營事業或是公股行庫共同參與生技產業創投基金,並結合國內創投,成立多個大規模的生技投資基金。這也讓生技資金管道鬆綁,活水蓄勢待發。

2015生醫新農勝出: 台康生技、聲博科技、愛派司

生醫新農業選秀 台康祥圃奪金獎 中央社 (2015-09-24 20:33)(中央社記者羅秀文台北24日電)「2015台灣生醫暨新農業產業選秀大賽」今天舉行頒獎典禮,生醫組由台康生技奪下金獎,新農業組金獎由祥圃實業贏得。「2015台灣生醫暨生農業產業選秀大賽」由工業技術研究院、台灣生物產業發展協會、台北市生物產業協會、時代基金會共同主辦、行政院科技會報辦公室指導,經過4個月徵選,今天舉行頒獎典禮,由總統馬英九、中央研究院院長翁啟惠、行政院科技會報辦公室執行秘書鐘嘉德、行政院科技部次長錢宗良、時代基金會執行長徐小波擔任頒獎人。今年共有19家企業獲獎,其中生醫組金、銀、銅獎分別由台康生技、聲博科技、愛派司生技獲得。此外,台睿生技、祈瑞新藥開發公司、國璽幹細胞應用技術公司、萊特先進生醫公司、蓋德科技5家公司獲得優選獎。新農業組金獎由祥圃實業獲獎;銀獎由瓜瓜園企業獲得;銅獎得主為佳展生技。新農業組優選獎由力佳綠能生技、元進莊企業、台霖生技、直興光電、淨旦生技、森岳、萬寶祿生技、綠藤生技8家公司獲獎。為鼓勵具有高市場價值技術的研發、新創團隊,或登記成立3年內的新創公司,今年「潛力新秀獎」生醫組由晶祈生技、台灣安麗莎醫療器材公司、國立交通大學機械工程學系生物力學與醫學應用實驗室獲獎。「潛力新秀獎」新農業組則由國立中興大學獸醫學系暨中央研究院農業生物科技研究中心、成大奧洁生技獲獎。計畫召集人翁啟惠表示,過去8年獲得優選獎、前三名的75家企業,已有近30家興櫃、上市櫃。為了持續發掘高潛力企業,評審團將參賽資格限為未上市、未上興櫃公司,以扶植更多具創新能量的中小企業。展望未來,翁啟惠認為,國內應該更加重視生物經濟,包括農業與工業生技,由政府引導,業界提出需求與改善方案,與學研界一起從社會變遷、民眾需求、技術演進等多方面思考和規劃,包括培育人才、有效運用資源、建立國際營運模式,都還有很大的創新改善空間,希望為台灣經濟發展的瓶頸突破解套。

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