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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。

祥圃實業 安全豬肉獲 新農金獎 !!

翁啟惠挖寶 選生技隱形冠軍 2015-09-25 00:07:36 經濟日報 記者高行/台北報導挖掘國內生技業隱形冠軍的「2015台灣生醫暨新農業產業選秀大賽」昨(24)日舉行頒獎,由中央研究院院長翁啟惠召集的評審團遴選出國內生技業的明日新星,馬英九總統蒞臨頒獎典禮;蛋白質藥廠台康生技及主攻生鮮安全豬肉的祥圃實業分別獲得生醫組和新農業組金獎。 2015台灣生醫暨新農業產業選秀大賽」由工研院、台灣生物產業發展協會、台北市生物產業協會及時代基金會共同主辦,獲獎廠商具備創新研發能力、獲利模式,也深具進軍國際架勢。過去八年獲得優選獎及前三名的75家企業,已近30家登錄興櫃及上市櫃。本屆大賽生醫組金獎由蛋白質藥廠台康生技奪下,超音波探頭廠聲博及創傷骨材廠愛派司分別獲得銀獎和銅獎。新農業組金獎得主為祥圃實業,銀獎和銅獎得主為瓜瓜園和佳展生技。主辦單位指出,該獎項透過挖礦般的選拔機制,衡量候選企業的創新研發能力及營運模式,挖掘更多後續可望登上國際市場的明日之星。參賽資格訂為未興櫃、未上市櫃公司,本屆進入優選名單共計20家企業,除具備優秀的創新研發能力外,其中不少也已進入獲利階段,其營運模獲得生醫組金獎的台康生技核心業務為大分子蛋白質藥品委託開發及代工製造服務,同步發展未來極具明星相的生物相似性藥品及抗體藥物複合體創新藥,並和全球小分子原料藥大廠台耀化學組成產業策略聯盟,具備國際競爭潛力。本屆評審團召集人中研院院長翁啟惠表示,生技為帶領台灣經濟突破瓶頸的明星產業,目前國內涵蓋生技醫療、工業及食品生技的生物經濟產值約2兆元,預期每年將以5%的速度成長,至2020年將突破3兆元規模,未來應更加重視生物經濟,促使產業具備競爭規模,擴產國際市場。翁啟惠強調,生技產業在人才培育、資源運用及建立國際營運模式等三大面向,仍有很大創新改善空間。

生醫/生農選秀獎: 時代基金會 招手 工研院/台灣生物產協/台北市生物產協

生醫新農業選秀 台康祥圃奪金獎 中央社-20150924下午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。

基改蘇力菌 農委會 say NO (有機農業) !!

農委會從嚴修法 「基因重組蘇力菌」不得用於有機農業 2015  09  25  in 農學堂 農委會上周預告修正《農藥標示管理辦法》,首度採用歐盟比較嚴格的基因改造定義,只要不是自然交配或重組改變的基因,都視為基改,且含基改的成品農藥,須在外包裝清楚標示「基因改造」,讓農民參考。最快九月底正式公告。

「基因重組」蘇力菌,有機農心驚驚修法起因是今年7月初,上下游報導嘉農公司出產的微生物農藥「高招」蘇力菌(40%水分散性粒劑),外包裝標示「基因重組」,由於蘇力菌是台灣市面上唯一的生物農藥,但現行有機農業不得使用任何含基改的資材,因此消息一出引起許多農民嘩然。不過基因重組是否等於基因改造?學界及政府部門間都沒有共識,連帶讓農民無所適從。當時防檢局解釋, 這款蘇力菌是利用人為篩選,把另一個菌株裡的毒蛋白基因,移到另一種蘇力菌菌株,屬於「種」之間的基因交換,一般基因改造的定義是不同「屬」以上之間的交換,因此不算是基因改造。

高招蘇力菌 順應國情,改採歐盟較嚴格法規國際上對於基改定義不一,台灣參考的是美國較寬鬆的法規,不過為求謹慎,防檢局後來邀請專家學者討論,最後決定改採歐盟定義。歐盟在2001年頒佈法令,基改是「人類除外之生物體,其體內基因經由非自然交配或重組改變而成者」。(an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination換句話說,農政單位認定,只要是經過人為操作技術產生的新物種,都視為基改,不再有種或屬的分別。防檢局植物防疫組組長張瑞彰表示,美國早已開放種植基改作物,但台灣還不允許,為了符合國情,改採歐盟比較嚴格的基改定義,目前只有一款農藥受到修法影響,就是之前有爭議的嘉農「高招」蘇力菌(40%水分散性粒劑)。業者向防檢局辦理農藥登記時,必須提出毒理資料、風險評估等,若含基改也要一併說清楚,張瑞彰舉例,如果業者說蘇力菌A和蘇力菌基因不同,必須舉出哪裡不同,防檢局會檢驗基因如何導入,若是天然雜交就不必標示,如果有人為導入則要標示基因改造。草案在這週預告期滿,防檢局說沒有收到反對意見,最快九月底就能正式公告。農糧署農業資材組科長王文良說,如果防檢局明確指出「高招」蘇力菌是基改,就不能用在有機農業

有機驗證機構肯定明確標示全世界和全台有機栽培,使用蘇力菌的比例超過8成,多半用來防治喜歡吃葉菜類的白蝶、蛾類害蟲,防檢局這次解釋明確、要求農藥業者必須標示,獲得許多有機驗證機構的肯定,嘉農公司則在截稿前都無回應。最早發現這起事件的「台灣寶島有機農業發展協會」表示,法規明確,對驗證單位來說很方便,旗下採用「高招」蘇力菌的農民只有個位數,7月就趕快請農民轉用其他牌了。中興大學農產品驗證中心人員吳正宗說,非常肯定明確標示,之前就請農民不要用有人為轉殖基因的資材,其實蘇力菌品牌多,不一定要堅持使用「高招」那一款。

小字典:蘇力菌——昆蟲的穿腸藥蘇力菌是一種昆蟲病原細菌,普遍存在於大自然,昆蟲幼蟲吃下後,蘇力菌會被分解出毒素,和昆蟲中腸上的皮細胞結合,讓細胞破孔,因此又稱昆蟲界的穿腸藥,而且毒素具有專一性,不會傷害到其他非目標物種,也不用擔心農藥殘留,成為農政單位大力推薦的安全農藥,目前台灣市面上的生物農藥殺蟲劑僅有蘇力菌。蘇力菌菌株有很多種,有的擅長對付蛾類,有的可拿來防蟎,全世界的蘇力菌產品已經超過100種,台灣目前登記通過的大約10種,不過只有一種是本土研發出的菌株。全世界和全台有機栽培,使用蘇力菌的比例超過8成,多半用來防治喜歡吃葉菜類的白蝶、蛾類害蟲。

醫學中心 看輕症 萬芳醫院比例最高 (19.63%)

醫學中心肥門診 萬芳、馬偕最嚴重 2015-09-18 〔記者林惠琴/台北報導〕醫學中心治療急重症為先,但醫改會發現,國內十九家醫學中心去年平均每一百名門診患者,有十四.五名是基層院所即可處理的輕症。有十六家都有「肥門診」或「看輕症」的問題,一年至少多耗掉健保九億元、約卅四萬人次的門診量,相對恐排擠卅四萬人次的急重症無法就醫。 健保會預定今日進行健保總額協商,分配明年高達六千億元的健保大餅。但醫改會昨開記者會質疑,健保醫院總額約每三元就有一元進到醫學中心口袋,卻不是每家都以照顧急重症或住院為主,許多中心有「肥門診」、「看輕症」問題。 看感冒 醫學中心健保給付多500 醫改會副執行長朱顯光說,同樣收治感冒患者,醫學中心每件可獲健保給付較地區醫院多五百元,「同病不同酬」,變相鼓勵醫學中心衝門診量;醫學中心治感冒和複雜心臟病的診察費都是二二八元,導致醫院避重症就輕症。 超收輕症34萬人次 多耗健保9億元 十九家醫院中,八家收治輕症比率高於平均值,其中萬芳醫院達十九.六三%最高,約每五人有一人是輕症。所有醫學中心門診超收輕症的卅四萬人次若全轉到基層院所,健保一年可少花五億。 醫改會另檢視門診費用占率,有五家醫學中心每一百元健保收入有五十五元以上來自門診,其中以新光醫院六十二.五元最多;門診量績效值也有九家高於平均值,馬偕高出一.八三倍居冠。兩指標過高也代表有拚門診疑慮。 調查也發現部分醫院有搶做觀光醫療及慢箋開立比率偏低現象,可一次開三個月的藥卻只開兩週,提高門診拿藥的患者數,也影響重症者掛號。 醫改會呼籲民眾改變就醫習慣 此次調查全數過關僅三家,包含高雄長庚、高醫附醫與高雄榮總。醫改會呼籲,民眾應改變就醫習慣,別讓醫學中心成輕症門診中心;健保會則應明訂醫學中心門診、住診費比例,建立輕症過多的核扣機制,更應改善同病不同酬等支付弊端。 萬芳醫院表示,先前病房護理人力短缺,造成門診比例上升,已努力改善。馬偕醫院表示,來院患者均是重點照護對象,不得拒診。新光醫院則說,門診費用偏高也與治療方式進步有關,以往須住院的化療、白內障,如今門診即可處理。 健保署強調,若發現醫院有輕症重醫個案,健保會有核減機制把關,未來門診也將逐步改為「同病同酬」。

食藥署: 優先呈現” 指示藥” 勿使用的族群

食藥署對醫改會指出[指示藥]標示不清,自行買藥恐陷藥害危機之說明 資料來源:食品藥物管理署 建檔日期:2015/09/24 更新時間:2015/09/24    有關醫改會今日召開記者會,表示指示藥品外盒標示漏警語,盒內說明像教科書,並呼籲食藥署提出「市售指示藥[換裝]範本」和廠商更換藥盒標示和說明書之日出條款。 衛生福利部食品藥物管理署(簡稱食藥署)說明如下: 現行指示藥品仿單(說明書),係經食藥署審核後依核准內容刊載,然食藥署考量指示藥品的仿單係供民眾閱讀,已要求新申請案件其藥品仿單內容應朝向口語化敘述。 另為更確保指示藥品仿單內容完整適時更新,食藥署每年透過「指示藥品審查基準」增修訂,制定更貼近消費者語言的適應症、警語與注意事項等,經公告則要求業者修訂仿單內容,確保內容更完整及口語化,自98年起已完成「鎮咳祛痰」、「胃腸製劑」、「綜合感冒劑」及「眼用製劑」等類別基準,例如要求綜合感冒藥品應新增:「患有肝、腎疾病或其他重大疾病之患者,服用本藥前,應先請教醫師藥師藥劑生」等警語,並持續修訂中。 配合民眾閱讀習慣,並參考美、日及英國規定,食藥署已重新編寫指示藥仿單格式,優先呈現「勿使用的族群」,讓民眾第一時間就可決定是否購買使用。為便於民眾可由外盒明瞭必要安全資訊,但考量藥品外盒版面有限,食藥署亦要求指示藥品外盒,參考仿單內容,將仿單中「勿使用族群」及廠商諮詢電話等資訊刊載於外盒上,將對新申請上市或變更之指示藥品優先要求於外盒標示。此外,對於原作為處方藥,如申請變更為指示藥的產品,食藥署將要求業者提供藥事人員用藥諮詢教育訓練資料,在上市後一年內,產品不得開架陳列,應由藥事人員進行用藥指導後,再交付民眾,並由社區藥局加強通報不良反應訊息。並要求限制藥品市售包裝量,避免民眾長期使用。 食藥署提醒,購買指示藥品,應先諮詢藥事人員了解藥品之相關資訊,若購買依仿單內容使用後,症狀未改善或有惡化之虞,則應立即停藥就醫,以維護自身健康。

匯特 GMP廠房建廠延後 !

匯特:公告本公司變更一○三年現金增資運用計畫 鉅亨網新聞中心2015-09-23 07:33:23  第三十四條 第141.董事會決議變更日期:104/09/22 2.原計畫申報生效之日期:103/03/133.變動原因:為配合公司業務發展需求,變更現金增資原計畫項目,重新分配增資款資金用途。4.歷次變更前後募集資金計畫:新臺幣:仟元興建GMP 充實營運資金 轉投資原計畫 100,000 50,000 0第一次變更 32,000 90,000 28,000第二次變更 12,000 100,000 38,0005.預計執行進度:變更後計畫預計於104年第4季執行完畢。6.預計完成日期:104年第4季。7.預計可能產生效益:本次變更現金增資用途主要原因有二:(1)因本公司興建GMP廠房之都市設計審議仍待主管機關核准中,建廠時程延後,故原規劃之資金需求部份分配至營運資金及轉投資(2)轉投資樂活醫務管理股份有限公司。本公司轉投資樂活公司,預期最快可於半年內獲得投資效益,另藉由其旗下之醫療診所,可在本公司進行人工玻璃體之人體臨床試驗時,轉介眼科病患,使成為本公司配合進行臨床試驗醫院之樣本,可加速人工玻璃體提早順利上市。8.本次變更對股東權益之影響:藉由投資標的物建立本公司產品之銷售通路,對股東權益無重大影響。9.原主辦承銷商評估意見摘要:未達重大變更故不適用。10.其他應敘明事項:無。

匯特(萊特) 新藥灌注 樂活公司 轉型拚IPO !!

匯特擬投資樂活診所 積極布局醫療市場 2015-09-24 15:18:58 聯合晚報 記者徐睦鈞/台北報導興櫃生技股匯特(6458)董事會通過決議,擬策略性投資樂活醫務管理公司(樂活診所),積極布局醫療市場。樂活醫務管理公司的樂活診所,位於師大路,連結台灣師大校園,已於今年初取得使用執照,第2季開始營運,將與匯特共同推動「多層級照護」的概念,在單一照護環境內提供健康、治療到復健階段之照護服務,為師大師生、鄰近社區、匯特和相關企業同仁、乃至雙北市居民提供最佳健康維護和醫療服務,提昇其生活品質。匯特生技除計畫投資樂活在台北的綜合健康照護診所,並規劃在新竹地區,結合台大竹北分部,設立樂活診所暨藥局,嘉惠新竹地區民眾、新竹科學園區和新竹生醫園區的員工。同時將由匯特關係企業-萊特生醫集團生技新藥公司,授權二期臨床生技新藥予樂活公司,協助其轉型為生技新藥產業,並共同推動申請股票初次公開發行IPO和上市(櫃)。

匯特切入醫療市場 砸千萬入股樂活診所 鉅亨網記者張旭宏 2015-09-2411:23  興櫃醫材廠匯特(6458-TW)董事會日前通過決議,策略性投資樂活醫務管理(樂活診所),將以每股10元,入股100萬股,總金額1千萬元,積極佈局醫療市場。樂活醫務管理公司的樂活診所,位於師大路,連結台灣師大校園,已於今年初取得使用執照,今年第二季開始營運,將與匯特共同推動「多層級照護」的概念,在單一照護環境內提供健康、治療到復健階段照護服務,提供最佳健康維護和醫療服務,提昇其生活品質。 匯特除計畫投資樂活在台北的綜合健康照護診所,並規劃在新竹地區,結合台大竹北分部,設立樂活診所暨藥局,同時將由匯特關係企業-萊特生技新藥公司,授權二期臨床生技新藥給樂活,協助其轉型為生技新藥產業,並共同推動IPO。匯特表示,生技新藥產業結合醫療資源,研發連結市場,跨越微笑曲線最高價值的兩端,成國際產業策略聯盟的風潮,結盟樂活的策略,為生技新藥產業創舉。