Pages

Friday, February 3, 2017

CDE行政法人化 終於過關! 衛福部 (何啟功) 審查縮短1~2月就很厲害 ~


新藥加速上市期程 將設國家藥物審查中心2017/02/03生技產業 | 呂雪彗/台北報導 生醫新藥審查可望仿效日本快轉!行政院會昨天拍板《國家藥物審查中心設置條例草案》,設立國家藥物審查中心,新藥審查由三階段簡化為二階段,該中心具有提升醫藥品審查速度、縮短新藥上市時程,及輔導諮詢新藥研發等兩大功能,有利打造台灣成亞太生醫研發重鎮,台灣生醫產業可望邁向新的里程碑。 衛生署早於87年捐助成立「財團法人醫藥品查驗中心」,委託該中心執行藥物申請查驗登記及臨床試驗技術資料審查等任務,但歐盟等外商動輒反映新藥審查程序太長,呼籲台灣縮短新藥上市流程,與國際接軌;另查驗中心財務仰賴國家預算,經費不穩定,若改為法人化,財務可自給自足。行政院會昨通過《國家藥物審查中心設置條例草案》,同時搭配《藥事法》修正案。衛福部次長何啟功表示,衛福部參考日本制度,規劃設立行政法人的國家藥物審查中心,專責辦理藥品跟醫材的技術性資料審查。何啟功表示,未來經衛福部公告之新藥,由現三階段縮為二階段,第一階段先送藥物審查中心審查技術性資料;第二階段由食藥署審查公共衛生需要或倫理,給予藥品、醫材上市許可證之核發。至於審查程序可以縮短多少時間?何啟功說,藥品種類很多,若能縮短時間12個月,就算很厲害。另該中心還有一大功能,就是協助國內業者研發時予臨床或非臨床試驗新藥輔導,避免業者走冤枉路,以協助安全有效藥物儘早上市。官員表示,目前新成分新藥平均一半在360天審查完成,學名藥僅41%在180天(半年)完成,個案差別很大,有的年限更長,國內外藥商皆抱怨審查效率太慢,未來查驗中心法人化後,期五年內讓新成分新藥90%比率360天內完成;學名藥90%在180內完成。

 

(The Lancet) 過量食用荔枝(litchi, Lychee)小心hypoglycin A, MCPG (methylenecyclopropylglycine): 低血糖抽搐


印度百童怪病亡 疑因空腹吃荔枝 20170203日【國際中心╱綜合報導】印度東北部一個小鎮每年夏天都有數百名兒童突然發高燒、抽搐,上百人因此死亡。專家研究多年,發現死因可能跟當地盛產的荔枝有關。近日刊於《刺胳針-全球衛生》期刊的研究指,印度穆札佛普爾鎮2014年時,近400名兒童突然染怪病,其中122人死亡。起初專家以為是貧窮地區營養不足或吃太多含農藥的農作物導致。但印度與美國專家聯手調查發現,染病的兒童發病前通常吃了許多荔枝,回家後可能就不想晚飯,導致血糖降低。正常狀況,血糖降低後,身體開始代謝脂肪酸,製造所需的葡萄糖,但這些病童的尿液樣本顯示,約2/3病童體內含存在於荔枝種子的毒素、次甘氨酸,使其體內無法合成葡萄糖。血糖過低時很快就出現急性腦腫而抽搐、失去知覺等症狀。印度政府前天據此研究,呼籲家長限制孩童吃荔枝的量且確保一定要吃晚餐。但研究也稱,盛產荔枝地區的兒童約每百人才1人發病,顯示可能不僅和吃荔枝有關,可能還包括遺傳基因變異等問題,須進一步研究。林口長庚臨床毒物科主任顏宗海昨表示,荔枝糖分高,吃多會致血糖升高,印度例子較特別,不能以單一因素解釋,有可能是小朋友本身營養不良,或遺傳基因變異,加上空腹大量吃荔枝,導致低血糖。台灣臨床沒有大量吃荔枝導致低血糖的病例。他提醒,若家人出現大量冒汗、意識不清,甚至抽搐或昏迷,可能是血糖過低的警訊,趕緊讓他們吃一顆糖並盡快送醫。

Lychee identified as cause for mystery deadly childhood illness in India Updated yesterday at 2:13pm For more than two decades, apparently healthy children in the Indian region of Bihar suffered sudden seizures and lost consciousness. A third of them died, leaving doctors baffled. But a team of American and Indian scientists say they have found the cause of the mystery illness, which killed more than 100 children a year: eating too many lychees on an empty stomach. The research, published in medical journal The Lancet, has found lychees — particularly unripe fruits — contain an amino acid that affects blood glucose levels. "Parents in affected villages report that during May and June, young children frequently spend their day eating lychees in the surrounding orchards; many return home in the evening uninterested in eating a meal," the researchers wrote, saying most children then arrived at hospital unconscious or having seizures in the middle of the night or early morning.  In South-East Asia, outbreaks of similar illnesses have been reported from lychee-growing areas of Bangladesh and Vietnam. 

How has this link not been made before?  The researchers said the lychee's potential toxic effects were noted in ancient literature from China, where the fruit originates, however the commercial lychee industry in India is relatively young and has expanded quickly. "This knowledge has been slow to reach certain parts of Asia where the so-called mysterious lychee disease has been attributed to various causes (fruit colouring, heat stroke) in Bihar, India, to an unidentified pesticide in north-west Bangladesh and, after an exhaustive negative virological search, to a yet-to-be-discovered neurotropic virus in northeast Vietnam," Professor Peter Spencer and Dr Valerie Palmer wrote in a Lancet paper discussing the research. The amino acid found to be the culprit is found in the fruit of many members of the Soapberry family, which also includes the lychee, along with rambutan, longan and ackee. To guard against the illness, the researchers recommended minimising lychee consumption and making sure children had an evening meal. The children's age and state of nourishment were also factors. If a child did become ill, the researchers said they should be treated quickly to correct their glucose levels to prevent lasting damage such as mental impairment, muscle weakness and movement disorders.  "Fortunately, the high cost of these imported fruits and the likelihood that would be eaten in small quantities by well-nourished consumers, suggests there is little reason for concern in the USA," Professor Spencer and Dr Palmer noted.  However, lychee production is increasing in Australia. The researchers also said there were now studies looking at how to put the lychee's glucose-lowering properties to good use in treating metabolic syndrome.

Association of acute toxic encephalopathy with litchi consumption in an outbreak in Muzaffarpur, India, 2014: a case-control study  (The Lancet) , Published: 30 January 2017

Background Outbreaks of unexplained illness frequently remain under-investigated. In India, outbreaks of an acute neurological illness with high mortality among children occur annually in Muzaffarpur, the country's largest litchi cultivation region. In 2014, we aimed to investigate the cause and risk factors for this illness.

Methods In this hospital-based surveillance and nested age-matched case-control study, we did laboratory investigations to assess potential infectious and non-infectious causes of this acute neurological illness. Cases were children aged 15 years or younger who were admitted to two hospitals in Muzaffarpur with new-onset seizures or altered sensorium. Age-matched controls were residents of Muzaffarpur who were admitted to the same two hospitals for a non-neurologic illness within seven days of the date of admission of the case. Clinical specimens (blood, cerebrospinal fluid, and urine) and environmental specimens (litchis) were tested for evidence of infectious pathogens, pesticides, toxic metals, and other non-infectious causes, including presence of hypoglycin A or methylenecyclopropylglycine (MCPG), naturally-occurring fruit-based toxins that cause hypoglycaemia and metabolic derangement. Matched and unmatched (controlling for age) bivariate analyses were done and risk factors for illness were expressed as matched odds ratios and odds ratios (unmatched analyses).

Findings Between May 26, and July 17, 2014, 390 patients meeting the case definition were admitted to the two referral hospitals in Muzaffarpur, of whom 122 (31%) died. On admission, 204 (62%) of 327 had blood glucose concentration of 70 mg/dL or less. 104 cases were compared with 104 age-matched hospital controls. Litchi consumption (matched odds ratio [mOR] 9·6 [95% CI 3·6 – 24]) and absence of an evening meal (2·2 [1·2–4·3]) in the 24 h preceding illness onset were associated with illness. The absence of an evening meal significantly modified the effect of eating litchis on illness (odds ratio [OR] 7·8 [95% CI 3·3–18·8], without evening meal; OR 3·6 [1·1–11·1] with an evening meal). Tests for infectious agents and pesticides were negative. Metabolites of hypoglycin A, MCPG, or both were detected in 48 [66%] of 73 urine specimens from case-patients and none from 15 controls72 (90%) of 80 case-patient specimens had abnormal plasma acylcarnitine profiles, consistent with severe disruption of fatty acid metabolism. In 36 litchi arils tested from Muzaffarpur, hypoglycin A concentrations ranged from 12·4 μg/g to 152·0 μg/g and MCPG ranged from 44·9 μg/g to 220·0 μg/g.

Interpretation Our investigation suggests an outbreak of acute encephalopathy in Muzaffarpur associated with both hypoglycin A and MCPG toxicity. To prevent illness and reduce mortality in the region, we recommended minimising litchi consumption, ensuring receipt of an evening meal and implementing rapid glucose correction for suspected illness. A comprehensive investigative approach in Muzaffarpur led to timely public health recommendations, underscoring the importance of using systematic methods in other unexplained illness outbreaks.

Funding US Centers for Disease Control and Prevention.

Evidence before this study We searched PubMed between Jan 30, and April 30, 2013, before our 2013 field investigation, for any studies related to the acute unexplained neurological illness in Muzaffarpur using the search terms "Muzaffarpur," AND ("encephalitis" OR "encephalopathy" OR "seizure.") This identified two articles that suggested potential causes for the outbreak illness varying from Japanese Encephalitis virus, another unknown virus, to heat stroke. Following the results of our 2013 investigation, which suggested hypoglycaemia might be an important factor in illness, and raised the possibility of a toxic origin, we repeated a PubMed search in December, 2013, using terms ("ackee hypoglycin" OR "ackee encephalopathy" OR "glycine analog AND litchi" OR "litchi encephalopathy" or "litchi methylenecyclopropylglycine" (MCPG), OR "Jamaican vomiting sickness") for studies describing an association between litchis, ackee fruit, hypoglycin, MCPG and acute neurologic illness published between Jan 1, 1954, and Dec 1, 2013. We found 61 studies; 11 described cases or outbreaks of ackee fruit poisoning which implicated hypoglycin toxicity; an additional 11 studies described the pathophysiology of hypoglycin A in animal models, and five described methods to characterise hypoglycin A in ackee fruits. An ecological study from 2012 from Vietnam indicated an association between litchi plantation surface area and acute encephalitis incidence. A study from 1962 described the isolation of MCPG in litchi seeds, and two studies from 1989 and 1991 described the hypoglycaemic effect of MCPG in animal studies. No studies implicated a direct epidemiological association between litchi consumption in affected individuals and encephalopathy. No studies showed hypoglycin or MCPG or their metabolites in affected individuals.

Added value of this study This study, to the best of our knowledge, is the largest investigation of the Muzaffarpur outbreak and the first comprehensive confirmation that this recurring outbreak illness is associated with litchi consumption and toxicity from both hypoglycin A and MCPG. We confirm the presence of MCPG and hypoglycin in litchis, and, for the first time, our data show the metabolites of these toxins in human biological specimens, the biological impact of these toxins on human metabolism, and the modifying effect of the lack of an evening meal on the impact of these toxins.

Implications of all the available evidence  Based on the results of our investigation, public health and clinical recommendations targeted at preventing illness and reducing morbidity and mortality from the Muzaffarpur outbreak illness were provided to state and national health authorities. This included recommendations to minimise litchi consumption among young children in the affected area, to ensure that children receive an evening meal throughout the outbreak period, and to rapidly assess and correct hypoglycaemia in any child suspected of having the outbreak illness. Evaluation of other potential factors, including missed evening meal, poor nutritional status, and as yet unidentified genetic differences, may provide further insights into additional risk factors for this outbreak illness. Application of a similar comprehensive and systematic approach to the evaluation of both infectious and non-infectious aetiologies of unexplained illness outbreaks in other parts of the world has the potential to contribute toward identifying interventions that can reduce morbidity and mortality.

(大解密: 單一員工產值6000萬元) 智擎: 開會一小時、補休三小時 (絕不虧待員工)


十年磨一藥 智擎18名員工創造11億元營收 2017-02-02 19:57:59 聯合報系 記者吳佩蓉/台北報導分享2016年台灣智擎以全球唯一可延長轉移性胰臟癌患者存活期的抗癌新藥「安能得」在美國、歐盟銷售亮眼,繳出傲人成績單,EPS上看78元,尤其以不到20人團隊,創造11億元營收,每位員工產值高達6000萬元,相當驚人。外界看智擎,以十年磨一藥,終於盼到新藥開花結果,證明智擎總經理暨執行長葉常菁選題的眼光,但智擎的成功不僅在「選題」,更在「選人」,尤其智擎以獨特的NRDONo research, Development only)模式,只專注於臨床試驗設計及法規認證,前端的藥物開發,後端的生產、國際市場行銷全數外包,如何選擇合作夥伴,將成果順利轉移,更考驗葉常菁的選人功力。葉常菁說,智擎選擇合作夥伴只有一個原則「選最好的」,不考慮國籍,專找各領域專家,只要找到最好的,就有物以類聚的效果,找到對的人,當大家發現各領域的頂尖專家都和智擎合作,就算不熟悉這家台灣小公司,也願意和智擎接觸。就這樣一步步以有限資源,連結全球生技產業能量,帶領智擎走向國際之路。根據統計,2016年生醫產業總產值除以總員工數,每名員工年均產值約339萬元新台幣。但是,智擎每一位員工產值高達6000萬元,足足是其他生技同業的20倍。更驚人的是,背負起超高產值的智擎員工更公認這是一家「幸福企業」。幸福企業、員工是重要資產可不是說說而已,葉常菁自豪地說,智擎員工18人,平均年資九年,半數員工年資超過10年,顯示智擎團隊向心力極強,智擎從2003年成立至今,不少元老級員工陪伴公司成長茁壯。連結全球夥伴,難免得在半夜與遠在美國、歐洲的合作夥伴開會,早在「一例一休」上路前,智擎就提供開會一小時、補休三小時的優厚條件,絕不虧待員工。葉常菁說,智擎選人除了重品性及過去經驗外,「對學習有渴望」是智擎選才的重要特質,希望看到員工可以相互學習、團隊合作;智擎員工不但人人都是專案經理人,也可發揮潛力,依任務編組,使命必達。台灣的新藥研發之路走來顛簸,但葉常菁仍認為新藥研發有其價值。她指出,台灣生技業雖然八成不賺錢,但EPS不是唯一的指標,除了EPS,還有產品線,產品線才能看出公司的潛力。尤其智擎除了胰臟癌藥安能得外,還有好幾個癌症新藥,陸續開花結果,智擎要證明台灣可以做新藥研發,把本夢比順利轉成本益比,更要讓無藥可治的病人重獲新生,體現新藥研發的無價。

禾生技 獲美專利 (Hyaluronic acid conjugated drugs)


禾生技 發言日期106/02/02發言時間19:45:43 發言人楊晴華發言人職稱營運管理處副總經理發言人電話0287975966 主旨本公司用於治療大腸癌、膠質母細胞瘤之透明質酸複合藥物(HACD)獲美國專利商標局發佈獲證通知 符合條款第43款事實發生日106/02/02 說明1.事實發生日:106/02/02 2.公司名稱:禾伸堂生技股份有限公司 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:本公司經由自行建立的HDD(Hyaluronan Drug Delivery)技術平台中,成功開發出的透明質酸複合藥物(Hyaluronicacid conjugated drugs, HACD),頃獲美國專利商標局發佈用於治療大腸癌、膠質母細胞瘤的獲證通知,此專利將應用於未來抗癌藥物之開發。 6.因應措施: 7.其他應敘明事項:

法德METOPROLOL ER長效型降血壓藥 美國銷售夥伴: Wockhardt/ Trupharma


法德藥與印度藥廠合作 200萬美元授權金入袋 2017-02-03 〔記者陳永吉/台北報導〕國內特殊學名藥廠法德藥(4191宣布與印度的國際製藥廠Wockhardt簽訂長效型降血壓產品METOPROLOL SUCCINATE ER Tablet)在美國地區銷售合約,Wockhardt將先支付法德藥銷售授權金共200萬美元。法德藥指出,未來Wockhardt公司將與法德藥之前簽約合作的美國通路商Trupharma,共同負責該產品美國市場的銷售,法德藥在產品上市後將可享有銷售利益最高5成的分潤所得。法德藥表示,Wockhardt公司總部設於印度,以歐、美市場為主要營運市場,占其整體營收比重6成,該公司旗下也曾有同款學名藥在20107月取得美國FDA核准上市,但因製造技術門檻相當高,導致產品上市生產後出現品質問題,於2013年底遭FDA禁止進口,此次藉由與法德藥達成美國地區銷售合作,可望讓產品重返美國市場。Wockhardt公司曾在2012於該產品上市核准後2年內成功搶下高達25%市占率,並佔Wockhardt公司美國市場營收總額的37%,為Wockhardt公司美國營收的主要來源之一。法德藥指出,基於METOPROLOL產品具高技術門檻的特性,雖然Wockhardt當時被迫退出,卻沒有新的競爭對手增加,產品市場的價格競爭情形並不嚴重。目前美國市場競爭者除了原廠及原廠貼牌廠商外,主要僅有2家學名藥廠同於市場銷售。據統計,美國市場每年市場規模穩定維持在9美元左右。

凌越生醫 66種過敏原微陣列 檢測 拼2017年健保給付 (TFDA/ CE/認證 )


新一代特異性過敏原檢測, 將於2017年進入健保給付市場 凌越生醫股份有限公司本新聞稿發佈於2017/02/02 目前各大醫院常用的特異性過敏原檢測,一次僅能檢測六種過敏原;然而,現代人接觸的環境多樣多變,也許要前往醫院檢測六到十次,藉由測出不同品項,才能找出真正引發過敏症狀的過敏原從今年起,過敏原檢測即將邁入劃時代的新紀元!專注於高精度過敏原晶片研製的凌越生醫公司,其新一代的特異性過敏原檢測生物晶片,將於2017年起推廣至健保給付的市場。凌越生醫過敏原生物晶片的獨特設計,只要抽一次血,即可全面檢測66種常見的過敏原,預計將大幅減少民眾舟車勞頓往返醫院的時間,也同時提高醫師的看診效率,更節省國家的健保資源。凌越生醫過敏原生物晶片,將亞洲最常見的過敏原,用微陣列的方式, 固定在一般手指甲大小的特製玻璃晶片上,經由與血液中過敏原特異性抗體的反應,運用特殊雷射掃描,就能準確地找到引發臨床症狀的過敏原元凶。

新一代特異性過敏原生物晶片檢測的優點:1.過敏原原材料挑選符合亞洲特有氣候、環境因素。目前在過敏原檢測運用的蛋白質試劑幾乎是歐美進口,其蛋白質比例及種類可能不同於亞洲地區,凌越生醫本土及在地化的蛋白質研造技術,原料純化萃取後,再經過DNA物種定序,提高過敏原測試準確性。2.靈敏度高。過敏原在接觸初期誘發過敏的特異性抗體剛出現時,即可被偵測到。有助於醫師提早發現原因,民眾藉由醫師的建議,建立個人健康飲食計畫,或避免接觸過敏原等方式,預防過敏臨床症狀的發生或加重。3.一次抽血能做最多過敏原品項的檢測產品。過敏原晶片較皮膚測試安全,僅需抽取一次微量的血液,即可快速篩檢測出66項經過衛福部認證許可的急性過敏原品項可以減少患者多次往返醫院的時間,提高門診醫師看診診斷的效率。超越市面上任何過敏原的檢測產品。凌越生醫公司是國內將生物晶片技術應用於臨床過敏原檢測的先驅,新一代特異性過敏原生物晶片已通過國家主管機關審查認證 (衛署醫器製字第003680);也是全世界第一個經由國家級臨床試驗認證(國食藥監械()20143400147的特異性過敏原生物晶片檢測產品。同時,本產品更取得歐盟CE(DE/CAO9/0760/IVD/1061)已經可以在歐盟22個國家自由銷售。以優秀的產品設計,國際級規格的品質標準,為過敏原檢測的過程和結果帶來更多樣、更便捷的方式。新聞稿有效日期,至2017/03/02為止

(OBP-301, Telomelysin)基亞 & Oncolys 授權 江蘇恒瑞: 簽約50萬美元 (總授權金1.02億)


基亞新藥OBP-301授權 最快本季有結果 2017-02-02 21:02經濟日報 記者黃文奇╱即時報導 基亞生技(31762日表示,公司旗下的溶瘤病毒(oncolytic virus)產品OBP-301Telomelysin),近期日本合作夥伴Oncolys與西方大廠洽談授權,最快本季將有具體進度,預告第二個授權案離開花結果的日子將不遠。基亞日前將OBP-3011.02億美元,把大中華區的權利授權江蘇恆瑞後,繼續加緊腳步擴大適應症範圍,其中,美國以黑色素細胞癌為主,日本則投入食道癌臨床試驗,最快本季啟動美國、日本兩地收案。2日股價收71.2元,下跌0.4元。基亞說,OBP-301中晚期肝癌領域正在台灣和韓國進行第一/第二期人體試驗 ,此外,國際開發有兩大主軸,包括美日的臨床試驗與西方大廠的授權案。臨床方面,基亞與美日當局主管機關積極溝通中,美國方面將從臨床二期開始做,依當前進度推估,將以首季為目標啟動收案,最晚不超過下季。目前基亞與Oncolys已經完成臨床準備,只要等進度完備後,即可啟動收案。OBP-301基亞享有的全球(含台灣、韓國)商業權利約三分之一,而Oncolys則掌握另外三分之二。業界預估,若以中國大陸授權金額上億美元估算,該產品未來授權給歐美大廠的商業價值將更可觀。基亞和Oncolys開發的OBP-301日前將大中華區權利授權江蘇恒瑞製藥;總授權金為1.02億美元,含簽約款50萬美元,研發階段里程碑金1,450萬美元,銷售里程碑金8,700萬美元,未來銷售權利金為銷售金額之711%。競爭力方面,溶瘤病毒能破壞癌細胞後所釋放出來的腫瘤蛋白質分子,依當前研究顯示,能讓當紅的免疫療法PD-1PD-L1系列藥物有加乘效果,換言之,基亞在抗癌領域以OBP-301為技術平台,長線而言具備實質潛在商機。

 

醫療便宜 最佳僑居國家TOP1: 台灣 (但須放棄 寧靜&路權)


醫療便宜物價低 調查:台灣最宜居 20170202日【記者黃捷瑄/綜合報導】旅外人士網站「InterNations」調查2016年生活品質指數排行榜,台灣擊敗了兩年的冠軍厄瓜多,在67個國家中拔得頭籌,獲選為生活品質最佳僑居國家。該評比顯示,可負擔的醫療及物價低廉是台灣宜居的主因。「財經內幕」(Business Insider)網站報導,InterNations對來自174個國家的14,300名旅外人士進行調查,就休閒、個人幸福、旅行及交通、醫療及福利、安全等指標進行評比,最後選出21個宜居國家。台灣在67個國家中,勝過第二名的奧地利及第三名的日本奧地利在水、空氣乾淨及交通上最獲青睞。日本則在交通、安全和醫療方面特別突出。不過在台北生活10年的《富比世》雜誌專蘭作家詹寧斯(Ralph Jennings)近日則發表文章說,儘管台灣在人權、勞工權益上有顯著提升,但在台灣生活得放棄「寧靜」、「路權」,而且「投訴難有成效」。詹寧斯說,台灣噪音汙染嚴重,很難擁有「平靜生活與工作空間」;機車騎上人行道、路邊停車等行人路權被漠視;此外,民眾雖然可以向政府、警方或民代投訴,但實際上很少獲得全面回覆。

疾管署 (羅一鈞) 春節流感少6成 主因 暖冬&疫苗擴大政策


疫苗奏效 春節急診類流感患者少6 發稿時間:2017/02/02去年春節流感疫情嚴重,讓疾管署嚴加戒備,祭出比往年多1倍、共600萬劑公費疫苗,加上今年天氣較暖,讓除夕到初五,急診類流感患者比去年同期少了近6成。(中央社檔案照片) (中央社記者張茗喧台北2日電)去年春節流感疫情嚴重,讓疾管署嚴加戒備,祭出比往年多1倍、共600萬劑公費疫苗,加上今年天氣較暖,讓除夕到初五,急診類流感患者比去年同期少了近6成。根據疾管署統計,去年春節期間急診類流感患者高達56358人次,今年則降到24450人次,不僅患者驟減6成,更創下4年來新低。疾管署副署長羅一鈞表示,去年10月開打的公費流感疫苗,從前年的300萬劑倍增到600萬劑,大幅提升接種率及群體保護力,加上今年暖冬影響,是流感患者驟減主因。疾管署春節前曾預估,今年急診類流感就診人次約2.5萬至2.65萬人次,如今春節已過,實際數量與預期幾乎吻合,評估疫苗擴大接種政策奏效,疾管署今年也會繼續爭取預算。值得注意的是,今年春節不只流感患者減,就連腸胃炎患者也比往年少,羅一鈞說,去年腸胃炎患者約17400人次,今年則降到約11400人次,減少近35認為應和事前宣導有關,但他也呼籲,13月都是腸胃炎高峰期,春節過後仍不得輕忽。1060202

食藥署 風管組查廠員公訴: 貪汙&洩密! 藥廠涉行賄緩起訴


食藥署約聘副稽查 當藥廠「門神」 2017-02-03 02:17聯合報 記者王長鼎/新北報導 衛福部食藥署風險管理組約聘僱陳姓副稽查員涉嫌當藥廠「門神」,於稽查前向國內多家藥廠通風報信,收錢的地點有公共場所、自家廁所,還有藥廠公司會議室。新北地檢署查出陳涉嫌收賄三百四十八萬餘元,昨天依貪汙治罪條例及洩密罪提起公訴,涉嫌行賄的藥商負責人共十人,均因為認罪予以緩起訴,並依行賄金額開罰繳交國庫。食藥署依西藥製劑製造工廠實施國際GMP標準公告時程,明訂自前年一月一日起,國內所有西藥製造廠商須全面完成實施PICS GMP評鑑,未符合者不得從事西藥生產,食藥署為執行評鑑以例行性及機動性兩種查廠方式進行查核。三年前食藥署多次對藥廠突襲檢查,發現陳姓約聘副稽查員負責的案件,多件都是零缺失,認為「有異常」,懷疑陳提前將查廠資訊通報給人人化學製藥、中生生技、威力化學、新喜國際企業、派頓化學製藥、漁人製藥、德山製藥、東洲及光南製藥等藥廠,主動通報廉政署。新北地檢署偵辦後,將陳起訴,指陳以稽查藥廠之名,行索賄之實,藉口擔任「顧問」名義,自二○一二年起涉嫌向國內多家知名藥廠,每月收賄二至四萬元不等,提前將查廠重點資訊及日期通報藥廠。陳為避免收賄走漏風聲,收錢都約在咖啡館、高鐵或捷運車站及餐廳等公共場所,也有業者趁登門拜訪,將賄款放在陳位於新北市住處廁所,也有業者不避嫌,直接在公司會議塞錢給陳。陳到案後承認收賄,先繳回一百萬元不法所得,十名名藥廠負責人也承認行賄,予以緩起訴,並依十六萬至八十四萬元不等的行賄金額開罰繳交國庫,陳在案發後已遭食藥署解聘。

川普治療雄性禿: 服用小劑量Propecia柔沛!!


頭毛是真的 醫師:川普吃柔沛促毛髮生長法新社 2017020215:52 美國總統川普從競選以來,其招牌髮型便引來外界好奇真假,而川普也曾多次強調頭髮全是真的。根據川普私人醫師表示,這位白宮新主人確實服用可促進毛髮生長的藥物,證實川普的頭髮全是真的。川普醫師伯恩斯坦(Harold Bornstein)接受《紐時》訪問時表示,川普目前服用3藥物:可促進毛髮生長的攝護腺藥物、治療酒糟鼻的抗生素及降血脂藥。此外,川普為防止罹患心血管疾病,也在醫師建議下每日吃小劑量阿斯匹靈。報導指出,這是外界首次得知川普服用與攝護腺有關的藥物,也可證實為何川普的攝護腺特地抗原(prostate specific antigenPSA)指數特別低。伯恩斯坦表示,川普服用的是小劑量柔沛(Propecia),用以治療雄性禿。蓄有一頭及肩長髮的伯恩斯坦說,他自己也服用此藥物:「我的頭髮都是自己的」、「他(川普)的頭髮也是」。(桂家齊/綜合外電報導)

台灣高檢署: 前基因國際董事長 等3人 提起上訴

胖達人案 S夫無罪定讞 20170203 04:10 陳志賢/台北報導 胖達人內線交易案,台灣高檢署認為,高院對藝人小S公公許慶祥減刑不當,另前基因國際董事長徐洵平、姜麗芬夫婦,判決違背法令,3人提起上訴;至於一、二審都判無罪的小S丈夫許雅鈞,檢方因受限速審法規定,未提上訴,許雅鈞無罪定讞。許雅鈞因本案纏訟3年,曾遭限制出境,帝寶豪宅也被搜索,但他一、二審均判無罪,依刑事妥速審判法規定,除非判決違背司法院解釋、判例或適用法令牴觸憲法,否則不得上訴三審,檢方審酌法律上幾乎無上訴空間,放棄上訴,許雅鈞從官司中脫身。許慶祥、許雅鈞父子與徐、姜2人,被控知悉胖達人自201368月淨利驟降、經營虧損,同年8月胖達人登記公司生技達人將更換董事長等重大消息,在消息公開前大量出脫基因股票避損,涉內線交易。一審因許慶祥不認罪,依證交法判2;徐、姜認罪並繳回犯罪所得,各判刑2年、18月,均緩刑3另許雅鈞無罪。高院審理期間,許雅鈞哽咽喊冤說股票多次漲停板都沒賣,何來內線交易?許慶祥則翻供認罪,指一生行醫救人,經此教訓後絕不再犯,請求緩刑。高院去年12月仍判許雅鈞無罪,許慶祥、徐洵平、姜麗芬3人認罪,改判許慶祥110月、緩刑4,須接受20小時法治教育。徐、姜各判18月、16月,緩刑3年,須受法治教育12小時。高檢署說,許慶祥在檢方偵查時未自白認罪,直到高院審理時才認罪,心態僥倖,適用減刑規定不當,另高院判決對徐、姜內線交易的認定,違背法令,對3人提上訴。(中國時報)