国家开发银行10亿元助北京医药研发

 发布时间：2012-7-10 来源：药品资讯网信息中心 北医健康产业园科技有限公司国家开发银行10亿元长期项目专项贷款日前正式获批。国家开发银行此举不仅将推动北京医药科研服务行业的发展，而且对我国行业整体发展也将起到强有力的支持作用。 目前，我国医药产业发展缓慢，自主研发能力薄弱，其中科研资金投入不足、低水平重复研发和企业内部管理落后等一系列问题成为发展的主要壁垒。作为第一家获得国家开发银行支持的科研服务企业，北医健康产业园隶属北大国际医院集团，园区日前在中关村生命科学园内动工，占地219亩，投资达20亿元，总建筑面积22万平方米，包括化学实验室、生物实验室、动物实验室、中试平台等，所有实验室均满足美国FDA认证的GLP等标准要求，可供不少于200家生物研发企业入驻，建成后将填补我国高端医药科研服务平台缺乏的空白。  

雷射矯正成長趨緩，大學光醫療服務拼轉型

 精實新聞 2012-07-09 10:29:13 記者 蕭燕翔 報導 國內雷射近視手術成長趨緩，大學光(3218)力拼眼科醫療服務轉型，今年開始推出醫療手術搭配眼整形的套裝服務，目標全年眼科手術營收貢獻能與去年持平；至於眼鏡產品銷售通路部分，今年底將持續增長至85家，營收貢獻將較去年成長，成為今年營業額成長的主力。 受到國內眼科名醫今年首季發表近視雷射矯正手術副作用的言論影響，大學光對今年雷射近視矯正手術的成長趨向保守，原年初預期開眼數及營收貢獻都能維持15-20%的增長，目前已下修至力拼持平，其中，開眼數目標維持與去年近2萬眼相當，其他眼科手術則仰賴非近視雷射矯正的貢獻。 大學光表示，今年眼科手術開始主推白內障、自費水晶體及其他眼整形手術，如提供中高齡人口白內障加上眼袋切除或近視矯正搭配雙眼皮的套裝服務，在其他業務搭配下，全年整體眼科手術的營收貢獻希望能與去年趨近。 至於眼鏡產品銷售部分，大學光表示，目前該公司全省通路已達80家，較去年底75家持續成長，且開始進入一級城市的中大型商圈，新店的平均月營收較以往舊店有明顯成長，今年底希望銷售據點能增加至85個，成為今年營收成長的主力。 不過，因傳統淡季及市場成長趨緩影響，法人估計，大學光第二季營收約1.7-1.75億元，季減16-19%，單季可能陷入虧損，第三季隨淡季影響趨緩，雷射近視手術的營收貢獻將自低點回升，全年營收可能與去年持平至個位數衰退，獲利則將力拼損益兩平以上。   

子宮肌瘤患者 別亂吃補品、蜂王乳

 2012/07/10 【台灣新生報／記者蘇湘雲／台北報導】 子宮肌瘤患者千萬不要亂吃補品、蜂王乳。台北中山醫院婦產科主治醫師郭安妮表示，曾遇到有些患者原本子宮肌瘤很小、沒有症狀，結果突然大血崩，細問之下，患者坦承吃了一些補品，推測可能是補品含有動情激素而引起子宮肌瘤惡化。 郭安妮醫師指出，宮肌瘤發生的原因至今還不明確，推估可能和遺傳及長期動情激素過度刺激有關。像蜂王乳、胎盤素就含有動情激素，有些補品號稱可以「回春」、讓精神變好，可能也含有動情激素。子宮肌瘤患者一旦食用含動情激素食品，很容易刺激子宮肌瘤變大。 根據醫師臨床觀察，國內三十歲以上女性罹患子宮肌瘤比例大約兩成，而四十至五十歲女性發生率更高達三成。由於越來越多女性晚婚、晚孕，門診因子宮肌瘤壓迫輸卵管造成不孕的病例也激增約兩成，醫師提醒，婚後一年以上、有正常性生活而無法順利懷孕的婦女應重視子宮肌瘤引發不孕問題。 二十幾歲子宮肌瘤患者人數較少，但這些患者往往不太清楚經血量過大、血崩是什麼狀況，即使出現貧血症狀如上課打瞌睡、上體育課特別喘、臉色蒼白等，卻還是不知道自己可能長有子宮肌瘤。郭安妮醫師建議，女性最好多留意經血量變化，如果月經量很多，不到一小時衛生棉就滿了，必須換衛生棉，或者月經來時出現許多大血塊，甚至產生貧血症狀，就要懷疑可能是經血量過大、血崩，最好到醫院接受進一步檢查。  

羅氏隱瞞死亡報告 暢銷藥幾乎全中招??!!!!

 2012年07月10日 10:45 來源：羊城晚報 暢銷藥物幾乎全部中招；羅氏稱在中國上市藥品適應症與在歐美產品不同，對中國市場沒有影響 根據歐洲藥監局披露， 瑞士制藥巨頭羅氏公司因隱瞞8 萬份致死或副作用報告而被歐洲藥品監管部門緊急調查。記者了解到，涉及隱瞞的8 款藥物中，多為羅氏的暢銷藥，其中有5 款在中國已經上市。對此，羅氏昨日回應羊城晚報採訪時稱，在中國上市的藥品適應症與在歐美市場上市產品不同， 目前而言對中國市場沒有任何影響。

被指瞞報1.5 萬死亡報告 據歐洲藥監局披露，上述8 萬份被隱瞞的死亡或不良反應報告是英國藥品和健康產品管理局（MHRA）在對羅氏總部進行關於藥物安全警戒系統的例行檢查時發現的。據英國《每日郵報》 昨日報道， 這些報告最早可以追溯到1997 年。 據披露，在這8 萬份報告是羅氏制藥在美國市場進行藥品銷售的同時收集而來的，而這些報告均沒有經過評估是否應作為疑似不良反應向歐洲藥品監管部門報告。8 萬份報告中有1.5 份為患者死亡的報告， 但目前仍不清楚死亡案例是否與藥物存在因果聯繫。 MHRA方面表示， "羅氏公司的這種做法不能接受， 我們的調查已確定羅氏公司的藥物安全警戒系統存在不足。"為此，歐洲藥監局正對羅氏藥物安全警戒程式所存在的缺陷展開調查。 但由於目前沒有證據表明對病人產生負面影響， 因此調查期間暫時仍不需要病人或醫護專業人員採取任何行動。MHRA 認為， 因為目前未發現藥品存在安全風險，患者應繼續服藥。

暢銷藥物幾乎全部中招 報道稱， 涉及瞞報報告的至少有八款藥物，主要治療乳腺癌、腸癌、B 型肝炎、皮膚和眼睛等疾病。 昨日，記者從羅氏中國獲悉，此次涉及的乳腺癌藥物赫賽汀、惡性淋巴瘤藥美羅華、丙肝藥物派羅欣、直腸癌藥物安維汀、肺癌藥物特羅凱等五款藥在中國都有售。其中，美羅華、安維汀、赫賽汀、派羅欣還是去年羅氏全球銷量最好的藥物，銷售額分別為60 億、53 億、52 億、14億瑞士法郎。作為 全球最暢銷抗癌藥之一的赫賽汀，在華上市長達10 年；而特羅凱進入中國已經達到5 年； 美羅華早在2000 年就進入中國市場， 在華上市時間也長達12 年。 羅氏中國方面接受羊城晚報記者採訪時表示，8 萬份報告中涉及哪些藥物適應症目前還在調查當中， 而中國上市的藥品適應症與在歐美市場上市產品又有所不同，因此，目前而言對中國市場沒有任何影響。記者陸志霖報道   

Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 'adverse reactions'

By JO MACFARLANE

PUBLISHED: 21:48 GMT, 7 July 2012 | UPDATED: 13:20 GMT, 8 July 2012

One of the world’s biggest drug companies is at the centre of an urgent investigation after failing to disclose reports that 15,000 people died while taking its medicines.

Swiss pharmaceutical giant Roche failed to pass on a further 65,000 reports of suspected side effects that were recorded by patients. All of the reactions took place in the United States over the past 15 years with medicines used to treat breast cancer, bowel cancer, hepatitis B, and skin and eye conditions.Roche, one of the world's biggest drug companies, is at the centre of an urgent investigation after failing to report that people died while taking their medicationThere is no evidence so far of  any direct link between the problems and the drugs – but medicines watchdogs say they are taking Roche’s failure to disclose possible concerns ‘extremely seriously’.The drugs involved include Herceptin, given to about 10,000 breast cancer patients in Britain, and Lucentis, which is used to treat about 20,000 UK patients a year with age-related vision loss. The NHS pays Roche millions of pounds for these treatments every year.The extent of the failings were discovered when the UK medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), carried out a routine inspection of Roche’s drug safety procedures at its headquarters in Welwyn Garden City, Hertfordshire.The company has now been ordered by the MHRA and the EU-wide regulator, the European Medicines Agency, to investigate immediately each of the total 80,000 deaths and side effects reported. Both agencies said they were ‘taking action’ over Roche’s failures.All of the deaths and possible adverse reactions were reported by patients who rang a call centre run by Roche’s US subsidiary Genentech. Staff there failed to pass on the reports to Roche’s drug safety team – but it is not known why Professor Sir Kent Woods, chief executive of the MHRA, said: ‘Patients should continue to take their medicines because our investigation has currently found no evidence of a safety risk to patients.‘Roche’s actions are unacceptable and our investigation has identified that its reporting systems are inadequate. We are taking urgent action to ensure that these are rectified by Roche as a matter of priority. We will take action to ensure that patients are protected now and in the future.’All of the deaths and possible adverse reactions were reported by patients who rang a call centre run by Roche’s US subsidiary Genentech. Staff there failed to pass on the reports to Roche’s drug safety team – but it is not known why.Roche, which made profits of £6.3 billion in 2010, has a legal duty to examine every suspected side effect and report them to regulators around the world so that potential safety concerns can be investigated.This means that each side effect reported to the patient support call centre should have been immediately sent to the safety team to be assessed.These must then be sent to regulators – within 15 days for the most serious reactions – even if no link between the drug and the reaction be proved.Some of the call centre’s records, which date back to 1997, are said to have been noted down on paper and kept in boxes.The European Medicines Agency, which made the findings public, said: ‘There is at present no evidence of a negative impact for patients and while the investigations and being conducted there is no need for patients or healthcare professionals to take any action.’

A number of drugs are being investigated following the incident

However, a spokeswoman  added: ‘It’s not often we make statements on such findings, so we do take this incredibly seriously. The numbers are huge but we’re not talking about confirmed reactions.  ‘Some might not be related, and some may have already been reported to the regulators via other mechanisms – for example directly to us by doctors.’ But she added: ‘We cannot rule out that additional safety concerns could be discovered.’When asked if legal action could be taken against Roche, she said: ‘We are looking at all options. There are penalty regulations and they could be fined.’Other drugs being examined  include Avastin, used for bowel and breast cancer; lung cancer medication Tarceva; Rituxan, which treats non-Hodgkin’s lymphoma; the stroke drug Alteplase; Actemra for rheumatoid arthritis; Pegasys for hepatitis B; and Raptiva for the skin condition psoriasis. If any new safety concerns emerge after examining the data, regulators could decide to withdraw the drugs or change their guidance to doctors.In a statement, Roche said: ‘Patient safety is of paramount importance to Roche. We acknowledge the concerns that can be caused by this issue for people using our medicines.

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杏昌(杏華)佈局 加護病房(ICU)市場 !

牙材成長帶動，杏昌6月營收創新高 精實新聞 2012-07-09 11:16:06 記者 蕭燕翔 報導 牙材營收貢獻成長，醫療器材廠商杏昌(1788) 6月營收1.95億元，創下單月新高，上半年營收10.95億元，年增9.35%。該公司表示，在牙材成長樂觀下，今年營收希望能有兩位數的年增成長，第三季底前也希望完成加護病房(ICU)領域的佈局，增添新的成長動能。 杏昌6月營收1.95億元，創下單月新高，該公司表示，主要是牙材的營收貢獻成長。而杏昌去年來自牙材的營收佔比約8%，今年希望能達到一成水準，以目前表現看來，目標應可順利達陣。 因牙材帶動新的營收成長動能，杏昌上半年營收10.95億元，年增9.35%，也高於往年及產業5-8%的自然成長。該公司表示，因牙材成長看法樂觀，今年營業額目標能拼兩位數成長，創下近年增長率的高峰。 除既有的血液透析及牙科外，杏昌也積極尋求新的成長動能。其中在ICU領域，先前已成立一家專責負責該領域的子公司杏華，杏昌持有51%，未來將透過換股方式，收購一家已在營運的耗材公司，預計第三季底完成。 杏昌表示，該公司去年營業額約1.3-1.5億元，主要銷售產品在ICU領域的呼吸治療部分，未來將分階段將該公司營收併入集團合併營收，也希望在通路資源共享下，擴大該部份營收貢獻，挹注新的成長動能。