中國抗癌藥Irinotecan (伊立替康) 進戰美國市場!!

連雲港恒瑞醫藥打下美國注射劑市場"第一針"   2012年04月14日新華報業網   "在美國市場，你到處可以看到'中國制造'，但你很難找到一瓶中國制造的注射劑成品藥。我們是制藥大國但不是制藥強國，能拿到美國市場成品藥'準入證'的企業寥寥無幾。"4月9日，在連雲港開發區恒瑞研發中心大樓，恒瑞醫藥董事長孫飄揚向記者講述他們衝擊世界最高市場標準的故事。去年12月，恒瑞醫藥的抗腫瘤藥伊立替康注射劑，在國內第一個通過美國FDA注冊認證，得以進入美國市場。今年1月，當新華社記者到美國食品和藥品管理局（簡稱FDA）駐北京辦事處採訪時，北京辦事處專門跟國內核實，最終由FDA總部的發言人帕特‧艾爾辛那威正式宣布了這個新聞。FDA對注射劑的生產技術和質量要求最為嚴格，中國本土制藥企業生產的西藥注射劑首次獲許在美國上市，也就意味著打開了參考FDA標準的其他海外市場的大門。 "我們做任何事情都強調一個'特'字，大家都一樣，就失去了競爭力。"孫飄揚說，正是在創新路上的幾次大步跳躍，使恒瑞醫藥把贏得競爭的機會牢牢掌握在自己手裏。  2011年，恒瑞醫藥第一個有知識產權的新藥艾瑞昔布獲準上市。這個新藥從立項研發到上市，經歷了14年，行內人稱它"見證了中國新藥注冊法規的完善和提升"。恒瑞醫藥總經理周雲曙向記者介紹，恒瑞醫藥1997年改制之前為連雲港市制藥廠，成立于1970年，當時從兩口大缸、幾口大鍋起家，灌裝現在已經不大有人用的紅藥水、紫藥水。1990年，孫飄揚擔任廠長，他在1992年做出了一個驚人舉措：拿120萬元，去北京科研單位購買新藥異環磷?胺。對于當時年利潤不到100萬元的制藥廠來說，120萬是個天文數字！       "你沒有技術，你的命運就在別人手裏"，孫飄揚解釋道："我們要把命運抓在自己手裏。"當時全廠醫藥專業的本科畢業生，連他自己在內只有七八人，孫飄揚硬是成立了自己的"藥物研究所"，來消化、研究、生產藥物。1992年，恒瑞在連雲港建起了建築面積2900平方米的研究大樓，後來被評為國家級企業技術中心，在蘇北建起了第一個博士後工作站。這樣還不夠，恒瑞接著做出了又一個驚人之舉：2000年投資近2億元，在上海建立新的研究中心。這個中心參照當時恒瑞的合作夥伴、美國第四大生物制藥企業Chrion研究中心的標準，公司所聘中外科研人員按照美國的工資待遇，在上海從事新化合物合成、新藥篩選、新劑型的研究。孫飄揚清楚，科學家需要科研環境，需要一個與導師和同行保持密切交往的"生態圈"，在外籍科學家眼裏，上海這樣的城市可以接受。2008年以後，恒瑞再次走出去，在美國新澤西和瑞士籌建海外研究所，就近聘請國外科技人員，直接追蹤世界藥物研究最前沿的信息。目前全國醫藥企業在研發上的平均投入，大約是銷售收入的3%，恒瑞研發投入多年保持在8%左右，在全國居于前列。作為銷售收入已達45.5億元的大企業，恒瑞目前生產一線和研發一線的人數都是1000多人，人數大體相當，一批來自美國、加拿大的海歸科學家在恒瑞的醫藥創新中唱起了主角。 "老板常常跟我開玩笑，去年在我身上花了7000萬。"恒瑞醫藥生物研究所所長蘇鴻聲是個親和力很強的人。他告訴記者，7000萬元當然不是花在他一個人身上。從1987年留學加拿大讀博士起，他已經在加拿大生活了20多年，在多家生物制藥公司工作過。2010年9月，一次偶然的機會，蘇鴻聲和孫飄揚一見如故，隨後成為恒瑞30多名海歸科學家中的一員。蘇鴻聲負責組建生物醫藥研究所，開拓恒瑞醫藥創新的全新領域。除了研發藥物，他的另一個任務是培養人，目前研究所有90個人，今年夏天還將招聘60人，以博士和碩士畢業生為主，這些人身上寄托著恒瑞醫藥新的未來。

韓國三星(Samsung) 生物學名藥先打”價格戰”!!

Samsung plans ambitious rollout of biosims at deep discounts    April 16, 2012 | By John Carroll   FierceBiotech    Samsung BioLogics is moving fast with some ambitious plans to start marketing biosmilars at a deep discount while striking more development deals like the one it has with Biogen Idec ($BIIB) and ramping up its own work on novel biologics. And it's betting that its global rep in the electronics market and construction industry will help make the conglomerate a leading contender in the biopharma business.   Samsung, better known for flat screen TV sets than therapeutics, tells the Financial Times that it will put the finishing touches to its manufacturing site outside of Seoul by June, with plans to have global regulatory sanctions in place by the end of this year. That would set the stage for Samsung and its partner Biogen Idec to have a slate of biosimilars ready to market in 2015, and it plans to offer generic antibodies at half the current price they're available.   "Biopharmaceutical companies are good for sales, and biotech companies for innovation, but neither is good for manufacturing," Tae-Han Kim, the president of Samsung BioLogics, tells the Financial Times. "It is in Samsung's DNA to produce products at low prices while meeting legal and industry requirements. The price of monoclonal antibodies is very expensive and not affordable to all patients. That is a heavy burden on governments and [healthcare] payers."   The article doesn't make clear exactly where Samsung will offer deep discounts. But for the U.S. market, analysts have been projecting far more modest discounts of about 10% to 20%. A 50% discount would represent a much greater challenge to drugmakers.

推拿協調 有生機?

推拿政策轉彎 「有立委喬事 衛署屈服」【2012/04/16 聯合報】           推拿人員退出中醫診所政策大轉彎，衛生署長邱文達和前署長楊志良不同調。楊昨天聽聞此結果，僅表示「不在其位，不謀其政」，但也盼中醫界能自我提升，不要「自甘墮落」。   坊間推拿人員絕大多數是師徒相授，都不是取得證照的醫事人員，楊志良擔任衛生署長的時候，決心整頓中醫院所，除了要求中醫師親自為病人推拿，同時訂下兩年緩衝期，期限一到，中醫診所裡的推拿人員，就須全面撤離，否則一律以「密醫」認定。   據衛署官員透露，近幾個月來，中醫界、推拿師自救會和部分藍綠立委聯手，不斷舉行公聽會和協調會，甚至擬大筆刪減衛署預算。執政黨立院黨團某有力人士居間穿梭，尤其讓衛署高層難以招架，最後選擇承認現狀，即推拿人員可在獨立的民俗調理區，繼續為自費病人服務。   對此，楊志良表示，推拿原先被衛署認定為醫療行為，理應由取得國家證照的醫師執行，這是為民眾健康把關；且衛署也協調勞委會和經濟部，未來可舉辦類似「丙級按摩士」的推拿人員技能檢定，推拿人員仍能從事民俗調理工作，並未置他們生計於不顧。   「接任署長也許另外有考量，我也不方便再說什麼。」但是話鋒一轉，楊志良說，中醫界對於推拿人員何去何從，內部也有不同意見，但從長遠看，中醫應自我提升服務品質，而不是讓少數中醫師維持既得利益，如果「有人願意自甘墮落，我也沒話說。」  

台北市衛生局 查緝團購醫療廣告…

揪團搶醫療好康 團購網挨罰   〔記者陳璟民／台北報導〕團購網站刊登醫療廣告違反醫療法，台北市衛生局醫護管理處今年已查獲廿件，處罰六家業者共八案。其中，耐德科技公司（Shopping99）被罰了三件最多；耐德負責人陳昶任表示，出租網路平台供商品上架，本身並非販售商品的業者，正循程序申訴。  醫管處公布涉違反醫療法而受處分的，除了耐德，還有英屬維京群島商台灣集購城（jigocity）、視野價值資訊有限公司（17shopping）、激光診所、依蝶兒美容有限公司、凱渥診所，各被裁罰五至十二萬元不等。  陳昶任說，耐德僅出租網路平台，也已經提醒業者並嚴格過濾上架商品，要求須遵守法規，一旦查獲違法，商品就下架，他希望衛生局具體告知怎樣才算合法的廣告標示、敘述。  衛生局主任秘書姜郁美說，依法只有醫療機構才能刊登廣告，且醫療廣告不能有贈送行為。  醫管處處長劉越萍指出，近年盛行整形，團購網站平台提供醫療機構以團購名義公開販售療程及諮詢券，但例如「…三堂只要五九九…折扣…三重循環淨化美白…」已經涉及違法。  衛生局四月起加強淨化團購網醫療廣告，專人專責每天監測違規醫療廣告，召集醫療機構及網站業者參與法規講習，還在網站設醫美訊息區宣導法令規定，五月中旬也將對醫療機構、團購網站進行教育訓練課程，也呼籲民眾若發現不法，踴躍檢舉。

40億美金!! 負壓創傷治療(negative pressure wound therapy, NPWT)市場

Burgeoning Market for Wound Care. April 16, 2012 Health Blog  By Laura Landro With the cost of chronic wound care rising, efforts are underway to improve prevention, early detection and treatment, as WSJ reports in today's special report on innovation in health care.  That's good news for the makers of wound-care products: Research firm Kalorama Information projects the global market will rise to nearly $21 billion in 2015 from $16.8 billion this year. Among the products expected to increase in use: negative pressure wound therapy which uses special dressings and vacuum technology to speed healing. London-based  GlobalData recently forecast that market will double to $4 billion by 2018 from $2 billion last year, with an increase in the use of single-use disposable devices and portable systems that can be used in home care.  Among the companies set to benefit, according to the research reports: KCI,  Smith & Nephew, ConVatec and Johnson & Johnson.  But with a gap in knowledge about the most effective treatments, the federal Agency for Healthcare Research and Quality last year awarded the Johns Hopkins Evidence-based Practice Center a $475,000 grant to review state-of-the-art wound care, determine what's known about medications, antibiotics, dressings and surgery, and establish strategies of care that are proven to work.  "There is a very limited amount of well-developed information about how you deal with wounds," co-investigator Dr. Gerald Lazarus tells the Health Blog. A dermatology professor and founder of the wound center at Johns Hopkins Bayview Medical Center, Lazarus says the focus of the review will be on chronic lower extremity wounds, which can be complications of leg ulcers and diabetes and can be exacerbated by obesity and poor nutrition.  But he expects what they learn to be applicable to other types of wounds such as pressure ulcers or bed sores, as well.  Close to seven million Americans suffer from chronic wounds and more than $25 billion is spent annually on their care, according to a 2009 study.  Among the issues that are debated in wound care is the role of antibiotics, which can promote development of resistant organisms in the wounds, and the most appropriate wound dressings, which range widely in price. Expensive oxygen chambers — known as hyperbaric therapy — are good for some kind of wounds, but may not be appropriate for all types, Lazarus says.  "Wounds that will not heal are frequently signs of larger and more complicated health problems, and can take a toll on patients far beyond the pain and discomfort of the wound," Lazarus says. "We always want to focus on what's best for the patient but with the runaway situation in health costs, there should be justification that the treatments being used have documented value."

Chin Implants Surge, Plastic Surgeons’ Group Says.

Health Blog April 16, 2012 By Laura Landro  Botox and breast augmentation remain the top cosmetic procedures in the U.S., but chin implants are the fastest-growing trend according to new data from the American Society of Plastic Surgeons.  The group, comprised of 7,000 physicians, says the number of chin implants grew 71% last year to 20,680. The procedures were about evenly divided between men and women, with the largest increase in patients 40 and older.  The group's president, Malcolm Z. Roth, suggests one reason may be the fact that more people see themselves on video-chat technology. "They may notice that their jaw line is not as sharp as they want to be."  Chin surgery, also known as mentoplasty, usually involves an incision inside the mouth or in the crease under the chin through which an implant made of silicon or another material is inserted in the soft tissue of the chin.  The procedure usually takes one to several hours and may be done under local or general anesthesia. ASAPS says the national average physician's fee is $1,851. The procedure is often performed with rhinoplasty, or nose reshaping, to achieve proportion.  David A. Hidalgo, a New York plastic surgeon, tells the Health Blog that many of his facelift patients get chin implants "in order to improve neck contour and relieve lip strain," or chin dimpling, that occurs in even modestly set-back chins. He also inserted a chin implant in a patient "to balance an overly projecting, but nicely shaped nose, thereby avoiding a rhinoplasty."  Hidalgo cautions: "Chin-implant selection should be conservative — nothing looks worse than one that is too large." And he also warns that patients with more severely recessed chins aren't good candidates for chin implants, which can result in bone erosion from pressure. An alternative is surgery to move the bone forward instead.