(纽约时报30日讯)
「医疗照顾」（Medicare）周三宣布，计划缴付治疗前列腺癌药物Provenge的药费。这种由Dendreon公司生产的药物，定价为9.3万元，价钱之贵引发有关癌症药价格与效果的争论。
「医疗照顾」和「医疗补助」（Medicaid）服务中心在其网站上贴出的备忘录上宣布，Provenge对治疗其针对的相关阶段的前列腺癌患者来说，是一种「合乎情理和必要的」治疗方法。但没有证据显示，这种药对治疗其它阶段的前列腺癌也有效，因此不认为应为其他病人缴付这种药费。
由于这个提议的药费负担是根据医疗照顾一个顾问委员会去年11月的发现作出，因此早在意料之中。医疗照顾通常涵盖FDA批准的药物的费用。这个提议将公开接受公众评论，最终决定将在6月份作出。
这一决定引发部分争议。有证券分析师对Dendreon公司的投资者及病人维权人士指出，「医疗照顾」这一行动代表打击贵价药物的开始。但「医疗照顾」方面却断然否认这一说法，表示他们只是想统一付款政策，而不是将决定权下放给「医疗照顾」的地区合约商。他们还指出，由于Provenge代表的是一个疗程，从而产生一些独特的问题。
长期以来，一直有「医疗照顾」专家指出，社会不能继续负担那些只延长病人生命几个月的癌症药。在对Provenge的临床试验中，患有晚期前列腺癌的男性，在接受这种药后，可以存活的中位数约为26个月，比接受安慰剂的人多活4个月。
「医疗照顾」官员在周三的备忘录中表示，他们不会在全国一刀切禁止缴付该药说明用途外的使用情况，将决定权下放到地方的「医疗照顾」合约商。但医疗照顾官员表示，他们希望，所有这类说明用途外使用的情况仅限于临床试验。
Provenge获准用于癌细胞已扩散至前列腺外的男性，以及对降低男性激素疗法无效但病症很小或没有症状的病人。
Thursday, March 31, 2011
Friday, March 11, 2011
50年来首个红斑狼疮治疗新药在美国问世
美国食品和药物管理局(Food and Drug Administration, 简称FDA)批准了Human Genome Sciences Inc. 和葛兰素史克(Glaxosmithkline plc, GSK)的红斑狼疮新药Benlysta上市，这是50多年来首次开发出红斑狼疮治疗新药。
预计Benlysta会非常畅销，年销售额最终将超过10亿美元。Benlysta同时也是Human Genome Sciences开发的首个申请上市药物，该药的销售收入将由Human Genome Sciences与葛兰素史克分成。
预计Benlysta会非常畅销，年销售额最终将超过10亿美元。Benlysta同时也是Human Genome Sciences开发的首个申请上市药物，该药的销售收入将由Human Genome Sciences与葛兰素史克分成。
Tuesday, March 1, 2011
Great News for Seattle Genetics...and also for Celldex
February 28, 2011
* Analysis by: GLG Expert Contributor
* Analysis of: Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
* Published at: phx.corporate-ir.net
Summary
* The regulatory piping being laid with Seattle Genetics' brentuximab vedotin is excellent for the company's second leading drug candidate, CDX-011, a Celldex collaboration, that potentially treats a much larger market
Analysis
Background
Seattle Genetics submitted its biologics license application (BLA) to the FDA only about three months after reporting very robust results at the American Society of Hematology (ASH) meeting for its drug candidate brentuximab vedotin. The drug is an antibody drug-conjugate that targets anaplastic large cell lymphoma and Hodgkin’s lymphoma that had very robust results in the pivotal trial. It is proof-of-concept that the company’s core technology, antibody-drug conjugation, works. The company’s next furthest along drug candidate is CDX-011 (anti-GPNMB), in which it is partnered with Celldex.
Discussion
Celldex looks like it has a very promising treatment with Rindopepimut (CDX-110) -- the company has a real-time observable biological marker to know that their vaccine is working, good progression-free survival data, and a safety profile consistent with any standard vaccination. What I believe will make the company though is CDX-011.
Many industry scientists, even as recently as a year ago, did not believe that antibody-drug conjugation would work in the clinic. With Seattle Genetics submission of the BLA, what the CEO called a “very strong package”, the regulatory piping is being laid for the new class of drugs. Celldex's CDX-011, the initial indication of which will all but certainly be refractory metastatic breast cancer, has tremendous market expansion opportunities. Significantly more patients express the GPNMB marker than the HER2 breast cancer marker, the biomarker that essentially made Genentech. The data suggests the drug may be particularly efficacious in triple-negative (ER, PR, HER2 negative) patients, where current treatment modalities are limited.
http://glgroup.com/News/Great-News-for-Seattle-Genetics...an d-also-for-Celldex-52752.html
* Analysis by: GLG Expert Contributor
* Analysis of: Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
* Published at: phx.corporate-ir.net
Summary
* The regulatory piping being laid with Seattle Genetics' brentuximab vedotin is excellent for the company's second leading drug candidate, CDX-011, a Celldex collaboration, that potentially treats a much larger market
Analysis
Background
Seattle Genetics submitted its biologics license application (BLA) to the FDA only about three months after reporting very robust results at the American Society of Hematology (ASH) meeting for its drug candidate brentuximab vedotin. The drug is an antibody drug-conjugate that targets anaplastic large cell lymphoma and Hodgkin’s lymphoma that had very robust results in the pivotal trial. It is proof-of-concept that the company’s core technology, antibody-drug conjugation, works. The company’s next furthest along drug candidate is CDX-011 (anti-GPNMB), in which it is partnered with Celldex.
Discussion
Celldex looks like it has a very promising treatment with Rindopepimut (CDX-110) -- the company has a real-time observable biological marker to know that their vaccine is working, good progression-free survival data, and a safety profile consistent with any standard vaccination. What I believe will make the company though is CDX-011.
Many industry scientists, even as recently as a year ago, did not believe that antibody-drug conjugation would work in the clinic. With Seattle Genetics submission of the BLA, what the CEO called a “very strong package”, the regulatory piping is being laid for the new class of drugs. Celldex's CDX-011, the initial indication of which will all but certainly be refractory metastatic breast cancer, has tremendous market expansion opportunities. Significantly more patients express the GPNMB marker than the HER2 breast cancer marker, the biomarker that essentially made Genentech. The data suggests the drug may be particularly efficacious in triple-negative (ER, PR, HER2 negative) patients, where current treatment modalities are limited.
http://glgroup.com/News/Great-News-for-Seattle-Genetics...an d-also-for-Celldex-52752.html
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