工笔花鸟简单图片大全:【medical

The scientist：2011年度医药新闻

中文翻译转载自 http://www.ebiotrade.com/

摘要：

　　新药的研发是一个非常复杂的过程，全面的学科知识、精明的监管及营销技巧，缺一不可。在过去的一年里，在新药的研发领域成功和失败的案例并存。12月20日，The Scientist（科学家）杂志发布了“Drug Headlines of 2011”，细数了2011年值得关注的药物研发进展。

新药的研发是一个非常复杂的过程，全面的学科知识、精明的监管及营销技巧，缺一不可。在过去的一年里，在新药的研发领域成功和失败的案例并存。12月20日，The Scientist（科学家）杂志发布了“Drug Headlines of 2011”，细数了2011年值得关注的药物研发进展。

值得关注的药物审批：

50多年来首个狼疮药物

2011年3月9日，美国食品与药物管理局（FDA）发布公告，批准Benlysta用于治疗狼疮。这是FDA在50多年来第一个批准的狼疮治疗新药。FDA在公告中指出，Benlysta（活性成分：belimumab）被批准用于治疗活动性、自身抗体阳性（系统性红斑狼疮）且正在接受标准治疗（包括类固醇皮质激素、抗疟药、免疫抑制剂和非甾体抗炎药）的狼疮患者。

Benlysta直接进入静脉（经静脉输注），是第一个被设计来抑制B淋巴细胞刺激因子（BLyS）的药物，它可以减少被认为是狼疮中一个问题的异常B细胞数量。

肝炎治疗的希望

2011年5月，FDA批准了顶点制药公司（Vertex Pharmaceuticals）公司的Incivek (telaprevir)和默沙东制药公司的（Merck’s Victrelis）的Victrelis (boceprevir)作为新一代丙肝治疗药物。这两种药物的适用人群为初治或既往接受过治疗但未获得持续病毒学应答(SVR)的患者(即复发者、部分应答者及无应答者)。此外。陆续可能还有更多的药物将获准治疗这一疾病：Gilead公司近期在丙肝市场放下大赌注，支付biotech Pharmasset公司月110亿美元进行交易。强生（Johnson & Johnson）和百时美施贵宝 (Bristol-Myers Squibb ）公司开发的鸡尾酒药物疗法即将于2010年启动III期临床试验。

新型抗癌药物

今年8月17日，FDA批准了基因泰克(Genentech)的Zelboraf (vemurafenib)用于治疗晚期或不可切除的黑色素瘤。Zelboraf特别适用于有基因BRAF V600E突变的黑色素瘤患者。Zelboraf获准的同时，FDA还批准了罗氏（Roche）首个用于检测cobas 4800 BRAF V600突变的检测方法，这一检测方法将有助于确定病人的黑色素瘤细胞是否存在BRAF V600突变。9天后，FDA又批准了辉瑞（Pfizer）的 Xalkori (crizotinib)胶囊，这是第一个对间变性淋巴瘤激酶（ALK）进行靶向治疗的药品，用于治疗通过FDA批准的检测方法诊断为ALK阳性的局部晚期或转移的非小细胞肺癌（NSCLC）。这些药物代表了“药物研发的一种新模式，对一部分明确诊断的患者给予明确的个体化治疗。”

药物撤销事件：

撤销抗癌药物Avastin治疗乳腺癌

FDA健康顾问委员会基于多年来的跟踪调查一致认为，罗氏（Roche）控股公司的抗癌药物阿瓦斯丁（Avastin）对于治疗乳腺癌是不安全的或不利于临床治疗的。该委员会通过投票决定，FDA将撤销其对抗癌药物阿瓦斯丁用于治疗乳腺癌的批准。

阿瓦斯丁在2008年获得了批准上市。旨在希望与标准的化学疗法结合可以延缓乳腺癌生长5个半月。作为加速审批程序的一部分，FDA要求罗氏运行了后续研究。但后来的研究发现，其对乳腺癌生长只能延缓1至3个月，且没有任何研究显示阿瓦斯丁队晚期乳腺癌患者的有延长生命的功效。一些患者也有严重的副作用，包括在胃和肠道出现严重出血和血块现象。

FDA将撤销阿瓦斯丁做为乳腺癌药物的批准，但仍然保持了其对结肠、肺、脑、肾等器官癌症治疗药物的批准。该公司表示，他们仍会进行后续研究，以证实阿瓦斯丁对乳腺癌的疗效。

Movectro撤回

今年6月，默克雪兰诺欧洲有限公司通知欧洲药品管理局（EMA），其决定撤回药物Movectro（克拉屈滨）10 mg片剂的欧盟上市许可申请。Movectro计划用于治疗复发-缓解多发性硬化症。

10年研发，Xigris被证实无效

10月，礼来（Eli Lilly）公司宣布从所有市场回收Xigris产品，因为该药物到达主要治疗目标：在28天治疗期间内大幅降低感染性休克病人的死亡率。

其他重大的医药新闻：

疟疾疫苗研制曙光乍现

期待已久的全世界首个大规模疟疾疫苗试验的一个较小范围的研究显示，这种名为“RTS,S”的疫苗能够提供部分的保护，减少疟疾在婴幼儿中一半的发病率。专家表示，尽管不如目前正在使用的大多数疫苗那样令人印象深刻，这种新的疫苗有助于显著减少因疟疾造成的大量死亡人数。

“RTS,S”是由比利时里克桑萨尔的葛兰素史克（GSK）生物制剂与PATH疟疾疫苗计划（MVI）合作研制的。它包含有一个能够与来自疟原虫的蛋白质片段相结合的基因工程蛋白质，以及有助于引发强烈免疫响应的来自乙型肝炎病毒的一种蛋白质。Ⅲ期临床试验，即最终的测试在撒哈拉以南非洲招募了超过15000名6到12周的婴儿，以及5到17个月的幼儿。10月19日，合作双方在资助该项试验的比尔和梅林达?盖茨基金会举行的一次会议上宣布了第一组数据，相关研究结果同时也在线发表于当天的《新英格兰医学杂志》网络版上。

失去专利保护

有一些重量级的药物将在2011年底专利到期。其中包括辉瑞公司的降胆固醇他汀类药物立普妥Lipitor (atorvastatin)，礼来公司（Eli Lilly）的抗精神病药物再普乐Zyprexa (olanzapine)以及强生公司（Johnson & Johnson）的注意力不足过动症治疗药物哌甲酯Concerta (methylphenidate)。

杰龙放弃干细胞研究

获得官方批准进行全球首例人类胚胎干细胞临床试验的美国杰龙(Geron)生物医药公司日前宣称，由于所需费用过高，他们已经决定终止这一试验。这一决定立刻引发慈善机构等希望从研究中受益的团体和个人的不满。

杰龙公司表示，在对人类胚胎干细胞临床试验成本进行战略评估后，他们决定终止这一里程碑式的研究项目。这家总部位于加州的公司此前首次获得美国联邦药物管理局批准，对脊髓伤害病人进行干细胞治疗临床试验，试验开始于2010年10月份，至今已有4位病人接受了试验治疗。

杰龙公司称，终止这项试验与安全问题无关，而是因为缺少资金以及“监管太过复杂”。他们将不再招收新的试验病人，但是将完成对那些已经接受试验的病人的治疗，这些病人每人都注射了200万个细胞。此后，杰龙公司会将重点转向癌症药物研究。

原文
http://the-scientist.com/daily/2011/12/20b.htm

Drug Headlines of 2011



A list of this year’s newsworthy successes—and failures—in drug development



By Hannah Waters |       December 20, 2011

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Wikimedia Commons, Ragesoss

Developing new medicines is tricky business, requiring sound science, regulatory savvy, and marketing skills. The past year has seen success and failure in all these realms. Here, The Scientist recounts some of the noteworthy drug developments of 2011.

Notable Drug Approvals:

First new lupus drug in 52 years

After more than 18 years of development, the US Food and Drug Administration (FDA) approved the first drug to treat lupus in more than a half-century. Benlysta (belimumab) is a human monoclonal antibody, produced by Human Genome Sciences and GlaxoSmithKline, that cuts B-cells proliferation, a proposed mechanism underlying the autoimmune disorder. The once-monthly injectable drug has limited efficacy, reducing the symptoms of 43 percent of patients compared to 34 percent of those on placebo in a Phase III trial, but nonetheless is a major advance for the disease with few approved treatments, reported The Wall Street Journal.

Hope for hepatitis

People with hepatitis C had cause for celebration with the approval of two new drugs for the liver-infecting virus. In May, the FDA approved Incivek (telaprevir) from Vertex Pharmaceuticals and Merck’s Victrelis (boceprevir). Both pills are protease inhibitors that interfere with the virus’s replication, and each “achieve what is effectively considered a cure” when combined with existing treatment, wrote The New York Times. Furthermore, it’s likely that there are more medicines to come for the disease: Gilead recently purchased the biotech Pharmasset and its hepatitis C pipeline for a staggering $11 billion, while Johnson & Johnson and Bristol-Myers Squibb have a drug cocktail up their sleeves, which will begin Phase III trials in 2012

New cancer drugs: gene-ie in a bottle

The FDA approved two mutation-specific cancer drugs in August alongside diagnostic tests for those mutations. Genentech’s Zelboraf (vemurafenib) for late-stage melanoma targets a specific mutation in the B-RAF oncogene that spurs cell growth, and is marketed with a companion diagnostic for the mutation from Roche. Nine days later, the FDA approved Pfizer’s Xalkori (crizotinib) for the 2-7 percent of people who have non-small-cell lung cancer and a mutation in the gene ALK, with a FISH probe for the gene made by Abbott. These drugs represent “a new paradigm for drug development, where a small but well-defined fraction of people get a very well-defined drug,” oncologist Paul Bunn of the University of Colorado Medical Center told the National Cancer Institute Cancer Bulletin.

Recent Drug Withdrawals:

Avastin nixed for breast cancer

Genentech’s Avastin (bevacizumab) had its breast cancer indication revoked in November, four months after an FDA advisory committee unanimously voted it down. The antibody administered with chemotherapy was originally approved for breast cancer in 2008 under the FDA’s accelerated approval program, but subsequent trial data suggested that the drug does not prolong length or quality of life for people with the disease. Genentech hasn’t given up yet, however: the company will begin a new Phase III trial of Avastin to identify a biomarker for those patients who do benefit from the therapy.

Movectro isn’t moving anywhere

In June, Switzerland’s Merck Serono (unaffiliated with the US-based Merck & Company) voluntarily withdrew Movectro (cladribine), the first oral pill for multiple sclerosis, as well as its regulatory applications to the FDA and the European Medicines Agency (EMA) after the FDA requested follow-up trials. The pill had already been approved in Australia and Russia but is no longer available.

Xigris doesn’t work—10 years late

After 10 years on the market, Eli Lilly announced in October that it was pulling its injection for the treatment of severe septic shock from the market. The recombinant human protein drotrecogin alfa, marketed as Xigris, did not increase survival in a follow-up Phase III trial initiated in 2008, and the company recommended that all patients on the drug stop taking it immediately. “While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use,” Lilly’s Chief Medical Officer Timothy Garnett said in a press release.

Other Big Drug News:

Promise for malaria vaccine



Flickr, US Army Africa

The RTS,S vaccine for malaria, built upon basic research from the 1960s and more than a decade of clinical development, cut the risk of infection by more than 50 percent after one year in babies aged 5-17 months. The results, released by GlaxoSmithKline in October, are the first batch from an international Phase III trial enrolling more than 15,000 children, with newborn (aged less than 12 weeks at time of vaccination) results expected in 2012 and full-trial data in 2014. The efficacy is modest compared with the typical high efficacy of childhood vaccines, but it’s better than nothing, Joe Cohen, head of the malaria vaccine project at GlaxoSmithKline, told ScienceNOW. “This vaccine will not be a magic bullet against what is a very, very difficult disease,” he said. “It is one weapon to be added to an arsenal of other interventions.”

Tumbling from the patent cliff

The end of 2011 saw the first of several blockbuster drugs lose their patent protection, falling off the proverbial patent cliff. Pfizer’s cholesterol-lowering statin Lipitor (atorvastatin) made the biggest splash, as the company worked to delay the yearly loss of $5 billion, as estimated by Daily Finance, by making deals with generic manufacturers. Other notable medicines that went off-patent in 2011 are Eli Lilly’s antipsychotic Zyprexa (olanzapine), which raked in more than $2 billion in 2010, and Johnson & Johnson’s drug for ADD/ADHD Concerta (methylphenidate), grossing nearly $1 billion in 2010.

Geron offs stem cell research

The pioneering stem cell treatment company Geron, which launched the first-ever clinical trial for human embryonic stem cell treatments in 2010, shut down its entire stem cell research unit in November, effectively ending its trial for spinal cord injury trial. Citing financial difficulty, the announcement came as a shock to researchers, raising doubts that the field of stem cell medicine has a future. “It’s certainly going to have a very chilling effect,” Robert Lanza, chief scientific officer at Advanced Cell Technology, the only other company currently engaged in clinical trials involving hESCs, told The Scientist. “There’s a lot of exciting potential here in this field, and it would just be a real shame for this not to move ahead full steam.”

[i]Correction: This story has been updated from its original version to state that Avastin is an antibody administered with chemotherapy, not chemotherapy itself. [/i]The Scientist[i] regrets the error.[/i]

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