1、病人死亡，FDA紧急终止基因治疗临床试验
在获悉一位病人死于一项腺病毒载体的临床试验后，FDA紧急终止了该临床试验的进行，并声称将对美国国内同样使用腺病毒载体进行基因治疗的28项临床试验进行重新评估。该周二，一名患者接受一项关节炎治疗药物的临床试验时意外身亡，试验组织单位--西雅图Targeted Genetics公司立刻向FDA通报了此事。
2、Schwan：Alnylam可能成为罗氏眼中的下一个“Genetech”
罗氏公司下任CEO，Severin Schwan说，“Alnylam制药公司或许将是罗氏公司在美国的下一个Genetech，为公司在生物技术领域开辟新的市场。” 罗氏公司近期刚刚和Alnylam公司签署了一项新药研发技术的授权协议，获得了研发药物的新技术平台。
3、FDA推迟审批Provenge引发激烈辩论
由于FDA推迟审批Dendrenon公司的前列腺癌药物Provenge触及了一些生物技术投资者和病***益组织的根本利益，引发美国国内的一场激烈辩论。反对人士通过举行抗议、写信辩论和博客等方式批评FDA的这项决定。而两位向FDA建议推迟审批的肿瘤专家也因此事被人怀疑是否清白。
4、研究人员发现压力导致肥胖的生物学机理
通过研究小鼠长期精神受压和高脂饮食的关系，研究人员发现了一个将压力和肥胖联系起来的神经化学通路。通过阻断该通路可以阻止小鼠体内的脂肪堆积，减少脂肪存储。研究人员希望在今后两年开始在人体上的类似试验。
5、美国众议院通过专利改革方案
美国众议院通过了一项专利改革方案，旨在将专利诉讼案流程化。该法案受到制药行业的反对，但是受到技术部门的支持。该法案和今天被提交参议院讨论的另外一项法案类似。
6、美国国会同意FDA的立法，跳过“后继生物药”
美国众议院以压倒性优势通过了一项法案，赋予FDA更大的权力来进行药品上市后的监管，并且要求制药企业在未来五年向FDA多交2.25亿美元的审批费用。但是在参议院的另一个类似法案中，FDA并没有得到审批“后继生物药”的权限。
7、诺华意欲进行更多收购
瑞士诺华制药公司声称将进行更多收购来增加产品供应，或者直接收购开发医疗产品的公司。诺华最近刚刚购买了一个治疗尼古丁瘾的疫苗所有权，并且将花费8.9亿美元进行两个肿瘤药物的研发。
8、自力更生，礼来进军生物技术领域
通过自己搭建产品流水线而不是进行收购，礼来正向生物技术行业进军并计划在该行业建立自身的优势地位。今年，礼来公司进入临床试验的药物一半是生物技术药物。公司计划自2011年起，每年有一个生物技术药物上市。
9、合成生物技术成为生物技术领域新的焦点
毫无疑问，目前生物技术领域内的“常规武器”是基因工程，而新型“武器”将是对整个基因组进行改造的合成生物学技术。创造第一个合成细胞并不是在创造生命，而更像是对基因进化程序的复制。
10、《今日美国》整理出25大医药事件
《今日美国》的25大医学事件包括艾滋病和肥胖的流行，他汀类药物的研发和肿瘤筛查的增加，还包括医学技术的发展，如PCR技术，自动体外除颤器和腹腔镜外科手术。
1) FDA halts gene therapy clinical trial after patient death
The agency suspended a gene therapy study and said it's reviewing the safety of 28 other U.S. gene therapy studies that are using the same virus, called adeno-associated, after learning of a patient's death. Seattle-based Targeted Genetics Corp. notified the agency of the death, which occurred Tuesday during a clinical trial of an inflammatory arthritis drug candidate. Washington Post, The (07/26) New York Times, The (07/27)
2) Schwan: Alnylam could be next Genentech for Roche
Severin Schwan, in line to be Roche Holding's next CEO, says Alnylam Pharmaceuticals could become Roche's "second Genentech" in the U.S. and "opens up a new front in biotechnology" for the company. Alnylam, which recently signed a drug-development licensing deal with Roche, "offers us entry to a new technology platform to develop medications," Schwan said. Forbes (07/22)
3) Provenge delay sparks intense debate
Debate over the FDA's delay in approving Dendreon Corp.'s prostate cancer drug reflects the interests and stakes of biotech investors and patient advocacy groups, who have launched protests, letter-writing campaigns and blogs to criticize the agency's move. Two cancer specialists who recommended the FDA delay approval also have been criticized for their role in the process. Washington Post, The (07/06)
4) Researchers find biological switch linked to stress, obesity
Researchers looking at the relationship between chronic stress and a high fat diet in mice have found a neurochemical pathway that links stress to obesity. The team says blocking signals prevented fat accumulation and shrank fat deposits in mice experiments, and they hope to begin trials in people within two years. ClipSyndicate (07/03) Washington Post, The (07/02)
5) House committee approves patent reform bill
A patent reform bill opposed by the drug industry but supported by the technology sector was cleared for a vote by the full House. The legislation, aimed at streamlining the process for patent lawsuits, is similar to a bill due for consideration today in a Senate committee. Wall Street Journal, The (subscription required) (07/19) Boston Globe, The (07/19) International Herald Tribune (07/18)
6) House approves FDA legislation, skips follow-on biologics
The U.S. House of Representatives overwhelmingly approved a bill giving the FDA more authority for post-approval monitoring and requiring drug companies to pay an additional $225 million in user fees over five years. The House bill differs from a similar Senate bill in that it does not provide a path for FDA approval of follow-on biologics. Wall Street Journal, The (subscription required) (07/12) Reuters (07/11)
7) Novartis expresses interest in more takeovers
The Swiss pharmaceutical acknowledged it is interested in more takeovers to strengthen its portfolio and will look to buy companies that make health care products. Novartis AG recently bought rights to an experimental vaccine to fight nicotine addiction and said it will spend up to $890 million on two experimental cancer drugs. Financial Times (subscription required) (07/18) Bloomberg (07/17)
8) Lilly enters biotech business from within, not acquisitions
Eli Lilly is getting into the biotech business by building its own pipeline, rather than through acquisitions, and is working to establish itself as a major presence in the industry. The company said half of its new drugs entering trials this year will be biologics and it plans to bring a new biotech product to market every year starting in 2011. Wall Street Journal, The (subscription required) (07/31)
9) Synthetic biology emerging as new biotech focus
Now that genetic engineering has become routine in the biotech world, the new scientific attraction is synthetic biology that can change entire genomes. Efforts to create the first synthetic cell are likely to be seen not as creation of new life but as copying the genetic programming of evolution. New York Times, The (07/08)
10) Top 25 medical events, developments compiled by USA TODAY
USA TODAY's top 25 medical events include the HIV/AIDS and obesity epidemics, the development of statins, and an increase in cancer screenings. Also included were advances in medical technology, such as the polymerase chain reaction, automatic external defibrillators and laparoscopic surgery. USA TODAY (07/16)
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