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2014-8-5国际信息信息大荟萃
1、从未作临床试验的抗埃博拉病毒新药临危受命
综合媒体报道，研发治疗埃博拉病毒药物可能出现突破，在西非染病的2名美国医护人员情况有好转，全靠一种仍在临床试验阶段的新药物。由于有关药物从未在人体正式试验，能否成功令埃博拉病毒疫情受控仍有待观察。
在西非染病的2名美国医护人员情况有好转。
美国医生布兰特利和女医护怀特博尔，在利比里亚治疗埃博拉患者时受到感染。美国传媒报道，布兰特利上月底染病以来一直感到不适，上周四注射了一剂，从未作临床人体试验的新药，病情在约一小时后突然好转。布兰特利返抵美国后再次注射新药，目前情况良好。 另一名即将返抵美国的教会义工里特博尔，早前接受新药后亦明显好转。令控制埃博拉病毒疫情出现转机。 有关药物是从感染埃博拉病毒的老鼠产生抗体后，提取老鼠血液制成，可以阻止埃博拉病毒进入及感染新细胞，过去只在猴子身上试验。研发公司的报告指，4只感染埃博拉病毒的猴子，24小时内用药全部痊愈，另外2只猴子在染病后48小时内用药亦告痊愈，有一只染病猴子并没有用药，5天后死亡。 这种实验药物首次用于人类身上，暂时效果看来令人鼓舞，但有传染病专家称仍需小心研究。新药始终未获准在人类身上使用，即使情况紧急，因未经申请，仍可能违反美国食品及药物管理局规定，但有关规定未知是否适用于美国境外地区。
2、百特Flexbumin（软袋装人血白蛋白）获FDA批准 发布日期：2014-08-05 来源：新药汇
百特Flexbumin（软袋白蛋白，5%溶液）获FDA批准。Flexbumin是全球首个也是唯一一个软袋白蛋白，也是全球首个迄今唯一获低碳认证的医疗产品。
百特国际（Baxter International）8月4日宣布，Flexbumin（软袋人血白蛋白，USP，5%溶液）获FDA批准，该药的适应症包括：常见原因导致的血容量不足（hypovolemia）、低白蛋白血症（ hypoalbuminemia ）、烧伤、心肺旁路手术患者。此次批准，扩大了Flexbumin的产品组合，规格包括：5%溶液（250ml），25%溶液（50ml），25%溶液（100ml）。Flexbumin是全球首个及唯一一个软袋白蛋白，同时也是全球首个、迄今唯一获低碳认证的医疗产品。百特计划在今年晚些时候在美国推出Flexbumin（5%溶液）新品。与传统瓶装白蛋白相比，Flexbumin软袋白蛋白带来了更多的应用利益，包括：（1）升级为闭合输注系统，降低中心静脉导管相关输液感染风险；（2）缩短输液准备时间达40%，减少操作失误；（3）抗摔抗压，可以避免高值药品的损耗；（4）质量轻40%，体积小60%，可以降低运输和仓储成本；（5）医用废物处置成本比瓶装白蛋白减少88.2%。闭合式输液系统极大地提高了静脉输液的安全性，是目前临床输液的发展方向。Flexbumin采用了百特专有的Galaxy柔性容器，该容器采用了Galaxy专利膜，由4层特殊结构层组成，实现了白蛋白溶液从瓶装升级为软袋装的历史性突破。英文原文：FDA Approves Baxter's FLEXBUMIN 5%, First and only 5% Human Albumin Solution in a Flexible Container Unique Flexible Container Offers Enhanced Safety, Efficiency, and Sustainability FeaturesDEERFIELD, Ill., AUGUST 4, 2014 - Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved FLEXBUMIN® [Albumin (Human)], USP, 5% Solution. FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery.This approval expands Baxter's FLEXBUMIN product portfolio to include both 5% in a 250 mL solution and 25% in 50 and 100 mL solutions. FLEXBUMIN is the first and only preparation of human albumin to be packaged in a flexible plastic container. The new FLEXBUMIN 5% solution will be available to U.S. customers later this year.The FLEXBUMIN flexible, shatterproof container offers unique safety features for hospitals by eliminating risk of glass breakage and affords the ability to infuse without a vented administration set. In addition, FLEXBUMIN 5% solution provides efficiency features for healthcare professionals through its streamlined three-step administration process, lighter weight and reduced space requirements compared to glass containers of equal volume, making it more compatible with hospital inventory storage systems."Human albumin is essential for hospitals in providing care to surgical, trauma and other critically ill patients," said Ron Lloyd, head of Baxter's BioTherapeutics business. "Our customers value the benefits of having this treatment available in a flexible container that more efficiently meets their needs for reduced waste and improved safety."FLEXBUMIN uses Baxter's GALAXY® flexible container, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature. The GALAXY container, which employs barrier technology and a continuous aseptic filling process, has been used in the United States for more than 16 years to package pharmaceutical products. The flexible infusion system allows for simple administration steps with a non-vented administration set.Compared with glass bottles of equal volume, shipping containers for FLEXBUMIN 5% contain approximately 45% less packaging materials and empty containers are 95% lighter, resulting in less waste.about FLEXBUMIN 5%
FLEXBUMIN 5% [Albumin (Human)] 5% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration.FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime.
3、勃林格殷格翰-礼来糖尿病复方药Jentadueto标签处方信息更新
勃林格-礼来糖尿病联盟更新降糖复方药Jentadueto美国处方信息，纳入IV期临床数据。该药是利拉利汀和二甲双胍复方药，于2012年获FDA批准。
勃林格殷格翰-礼来糖尿病联盟8月4日宣布，糖尿病药物Jentadueto片（利拉利汀/盐酸二甲双胍）美国处方信息更新，纳入了一项为期24周的IV期临床数据：与利拉利汀（linagliptin）单药相比，利拉利汀+二甲双胍复方疗法使高基线A1C水平（糖化血红蛋白）初治2型糖尿病成人患者的血糖水平取得了统计学意义的显著下降。该IV期临床试验是一项24周、随机、双盲研究，在高基线A1C水平（8.5%≤A1C≤12.0%）的初治2型糖尿病成人患者中开展，评价了利拉利汀（5mg/天）+二甲双胍（1500-2000mg/天）复方疗法（n=159）相对于利拉利汀（5mg/天）单药疗法（n=157）的疗效和安全性。研究的主要终点是，经过24周治疗后A1C水平从基线的变化。数据表明，利拉利汀+二甲双胍复方组A1C水平从基线下降2.9%，利拉利汀单药组A1C水平从基线下降2.0%，数据具有统计学显著差异。关键次要终点方面，与利拉利汀单药组相比，利拉利汀+二甲双胍复方组空腹血糖（FPG）取得了统计学意义的显著下降（FPG：54mg/L vs 35mg/L），复方组有更多的患者实现A1C≤7的目标（54% vs 30%）；研究者定义的低血糖事件在2个治疗组相似（复方组1.9%，单药组3.2%）。该项研究中，初治成人患者的定义为，在进入随机化治疗前的12周，患者未接受任何降糖疗法。利拉利汀（linagliptin）在美国的品牌名为Tradjenta，该药为每日一次的5mg片剂，结合饮食和运动，用于改善2型糖尿病（T2D）患者的血糖控制。该药不适用于1型糖尿病及糖尿病酮症酸中毒的治疗。利拉利汀/盐酸二甲双胍复方药的品牌名为Jentadueto，该药是一种处方药，于2012年1月获FDA批准，适用于适合利拉利汀和二甲双胍治疗的2型糖尿病患者。Jentadueto不适用于1型糖尿病及糖尿病酮症酸中毒的治疗。Jentadueto的标签附有一个黑框警告，指示乳酸性酸中毒风险。英文原文： Type 2 diabetes: Jentadueto® (linagliptin and metformin hydrochloride) tablets label updated to include new data on blood glucose reductions in treatment-naive adults with high baseline A1C- Combination of linagliptin and metformin significantly reduced blood glucose levels compared with linagliptin aloneRIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 4, 2014 /PRNewswire/ -- The U.S. Prescribing Information for Jentadueto® (linagliptin and metformin hydrochloride) tablets now includes clinical trial data that showed linagliptin co-administered with metformin provided statistically significant decreases in blood glucose compared with linagliptin alone in treatment-naive* adults with type 2 diabetes and high baseline A1C levels (A1C of > /=8.5 to < /=12.0 percent). Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) announced today that the data, based on results from a prospective 24-week phase IV clinical trial, have been added to the "Clinical Studies" section of the JENTADUETO U.S. Prescribing Information."We are extremely pleased with the addition to the JENTADUETO label. These data support the use of JENTADUETO as an initial type 2 diabetes treatment option in an important patient population - treatment-naive adults who have high baseline A1C levels," said Christophe Arbet-Engels, M.D., Ph.D., vice president, metabolic clinical development and medical affairs, BIPI. "In addition, these data reinforce the use of JENTADUETO, as an adjunct to diet and exercise, in helping adults with type 2 diabetes improve glycemic control."The 24-week, randomized, double-blind study assessed the efficacy and safety of linagliptin (5 mg per day) in combination with metformin (1500 to 2000 mg per day; n=159) vs. linagliptin (5 mg per day; n=157) alone in treatment-naive adults with type 2 diabetes and high baseline A1C (A1C of > /=8.5 to < /=12.0 percent).The primary endpoint of the trial — change from baseline in A1C after 24 weeks — demonstrated that initial therapy with the combination of linagliptin and metformin reduced A1C levels from baseline by 2.9 percent compared with 2.0 percent for linagliptin alone. There was a statistically significant mean difference in A1C between the combination and linagliptin alone of -0.84 percent. Key secondary findings showed fasting plasma glucose (FPG) levels were significantly decreased with the combination treatment compared with linagliptin alone (54 mg/dL vs. 35 mg/dL, mean difference -18 mg/dL) and that a greater percentage of patients achieved an A1C less than 7 percent with the combination of linagliptin and metformin (54 percent) compared with linagliptin alone (30 percent). The percentage of patients with investigator-defined hypoglycemic events was similar between treatment arms (linagliptin and metformin, 1.9 percent; linagliptin, 3.2 percent).*note: Treatment-naive adults in this study were defined as adults with no antidiabetic therapy for 12 weeks prior to randomization.Please see full Prescribing Information for JENTADUETO, including Boxed Warning regarding the risk of lactic acidosis, and Medication Guide.about Linagliptin
Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA has not been studied in patients with a history of pancreatitis.about Linagliptin/Metformin HydrochlorideLinagliptin/metformin hydrochloride, which is marketed as Jentadueto® (linagliptin and metformin hydrochloride) tablets in the U.S., is a prescription medicine that contains two diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to improve glycemic control in adults with T2D when treatment with both linagliptin and metformin is appropriate. JENTADUETO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JENTADUETO has not been studied in patients with a history of pancreatitis. The JENTADUETO label contains a Boxed Warning for the risk of lactic acidosis, a rare, but serious, complication that can occur due to metformin accumulation during treatment with JENTADUETO.JENTADUETO was approved based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of JENTADUETO was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects.What is JENTADUETO?
JENTADUETO is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.JENTADUETO is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
4、Abbvie脑癌单抗新药ABT-414获FDA和EMA孤儿药认定 发布日期：2014-08-05 来源：marketwatch
美国Abbvie制药公司8月4日宣布，公司旗下在研的脑癌新药ABT-414同时获得美国食品药品监督管理总局（FDA）和欧盟药监局（EMA）的孤儿药认定。
孤儿药认定适用于治疗罕见疾病的药物。美国FDA和欧盟EMA的孤儿药认定给相关公司税收优惠以及7年专利保护。 ABT-414是一种实验性表皮生长因子受体抗体（anti-EGFR）的单抗药物，适用于多形性成胶质细胞瘤的治疗。目前正处于临床I期研究。 多形性成胶质细胞瘤是最为常见也是致死率最高的一种脑肿瘤，其发病率为2-3人/100,000人，5年存活率低于4%。该疾病目前并无有效的治疗手段。
AbbVie Receives EMA and FDA Orphan Drug Designation for Investigational Compound ABT-414 in the Treatment of Glioblastoma Multiforme- Results from Phase I program in glioblastoma multiforme presented at ASCO earlier this year
NORTH CHICAGO, Ill., Aug. 4, 2014 /PRNewswire/ -- AbbVie /quotes/zigman/13067932/delayed/quotes/nls/abbv ABBV +1.54%today announced the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme.1 Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Each year in the U.S. and Europe, two to three out of every 100,000 people are diagnosed with glioblastoma multiforme, which has a five year survival rate of approximately four percent.2"The orphan drug designation is an important regulatory advancement as we further our development in recurrent glioblastoma multiforme, a disease that is uniformly fatal with limited treatment options," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "We are pleased to continue developing ABT-414 in Phase II trials in patients with glioblastoma multiforme based on the results of our Phase I program."Results from the Phase I clinical program evaluating ABT-414 in patients with recurrent or unresectable glioblastoma multiforme were presented at the 50th American Society of Clinical oncology (ASCO) meeting in Chicago earlier this year.3about Orphan Drug Designation Orphan drug designation is a status assigned to a medicine intended for use in rare diseases.4 In the U.S., the Orphan Drug Designation program provides orphan status to medicines intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. or that are not expected to recover the costs of developing and marketing a treatment.5 In Europe, a medicine must meet similar criteria to be granted orphan status. The criteria include that the medicine must be intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of up to five in 10,000, and the intended medicine must aim to provide significant benefit to those affected by the condition.4 Orphan status provides sponsors with development and commercial incentives for designated compounds and medicines.The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval for an investigational use. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.about AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit [url]www.abbvie.com . Follow @abbvie on Twitter or view careers on our Facebook or linkedIn page.[/url]about ABT-414 ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate (ADC) being evaluated for the treatment of patients with various cancer and tumor types. As an ADC, ABT-414 is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells. Developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics, ABT-414 is currently being investigated for the treatment of glioblastoma multiforme, the most common and most aggressive malignant primary brain tumor. ABT-414 is also in clinical trials for the treatment of patients with squamous cell tumors. ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA.about Glioblastoma Multiforme Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Prior to diagnosis, most patients experience a serious symptom of glioblastoma multiforme, such as a seizure.6 Typically patients succumb to the disease approximately 15 months after diagnosis.2,6 Treatment for glioblastoma multiforme remains challenging and no long-term treatments are currently available. Standard treatment is surgical resection, radiotherapy and concomitant adjunctive chemotherapy.2about AbbVie oncology AbbVie's oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. Our oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. For more information on AbbVie oncology and our oncology portfolio, please visit [url]http://oncology.abbvie.com .[/url]1 [url]http://clinicaltrials.gov/ct2/show/NCT01800695?term=ABT-414&rank=1
2 National Brain Tumor Society web site. "Tumor Types." http://www.braintumor.org/brain- ... blastoma-multiforme . Accessed April 22, 2014.
3 http://abstracts.asco.org/144/AbstView_144_133972.html
4 European Medicines Agency web site. "Orphan Designation." http://www.ema.europa.eu/ema/ind ... =WC0b01ac05800240ce . Accessed June 5, 2014.
5 U.S. Food and Drug Administration web site. "Regulatory Information: Orphan Drug Act." http://www.fda.gov/regulatoryinf ... drugact/default.htm . Accessed June 11, 2014.
6 American Brain Tumor Association. (2012) "Glioblastoma and Malignant Astrocytoma." http://www.abta.org/secure/glioblastoma-brochure.pdf Accessed March 6, 2014.[/url]SOURCE AbbVieCopyright (C) 2014 PR Newswire. All rights reserved
5、BMS与Allied Minds成立合资公司 专注早期创新
百时美施贵宝与Allied Minds成立合资公司，专注于将早期学术创新转化为候选药物用于临床研究。
百时美施贵宝（BMS）和Allied Minds公司8月4日宣布，双方联合创建合资公司Allied-Bristol生命科学公司，该合资公司将专注于将来自全美一流大学及研究机构的早期创新，向药物研究及临床前开发转化。Allied-Bristol生命科学公司将专注于高效和有效地将高效科研机构的发现转化为候选药物，用于临床开发，并最终获批用于解决严重的疾病。对于合资公司确定的项目，高校科研人员将能够获取百时美施贵宝的药物发现专业知识以及Allied Minds公司的财务和管理经验。根据协议条款，双方已共同成立并资助Allied-Bristol生命科学公司，该合资公司将与高校研究人员合作，鉴定具有治疗和商业潜力的重大发现，同时为这些早期的机会提供必要的研发支持，将其从最初的可行性向临床前候选药物推进。此外，Allied Minds和百时美施贵宝还将联合成立新的公司，来开展可信性研究和全期（all-phase）发现项目。根据事先约定的条款，一旦某个项目成功鉴定出一种临床前候选药物，百时美施贵宝将拥有收购来自Allied-Bristol生命科学公司的选择权。Allied Minds是一家创新的美国科学和技术开发及商业化公司，自2006年运营以来，该公司一直从事创立、资助、管理和构建基于美国知名大学和联邦政府科研机构开发的创新技术的产品和业务，该公司已与全美超过33所著名大学和美国国防部和能源部下属32个联邦研究中心和实验室达成合作。目前，Allied Minds在美国运营18家公司。英文原文： Allied Minds and Bristol-Myers Squibb Form New Enterprise to Advance Discoveries of Biopharmaceutical Innovations at Leading U.S. Academic Research InstitutionsAllied-Bristol Life Sciences LLC to identify and speed development of promising science and technologiesUnique collaboration focused on transforming early-stage academic innovation to therapeutic candidates for clinical studyMonday, August 4, 2014 2:00 am EDTBOSTON & NEW YORK--(BUSINESS WIRE)--Allied Minds (LSE: ALM) and Bristol-Myers Squibb Company (NYSE: BMY) today announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the U.S.Allied-Bristol Life Sciences LLC will focus on efficiently and effectively converting discoveries from university research institutions into therapeutic candidates for clinical development, and ultimately approved therapies that address serious diseases. For programs identified by the new enterprise, university researchers will be able to access Bristol-Myers Squibb’s drug discovery research expertise, and Allied Minds’ financial and management experience.“The innovations developed in U.S. research institutions represent an important resource for scientific advancement, as well as economic development and financial returns,” said Chris Silva, Chief Executive Officer of Allied Minds. “Our partnership with Bristol-Myers Squibb combines complementary strengths, resources, reach and expertise to create an exciting new paradigm in the drug development space.”“Allied-Bristol Life Sciences LLC brings together cutting-edge ideas, BioPharma experience and drug discovery expertise focused on maximizing the potential of new scientific approaches to addressing serious disease,” said Carl Decicco, senior vice president and Head of Discovery, Bristol-Myers Squibb. “We believe this new venture will enhance the translation of early-stage academic research and will ultimately help advance important potential new medicines more efficiently.”Under the terms of the agreement, the companies have jointly formed and funded Allied-Bristol Life Sciences LLC, which will work with university researchers to identify discoveries it believes has promising therapeutic and commercial potential, and will support the research and development needed to take these early-stage opportunities from initial feasibility to pre-clinical candidacy. Allied Minds and Bristol-Myers Squibb together will form and fund new companies to conduct feasibility and full-phase discovery programs. once a program succeeds in identifying a pre-clinical candidate, Bristol-Myers Squibb will have the option to acquire the company from Allied-Bristol Life Sciences LLC under pre-agreed terms.about Allied MindsAllied Minds (LSE: ALM) is an innovative U.S. science and technology development and commercialization company. Operating since 2006, the company forms, funds, manages and builds products and businesses based on innovative technologies developed at leading U.S. universities and federal research institutions. Allied Minds serves as a diversified holding company that supports its businesses and product development with capital, central management and shared services. More information about the Boston-based company can be found at www.alliedminds.com.Allied Minds’ investment model is to form, fund, manage and build companies and jobs for the long term. The company takes a majority ownership stake in each business it establishes, and provides funding and central management so that it’s intimately involved at each stage of strategy and growth. Allied Minds currently works with more than 33 leading universities, several of which exceed $1 billion each in annual research spending, as well as 32 federal research centers and laboratories managed by the U.S. Departments of Defense and Energy on a similar commercialization structure. It currently has 18 operating companies in the U.S.
6、GSK在美国推出糖尿病新药Tanzeum（albiglutide）
葛兰素史克在美国推出糖尿病新药Tanzeum，该药为胰高血糖素样肽-1（GLP-1）受体激动剂，每周皮下注射1次，于2014年4月获FDA批准。
葛兰素史克（GSK）近日宣布，在美国推出糖尿病新药Tanzeum（albiglutide），该药为每周一次的皮下注射药物，辅助饮食和运动，用于改善2型糖尿病成人患者的血糖控制。Tanzeum于2014年4月获FDA批准，该药的获批，是基于全面III期Harmony项目的数据，该项目包含8项试验，涉及超过5000例患者，其中有超过2000例患者接受了Tanzeum的治疗。Harmony项目在不同阶段2型糖尿病患者群体中评估了albiglutide相对于常规2型糖尿病药物（包括胰岛素、二甲双胍、格列美脲、吡格列酮）的疗效和安全性。Albiglutide为胰高血糖素样肽-1（GLP-1）受体激动剂，这是一种生物制品，开发用于2型糖尿病的治疗，每周皮下注射1次。该药与诺和诺德的Victoza、百时美施贵宝（BMS）和阿斯利康（AstraZeneca）Amylin单元的Byetta及Bydureon属于同一类注射型人胰升血糖素样肽-1（GLP-1）药物。Albiglutide最初由人类基因组科学公司（HGS）研发。GLP-1是一种重要的肠促胰岛素激素，帮助恢复正常的血糖水平。在欧盟，albiglutide于2014年3月获欧洲药品管理局（EMA）批准，品牌名为Epenzan。英文原文： GSK's Tanzeum? is now available in pharmacies in the U.S.PHILADELPHIA, July 29, 2014 /PRNewswire/ -- GSK (LSE/NYSE: GSK) today announced that once-weekly Tanzeum (albiglutide), a prescription injectable treatment for type 2 diabetes in adults, as an adjunct to diet and exercise, is now available in pharmacies throughout the U.S.Cheryl MacDiarmid, Vice President of GSK's General Medicine business said, "With approximately 21 million adults diagnosed with diabetes in the US1, and up to 95 percent of those patients living with type 2 diabetes, we're excited that for the appropriate patients Tanzeum is now available as a treatment option for healthcare professionals."Tanzeum, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a once weekly option for patients, in combination with some other glucose-lowering medicines. The medicine was approved by the FDA on April 15, 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Tanzeum is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Tanzeum has not been studied in patients with a history of pancreatitis. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Tanzeum is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. Tanzeum is not a substitute for insulin in these patients. Tanzeum has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of Tanzeum is not recommended in patients with pre-existing severe gastrointestinal disease. Tanzeum has not been studied in combination with prandial insulin.MacDiarmid continued, "GSK has a commitment to taking a responsible approach to pricing. Tanzeum has been priced in line with this commitment."about diabetes
Diabetes is a global epidemic, affecting 382 million individuals globally, almost 21 million of whom are in adults the US.1,2 Up to 95% of these patients have type 2 diabetes.1 Type 2 diabetes is a life-long, progressive and, in some cases, preventable condition characterized by high blood sugar levels, known as hyperglycemia. A lack of physical activity, obesity, increasing age, high blood pressure and genetics are known risk factors that can contribute to the development of type 2 diabetes3,4about Tanzeum? (albiglutide)
Tanzeum is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
7、Biota流感药物辛酸拉尼米韦2期试验遭遇失败 公司市值下跌近50% 发布日期：2014-08-05 来源：新药汇 Biota制药自从其主要的项目暂停后持续低迷，该项目是一个治疗流感的药物叫做辛酸拉尼米韦，在中期研究中未能击败安慰剂，公司股价因此跌至有史以来的最低点。
澳大利亚制药公司Biota自从其主要的项目暂停后，上周持续低迷，该公司透露该项目是一个治疗流感的药物叫做辛酸拉尼米韦，在中期研究中未能击败安慰剂，公司股价因此跌至有史以来的最低点。2期临床试验涉及638例患者，研究主要终点是减轻流感症状所需的时间，这方面无论是40mg或80mg剂量的辛酸拉尼米韦都无法显著击败安慰剂。这种药物是一种神经氨酸酶抑制剂，该公司指出其已经通过了一些次要目标，并且具有类似于安慰剂的安全性。这次最新的挫折让Biota这一年充满了挑战。去年秋天，该公司暂停了一个临床前抗生素的工作，以更好地专注于辛酸拉尼米韦的研发，并获得了由联邦生物医学高级研究与发展管理局（BARDA）提供的2.31亿美元的合同。但在今年四月，BARDA暂停了这笔交易，使得Biota的项目搁浅，迫使这家澳大利亚公司裁掉2/3的员工。幸运的是由于Biota在2003年与Daiichi Sankyo公司达成交易，辛酸拉尼米韦已经在日本上市，名为Inavir。Biota仍持有该药物在全球其他地区的销售权，但首席执行官Plumb表示，鉴于该药2期的失败，该公司正在重新考虑其全球战略。“我们预计将在未来几个月完成更多的临床，安全性和药代动力学数据，并对试验数据进行充分的分析，”Plumb在一份声明中称，“不过，此时我们没有任何计划推动LANI作为流感药物独立发展，并准备与我们的合作伙伴Daiichi Sankyo公司评估LANI在日本以外的下一步计划。”辛酸拉尼米韦的在2期试验阶段的失败使得Biota的股价在8月1日下跌了29%，自BARDA交易停止以来，公司的市值下跌了近50%。信源地址： http://www.fiercebiotech.com/sto ... phase-ii/2014-08-01
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