- Astra slumps as heart drug hit by new setback
Astrazeneca's ambitions for its Brilinta drug have suffered another blow after US regulators held back their approval and asked for additional analysis of clinical trial data, delaying the launch of the pharma group's much anticipated heart medicine. 米国の規制当局は、その承認を滞らせ後、臨床試験データの追加分析を求め、製薬グループの待望の心臓薬の発売を遅らせるのBrilinta薬のアストラゼネカの野心は、別の打撃を受けている
- Study Finds Early Treatment Can Prevent Spread Of AIDS
Clinical trial shows that when an infected partner gets early treatment, the risk of transmitting the disease to is dramatically reduced 臨床試験は、感染したパートナーは、早期治療を取得するときに、病気を送信するリスクが大幅に削減されていることを示しています
- Why Pfizer's Biggest Experimental Drug Got A Name Change
Earlier this week Pfizer released a neat-o interactive version of its pipeline of experimental drugs, including updates on which have moved into new clinical trials. 今週ファイザー社は、新しい臨床試験に移動している更新プログラムを含む実験的な薬、そのパイプラインのきちんとしたの- oインタラクティブなバージョンをリリースしました
- Let's Cut Medicare Waste Off At The Knees
In a recent New York Times op-ed, Dr. Rita Redberg identified numerous treatments that Medicare pays for despite offering few positive clinical results – and in a few cases causing potential harm. From unnecessary colonoscopies to ineffective cardiac stents, Dr. Redberg estimates that Medicare could reduce spending by as much as $150 billion -- 30% of the program’s annual expenditures -- without compromising needed services. As a cardiologist and professor of medicine at the University of California-San Francisco, as well as editor of the Archives of Internal Medicine, Dr. Redberg is eminently well qualified to make those judgments. 潜在的な危害を引き起こすいくつかのケースで - 最近の新ニューヨークタイムズ紙は社。博士リタレッドバーグは、メディケア、いくつかの正の臨床試験の結果を提供するにもかかわらず、支払うことが多くの処理を識別します
- How Comparative Effectiveness Research Gets Corrupted by Politics
I’m a supporter, in principle, of comparative effectiveness research. Comparative effectiveness research involves running large, statistically robust clinical trials so we can judge how different therapies for a particular disease compare to each other. Indeed, the private sector spends hundreds of billions of dollars a year on such research—not that you would know it from the way the issue is discussed in the media. 比。効果研究の原則的に私のサポーター、
- AHA 2011 in Orlando: Late-Breaking Clinical Trials
Late-Breaking Clinical Trials I.
Sunday, Nov 13, 2011, 3:45 PM - 5:13 PM
West Hall B4
Moderators: Jeffrey Weitz, Hamilton, ON, Canada; Gilles Montalescot, Paris, France
3:45 PM: Intracoronary Compared with Intravenous Bolus Abciximab Application During Primary Percutaneous Coronary Intervention: AIDA STEMI Trial
Holger Thiele, Herzzentrum Leipzig, Leipzig, Germany; Jochen Wöhrle, Univ of Ulm, Ulm, Germany; Rainer Hambrecht, Klnikum Links der Weser, Bremen, Germany; Harald Rittger, Klnikum Coburg, Coburg, Germany; Ralf Birkemeyer, Klnikum Villingen-Schwenningen, Villingen-Schwenningen, Germany; Bernward Lauer, Zentralklinik Bad Berka, Bad Berka, Germany; Petra Neuhaus, Oana Brosteanu, KKSL, Leipzig, Germany; Peter Sick, Krankenhaus Barmherzige Brüder, Regensburg, Germany; Marcus Wiemer, HERHerz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany; Sebastian Kerber, Herz- und Gefäß-Klinik, Bad Neustadt, Germany; Ingo Eitel, Herzzentrum Leipzig, Leipzig, Germany; Klaus Kleinertz, Ambulantes Herzzentrum Chemnitz, Chemnitz, Germany; Gerhard Schuler, Herzzentrum Leipzig, Leipzig, Germany
Discussant: Alice K Jacobs, Boston, MA 最新の臨床試験I. 2011年11月13日（日曜日）、15:45 - 17:13西ホールB4モデレーター：カナダ、ONジェフリーウェイツ、ハミルトン、、ジルMontalescot、パリ、フランス15:45：冠動脈内に比べて、ヨッヘン。öhrle、ウルム、ウルム、ドイツの大学、ライナーハンブレヒト、Klnikumリンクデルヴェーザー、ブレーメン、ドイツのハラルドRittger、AIDA STEMI裁判ホルガーティーラ、Herzzentrum Leipzig、ライプツィヒ、ドイツ：プライマリ経皮的冠動脈インターベンション時の静脈内ボーラスのアブシキシマブのアプリケーションとKlnikumコーブルク、コーブルク、ドイツ、ラルフBirkemeyer、Klnikumフィリンゲンシュウェニンゲン、フィリンゲンシュウェニンゲン、ドイツ、Bernwardラウアー、Zentralklinik悪いBerka、悪いBerka、ドイツ、ペトラノイハウス、大穴Brosteanu、KKSL、ライプツィヒ、ドイツ、ピーター病気、クランケンハウスBarmherzigeブルーダー、レーゲンスブルク、ドイツ、マーカスウィーマー、HERHerzウントDiabeteszentrum NRW、バートオインハウゼン、ドイツ、セバスチャンカーバー、ヘルツウントGefäß - Klinik、バートノイシュタット、ドイツ、インゴアイテル、Herzzentrum Leipzig、ライプツィヒ、ドイツのクラウスKleinertz、Ambulantes Herzzentrumケムニッツ、ケムニッツ、ドイツのゲルハルトシュラー、Herzzentrum Leipzig、ライプツィヒ、ドイツ討論者：アリスKジェイコブス、ボストン、MA
- Spanish HIV Vaccine Shows 90 Percent Success in Early Trial
Promising results pave way for further clinical trials on HIV-infected volunteers 有望な結果は、HIVに感染した人のボランティアのさらなる臨床試験への道を開く
- UN Prosecutors Seek 2 Separate Trials for Mladic
Prosecutors express concern that Ratko Mladic's health may deteriorate before an all-encompassing trial is completed 検察はすべての包括的な臨床試験が完了する前にRatko Mladicの健康が低下するという懸念を表明
- Regeneron Announces Strong Results In Gout Study
Regeneron Pharmaceuticals of Tarrytown, N.Y., announced positive results from a second late-stage clinical trial showing that its drug Arcalyst, currently approved for a rare disease, can treat gout, a much more lucrative opportunity. タリータウン、ニューヨークのリジェネロン医薬品は、現在まれな疾患のための承認されたその薬Arcalystは、はるかに有利な機会を痛風を扱うことができることを示す臨床試験の第二後期から肯定的な結果を発表した
- Repligen Shares Hammered, Green Dot Sees Red
Repligen announced on Monday that a mid-stage clinical trial showed one that its drug, RG2417, also known as uridine, was not significantly better than a placebo in treating bi-polar depression. Repligenは、中間段階の臨床試験もウリとして知られる薬は、RG2417、大幅に双方。極性うつ病の治療において、プラセボよりもされていないことを示すことが月曜日に発表した
- Today's Big Losers: RGEN, GDOT
Repligen (RGEN) announced on Monday that a mid-stage clinical trial showed one that its drug, RG2417, [...] Repligenは（RGEN）中間段階の臨床試験を示すことが月曜日に発表、その薬、RG2417、[...]
- Why Contract Research Organizations Are So Hot
With more drugmakers outsourcing more trials to contract research organizations, few should be surprised that the CRO sector is generating investor interest. The attention-grabbing deal announced this week in which two private equity firms - Carlyle Group and Hellman & Friedman - agreed to pay $3.9 billion in cash to buy Pharmaceutical Product Development is no random bet. より多くの製薬会社は、受託機関に多くの臨床試験をアウトソーシングすると、いくつかは、CRO部門が投資家の関心を生成していることに驚くはずです
- Letters: EU drug trials law
Ben Goldacre raises important concerns about revolving doors and lack of transparency at the European medicines regulator (Bad science, 5 March). The European commission has now referred the case of Thomas Lonngren, who left the to the European Medicines Agency to go into consultancy, to the EMA management board, which will decide what action to take. I recognise Goldacre's wider concerns on transparency. The old system left a lot to be desired. But the legislation has just been revised and full details about drug-safety meetings will be put online, including minutes, and recommendations for decision (including divergent positions). Public hearings will even be held. And as for clinical trials, a public version of the EMA's clinical trials' database goes live this week. There is also due to be an overhaul of clinical trial laws next year, which is an opportunity to resolve any outstanding issues.Linda McAvan MEPLabour European spokesperson on health and rapporteur on pharmacovigilancePharmaceuticals industryEuropean commissionEuropean Unionguardian.co.uk © Guardian News & Media Limited 2011 | Use of this content is subject to our Terms & Conditions | More Feeds
ベンGoldacreは、欧州医薬品レギュレータで回転ドアおよび透明性の欠如についての重要な懸念を（悪い科学、3月5日）が発生します
- DealBook: French Doctor Arrested on Insider Trading Charges
A prominent French doctor has been arrested on criminal fraud charges that accused him of tipping off a hedge fund manager about setbacks in a clinical drug trial that had not yet been made public. 著名なフランスの医者はまだ公表されていなかった薬の臨床試験での挫折についてヘッジファンドマネージャーをオフに転倒、彼を非難した犯罪詐欺容疑で逮捕されています
- New Rules Put Clinical Testing in Doubt
Clinical testing of medication may become illegal in Russia after the government issued insurance requirements for participating patients that are practically impossible to satisfy.
政府は実質的に満足させるのは不可能である患者を参加するための保険要件を発行した後、薬の臨床試験は、ロシアでは違法になる場合があります
- Stem cells: A factfile
Embryonic stem cells have crossed a threshold with the announcement Monday that this novel but also contested treatment has moved out of the lab and into a clinical trial. 胚細胞はこの小説だけでなく、激戦の治療は、ラボの外に移動したことを臨床試験への発表は月曜日としきい値を超えている幹
- Global drug firms eye mainland market
Global drug firms have embarked on clinical trials for diseases prevalent among Chinese people, an area they had previously ignored, as they jostle to develop products targeted at the mainland's massive and ageing population.
彼らは本土の大規模かつ人口の高齢化をターゲットに製品を開発してフェリーの世界的な医薬品会社の病気中国の人々の間で流行のための臨床試験に着手して、面積が、以前は無視していた
- Haggling over the price of children's lives
Trials show a new vaccine can slash deaths from diarrhoea, which kills half a million children in poor countries every year. But will donors have to choose between paying for that or supporting Aids, TB and malaria care?Good news at the end of last week - rotavirus vaccine works in Africa and Asia, protecting children against diarrhoea, one of their biggest killers. Trial results published in the Lancet clearly show that vaccines which are already licensed for use in the wealthier parts of the world can save lives in poor countries too. Severe rotavirus gastroenteritis kills half a million children a year. Even before these trials, the World Health Organisation had recommended all countries introduce the vaccine. This is Dr John C Victor of PATH in Seattle, which helped run trials in Bangladesh and Vietnam:With a WHO recommendation for rotavirus vaccines now in place, governments of developing countries in Africa and Asia are deciding how to prioritise introduction of rotavirus vaccine in their public health agendas. Our trial shows that a live oral rotavirus vaccine has the potential to halve the incidence of severe rotavirus gastroenteritis in developing populations in Asia. Alongside efficacy results for this vaccine in Africa, our study supports WHO's strong recommendation for expansion of rotavirus vaccine use to the poorest nations in Africa and Asia. Rotavirus vaccines have the potential to protect the lives of nearly 2 million children in the next decade alone.And here are Dr George E Armah, University of Ghana, and Dr Kathleen M Neuzil, also of PATH, who ran the Africa trial:In Africa, where young children are dying from diarrhoeal disease and prompt medical care is often out of reach, the need to prevent rotavirus is especially urgent. Introduction of rotaviru 試験は、新しいワクチンは、毎年貧しい国々で50万人の子供を殺す下痢、死亡を大幅に削減できることを示す
- Pfizer set up research center in Wuhan
Pfizer Chairman and CEO Jeff Kinder announced that a global research and development center for radiation biology and drug development has been officially established in Wuhan, capital of central China's Hubei Province, where he arrived on the same day by his special plane.
Wuhan Pfizer R&D center will provide intellectual support for the company's clinical drug development projects in the world, including clinical trials from Phase I to IV, and will carry out deep collaboration with local i ... ファイザー会長兼CEOのJeffキンダーの中心Dを開発センターのための放射線生物学および発表した世界的な研究は、＆Rの薬ファイザー武。開発しています
- 監視する薬： マイクロチップが埋め込まれた錠剤の承認が間近
we are taking forward this transplant drug with a chip and
- Stem-cell therapy to begin on humans
NEW YORK: The US Food and Drug Administration (FDA) has given the all-clear to a clinical trial of embryonic stem cells as a treatment for spinal-cord injury. ニューヨーク：米国食品医薬品局は（FDA）は脊髄損傷の治療薬として胚性幹細胞の臨床試験にすべて明確に与えている
- A radical plan to save antibiotics
Drug resistance is fast destroying the power of antibiotics. Tighter infection control and incentives for drug companies to invent more antibiotics are usually proposed as the answer. But the authors of a new paper say we have to think out of the box.What are we to do about the diminishing power of antibiotics - once the miracle drugs that looked set to end infectious diseases? We know the problem is becoming very serious - here is a piece I wrote about the alarming prospects for a future without antibiotics.But we don't hear much in the way of imaginative answers. So it's refreshing to read a paper out this morning from Aaron Kesselheim, from Brigham and Women's Hospital and Harvard Medical School in Boston, and Kevin Outterson, a professor at Boston University Law School.Their analysis, published in the journal Health Affairs, says the usual idea, to give pharmaceutical companies financial incentives to invent and manufacture more antibiotics, won't work. One of the reasons we are in this parlous state of affairs, they say, is that drug companies in the past have tried too hard to sell more tablets. Of course, the misuse of the drugs - physicians over-prescribing and patients not completing the course - is largely to blame, but companies have been disciplined for promoting wrong uses of antibiotics. They cite two cases involving Pfizer. In one of those, in 2005, the company, they say, was warned by the Food and Drug Administrationthat its 'misleading promotion' of linezolid (Zyvox) as a treatment for a wide range of methicillin-resistant Staphylococcus aureus (MRSA) infections 'poses serious public health and safety concerns because of its potential to result in inappropriate use'. The FDA concluded that the clinical trial data did not support linezolid's use for thos 薬剤耐性は、高速抗生物質の力を破壊している
- Wallace Fox obituary
Medical researcher who revolutionised the treatment of TBWallace Fox, who has died aged 89, was the leader of the Medical Research Council (MRC) programme that developed the standard worldwide treatment of tuberculosis. TB sanatoriums closed by the end of the 1960s after he showed that home treatment was just as good, and then he shortened the period of treatment from a year to six months. The work he did at the MRC tuberculosis research unit, in collaboration with many researchers elsewhere, helped change TB from being an untreatable disease to one that can be alleviated in both rich and poor countries – a major medical advance.Wallace was born in Bristol, where he attended Cotham grammar school, and undertook his medical education in London at Guy's hospital, followed by hospital posts at Guy's, Preston Hall sanatorium, Kent, and then in London at the Hammersmith chest clinic. He caught TB himself soon after medical qualification, and was treated with bed rest for two years at the Bristol Royal Infirmary.He joined the staff of the MRC tuberculosis research unit, directed by Philip D'Arcy Hart, in 1952. At that time, half of those who developed TB died from it, but new anti-bacterial drugs, such as streptomycin and isoniazid, were being introduced to treat the disease. The principal method for TB control then considered by the World Health Organisation (WHO) was BCG (Bacillus Calmette-Guérin) vaccination. But Wallace took an early decision to concentrate on treatment, thus anticipating a later change in WHO policy.TB treatment was primitive. The first clinical trial had shown that treatment with streptomycin alone resulted in drug-resistant tubercle bacilli. But when streptomycin was combined with PAS (para-aminosalicylic acid) or, better, with the more potent isoniaz TBWallaceフォックス、89歳で死亡したの治療に革命をもたらしました医療研究者は、医学研究評議会（MRC）は結核の世界標準治療を開発プログラムの指導者だった
- Indo-Pakistani talks require caution | Anita Inder-Singh
The resumption of dialogue between India and Pakistan is welcome, but expectations of its outcome should be kept lowDoes the decision taken by prime ministers Manmohan Singh and Yusuf Raza Gilani to resume dialogue to settle differences between India and Pakistan offer a chance to open the door to greater regional and international security? If so, the latest summit of the eight-member South Asian Association for Regional Cooperation (SAARC) in Thimpu, the capital of the Himalayan kingdom of Bhutan – which served as the occasion for the Singh-Gilani meeting – could turn out to be most memorable since its creation in 1985.Dominated by South Asia's two arch-rivals, India and Pakistan, SAARC is, in the words of India's Singh, a glass half-empty.The Indo-Pakistani schism over Kashmir is the main reason why SAARC has yet to craft the norms of co-operation that could improve the management of natural resources, prevent land and water degradation, and increase human security in South Asia.So will the resumption of dialogue ease tensions between India and Pakistan? The decision is welcome, but expectations about its outcome should be kept low.The most recent barrier to dialogue has been Islamabad's refusal to act against the seven Lashkar-e-Taiba (LeT) men currently on trial in Rawalpindi for their involvement in the November 2008 terrorist attacks in Mumbai. And India says that the last few months have seen a rise in extremist forays into India's half of Kashmir (Jammu and Kashmir).Gilani has promised that Pakistani territory will not be misused to launch terrorist assaults on India. But similar complaints and promises have been made in the past, and New Delhi is not convinced that Islamabad intends to stop using militants as an instrument of state policy.Whether extremist inf インドとパキスタンは歓迎されて間の対話の再開が、その結果の期待が維持される必要があります決定を首相マンモハンシンユスフラザギラニで撮影した対話をインドとパキスタンの間の違いを解決する再開するlowDoesはチャンスの扉を開くために提供していますより地域と国際安全保障？もしそうなら、Thimpuで8人の南アジア地域協力連合（SAARC）の最新の首脳会議は、ヒマラヤの王国ブータンの首都 - どのシン-ギラニ会議の機会を務めた - ほとんどのことになりそうだ思い出に残る南アジアの2つのライバル、インド、パキスタン、SAARCは、インドのシン、カシミールをめぐるガラス半empty.Theインドパキスタン分裂の言葉ですが1985.Dominatedの創設は、なぜSAARCはいる主な理由であるため、まだ土地と水の劣化を防ぐため、天然資源の管理を向上させることが協力の規範を作るとサウスAsia.Soの対話の意志再開インドとパキスタン間の緊張を緩和する人間の安全保障を向上させる？決定は歓迎ですが、その結果についての期待は対話にイスラマバードの拒否を7ラシュカーリ電子タイバagainst（LET）が11月に関与ラワルピンディin目下臨床試験中で男性actにされているlow.The最新の障壁を保持されるべきムンバイ2008年のテロ攻撃
- The Guardian's Science Weekly podcast: It's all about altitude at World Cup 2010
Steve Haake, head of sports engineering at Sheffield Hallam University, joins us to explain why altitude could make the difference between triumph and disaster at World Cup 2010 in South Africa. He also predicts that goalkeepers will be moaning about the design of the balls. Steve will be giving a talk at the Royal Institution on 8 June. We look at some of your responses to last week's live recording of this podcast at the Science Museum in London. Following a discussion at the Hay Festival on 10 years of the Human Genome Project, we reveal what Nobel laureates John Sulston and Martin Evans, and Michael Morgan, former CEO of the Wellcome Trust Genome Campus, had to say about Craig Venter's creation of the world's first synthetic genome. We visited the Royal Society's exhibition celebrating its 350th anniversary. Keith Moore, its librarian, tells us about Robert Boyle's list of scientific ambitions. View a gallery of the Royal Society exhibition here. In the newsjam we discuss the ban on mephedrone, trials to begin on a breast cancer vaccine, a resignation over GM foods, and why six men will be spending 520 days locked inside a spaceship in a Moscow car park. Guardian science correspondent Ian Sample and Observer science editor Robin McKie were on hand in the studio to throw around the World Cup ball. WARNING: contains strong language.Follow the podcast on our Science Weekly Twitter feed and receive updates on all breaking science news stories from Guardian Science. Email scienceweeklypodcast@gmail.com. Join our Facebook group. Listen back through our archive.Subscribe free via iTunes to ensure every episode gets delivered. (Here is the non-iTunes URL feed).Alok JhaAndy DuckworthIan SampleRobin McKieJohn Sulston
スティーブハエーク、シェフィールドハラム大学スポーツ工学の長は、私たちはなぜ高度が南アフリカ共和国の2010年W杯での勝利と災害の違いを作ることを説明する結合します
- Investors look to foreign media
Chinese private investment in Southeast Asian Nations (ASEAN) has now extended to the media sector.
ASEAN Finance, a Chinese business magazine established by three businessmen in Anhui Province, will soon debut in both ASEAN countries and China, said CEO Hsin Ling Chi at a press conference held in Beijing Thursday.
The bimonthly magazine, authorized by Singaporean authorities September 28, is now running trials and initiating an investigation on Chinese enterprises' investment in the ASEAN r ... 東南アジア諸国連合（ASEAN）に中国の民間投資を今すぐに両方のASEAN諸国と中国でのデビューを果たすメディア部門
- Terrorists don't stand still, and neither can we | Chris Huhne
If they are effective and available, body scanners at airports should have been rolled out by the government years agoNo one wants to have full body scanners in airports. No one wants to be electronically strip-searched at the start of their holidays. It is an invasion of privacy we would all rather avoid. But the foiled bombing attempt on a Detroit-bound plane over Christmas demonstrates that terrorists still have an unhealthy addiction to air travel, and we have to move with the developing threat. Terrorists do not stand still, and neither can we. The government's assessment is that there would have been a 60 percent chance of identifying the explosive on Umar Farouk Abdulmutallab had he been scanned.I agree that the timing of the government's announcement is not great. In the aftermath of an attack or an attempted attack, such policies are a visible way for a government to demonstrate that it is taking action. However, four of these £100,000 machines have lain in storage in Heathrow despite successful trials over the last few years. Seventeen of these machines remain mothballed in Amsterdam's Schiphol airport, where the would-be bomber Abdulmutallab stopped off in transit. The government has been in no rush to introduce what we are now being told is an effective way of detecting would-be bombers. This is not acceptable. If they are effective, tested and available, they should have been rolled out years ago, and not as a knee-jerk reaction to an attempted terrorist attack in the United States.Too often, the immediate response to terror attacks or the threat of terror attacks has been disproportionate. For example, there was the proposal for 90 days detention without charge, the Belmarsh provisions locking people up by ministerial fiat, control orders imposing house ar もし効果があるとあり、空港でのボディスキャナは、政府は年によってロールバックされている必要が1つの空港でのフルボディスキャナーを要求してagoNo
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