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19 апреля, 05:54

О'Нил: Мэй хочет мандат на жесткий Brexit

Москва, 18 апреля - "Вести.Экономика". Известный британский экономист Джим О'Нил отметил, что решение о проведении досрочных выборов в Британии является "политическим оппортунизмом" Терезы Мэй и Консервативной партии, а также отметил, что валютный рынок, возможно, ошибочно интерпретирует его последствия.

18 апреля, 22:41

О'Нил: Мэй хочет мандат на жесткий Brexit

Известный британский экономист Джим О'Нил отметил, что решение о проведении досрочных выборов в Британии является "политическим оппортунизмом" Терезы Мэй и Консервативной партии, а также отметил, что валютный рынок, ошибочно интерпретирует его последствия.

18 апреля, 22:41

О'Нил: Мэй хочет мандат на жесткий Brexit

Известный британский экономист Джим О'Нил отметил, что решение о проведении досрочных выборов в Британии является "политическим оппортунизмом" Терезы Мэй и Консервативной партии, а также отметил, что валютный рынок ошибочно интерпретирует его последствия.

30 марта, 17:48

The nominee to run America’s drug regulator is a sound choice

WHEN the names of potential candidates for the new head of America’s regulatory agency for drugs, the Food and Drug Administration (FDA), were first circulated, you could almost hear the sound of jaws hitting desks throughout the pharmaceuticals industry. One contender was Jim O’Neill, head of Mithril Capital Management, an investment firm, who is such a libertarian that he doesn’t think the FDA should insist that medicines have to work. Another was Balaji Srinivasan, an entrepreneur from Silicon Valley, who thought roughly the same. Removing such a core regulation might seem appealing to business. In fact, the idea of not approving drugs for efficacy is as unwelcome to the industry as it is to doctors and patients. It spends billions of dollars every year on research to deliver better treatments; this would be impossible to justify if drugs had merely to be safe. Patients, meanwhile, would face the awful prospect of having to identify which life-saving medications worked. So, when the name of the FDA nominee was announced in March, there was widespread relief. Scott Gottlieb (pictured) a resident fellow at the American Enterprise Institute, a conservative...

11 марта, 03:19

Trump Nominates FDA Head With Deep Ties To Drug Companies

function onPlayerReadyVidible(e){'undefined'!=typeof HPTrack&&HPTrack.Vid.Vidible_track(e)}!function(e,i){if(e.vdb_Player){if('object'==typeof commercial_video){var a='',o='m.fwsitesection='+commercial_video.site_and_category;if(a+=o,commercial_video['package']){var c='&m.fwkeyvalues=sponsorship%3D'+commercial_video['package'];a+=c}e.setAttribute('vdb_params',a)}i(e.vdb_Player)}else{var t=arguments.callee;setTimeout(function(){t(e,i)},0)}}(document.getElementById('vidible_1'),onPlayerReadyVidible); WASHINGTON, March 10 (Reuters) - U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, a White House official said on Friday. If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco. Gottlieb is well known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by drug companies and pharmaceutical investors. A former FDA official, Gottlieb also sits on the board of pharmaceutical companies. “Thank God it’s Gottlieb,” Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. “We view this as a favorable development for the sector.” Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products. “Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with,” said John Taylor, a lawyer and president of compliance and regulatory affairs with the consulting firm Greenleaf Health and a former acting FDA deputy commissioner. Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O’Neill’s stated view that drugs should be approved before being proven effective generated widespread alarm. Gottlieb, who declined to comment on the nomination, is unlikely to up-end the FDA in the way O’Neill might have, but he is nonetheless expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process. In this he will be supported by the recently passed 21st Century Cures Act which instructs theFDA among other things to consider the use of “real world evidence” to support new drug applications. This could include anecdotal data, observational studies and patient reports “People don’t want to take chances with safety, but there’s increasingly some clamor to be more flexible on the efficacy side,” said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. “You need to have some signal of efficacy. The question is, how much?” One of Gottlieb’s priorities will likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards. A survey conducted by Mizuho Securities USA Inc of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced. “He will be a pragmatic leader with an eye toward both expedited approvals and safety,” one executive wrote. Others were less sanguine, citing his deep ties to industry, including his seat on multiple pharmaceutical company boards, as potential conflicts of interest. Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Gottlieb “has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry.” If confirmed, he added, “he will have to be recused from key decisions time and time again.”   CLINICAL TRIAL FLEXIBILITY The FDA has attempted to push back against moves to sideline randomized clinical trials, long considered the gold standard. In January it issued a report documenting 22 cases in which drugs that appeared to show promise in early trials turned out to be either ineffective or unsafe or both in larger trials. But it has already moved to decrease the requirements for proving that a drug works. Last year, Dr. Janet Woodcock, the agency’s powerful head of pharmaceuticals, ordered the approval of Sarepta Therapeutics Inc’s drug to treat Duchenne muscular dystrophy based on little more than a hint of efficacy. In doing so she overrode the recommendation of a panel of outside advisors and top scientists at the agency and set what some say is a precedent for approving drugs based on minimal data. “How can you say it’s OK for this company but not that company?” Mark Mansour, a partner with the law firm Mayer Brown LLP said. “The administration is going to be pushing for quicker approval of drugs for all sorts of diseases with similar, vociferous patient populations who are crying out for a solution.” Other companies that may benefit from Gottlieb’s presence are manufacturers of electronic nicotine delivery systems such as e-cigarettes. The American Enterprise Institute has consistently argued that there is no evidence to show that the risk of vaping comes near to the risk of smoking. Between 2005 and 2007 he was FDA deputy commissioner for medical and scientific affairs. Previously he was a senior advisor to the commissioner and acted as the agency’s director of medical policy development. (Reporting by Toni Clarke; Editing by Alistair Bell and Lisa Shumaker) -- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. It may be used for personal consumption, but may not be distributed on a website.

10 марта, 22:55

Donald Trump Poised To Nominate Scott Gottlieb To Head FDA: Reports

WASHINGTON (Reuters) - The White House is expected as early as Friday to nominate Dr. ScottGottlieb, a physician and conservative health policy expert, to lead the U.S. Food and Drug Administration, sources familiar with the matter said. If confirmed by the Senate, Gottlieb would be in charge of implementing President Donald Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco. Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products. Gottlieb is well-known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by the pharmaceuticals industry. A survey conducted by Mizuho Securities USA Inc of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced. “He will be a pragmatic leader with an eye toward both expedited approvals and safety,” one executive wrote. Between 2005 and 2007 Gottlieb was FDA deputy commissioner for medical and scientific affairs. Previously he was a senior advisor to the commissioner and acted as the agency’s director of medical policy development. “Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with,” said John Taylor, a lawyer with the FDA consulting firm Greenleaf Health and a former acting FDA deputy commissioner. Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O’Neill’s stated view that drugs should be approved before being proven effective generated widespread alarm. One of Gottlieb’s areas of interest is streamlining the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards. CLINICAL TRIAL FLEXIBILITY Gottlieb declined to comment on the pending nomination, which was going through last-minute vetting on Friday. He is expected to encourage the agency to increase flexibility in the clinical trial development process. In this he will be supported by the recently passed 21st Century Cures Act which instructs the FDA among other things to consider the use of “real world evidence” to support new drug applications. This could include anecdotal data, observational studies and patient reports. “People don’t want to take chances with safety, but there’s increasingly some clamor to be more flexible on the efficacy side,” said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. “You need to have some signal of efficacy. The question is, how much?” The FDA has attempted to push back against moves to sideline randomized clinical trials, long considered the gold standard. In January it issued a report documenting 22 cases in which drugs that appeared to show promise in early trials turned out to be either ineffective or unsafe or both in larger trials. Critics say moves to water down clinical trials could jeopardize patient safety. “Destroying medication and device approval standards at the FDA will have devastating, life-and-death consequences for hundreds of thousands of Americans,” Robert Weissman, president of the watchdog Public Citizen, said recently in a statement. The agency has already taken multiple steps to speed the approval process, though not enough for some. “They can always do more.” Brent Saunders, chief executive of Allergan Plc said. Last year, Dr. Janet Woodcock, the agency’s powerful head of pharmaceuticals ordered the approval of Sarepta Therapeutics Inc’s drug to treat Duchenne muscular dystrophy based on little more than a hint of efficacy. In doing so she overrode the recommendation of a panel of outside advisors and top scientists at the agency and set what some say is a precedent for approving drugs based on minimal data. “How can you say it’s ok for this company but not that company?” Mark Mansour, a partner with the law firm Mayer Brown LLP said. “The administration is going to be pushing for quicker approval of drugs for all sorts of diseases with similar, vociferous patient populations who are crying out for a solution.” Other companies that may benefit from Gottlieb’s presence are manufacturers of electronic nicotine delivery systems such as e-cigarettes. The American Enterprise Institute has consistently argued that there is no evidence to show that the risk of vaping comes near to the risk of smoking.   (Reporting by Toni Clarke; Editing by Meredith Mazzilli and Alistair Bell) -- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. It may be used for personal consumption, but may not be distributed on a website.

10 марта, 22:29

Trump taps Gottlieb for FDA commissioner

Donald Trump will nominate Scott Gottlieb, a conservative drug industry insider and former FDA and CMS official, to serve as FDA commissioner, industry sources close to the White House tell POLITICO.Gottlieb, a physician, is a far more traditional pick to lead the Food and Drug Administration than other candidates Trump had considered. One, Silicon Valley investor Jim O’Neill, had shocked public health advocates with his comments that the FDA should approve drugs without proof they worked. However, Gottlieb’s close ties with industry are likely to draw Senate scrutiny. A classic Washington insider who has occupied conservative turf in the health care debate for two decades, Gottlieb is a board member or adviser to various drug companies and plays a role in funding the industry through a venture capital firm, New Enterprise Associates.If confirmed, Gottlieb would play a major role in the Trump’s administration’s efforts to speed up the regulatory approval of drugs. Trump, who’s been critical of high drug prices, has often argued that shortening the FDA approval process and cutting regulations would bring prices down.The White House could announce Gottlieb's nomination as soon as Friday.The FDA, which oversees the review and approval of drugs, vaccines and medical devices, and the regulation of tobacco, food and cosmetics, has an annual budget of $5 billion, close to 15,000 employees, and plays a regulatory role in about a fifth of the economy. A slew of FDA user fee programs, in which industry essentially funds half the FDA budget, are up for reauthorization in the fall; it would fall upon Gottlieb, if approved, to shepherd the agreements — negotiated under his predecessor — through Congress.Gottlieb has broad experience in regulating health care and working for the industry. He received nearly $200,000 in payments in 2015 from eight pharmaceutical companies, according to federal database tracking drug industry payments. All were classified as “general” payments, meaning they were for things like travel and lodging, consulting or speaking fees. In 2014, he received more than $160,000 in general payments from companies.Gottlieb has been on GlaxoSmithKline’s research and development board since 2010, according to his résumé, and previously served on its oncology board. He advises Bristol Meyers Squibb on its cancer drugs and Cell Biotherapy, an oncology start-up. Gottlieb was a senior adviser to Vertex Pharmaceuticals, maker of expensive cystic fibrosis drugs, from 2009 through 2016. He holds seats on the boards of drug companies Daiichi Sankyo and Tolero Pharmaceuticals; medical lab company American Pathology Partners; MedAvante, a contract research organization, and Glytech, which makes an FDA-approved insulin dosing support system. He also has served on the board of insurance and medical diagnostic companies.Gottlieb was the FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007, and chief policy adviser to the CMS administrator in 2004, during implementation of Medicare Part D. Earlier, he was a senior adviser and director of medical policy development at the FDA, where he worked on issues like orphan drugs and combination products. Gottlieb has long been a resident fellow at the right-leaning American Enterprise Institute. He serves on the Federal Health IT Policy Committee, which makes recommendations to the Department of Health and Human Services Office for Healthcare Information Technology. He practices medicine at New York University where he is a clinical assistant professor. Gottlieb's free-market health policy positions are well known, thanks to regular op-eds in The Wall Street Journal and Forbes, and FDA-related testimony to Congress. This past fall, he gave testimony criticizing the FDA’s regulation of generic drugs, during a hearing on pharmaceutical industry competition occasioned by the rising prices of the EpiPen.

04 марта, 07:59

Стоит ли человечеству жить вечно: паранойя, бесконечные хобби и другие побочные эффекты бессмертия

Автор журнала The Atlantic побеседовала со сторонниками и противниками движения за продление человеческой жизни, которое объединяет профессоров, миллиардеров Кремниевой долины и даже одного кандидата в президенты Америки. Редакция vc.ru публикует перевод материала.

26 февраля, 15:06

Donald Trump's 'shadow president' in Silicon Valley

Billionaire iconoclast Peter Thiel's fingerprints are all over the administration.

23 февраля, 01:00

LIFE AMONG THE TRANSHUMANISTS. Well, I don’t exactly want to live forever. Just a lot longer and h…

LIFE AMONG THE TRANSHUMANISTS. Well, I don’t exactly want to live forever. Just a lot longer and healthier. Plus, more reason to like Trump: “Under President Donald Trump, the quest for immortality might pick up steam: Among the candidates he is reportedly considering to head the Food and Drug Administration is Jim O’Neill, who sits […]

09 февраля, 00:37

Удивительная стойкость мировой экономики

Мировая экономика находится в довольно уязвимом положении, особенно после громких политических потрясений, таких как Brexit и победа Трампа на выборах в США.

09 февраля, 00:37

Удивительная стойкость мировой экономики

Мировая экономика находится в довольно уязвимом положении, особенно после громких политических потрясений, таких как Brexit и победа Трампа на выборах в США.

31 января, 18:03

Trump tells drugmakers he'll tackle prices

President Donald Trump pledged Tuesday to expedite drug approvals and force foreign nations to pay their fair share for drugs manufactured in the U.S.“We’re gonna be changing a lot of the rules. We’re going to be ending global free loading,” Trump said during a White House meeting with pharmaceutical industry executives. “Foreign price controls reduce the resources of American drug companies to finance drug and R&D innovation.” Trump added that “it’s very unfair to this country” and promised an America-first trade policy. “Our trade policy will prioritize that foreign countries pay their fair share for U.S.-manufactured drugs so our drug companies have greater financial resources to accelerate the development of new cures,” he said. “And I think it’s so important.” He added that his administration would also focus on getting the Food and Drug Administration to speed up drug approvals. "We're going to get the approval process much faster," Trump said.

25 января, 20:13

It’s Official: Marijuana Legalization Advocate Could Head Up The FDA

By Alice Salles In December of 2016, Bloomberg News reported that Jim O’Neill, a managing director at Peter Thiel’s Mithril Capital, was being eyed by...

25 января, 15:00

ALEX TABARROK: We need an FDA commissioner who sees the invisible graveyard. “As someone who has w…

ALEX TABARROK: We need an FDA commissioner who sees the invisible graveyard. “As someone who has written about FDA reform for many years it’s gratifying that all of the people whose names have been floated for FDA Commissioner would be excellent, including Balaji Srinivasan, Jim O’Neill, Joseph Gulfo, and Scott Gottlieb. Each of these candidates […]

23 января, 15:14

Will Trump Appoint a Great FDA Commissioner?

As someone who has written about FDA reform for many years it’s gratifying that all of the people whose names have been floated for FDA Commissioner would be excellent, including Balaji Srinivasan, Jim O’Neill, Joseph Gulfo, and Scott Gottlieb. Each of these candidates understands two important facts about the FDA. First, that there is fundamental tradeoff–longer and […] The post Will Trump Appoint a Great FDA Commissioner? appeared first on Marginal REVOLUTION.

18 января, 13:07

Globalisation has made the world a better place | Jim O'Neill

Trade has led to higher living standards in Asia and elsewhere. Are globalisation’s critics against eradicating global poverty?I was recently in beautiful Chile for a Futures Congress, and I had a chance to travel south to the very tip of Latin America. I also recently made a BBC radio documentary called Fixing Globalisation, in which I criss-crossed the UK in search of ideas for improving certain aspects of it and discussed topical issues with well-known experts. In both cases, I saw things that convinced me that it is past time for someone to come to globalisation’s defence.Chile today is Latin America’s richest country, with per capita GDP of about $23,000 – similar to that of central European countries. This is quite an achievement for a country that depends so heavily on copper production, and it sets Chile apart from many of its neighbours. Like many other countries, Chile is facing economic challenges, and its growth rate leaves something to be desired; but it also has many promising opportunities beyond its borders. Continue reading...

14 января, 12:17

Дурманов: кризис медицины и биологические угрозы

Развитие технологий не панацея для человечества. Никакие "суперпротезы" и "нанолекарства" не гарантируют нам полную защиту от биологических угроз - как естественных, так и рукотворных. Об этом предупредил Николай Дурманов, экс-глава "РУСАДА" на IV форуме VESTIFINANCE, посвященном перспективам комплексного развития России, "Экономика: следующие 20 лет".

13 января, 22:35

Дурманов: кризис медицины и биологические угрозы

Развитие технологий не панацея для человечества. Никакие "суперпротезы" и "нанолекарства" не гарантируют нам полную защиту от биологических угроз - как естественных, так и рукотворных. Об этом предупредил Николай Дурманов экс-глава "РУСАДА" .

13 января, 22:35

Дурманов: кризис медицины и биологические угрозы

Развитие технологий не панацея для человечества. Никакие "суперпротезы" и "нанолекарства" не гарантируют нам полную защиту от биологических угроз - как естественных, так и рукотворных. Об этом предупредил Николай Дурманов, экс-глава "РУСАДА" .

11 апреля 2014, 22:47

О замедлении, сближении и декаплинге развитых и недоразвитых

Появилась очередная серия докладов МВФ с прогнозами. По этому поводу есть несколько записей в блоге. Один из самых известных рисунков показывает темпы роста ВВП стран с развитой экономикой и БРИК/МИНТ и Ко., которых 16. Это из довольно мутного рассказа на русском языке о внешних и внутренних факторах роста недоразвитых стран. Разница в темпах роста огромная и никуда не делась. Из рисунка очень понятно, что до кризиса страны с формирующимися рынками росли необычно быстро. Во время глобального финансового кризиса у всех был провал, затем отскок благодаря стимулирующей политике Китая и других стран. Но уже с 2012 практически везде наблюдается замедление роста. До 2013 года динамика российского роста хорошо вписывалась с общую картинку. Аномальные темпы роста около 7% в год и ошибки в экономической политике затем аукнулись большим спадом. После кризиса, как и следовало ожидать, темпы роста снизились до более нормальных 3-4%. После периода полной несознанки с призывами вернуться к росту 5-6%, МЭР и ЦБ теперь бросились в другую крайность, настаивая на том, что "новой нормой" для российской экономики является что-то меньше 2% в год. Джим О'Нил думает, что народ пугают реформаторы потому что хотят перемен. Другим объяснением может быть банальная "советская" попытка чиновников "занизить плана", чтобы его поток перевыполнить и получить за это грамоты и премии за уже проводимые структурные реформы.  Чтобы поддержать российских реформаторов, России на этот год МВФ прочит 1,3%, а в обозримом будущем рисуют 2,5% в год (Польше за ее институты обещают 3,5%). Среди 16 стран Китай стоит особняком. Резким замедлением китайского роста или даже финансовым крахом в этой стране пугают уже много лет. В этой связи обращает на себя внимание другая картинка и запись в блоге МВФ под названием "Размер важен".  Все знают, что экономика Китая долгие годы стабильно росла темпами по 10% в год. В 2003-2007 темпы роста были еще выше, в среднем 11,7%.  На 2014 год Китаю прогнозируют рост около 7,5%. А в 2015-2019 МВФ ожидает "всего" 6,8%.  МВФ замечает, что те, кто пугают нас таким замедлением, плохо понимают арифметику. Экономика Китая уже стала такой огромной, что китайские 6,8% в год добавляют к росту экономики мира БОЛЬШЕ, чем 11,7% до кризиса. До кризиса Китай добавлял в среднем 1 процентный пункт к общему росту ВВП, а в ближайшие годы будет добавлять 1,1 пп. Вклад Китая на рисунке помечен красным, вклад США синим, вклад большой, но слабенькой еврозоны желтым.  Еще одна известная иллюстрация того, что экономика Китая за пять потерянных для Запада лет стала огромной. США с середины 2008 года росли еле еле. Еврозона еще хуже, не будем ее даже обижать. А вот Китай не стоял на месте, сегодня его экономика уже на 60% больше, чем в середине 2008 года.(картинка отсюда, но таких много)