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21 апреля, 18:21

What's in Store for GlaxoSmithKline (GSK) in Q1 Earnings?

GlaxoSmithKline plc (GSK) is scheduled to report first-quarter 2017 results on Apr 26 before market opens. Last quarter, the company delivered a positive earnings surprise of 14.04%.

19 апреля, 20:01

Freshfields hires SFO’s joint head of anti-corruption

Ben Morgan led investigations into Rolls-Royce, Airbus and GlaxoSmithKline

13 апреля, 17:39

Why Juno Therapeutics' Stock Tumbled in the Past One Year

Juno Therapeutics, Inc.'s (JUNO) stock has significantly underperformed Zacks classified Medical-Biomed/Genetics industry in the past one year.

13 апреля, 00:03

Mylan Down on FDA Warning Letter to Manufacturing Facility

Shares of Mylan, Inc. (MYL) dropped 2% after the company received a warning letter from the FDA for its manufacturing facility in India

12 апреля, 16:41

Inovio's Ebola Vaccine Positive in Expanded Phase I Study

Inovio Pharmaceuticals, Inc. (INO) recently reported positive preliminary results from the expanded stage of its phase I study, EBOV-001.

11 апреля, 14:00

Why Is Agenus (AGEN) Down 16.8% Since the Last Earnings Report?

Agenus (AGEN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.

10 апреля, 19:01

Sexual harassment claims to be probed

Fox News parent Twenty-First Century Fox Inc said on Sunday it will investigate a sexual harassment claim against TV anchor Bill O’Reilly, who has seen several companies pull their ads from his top-rated

Выбор редакции
10 апреля, 14:25

Why Is Epizyme (EPZM) Down 3.6% Since the Last Earnings Report?

Epizyme (EPZM) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.

08 апреля, 00:03

Novartis (NVS) In-Licenses Ophthalmic Drug from Lubris LLC

Novartis AG (NVS) recently announced that it has exercised an option to in-license ECF843 for ophthalmic indications worldwide from Lubris LLC.

Выбор редакции
06 апреля, 19:50

O'Reilly's top advertiser -- a gold company -- is staying

Car giants Mercedes-Benz and Hyundai, insurer Allstate and Big Pharma/consumer healthcare companies Sanofi and GlaxoSmithKline are among the dozens of blue chip companies that have pulled ads from "The O'Reilly Factor."

06 апреля, 17:42

Bill O’Reilly faces allegations of sexual harassment

Lights, camera, where’s the action? EVEN for Rupert Murdoch and Fox News, no strangers to controversy, the allegations against Bill O’Reilly present an extreme test. On April 1st the New York Times published an investigative report that described accusations of sexual harassment and other inappropriate behaviour from at least seven women against the presenter. He and the network, the paper said, have paid about $13m to five women since 2002 to settle cases where they alleged such behaviour. Mr O’Reilly denied the merits of the claims. The news came less than nine months after Roger Ailes, the network’s founding boss, stepped down following multiple sexual-harassment claims against him. This week around 50 advertisers left Mr O’Reilly’s programme, “The O’Reilly Factor”, among them several car brands, including Mercedes-Benz and Toyota’s Lexus, as well as GlaxoSmithKline, a drugs company. The National Organisation for Women has called for him to be fired. All eyes are on Mr Murdoch, who has been running Fox News himself since he pushed out his friend, Mr Ailes. Mr O’Reilly has probably been just as...

06 апреля, 16:00

How Pharma Companies Game the System to Keep Drugs Expensive

I help the University of Utah hospital system manage its drug budgets and medication use policies, and in 2015 I got sticker shock. Our annual inpatient pharmacy cost for a single drug skyrocketed from $300,000 to $1.9 million. That’s because the drug maker Valeant suddenly increased the price of isoproterenol from $440 to roughly $2,700 a dose. Isoproterenol is a heart drug. It helps with heart attacks and shock and works to keep up a patient’s blood pressure. With the sudden price increase, we were forced to remove isoproterenol from our 100 emergency crash carts. Instead, we stocked our pharmacy backup boxes, located on each floor of our hospitals, to have the vital drug on hand if needed. We had to minimize costs without impacting patient care. This type of arbitrary and unpredictable inflation is not sustainable. And it’s not the way things are supposed to work in the United States. Isoproterenol is a drug that is no longer protected by a patent. Theoretically, any drug company should be able to make a generic version and sell it at a competitive cost. We should have had other options to buy a competitors’ copy for $440 or less. But that’s not happening like it should. The promise of generic medications is getting further from reality each day. As the U.S. Senate considers President Donald Trump’s choice to head the Food and Drug Administration, now is the time refocus efforts on generic drugs. How generics are supposed to work The 1984 Drug Price Competition and Patent Term Restoration Act gave pharmaceutical companies exclusive protections for innovating a new drug. If they brought a new therapy to life, they enjoyed patent protection to effectively monopolize the market. That was the payoff for shouldering the high risk and high costs of developing new drugs. But once the patent and the exclusive hold on the market expires, the legislation encouraged competition to benefit consumers. Any drug company would be able to manufacturer non-brand name versions of the very same drug, so-called “generics.” And for a while, the system worked well. Not anymore. The system intended to reward drug companies for their innovations, but eventually protect consumers, is systematically being broken. Drug companies are thwarting competition through a number of tactics, and the result is high prices, little to no competition, and drug quality problems. The ways companies stop generics One of the ways branded drug manufacturers prevent competition is simple: cash. In so-called “pay for delay” agreements, a brand drug company simply pays a generic company not to launch a version of a drug. The Federal Trade Commission estimates these pacts cost U.S. consumers and taxpayers $3.5 billion in higher drug costs each year. “Citizen petitions” offer drug companies another way to delay generics from being approved. These ask the Food and Drug Administration to delay action on a pending generic drug application. By law, the FDA is required to prioritize these petitions. However, the citizens filing concerns are not individuals, they’re corporations. The FDA recently said branded drug manufacturers submitted 92% of all citizen petitions. Many of these petitions are filed near the date of patent expiration, effectively limiting potential competition for another 150 days. “Authorized generics” are another tactic to limit competition. These aren’t really generic products at all; they are the same product sold under a generic name by the company that sells the branded drug. Why? By law, the first generic company to market a drug gets an exclusivity period of 180 days. During this time, no other companies can market a generic product. But the company with the expiring patent is not barred from launching an “authorized generic.” By selling a drug they’re already making under a different name, pharmaceutical firms are effectively extending their monopoly for another six months. Another way pharmaceutical firms are thwarting generics is by restricting access to samples for testing. Generic drug makers need to be able to purchase a sample of a brand-name product to conduct bioequivalence testing. That’s because they have to prove they can make a bioequivalent product following the current good manufacturing practices (CGMP) standard. These manufacturers don’t need to conduct clinical trials like the original drug company did. But the original drug developer often declines to sell drug samples to generics manufacturers by citing “FDA requirements,” by which they mean the agency’s Risk Evaluation and Mitigation Strategies program. The idea behind this program is a good one: give access to patients who will benefit from these personalized medicines, and bar access for patients who won’t benefit and could be seriously harmed. However, brand drug makers are citing these requirements for the sole purpose of keeping generics from coming to market. Problems with generic drug makers Although makers of a branded drug are using a variety of tactics to create barriers to healthy competition, generic drug companies are often not helping their own case. In 2015, there were 267 recalls of generic drug products—more than one every other day. These recalls are for quality issues such as products not dissolving properly, becoming contaminated, or even being outright counterfeits. A few high-profile recalls have shaken the belief that generic drugs are truly the same. In 2014, the FDA withdrew approval of Budeprion XL 300 — Teva’s generic version of GlaxoSmithKline’s Wellbutrin XL. Testing showed the drug did not properly release its key ingredient, substantiating consumers’ claims that the generic was not equivalent. In addition, concerns about contaminated generic Lipitor caused the FDA to launch a $20 million initiative to test generic products to ensure they are truly therapeutically equivalent. In some cases, patent law also collides with the FDA’s manufacturing rules. For example, the Novartis patent for Diovan expired in 2012. Ranbaxy received exclusivity for 180 days for the first generic product. However, due to poor quality manufacturing, Ranbaxy couldn’t obtain final FDA approval for its generic version. The FDA banned shipments of Ranbaxy products to the United States. Ranbaxy ended up paying a $500 million fine, the largest penalty paid by a generic firm for violations. Due to these protracted problems with the company that had won exclusivity, a generic product did not become available until 2014. The two-year delay cost Medicare and Medicaid at least $900 million. Ranbaxy’s poor-quality manufacturing also delayed other key generic products like Valcyte and Nexium. Ironically, it was Mylan—involved in its own drug pricing scandal over its EpiPen allergy-reaction injector—that filed the first lawsuit to have the FDA strip Ranbaxy of its exclusivity.  Mylan made multiple attempts to produce generic products but was overruled in the courts. Ways to Fix the System Pharmaceutical firms are currently using a set of tactics to make their temporary monopolies semi-permanent. Eliminating these tactics will not be easy. Still, doing so will fulfill the deal that policy makers offered to drug makers and consumers: a temporary monopoly on sales to help pay for drug development. First, restrictive distribution programs need to be stopped. Generic companies must also be allowed to purchase samples of these medications to conduct bioequivalence studies. (One measure to close these loopholes already has bipartisan support.) Next, pay-for-delay agreements should be eliminated as well as a corporation’s ability to issue citizen petitions with the intent of delaying generic competition. Encouraging and enforcing high-quality standards for medications must also be an industry imperative. To create transparency around drug quality, the FDA has proposed a system of letter grades for manufacturers. In an economic study, one official notes that lack of transparency “may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.” Another way to achieve greater transparency in medication quality is to change the product labeling laws. Labels should disclose the medication’s manufacturer. Currently, hospitals and pharmacies don’t always know which company actually made the product. This makes it difficult to base purchase decisions on quality. Generic medications can provide great benefits for patients and health systems when there is adequate competition and quality. But their promise is unfulfilled, and it’s costing consumers. By eliminating restrictive distribution schemes, pay-for-delay, and citizen petitions as well as providing more transparency around quality, hospitals, clinicians, lawmakers, and the new leaders at the FDA have a clear opportunity. They can start to reverse rising health care costs and ensure quality medications are accessible to the American people.

05 апреля, 18:35

Advertisers Are Ditching Bill O’Reilly Over Harassment Allegations

More than two dozen companies are pulling ads from the most-watched cable-news show amid yet another scandal at Fox News.

05 апреля, 14:07

More advertisers say they have ditched Fox's O'Reilly show

BILL O'Reilly's top-rated Fox News show may be starting to feel a financial sting after allegations that he sexually harassed several women. A dozen major advertisers, ranging from automakers Hyundai

05 апреля, 00:41

Bill O'Reilly faces new pressure as 12 companies pull ads from Fox News show

Hyundai and Allstate among companies taking action following reports he and employer paid several women to settle sexual harassment claimsBill O’Reilly’s top-rated Fox News show may be starting to feel a financial sting, with 12 firms taking action after allegations that he sexually harassed several women.The automakers Hyundai, BMW and Mitsubishi, the financial firm T Rowe Price, the personal finance site Credit Karma, the insurer Allstate, the drugmakers Sanofi and GlaxoSmithKline, the pet food company Ainsworth, the men’s shirt seller Untuckit, and the online marketing firm Constant Contact said Tuesday that they had joined Mercedes-Benz in pulling their ads from the show. Continue reading...

05 апреля, 00:04

FDA Nominee Gottlieb's Many Industry Entanglements Will Be A Focus Of Wednesday Hearing

by Niv Sultan This week, all the attention’s on Judge Neil Gorsuch, President Donald Trump‘s nominee to become an associate justice of the U.S. Supreme Court. But there’s another position in play: Tomorrow (April 5), the Senate Committee on Health, Education, Labor and Pensions will hold a confirmation hearing for Scott Gottlieb, who’s in line to head the Food and Drug Administration. It would be a return trip to the agency for Gottlieb, who was a deputy commissioner under President George W. Bush. Gottlieb, whose stance is relatively deregulatory, wrote in 2012 that “a few key structural reforms” could improve the FDA’s “counterproductive” culture. He also wrote about the agency’s “cumbersome [drug] approval process,” which dovetails with Trump’s description of the FDA as “slow and burdensome” — though many note that the U.S. drug approval process is already the speediest in the world. But Gottlieb has held posts that could please people on both sides of the aisle. He’s worked at FDA in two other capacities, besides being deputy commissioner, and he’s been a clinical assistant professor at New York University’s School of Medicine since 2011. More controversial is Gottlieb’s history of working with pharmaceutical companies. According to his personal financial disclosure, Gottlieb has been on the boards of directors of eight pharmaceutical companies and one laboratory company, and is still on the board of four of them. He’s also a member of the product investment board at GlaxoSmithKline, the world’s sixth-largest public pharmaceutical company. Gottlieb’s non-board positions in health-related companies have also been numerous, from serving as acting CEO and director of Cell BioTherapy, Inc., an animal medicine company, to being a venture partner at New Enterprise Associates, a venture capital firm that invests in technology and health care companies. Critics believe that appointing Gottlieb, a fellow at the conservative American Enterprise Institute since 2007, would invite conflicts of interest and other ethics troubles. “The major problem is that he has deeply-rooted ties to big pharma that span more than a decade,” said Michael Carome, director of Public Citizen’s Health Research Group. “His ties include receiving hundreds of thousands of dollars in payments to be a consultant and a speaker; he’s a venture partner at a venture capitalist company that funds multiple large and small companies that do work on biopharmaceuticals and medical devices; and he is someone who in addition to being entangled with multiple industry ties, he’s advocated for a dangerous deregulatory approach to the review of medications.” The pharmaceutical industry has rewarded Gottlieb well. Over the past 12 months, GlaxoSmithKline paid him more than $87,000, and Daichii Sankyo U.S. sent over $52,000 his way. Tolero Pharmaceuticals paid him $35,000, and he exercised and sold another $193,111 in Tolero stock options. For more information, including sources of income exceeding $5,000 per year (lots of speaking gigs there) and employment agreements and arrangements that Gottlieb had in the past 12 months, check out his personal finance disclosure statement. For his part, Gottlieb, in his ethics agreement, says that for a period of one year, he’ll recuse himself from FDA decisions involving the companies where he currently holds positions. That year-long firewall would begin as soon as he resigns from the firms. A similar recusal would apply to his consulting clients, but the one-year period would be retroactive to the last date he did work for them. For companies in which he has financial interest, like Collective Health and Golden State Medical, the recusal would last until he divests his stock — but would apply only to issues that, to Gottlieb’s knowledge, have “direct and predictable effect[s] on the financial interests” of the organizations. Carome’s not convinced that those recusals will suffice. “The letter basically affirmed what we already knew: That he’s entangled in a wide web of financial conflicts of interests. No amount of recusal will disentangle himself from all those conflicts of interests,” he said. “He’s going to be involved in decisions that will impact the bottom line of these companies for years.” Alternatively, Paul S. Ryan, vice president of policy and litigation at Common Cause, acknowledged that Gottlieb’s plan of recusal and divestment fits the bill of what’s expected of federal employees. “It sounds like he’s doing the right thing, the required thing, when he divests from the pharmaceutical companies,” he said. But Ryan also raised Gottlieb’s potential to return to work in the pharmaceutical industry after having overseen it. Trump’s executive order on ethics restricts how soon a govenment official can take a job lobbying for an organization; Gottlieb’s case is different, Ryan said. “[W]e’re talking about going to work at a company and getting a big paycheck after having done things to benefit that company during your time as a federal employee.” That situation’s not unique to Gottlieb, of course. James Shehan, head of the FDA regulatory practice at Lowenstein Sandler, is more heartened by than worried about Gottlieb’s background. Regarding what some perceive as potential conflicts of interest, Shehan said, “To me, it’s indicative that he’s familiar with a lot of the issues that are relevant to FDA because he’s been continuously involved with them for many years. And I kind of expect him to be a good FDA commissioner.” “To me, the question is never does someone have a potential conflict of interest — it’s how do you deal with it,” he added. Here are the organizations listed in Gottlieb’s ethics letter, with the recusal terms for each of them. Gottlieb’s Senate confirmation hearing is scheduled to begin at 10 a.m. tomorrow, April 5. -- 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.

04 апреля, 22:22

Novartis' Tafinlar, Mekinist Get EU Approval for NSCLC

Novartis AG (NVS) recently announced that the European Commission has approved Tafinlar in combination with Mekinist for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).

04 апреля, 21:55

These Advertisers Are Fleeing Bill O'Reilly's Show

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); At least nine companies have pulled advertising from Fox News’ “The O’Reilly Factor” amid revelations that several women have accused host Bill O’Reilly of sexual harassment.  Following an explosive New York Times report that O’Reilly and Fox News had paid around $13 million in settlements addressing complaints brought by five of the conservative host’s previous female colleagues, several advertisers moved to remove their commercials from the hit show. Among them are several automakers, including Mercedes-Benz and Hyundai. “The allegations are disturbing and, given the importance of women in every aspect of our business, we don’t feel this is a good environment in which to advertise our products right now,” Mercedes-Benz spokeswoman Donna Boland told CNN, which first reported the company’s decision to pull advertising on Monday.  Hyundai announced its decision late Monday night. “As a company we seek to partner with companies and programming that share our values of inclusion and diversity,” a Hyundai spokesman said.  Emily Steel, an author of the Times’ investigation, reported Hyundai’s full statement on Twitter. Full statement from Hyundai spokesman on decision to pull ads from The O'Reilly Factor, following sexual harassment allegations. pic.twitter.com/EBBAvBD8bA— Emily Steel (@emilysteel) April 4, 2017 BuzzFeed News reached out to about 50 companies that advertise on “The O’Reilly Factor” and confirmed Tuesday that automaker BMW, Sanofi Consumer Healthcare and marketing company Constant Contact had pulled commercials. Drugmaker GlaxoSmithKline also told BuzzFeed that it has temporarily pulled advertising.  “We are continually reviewing our advertising to ensure it is conducted in a responsible manner aligned with our values,” a GSK spokesperson told BuzzFeed. Insurance company Allstate, the men’s clothing line Untuckit and pet food company Ainsworth Pet Nutrition all confirmed Tuesday that they are withdrawing commercials from the show, NBC News reported.  “Inclusivity and support for women are important Allstate values,” Allstate spokesman Justin Herndon told the network. “We are concerned about the issues surrounding the program and we have suspended our advertising.”  This is a developing story. Check back for updates.  -- 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.

03 апреля, 23:11

GlaxoSmithKline Initiates Phase III Study with Mepolizumab

GlaxoSmithKline plc (GSK) announced the initiation of a phase III study with Nucala (mepolizumab,) in patients with severe hypereosinophilic syndrome (HES).

31 марта, 23:36

Mylan Receives CRL for Generic Advair Diskus From the FDA

Mylan N.V. (MYL) recently suffered a huge setback when it received a complete response letter from the FDA regarding its ANDA for the generic version of asthma drug Advair Diskus.

14 мая 2014, 18:13

Китай обвинил британского менеджера GlaxoSmithKline в даче взяток - economy

Китайская полиция предъявила обвинения в даче взяток бывшему руководителю китайского подразделения британской фармацевтической компании GlaxoSmithKline. Пекин заявляет, что Марк Рейли, возглавлявший бизнес в Китае с 2009 года, и два китайских менеджера организовали коррупционную сеть: персонал GSK подкупал врачей за продвижение лекарств фирмы, благодаря чему продажи выросли на сотни миллионов евро. Сумма взяток оценивается китайской полицией в 400 млн евро. Дело GSK - крупнейший в Китае корруп... ЧИТАТЬ ДАЛЕЕ: http://ru.euronews.com/2014/05/14/glaxosmithkline-bosses-in-china-charged-with-bribery Последние новости смотрите здесь: http://eurone.ws/1hfoGvh euronews: самый популярный новостной канал в Европе. Подписывайтесь! http://eurone.ws/ZdZ0Zo euronews доступен на 14 языках: http://eurone.ws/11ILlKF На русском: Сайт: http://ru.euronews.com Facebook: http://www.facebook.com/euronews Twitter: http://twitter.com/euronewsru Google+: http://eurone.ws/1eEChLr VKontakte: http://vk.com/ru.euronews