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Выбор редакции
17 апреля, 16:52

Аналитики RBC Capital пересмотрели целевую цену акций Apple и Mylan

Сегодня, 17 апреля, аналитики RBC Capital пересмотрели целевую цену акций американской корпорации Apple, а также одного из крупнейших в США производителей непатентованных лекарственных препаратов Mylan. Так, прогнозная стоимость бумаг Apple была увеличена с $155 до $157, тогда как целевая цена акций Mylan понижена с $48 до $46.

17 апреля, 14:27

Аналитики RBC Capital пересмотрели целевую цену акций Apple и Mylan

Сегодня, 17 апреля, аналитики RBC Capital пересмотрели целевую цену акций американской корпорации Apple, а также одного из крупнейших в США производителей непатентованных лекарственных препаратов Mylan. Так, прогнозная стоимость бумаг Apple была увеличена с $155 до $157, тогда как целевая цена акций Mylan понижена с $48 до $46.

17 апреля, 13:56

Mylan stock price target cut to $46 from $48 at RBC Capital

This is a Real-time headline. These are breaking news, delivered the minute it happens, delivered ticker-tape style. Visit www.marketwatch.com or the quote page for more information about this breaking news.

13 апреля, 14:36

Pharma Stock Roundup: Merck Gets CRL for Label Expansion Effort, Roche Cancer Drug Tops

Key highlights this week include a complete response letter (CRL) for Merck (MRK) and some positive data from Roche.

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

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12 апреля, 20:35

FDA Warns Mylan Over Quality Concerns At India Facility

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); The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3. India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of key suppliers to the United States. “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the FDA said in the letter to Mylan. bit.ly/2p2bKGV The agency’s concerns stem from an inspection in September of a facility located at Nashik in the western Indian state of Maharashtra that produces antiretroviral therapies (ARVs) used to treat HIV. “When something reaches a warning letter stage, it can show that the FDA is dissatisfied with the company’s attempts to explain or remediate the issue,” Wells Fargo analyst David Maris said. The FDA outlined several violations at Mylan’s Nashik facility, including a failure to “thoroughly investigate” unexplained discrepancies in drug batches and cited examples of “missing, deleted, and lost data”. The agency said Mylan had opened an investigation into the “lost” data, but attributed it to power interruptions, connectivity problems and instrument malfunctions. “You could not explain why these events occurred with frequency in your laboratory, nor had you undertaken a comprehensive investigation into the problem or sought to correct it and prevent its recurrence,” the FDA wrote. Until the regulator can confirm Mylan’s compliance with standard manufacturing practices, it may withhold approval of any new applications listing the firm as a drug manufacturer, the FDA said. Mylan has nine independent sites, including the Nashik facility, that produce and supply ARVs, which helps maintain continuous supply, Mylan spokeswoman Nina Devlin told Reuters. “In the decade that Mylan has supplied ARVs, we have never had any supply disruption due non-compliance at any site and, again, we do not anticipate any supply disruption at this time,” Devlin said. The FDA had in 2015 had sent a warning letter expressing concerns over quality controls at three Mylan facilities in the south Indian city of Bengaluru. Mylan’s shares were down 1.9 percent at $38.50 in afternoon trading on the Nasdaq.   (Reporting by Natalie Grover in Bengaluru; Editing by Sai Sachin Ravikumar) -- 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.

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11 апреля, 19:50

Mylan stock drops nearly 2% after FDA warning letter about manufacturing facility

This is a Real-time headline. These are breaking news, delivered the minute it happens, delivered ticker-tape style. Visit www.marketwatch.com or the quote page for more information about this breaking news.

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10 апреля, 23:35

Is Mylan Allergic to Good PR?

Mylan stock sank last week after yet another EpiPen scandal. Some injectors have malfunctioned, prompting a global recall. Can the stock recover?

10 апреля, 11:01

Sucampo (SCMP) Down 7.6% Since Earnings Report: Can It Rebound?

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

06 апреля, 17:10

Acorda (ACOR) to Reduce Workforce, Focus on Product Pipeline

Acorda Therapeutics, Inc. (ACOR) recently announced plans to reduce its workforce by approximately 20%.

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.

04 апреля, 20:41

Mylan Hit With New Class Action Lawsuit Over EpiPen Pricing

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); Mylan NV (MYL.O) has been hit with a new proposed class action lawsuit over the price of its EpiPen allergy treatment, which shot up to more than $600 for a two-pack of the device from less than $100 in 2007. The lawsuit was filed on Monday in Tacoma, Washington, federal court by three EpiPen purchasers. It claims Mylan engaged in a scheme with pharmacy benefit managers, or PBMs - companies that act as intermediaries between pharmacies, insurers and drug companies - to dominate the market and overcharge consumers. Although other lawsuits have been filed over EpiPen pricing, Monday’s is the first to focus on the role of PBMs and to bring claims under the Racketeer Influenced and Corrupt Organizations Act, a federal law historically used against organized crime. Mylan spokeswoman Nina Devlin declined to comment. The EpiPen, acquired by Mylan in 2007, is a hand-held device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine. The company now sells a $300 generic version. The plaintiffs in Monday’s lawsuit say Mylan paid large rebates to PBMs so they would favor EpiPen over competitors. In helping Mylan control 95 percent of the epinephrine auto-injector market, the rebates artificially inflated EpiPen’s sticker price, resulting in higher costs for many patients, the suit said. The lawsuit says the three largest U.S. pharmacy benefits managers - CVS Caremark, part of CVS Health (CVS.N); Express Scripts Holding Co (ESRX.O) and OptumRX, part of UnitedHealth Group Inc (UNH.N) - aided Mylan’s alleged scheme. They were not named as defendants. The plaintiffs are seeking damages to represent a nationwide class of EpiPen purchasers. Mylan has grappled with a growing backlash from U.S. consumers over the price of EpiPen in the last year. Other class action lawsuits have been filed against Mylan over the pricing of EpiPen, including two currently consolidated in Kansas federal court. However, they have not focused on the role of PBMs. The company is also under investigation by the Federal Trade Commission and said last September that it had agreed to a $465 million settlement with the U.S. Justice Department over how the drug was classified for government buyers. The Justice Department has not confirmed the settlement. Mylan Chief Executive Officer Heather Bresch has said that the company makes only about $100 per EpiPen pack, and that most consumers pay less than $50 for a two-pack. The plaintiffs in Monday’s lawsuit said Bresch falsely tried to paint Mylan as a “victim” of a flawed healthcare system and avoid its own responsibility in setting rebates. The case is Rainey et al v. Mylan Specialty LP, U.S. District Court, Western District of Washington, No. 17-cv-05244.   (Reporting by Brendan Pierson in New York; Editing by Dan Grebler) -- 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, 20:41

Mylan Hit With New Class Action Lawsuit Over EpiPen Pricing

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); Mylan NV (MYL.O) has been hit with a new proposed class action lawsuit over the price of its EpiPen allergy treatment, which shot up to more than $600 for a two-pack of the device from less than $100 in 2007. The lawsuit was filed on Monday in Tacoma, Washington, federal court by three EpiPen purchasers. It claims Mylan engaged in a scheme with pharmacy benefit managers, or PBMs - companies that act as intermediaries between pharmacies, insurers and drug companies - to dominate the market and overcharge consumers. Although other lawsuits have been filed over EpiPen pricing, Monday’s is the first to focus on the role of PBMs and to bring claims under the Racketeer Influenced and Corrupt Organizations Act, a federal law historically used against organized crime. Mylan spokeswoman Nina Devlin declined to comment. The EpiPen, acquired by Mylan in 2007, is a hand-held device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine. The company now sells a $300 generic version. The plaintiffs in Monday’s lawsuit say Mylan paid large rebates to PBMs so they would favor EpiPen over competitors. In helping Mylan control 95 percent of the epinephrine auto-injector market, the rebates artificially inflated EpiPen’s sticker price, resulting in higher costs for many patients, the suit said. The lawsuit says the three largest U.S. pharmacy benefits managers - CVS Caremark, part of CVS Health (CVS.N); Express Scripts Holding Co (ESRX.O) and OptumRX, part of UnitedHealth Group Inc (UNH.N) - aided Mylan’s alleged scheme. They were not named as defendants. The plaintiffs are seeking damages to represent a nationwide class of EpiPen purchasers. Mylan has grappled with a growing backlash from U.S. consumers over the price of EpiPen in the last year. Other class action lawsuits have been filed against Mylan over the pricing of EpiPen, including two currently consolidated in Kansas federal court. However, they have not focused on the role of PBMs. The company is also under investigation by the Federal Trade Commission and said last September that it had agreed to a $465 million settlement with the U.S. Justice Department over how the drug was classified for government buyers. The Justice Department has not confirmed the settlement. Mylan Chief Executive Officer Heather Bresch has said that the company makes only about $100 per EpiPen pack, and that most consumers pay less than $50 for a two-pack. The plaintiffs in Monday’s lawsuit said Bresch falsely tried to paint Mylan as a “victim” of a flawed healthcare system and avoid its own responsibility in setting rebates. The case is Rainey et al v. Mylan Specialty LP, U.S. District Court, Western District of Washington, No. 17-cv-05244.   (Reporting by Brendan Pierson in New York; Editing by Dan Grebler) -- 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, 17:24

Teva's Austedo Gets FDA Nod for Huntington Disease Treatment

Teva Pharmaceutical Industries Ltd. (TEVA) recently announced that the FDA has approved its investigational drug, Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington disease (HD).

04 апреля, 13:44

Tuesday's Morning Email: The Latest In The Russia Revelations

TOP STORIES (And want to get The Morning Email each weekday? Sign up here.) BREAKING DOWN THE RUSSIA REVELATIONS Two bombshell reports dropped Monday from The Washington Post and BuzzFeed. The first alleged that the United Arab Emirates set up a secret meeting in January between Betsy DeVos’s brother, Erik Price ― the founder of Blackwater ― and a Russian who was close to President Vladi­mir Putin “as part of an apparent effort to establish a back-channel line of communication between Moscow and President-elect Donald Trump.” And BuzzFeed confirmed former Trump advisor Carter Page “met with and passed documents to a Russian intelligence operative.” [WaPo] THE GOP HEALTH CARE DEAL ISN’T DEAD YET “House Republicans still don’t have a deal to revive their health care bill, but the White House is laying the groundwork for negotiations to move quickly, meeting individually Monday with moderates and conservatives to discuss a possible agreement.” [HuffPost] ‘THIS IS HOW THE NEXT WORLD WAR STARTS’ David Wood examines how an intercept gone wrong could mean WWIII. [HuffPost] AUTHORITIES IDENTIFIED ST. PETERSBURG BOMBER Akbarzhon Jalilov, a Russian citizen born in Kyrgyzstan, is the top suspect in the blast that killed 11 and wounded 45 on a St. Petersburg train. [Reuters] NORTH CAROLINA BATTLED OUT A NATIONAL CHAMPIONSHIP WIN OVER GONZAGA Which this author called since she’s been loyal ever since winning her eighth grade pool with the help of the Tar Heels. [Reuters] HYUNDAI AND MERCEDES-BENZ PULL ADS FROM ‘O’REILLY FACTOR’ Over the latest sexual harassment allegations against host Bill O’Reilly. [HuffPost] DEMOCRATS HAVE LOCKED IN THE VOTES FOR A FILIBUSTER ON NEIL GORSUCH The so-called “nuclear option” is looking more likely than ever. [HuffPost] AT LEAST 35 DEAD IN SUSPECTED GAS ATTACK IN SYRIA Nine of the victims in the northwestern province of Idlib were children. [Reuters] WHAT’S BREWING INSIDE THE HUGE SPORTS SEX ABUSE SCANDAL You haven’t paid enough attention to. [HuffPost] YOU’D THINK IT’S GREAT NEWS TO LEARN YOU CAN BUY GIRL SCOUT COOKIES ON AMAZON But here’s why you shouldn’t. [HuffPost] ANNE HATHAWAY IS OVER EVERYONE ASKING WHAT IT’S LIKE TO BE HATED “How the world feels about me has nothing to do with me.” [HuffPost] TAKE 20 PERCENT OFF FOR EQUAL PAY DAY At over 300 businesses. [HuffPost] OF COURSE ‘S-TOWN’ ALREADY HAS 10 MILLION DOWNLOADS ALREADY You mean you haven’t finished the hit podcast yet? Feel free to email in with commentary, we’re always up to discuss. [HuffPost]  BEFORE YOU GO Take a look at Melania Trump’s first official White House portrait​. We’re getting mixed signals about a “Big Little Lies” season two, and you just can’t jerk us around on news like that. The internet cannot handle Michelle Obama rocking her natural hair. This teen is proof punching a shark in the face works. Deciphering Zayn Malik’s new tattoo. For Alec Baldwin, a leaked 2007 voicemail forever injured his relationship with his daughter. Meet the “Banksy of punctuation.” Take a look at the states where the pay gap is the worst. Harrison Ford will keep his pilot’s license after nearly colliding with a passenger plane. All is right with the world: There are now lullaby versions of your favorite “Hamilton” songs so your kid isn’t left out of the fun. Make sure your EpiPen is not one of the ones recalled by Mylan. And find out where President Trump donated his salary thus far. -- 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.

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03 апреля, 23:10

Mylan hit with new class action lawsuit over EpiPen pricing

(Reuters) - Mylan NV has been hit with a new proposed class action lawsuit over the price of its EpiPen allergy treatment, which shot up to more than $600 for a two-pack of the device from less than $100 in 2007.