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Raritan, NJ (March 31, 2014) - Janssen Research & Development, LLC (Janssen) announced today it is adding three new clinical trials to its EXPLORER global cardiovascular research program for XARELTO® (rivaroxaban), the most studied and broadly indicated oral Factor Xa inhibitor in the world today. The additional trials will evaluate rivaroxaban for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient populations, including those at risk for DVT or PE due to a concurrent medical illness. The new studies will include more than 11,000 patients in over 30 countries. With the addition of these studies, the EXPLORER global cardiovascular research program now encompasses eight clinical trials assessing the safety and efficacy of rivaroxaban in high-risk patient populations, including those with chronic heart failure, coronary artery disease and peripheral artery disease. EXPLORER is an integral part of the extensive clinical development program for rivaroxaban, evaluating its use in a broad range of cardiovascular conditions. "Each year in the U.S., more people die from DVT and PE than from motor vehicle accidents, breast cancer and HIV combined," said Anne Hermanowski Vosatka, M.D., Ph.D., FACC, vice president and compound development team leader for XARELTO® at Janssen. "New trials added to the EXPLORER global cardiovascular research program will broaden our understanding of how rivaroxaban might help patients at risk for developing blood clots such as DVT or PE, addressing an urgent unmet need. MARINER is a Phase 3 study designed to evaluate the efficacy and safety of rivaroxaban once-daily compared with placebo to reduce the risk of symptomatic DVT and/or PE due to a concurrent medical illness for up to 45 days after hospital discharge. This study will include approximately 8,000 patients in more than 15 countries. EINSTEIN JUNIOR, including Phase 1, 2a, 2b and 3 clinical trials, will evaluate rivaroxaban according to an age- and body weight-adjusted dosing schedule for the treatment and secondary prevention of DVT and/or PE in pediatric populations. The study program will include at least 150 patients in 20 countries, and is currently enrolling participants for Phase 2 trials. The Phase 3 study is expected to start in September 2014. Please click here for more information. EINSTEIN CHOICE is a Phase 3 study designed to evaluate whether once-daily rivaroxaban in doses of 10mg or 20mg is superior to aspirin for the prevention of symptomatic recurrent DVT and/or PE in patients who have completed between six and 12 months of anticoagulant therapy. The study will include approximately 2,850 patients in 31 countries and is currently enrolling participants. Please click here for more information. In total, the global clinical development program for rivaroxaban will include 15 Phase 3 clinical trials, 10 of which are completed. By the time of its completion in 2018, more than 136,000 patients are expected to have participated in the global clinical development program, including those patients assessed in EXPLORER. In addition, Janssen and Bayer recently entered into an agreement with Portola Pharmaceuticals, Inc. to initiate Phase 3 studies evaluating Portola's investigational Factor Xa inhibitor reversal agent, andexanet alpha, for use with XARELTO® in emergency situations, such as for patients with major bleeding or those requiring emergency surgery. The clinical collaboration will be in effect through completion of Phase 3 studies with XARELTO® and any potential U.S. and EU regulatory approval of andexanet alfa. Phase 3 studies are expected to start in the first half of 2014. DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and travels to the lung, via the heart, where it can partially or completely block a branch of the pulmonary artery. When PE occurs with large clots, multiple clots or when the patient already has pre-existing heart or lung disease, the event may be fatal. Each year up to 900,000 Americans experience a DVT or PE, resulting in up to 300,000 deaths. The EXPLORER global cardiovascular research program is an integral part of the extensive clinical development program for rivaroxaban, evaluating its use in a broad range of cardiovascular conditions, making it the most studied and broadly indicated oral Factor Xa inhibitor in the world today. COMMANDER-HF is evaluating rivaroxaban in patients with chronic heart failure and significant coronary artery disease who are receiving standard care. The study will include 5,000 patients in 12 countries. Please click here for more information. COMPASS is evaluating rivaroxaban in patients with coronary artery disease or peripheral artery disease. This study includes 20,000 patients across 25 countries and will be conducted in collaboration with the Population Health Research Institute (PHRI) at McMaster University in Hamilton, Ontario, Canada. Please click here for more information. PIONEER AF-PCI is evaluating rivaroxaban in 2,100 patients who have non-valvular atrial fibrillation (NVAF) and are undergoing percutaneous coronary intervention (PCI) with stent placement. The trial is assessing rivaroxaban in combination with dual antiplatelet therapy and when aspirin is not used. Please click here for more information. VENTURE-AF is evaluating the use of rivaroxaban in patients with NVAF undergoing catheter ablation, a procedure that uses energy delivered through catheters to eliminate the abnormal tissue that is causing the arrhythmia. The study will include up to 250 patients in four countries. Please click here for more information. X-VeRT is evaluating patients with atrial fibrillation scheduled for cardioversion - a medical procedure to convert abnormally fast heart rate to a normal rhythm, using electricity or antiarrhythmic medications. The study includes 1,500 patients across 17 countries and will compare rivaroxaban to dose-adjusted vitamin K antagonist. Please click here for more information. XARELTO® works by blocking the blood clotting Factor Xa and does not require routine blood monitoring. To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke. To treat patients with deep vein thrombosis (DVT). To treat patients with pulmonary embolism (PE). To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism. To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery. To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery. Eight million patients have received XARELTO® worldwide, and more than five million prescriptions have been written for XARELTO® in the U.S. XARELTO® has earned a strong reimbursement profile among oral anticoagulants, with 90 percent of patients on Medicare Part D and 90 percent of commercial patients covered at the lowest branded co-pay. Janssen Research & Development, LLC and Bayer HealthCare together are developing rivaroxaban. For more information about XARELTO®, visit www.xarelto-us.com. The XARELTO® CarePath™ Support Program is a resource designed for healthcare providers, patients and caregivers. Visit www.xareltocarepath.com or call 1-888-XARELTO to learn more about the XARELTO® CarePath™ resources focused on access, education and adherence. XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke. XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again. XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery. People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke. If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily and it may take longer for bleeding to stop. Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence). XARELTO® is not for patients with artificial heart valves. Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO®. Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby. Tell your doctor right away if you become pregnant while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss. Are breastfeeding or plan to breastfeed. It is not known if XARELTO® passes into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed. Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. St. Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Take XARELTO® exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO® unless your doctor tells you to. Your doctor will tell you how much XARELTO® to take and when to take it. Your doctor may change your dose if needed. Atrial Fibrillation: Take XARELTO® 1 time a day with your evening meal. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Take XARELTO® once or twice a day as prescribed by your doctor. Take XARELTO® with food at the same time each day. and take XARELTO® 2 times a day: Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time. and take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®. Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO® without talking to your doctor first. Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure. Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses. If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away. Please see "What is the most important information I should know about XARELTO®?" above. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736). Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide. Trademarks are those of their respective owners. At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc., are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information. (This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. kchang12@its.jnj. cchan20@its.jnj. This site is governed solely by applicable U.S laws and governmental regulations. Please see our Privacy Policy. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy.Your use of the information on this site is subject to the terms of our Legal Notice. You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson.Contact Us with any questions or search this site for more information. 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Climate of Fear Sparks Strange Behavior in PyongyangA climate of fear in North Korea since the bloody execution of leader Kim Jong-un's uncle Jang Song-taek is manifesting some odd behavior, especially in Pyongyang where the nervous elite live. Those who are part of the elite already are turning to superstition to ward off ill fortune, while those outside are going to great lengths to avoid being noticed and raising their profile. Many high-ranking officials in the North are visiting fortune tellers to quell their fears that they might be next. A source in North Hamgyong Province said, "A crackdown on superstitious practices reduced business for fortune tellers last year, but since the execution of Jang Song-taek they're getting a lot of customers again. The source said the main customers are the wives of high-ranking officials who worry about the safety of their husbands. "These days officials live in terror of being dragged away without notice and feel safe only when they get home at the end of each day. Some senior officials apparently ask fortune tellers to their homes to avoid bumping into other customers. For the fortune tellers at least the trend means a healthy uptake in earnings. The regime has started yet another campaign to revive the personality cult surrounding nation founder Kim Il-sung. Until last year, the state-run media were more focused on his son Kim Jong-il, and massive rallies marked the anniversary of his death. But recently state television has been airing endless documentaries and movies glorifying the life and times of Kim Il-sung. The shift seems to stem from the belated recognition that Kim Jong-il was widely disliked for his brutal and erratic behavior, while many genuinely revere his father. Meanwhile, the regime is busy winning hearts and minds through state-sponsored programs helping the young and elderly, with the result that there are fewer children begging in the streets of Pyongyang. The program seems aimed at evoking memories of the early heyday of North Korean communism. So terrified are many women of being recruited for the entertainment troupes that serve senior officials that they have resorted to scarring their faces to avoid passing muster. In the past, it was considered an honor for a woman to be chosen for these troupes, but the brutal execution of a number of them last year brought home that closeness to power is a dangerous place. Kim Jong-il, who was short, chose women who were at least 160 cm tall and men who were at least 170 cm for the entertainment troupes. His son Kim Jong-un has upped the requirements by five centimeters, and in a country where poor nutrition often stunts growth, candidates are increasingly hard to find. This has prompted officials to look beyond the traditional recruitment ground of Pyongyang and scour the provinces for likely candidates.englishnews@chosun.com / Feb. Most S.Korean Men Would Marry N. Why Is There a Shortage of Men in N. Thousands of Kids of N. N. Matching N.Korean Women with S. Human Trafficking Thrives Across N. 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expressclassifiedstt. Two men holding public office are alleged to have perpetrated abomi­nable acts of violence against women in the past few weeks. These incidents are symptomatic of a deep sickness that pervades Trinbagonian society at all levels. A deep lack of love for our women and girls is manifested time and again, and little is being done to change it. In 2012, there were 2,517 female victims of violent crimes in Trinidad and Tobago (rape, assault, etc). For the 2009/2010 law term, 12,106 new domestic violence applications were filed in the magistrate’s courts. These numbers are just the tip of the iceberg, due to the fact that most of these crimes are not reported. As a society, we must work toge­ther to combat this problem and mitigate its effects. This requires both the Government and NGOs (non-governmental organisations) to implement strategies to combat this violence. UNIFEM’s (United Nations Devel­opment Fund for Women) “National Accountability Framework to End Violence against Women” recommends a holistic approach, combi­ning Government services, such as public health and law enforcement, with educational institutions and other actors such as trade unions and NGOs. In effect, everyone has a part to play in ending violence against wom­en. We must continue to develop a no-tolerance policy towards this problem. Violence against women must not only be condemned but punished at every opportunity. I urge everyone reading this to become your sister’s keeper; if you know of a woman who is abused, do not turn a blind eye but rather offer a helping hand. Trinidad and Tobago, since 1996, has ratified the Inter-American Con­vention on the Prevention, Punish­ment and Eradication of Violence Against Women. violence against women. Tri­nidad and Tobago needs to change. It seems to me that we have a full-blown culture of violence that must be transformed into a culture of peace and loving kindness. Husbands ought to love their wives as their own bodies, and people ought to love their neighbours as themselves. Do we truly love our women as a society? Then we must protect them. This content requires the latest Adobe Flash Player and a browser with JavaScript enabled. Click here for a free download of the latest Adobe Flash Player. ... Newsletter Sign UpSubscribe to our FREE Digital Divide Newsletter. Powered by Broadcast Interactive Media. 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Skip to search. Canada HomeB.C. World HomeU.S. Odd News HomeOdd News VideoWho Knew? VideoTrending Now VideoDaily BuzzOdd VideoBlogs HomeCanada NewsPolitical PointsScience & WeatherGood NewsPersonal TechDaily BuzzDavid vs. By Andy RadiaPolitics ReporterPostsWebsiteEmailBy Andy Radia | Canada Politics – 9 hours agoOne of the emerging themes as we inch toward the 2015 federal election is that of a political leader's judgement. We saw a hint of this on Monday when Conservative Party Officials questioned Justin Trudeau's after the Liberal leader dropped an f-bomb at a charity boxing match over the weekend. Trudeau countered, questioning Stephen Harper's judgement over the sudden resignation of the prime minister's hand-picked Conservative Party executive director Dimitri Soudas. Soudas resigned on Sunday after allegations emerged of him interfering with a nomination battle in Oakville involving his fiance MP Eve Adams. "It's yet another example of this government in general, but Mr. Harper in particular, showing poor judgement in his appointments process. Whether its for senators or executive directors or chiefs of staffs," Trudeau told reporters on Monday. "This is just part of a pattern of a government that has shown itself incapable of putting the right people in the right place. But both leaders have had their fair share of questionable decisions in recent years. For Harper, thiss errors in judgement seem revolve around the people that he surrounds himself with. Perhaps it's a little unfair for the Harper to shoulder all of the blame, but some ket members of the his government have really let the prime minister down over the years. Nigel Wright, Prime Minister Harper's former chief of staff. REUTERS/Chris WattieBrought on board in 2010, Nigel Wright was Prime Minister Harper's Chief of Staff and right hand-man. That ended last spring when news that Wright had gifted Senator Mike Duffy a $90,000 to pay back the embattled senator's improperly claimed living allowances came to light. Last summer, the RCMP announced that they were investigating the transaction. Wright denies any wrongdoing. Suspended Senators Pamela Wallin, Patrick Brazeau, and Mike Duffy. Radio Canada photo.After saying he wouldn't appoint any senators, Harper appointed 18 in December 2008. Three of the senators — Duffy, Wallin and Brazeau — are now alleged to have claimed inappropriate expenses and are all under RCMP investigation. All three senators claim that they're innocent. To make matters worse for Harper, both Duffy and Wallin were once gallivanted around the country to promote the Conservative Party brand. Arthur Porter. CBC photo.In 2010, the prime minister appointed Dr. Arthur Porter as the top watchdog for Canada's spy agency. As explained by the Montreal Gazette, Porter resigned from that post in 2010 after reports suggested that he wired $200,000 to an international arms dealer as part of a botched business deal. Last February, Quebec's anti-corruption squad issued a warrant for his arrest for his alleged involvement with fraud in relation to a Montreal hospital project. He was arrested in Panama in May. None of the allegations have been proven in court. Bruce Carson worked as a senior aide to Prime Minister Harper until 2008. CBC photo.Bruce Carson was a senior aide to Harper from 2006 to 2008. According to a recent CBC report, the RCMP is investigating allegations he illegally lobbied his former government colleagues. As for Justin Trudeau, his lapses of judgement seem to come when his emotions get the better of him. Either that, or he tries to be funny. It is very worrisome, particularly since Russia lost in [Olympic] hockey, they will be in a bad mood and we fear Russian involvement in the Ukraine.He eventually apologized. You know, there's a level of of admiration I actually have for China because their basic dictatorship is allowing them to actually turn their economy around on a dime and say ‘we need to go green fastest...we need to start investing in solar. I mean there is a flexibility that I know Stephen Harper must dream about of having a dictatorship that he can do everything he wanted that I find quite interesting. Who can forget this Radio Canada interview from 2010, which surfaced some two years later. Not surprisingly, the Conservatives made hay with the video. They posted it on their website with this quote: "We knew these anti-Alberta attitudes were deeply held within the Liberal Party, we just didn't know how close to the surface they were. Former Environment Minister Peter Kent. CBC photo.The f-bomb at the boxing match on the weekend wasn't Trudeau's first brush with foul language in public. During Question Period in December 2012, Trudeau called then-Environment Minister Peter Kent a "piece of sh$%" after Kent chided an NDP member for her question. Trudeau later apologized claiming he lost his temper. While it's difficult to dub one of these leaders more egregious than the other, it's clear that both are guilty of misjudgments. If the 2015 election is fought on judgement, voters will have to decide what's worse: a prime minister who has a significant record of handpicking the wrong people, or a prime minister who occasionally says some really dumb things. Magnitude-8. 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