A Big W customer has been left in shock after opening a newly purchased phone to find it full of batteries and toilet paper. Source: Facebook
A Big W customer has been left in shock after opening a newly purchased phone to find it full of batteries and toilet paper. Source: Facebook
Study quantified coronary plaque changes in patients administered 4 g/day of VASCEPA® (icosapent ethyl) on top of statin therapy Effect on coronary plaque stabilization reported to be significant at 9 months and sustained at 18 months DUBLIN, Ireland and BRIDGEWATER, N.J., April 17, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that further analyses from the Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: EVAPORATE Trial were presented as Late-Breaking Science at European Society of Cardiology (ESC) Preventive Cardiology 2021, the Annual Congress of the European Association of Preventive Cardiology, on April 17, 2021, 3:50 PM CEST (Central European Summer Time) by Andrew Buckler, Founder and CTO of Elucid. As previously reported and published in the European Heart Journal, VASCEPA® (icosapent ethyl) demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. The Effect of Icosapent Ethyl on Changes in Coronary Plaque Morphology: EVAPORATE analyses presented at ESC Preventive Cardiology 2021 demonstrated that with administration of 4 g/day of VASCEPA on top of statin therapy, there was an observed change in plaque stability occurring at 9 months and sustained through 18 months. “The EVAPORATE plaque morphology study provides valuable insight into how we can utilize scientific imaging to examine the mechanisms at work that may contribute to observed clinical trial results,” commented Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA, the study sponsor. “The results suggest consistent benefits of icosapent ethyl on clinical cardiovascular outcomes as observed in the REDUCE-IT® cardiovascular outcomes study, and on plaque progression and plaque vulnerability as observed in EVAPORATE.” Of the 80 patients that were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial, 55 patients had images that were able to be utilized for the histology-validated software. The EVAPORATE plaque morphology study used ElucidVivo (Elucid, Boston, MA), the first FDA-cleared analysis for specific tissue characterization using histopathologic correlates to assess plaque morphology characteristics, including Lipid Rich Necrotic Core (LRNC), fibrous cap thickness, and intraplaque hemorrhage (IPH). Whereas with placebo LRNC increased and cap thickness decreased, both indicative of moving to a less stable phenotype, with icosapent ethyl there was a measured LRNC decrease and cap thickness increase, indicative of moving to a more stable phenotype. “Coronary plaque stabilization is an important finding with VASCEPA and may explain, in part, the substantial cardiovascular benefit seen in REDUCE-IT,” said Craig Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief medical officer. “The EVAPORATE plaque morphology study results provide additional insight into one of the likely multifactorial effects of VASCEPA, which effects collectively have been shown or observed to lower residual cardiovascular risk.” The primary limitation of this single coronary plaque study as identified by its investigators is its small sample size. More study is needed to more fully understand the effects of VASCEPA on coronary plaque to determine the relationship, if any, of such plaque effects on cardiovascular risk reduction. More information on ESC Preventive Cardiology 2021 can be found here. About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland as well as commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management. About Cardiovascular RiskCardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.1 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.2 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.3,4,5 About REDUCE-IT®REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.8 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com. About VASCEPA® (icosapent ethyl) CapsulesVASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. Indications and Limitation of Use (in the United States)VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below: Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT VASCEPAPlaceboVASCEPA vs PlaceboN = 4089n (%)Incidence Rate (per 100 patient years)N = 4090n (%)Incidence Rate (per 100 patient years)Hazard Ratio (95% CI)Primary composite endpointCardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)705(17.2)4.3901(22.0)5.70.75(0.68, 0.83)Key secondary composite endpointCardiovascular death, myocardial infarction, stroke (3-point MACE)459(11.2)2.7606(14.8)3.70.74(0.65, 0.83)Other secondary endpointsFatal or non-fatal myocardial infarction250(6.1)1.5355(8.7)2.10.69(0.58, 0.81)Emergent or urgent coronary revascularization216(5.3)1.3321(7.8)1.90.65(0.55, 0.78)Cardiovascular death 174(4.3)1.0213(5.2)1.20.80(0.66, 0.98)Hospitalization for unstable angina 108(2.6)0.6157(3.8)0.90.68(0.53, 0.87)Fatal or non-fatal stroke98(2.4)0.6134(3.3)0.80.72(0.55, 0.93) Includes adjudicated cardiovascular deaths and deaths of undetermined causality. Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential impact of VASCEPA in various clinical uses. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact InformationInvestor Inquiries:Investor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com (investor inquiries) Solebury Troutamarinir@troutgroup.com Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media inquiries) AMARIN, VASCEPA, VAZKEPA and REDUCE-IT are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States. 1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.6 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.7 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.8 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
Elucid, a medical technology company developing AI software for physicians to optimize the treatment of patients with known or suspected vascular disease, announced that first author and Elucid founder Andrew Buckler presented findings today from the EVAPORATE (Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy, ClinicalTrials.gov Identifier: NCT02926027) study at the live session "Late-Breaking Science: be the first to know!" for ESC Preventive Cardiology 2021. The presentation, entitled Effect of Icosapent Ethyl (IPE) on Changes in Coronary Plaque Morphology, details the effects of IPE on cardiovascular events and plaque characteristics using the ElucidVivo software on CT angiography (CTA). The ElucidVivo software is the first and only FDA-cleared arterial analysis tool designed to quantify morphology from CTA as if performed ex vivo by a cardiovascular pathologist.
After trying to block a pass, Donovan Mitchell landed and rolled his right ankle hard on the court on Friday afternoon.
Diversity in Hollywood is “better in some ways and worse in others,” actor Alfonso Ribeiro, star of The Fresh Prince of Bel-Air and Host of America's Funniest Home Videos told Yahoo Finance when discussing how the industry has evolved over the years.
The Duke’s royal ceremonial funeral on Saturday 17 April will be a striking departure from those of the Queen Mother, Princess Diana and royalty before them, says Victoria Murphy
Members of the royal family have gathered at Windsor for the Duke of Edinburgh’s final farewell. The Duchess of Cornwall, the Duchess of Cambridge and the Countess of Wessex, in mourning black and wearing face masks, were among those leaving the historic castle by car to make the short journey to the chapel. The Queen mourning the husband she was married to for 73 years, will lead the royal family in St George’s Chapel on Saturday.
Early risers flocked to support Queen Elizabeth II ahead of her husband Prince Philip's funeral on Saturday, taking advantage of cloudless skies to honour him with flowers and tributes.
Several hundred members of the military are taking part in the proceedings at Windsor Castle ahead of the Duke of Edinburgh’s funeral this afternoon. The hearse, a specially modified Land Rover, arrived at the castle shortly before 2.30pm to collect the coffin. The Defender TD5 130 chassis cab vehicle was made at Land Rover’s factory in Solihull in 2003, the year he turned 82.
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(Bloomberg) -- Iran’s lead negotiator in talks aimed at reviving the nuclear deal said world powers had reached a “new understanding” and should soon start drafting a text outlining how they will restore the accord.Speaking to Iranian state television, Deputy Foreign Minister Abbas Araghchi said that serious disagreements still remained but that Iran was working on a draft text that could work as a framework for subsequent talks.“The drafting of the text can begin now and the Iranian delegation has prepared and presented its text on the nuclear sphere and the lifting of sanctions,” Araghchi said.The comments inject new hope into a process that was plunged into crisis earlier last week after an attack on a major Iranian enrichment facility triggered the Islamic Republic into enriching uranium at levels nearing weapons grade. Iran insists that the heavy metal will be used for medical purposes only. While the U.S. is yet to comment on the latest round of negotiations, which will resume on Sunday, the European Union and Russia, which are also taking a key role in the negotiations, echoed Araghchi’s cautious optimism.On Friday, President Joe Biden, who wants to bring the U.S. back into the 2015 nuclear deal, criticized Iran’s move to enrich uranium to 60% but said that it wouldn’t prevent the talks and said he was “pleased” that Iran continued to engage in discussions.Biden Criticizes Iran’s Uranium Enrichment But Says Talks Go OnEnrique Mora, who is leading the talks in Vienna on behalf of the EU, said in a tweet that the talks were “intensive” and that “progress has been made in a far from easy task”, adding that the group needed to now focus on more detailed workm without elaborating.He said it was “key” that all the parties are committed to seeing the U.S. rejoin the accord that former President Donald Trump abandoned in 2018, and that it’s fully implemented by both Washington and Tehran, which significantly ramped up atomic activity in response to tough U.S. sanctions.Russia’s envoy to the International Atomic Energy Agency, Mikhail Ulyanov, said that the countries would continue working over the weekend and into next week as they agreed to “not waste time” and reach a successful outcome “as soon as possible”.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2021 Bloomberg L.P.
The pregnant duchess was told by her doctors not to fly to the UK for the service.
She was seen pulling into Windsor Castle with Prince William.
Injury hit West Ham passed up the chance to move third after coming out on the wrong side of a five-goal thriller at Newcaslte. The Hammers have managed well without key players so far, but felt the absence of Declan Rice, Aaron Cresswell and Michail Antonio keenly here. The return of Angelo Ogbonna was supposed to restore calm at the back but the Hammers but in one of the poorest defensive displays of the season in the first half.
(Bloomberg) -- The Biden administration is evaluating the impact of new sanctions on Russia and is prepared to escalate those penalties if the Kremlin fails to rein in hacking attacks and attempts to interfere with the U.S. political process, according to people familiar with the matter.Options available to President Joe Biden include expanding the measures announced Thursday to bar U.S. financial institutions from the secondary market for ruble-denominated bonds issued by Russian state banks, said the people, who discussed the matter on condition of anonymity.Biden ordered the latest sanctions on Russia -- including limits on buying newly issued sovereign debt -- in response to allegations that Moscow was behind a hack on SolarWinds Corp. and interfered with last year’s U.S. election.The U.S. also sanctioned a number of entities and individuals, while expelling 10 Russian diplomats working in Washington, including some intelligence officers.Yet the moves were calibrated by the U.S. to punish the Kremlin for past misdeeds while keeping relations from deteriorating further, especially as tensions grow over a Russian military buildup near Ukraine.Two days before announcing the sanctions, Biden offered to meet Russian President Vladimir Putin later this year, even as he warned his counterpart about a litany of transgressions.White House communications staff didn’t immediately offer a comment.For now, U.S. officials are waiting to see how Putin responds. On Friday, Russia expelled 10 American diplomats and imposed sanctions on eight officials in tit-for-tat moves that stopped short of responding to U.S. restrictions on its sovereign debt.Foreign Minister Sergei Lavrov told reporters in Moscow that Russia could take steps that harm the interests of U.S. businesses but will hold those in reserve for now.Market ImpactThe Biden administration is also watching global markets to see the impact of its latest measures, including on the ruble, and any shifts in foreign ownership of Russian ruble bonds, according to the people. Interest rate decisions by Russia’s central bank and capital flows will also provide important clues, they said.The Bank of Russia’s next interest rate decision is scheduled for April 23.Under the sanctions unveiled Thursday, the Biden administration will bar U.S. financial institutions from participating in the primary market for new debt issued by the Russian central bank, Finance Ministry and sovereign wealth fund. Those limits would take effect starting June 14.Russian bonds fell and the ruble dropped the most since December on news of the impending penalties, but recovered their losses on Friday as investors concluded that the measures were milder than had been feared.White House officials sought to limit the sanctions’ fallout for the U.S. and global financial system while sparing the Russian civilian population from unnecessary harm, the people said. The Biden team now hopes to begin de-escalating tensions and believe that would benefit financial markets and the Russian economy, one of the people said.Still, U.S. officials are holding in reserve other potential escalations, including moves aimed at preventing secondary market trading in any ruble debt for the first 90 days or more after issuance, the person said.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2021 Bloomberg L.P.
The Man Who Pays His Way: Heathrow, just one of many organisations dependent on our mobility, is losing £60 per second
The outage is the second in only a few hours
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Duchess had been ‘hopeful’ to attend
An error-strewn five minutes has handed a huge blow to West Ham’s Champions League hopes in today’s defeat at Newcastle. An own goal from Issa Diop, which saw Craig Dawson sent off for a foul in the build-up, was quickly followed by Lukasz Fabianski dropping a corner on his goal line which Joelinton slammed home. West Ham finally snapped into gear as Diop made amends and Jesse Lingard scored from the penalty spot, only for Joe Willock to head in a late winner for Newcastle.
Chelsea will be motivated to pull of a major shock this evening in the FA Cup semi-finals as they take on a Manchester City side on a rampage. Pep Guardiola’s men are already into the Carabao Cup final next weekend and are targeting an unprecedented quadruple.