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|By PR Newswire
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|September 23, 2013 03:00 AM EDT
-- First and Only Subcutaneous Biologic Treatment Administered Every Four Weeks Approved for Ulcerative Colitis
LEIDEN, The Netherlands, Sept. 23, 2013 /PRNewswire/ -- Janssen Biologics B.V. ("Janssen") announced today that the European Commission has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. The European Commission approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2013 recommending the use of SIMPONI. UC, a chronic inflammatory bowel disease (IBD) affecting 1.1 million individuals in Europe[1] and 2.5 million people worldwide,[2] is marked by inflammation and ulceration of the colonic mucosa, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.
"The European Commission approval of SIMPONI for the treatment of moderately to severely active ulcerative colitis is an important milestone for patients and the gastroenterology community," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. "SIMPONI demonstrated efficacy across multiple disease parameters in the study of this devastating inflammatory bowel disease according to the PURSUIT clinical development program, which represents the largest conducted for an anti–tumor necrosis factor-alpha therapy in the treatment of ulcerative colitis."
SIMPONI is the first and only subcutaneous anti–tumor necrosis factor (TNF)-alpha treatment administered as an every-4-week maintenance therapy for UC. For patients with a body weight less than 80 kg, SIMPONI is given subcutaneously as an initial dose of 200 mg, followed by 100 mg at week 2 and then 50 mg every 4 weeks thereafter. For patients with a body weight greater than or equal to 80 kg, SIMPONI is given as an initial dose of 200 mg, followed by 100 mg at week 2 and then 100 mg every 4 weeks thereafter.
Data from the clinical development Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT), which served as the basis for European Commission approval, showed that induction treatment with SIMPONI induced clinical response, clinical remission, mucosal healing and improved quality of life as measured by the inflammatory bowel disease questionnaire (IBDQ) in patients with moderately to severely active UC. Further, per the European Commission–approved Summary of Product Characteristics, maintenance therapy with SIMPONI maintained clinical response through week 54. In addition, in patients who had initially responded to induction therapy with SIMPONI, more SIMPONI-treated patients demonstrated sustained clinical remission and mucosal healing at weeks 30 and 54 compared with patients in the placebo group.[3]
About PURSUIT
The Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) included Phase 3 multicenter, randomised, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-4-week maintenance regimens of SIMPONI in adults with moderately to severely active UC. All trial patients had failed to respond to or tolerate treatment with 6-MP, AZA, corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent. Study participants were naive to treatment with TNF inhibitors and had a baseline Mayo score between 6 and 12 and an endoscopic subscore of 2 or more. The Mayo score is a 12-point clinical assessment and colonoscopy-based measure of disease activity, which assesses improvement in symptoms based on rectal bleeding, endoscopic findings, stool frequency and a physician's global assessment.
The induction trial (PURSUIT-SC) had an adaptive design with a Phase 2 dose-finding portion, followed by a Phase 3 dose-confirming component. The primary endpoint was clinical response at week 6. Secondary endpoints at week 6 included clinical remission and mucosal healing (Mayo endoscopy score of 0 or 1). Overall, 1,065 patients were treated in the study; 761 of these patients were randomised into the Phase 3 component of the study.
Patients responding to induction treatment with SIMPONI were eligible to be randomised in the Phase 3 PURSUIT-Maintenance study. The primary endpoint in this study was maintenance of clinical response through week 54, and secondary endpoints included clinical remission and mucosal healing (Mayo endoscopy score of 0 or 1 at both weeks 30 and 54).
The safety results of SIMPONI observed in the PURSUIT studies were consistent with the known safety profile of SIMPONI in labeled rheumatologic indications. For more information regarding the safety profile for SIMPONI, please see "Important Safety Information" below.
About Ulcerative Colitis
Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) affecting 1.1 million individuals in Europe[1] and 2.5 million worldwide,[2] is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.[4] Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus.[4] Symptoms of the disease may lead to loss of appetite, subsequent weight loss and fatigue.[4] On average, people are diagnosed with UC in their mid-30s, but the disease can occur at any age.[4] As many as 30 percent of people living with UC will require surgery at some point in their life.[5] UC is a chronic disease, and there is no cure. Although progress has been made in IBD research, researchers do not know what causes this disease.[4]
About SIMPONI® (golimumab)
SIMPONI is a human monoclonal antibody that targets and neutralises excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. SIMPONI is approved in 70 countries for rheumatologic indications, including the European Union (EU), where SIMPONI received European Commission approval in October 2009 for the treatment of moderate-to-severe, active rheumatoid arthritis in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis. In September 2013, SIMPONI received European Commission approval for the treatment of moderately to severely active ulcerative colitis. SIMPONI is available either through the SmartJect® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection. For more information about SIMPONI in the EU, visit www.SIMPONI.eu.
Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product in the United States. The Janssen Pharmaceutical Companies market SIMPONI in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc.
In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.
For further information about SIMPONI, please consult the relevant official product information applicable to that country location.
Important Safety Information
In the European Union, SIMPONI is contraindicated in patients with active tuberculosis, severe infections such as sepsis, opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who are hypersensitive to SIMPONI or any of its excipients. Serious infections, including sepsis, pneumonia, tuberculosis (TB), invasive fungal and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI. Some of these infections have been fatal. SIMPONI should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of SIMPONI in patients with a chronic infection or a history of recurrent infection. Patients must be monitored closely for infections including TB before, during and after treatment with SIMPONI. If a patient develops a new serious infection or sepsis, SIMPONI therapy should be discontinued and appropriate antimicrobial therapy should be initiated until the infection is controlled. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. For patients who have resided in or traveled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of SIMPONI treatment should be carefully considered before initiation of SIMPONI therapy. All patients must be evaluated for the risk of TB, including latent TB, prior to initiation of SIMPONI. If active TB is diagnosed, SIMPONI must not be initiated. If latent TB is suspected or diagnosed then the benefit/risk balance of SIMPONI treatment should be considered. Treatment of latent tuberculosis infection should be initiated prior to therapy with SIMPONI. Antituberculosis therapy prior to initiating SIMPONI should also be considered in patients who have several or highly significant risk factors for tuberculosis infection and have a negative test for latent tuberculosis. Patients receiving SIMPONI should be monitored closely for signs and symptoms of active tuberculosis during and after treatment, including patients who tested negative for latent tuberculosis infections.
The use of TNF blocking agents including SIMPONI has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of the virus. Some of these cases have been fatal. Patients should be tested for HBV infection before initiating treatment with Simponi. Carriers of HBV who require treatment with Simponi should be closely monitored during treatment with, and for several months following discontinuation of SIMPONI. In patients who develop HBV reactivation, SIMPONI should be discontinued.
Lymphomas and leukemia have been observed in patients treated with TNF blocking agents, including SIMPONI. The incidence of non-lymphoma malignancies was similar to controls, and lymphoma is seen more often than in the general population. The potential role of TNF-blocking therapy in the development of malignancies is not known. Based on an exploratory clinical trial in patients with COPD using another anti-TNF agent, caution should be exercised when using any TNF-blocking therapy in COPD patients, as well as in patients with an increased risk for malignancy due to heavy smoking. Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
It is not known if SIMPONI treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma, or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Melanoma has been reported in patients treated with TNF-blocking agents, including Simponi. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Worsening and new onset congestive heart failure (CHF) and increased mortality due to CHF have been reported with another TNF blocker. SIMPONI has not been studied in patients with CHF. SIMPONI should be used with caution in patients with mild heart failure and must be discontinued if new or worsening symptoms of heart failure appear.
TNF-blocking agents, including SIMPONI, have been associated in rare cases with new onset or exacerbation of demyelinating disorders, including multiple sclerosis. The benefits and risks of anti-TNF treatment should be carefully considered before initiation of SIMPONI therapy in patients with pre-existing or recent onset of demyelinating disorders.
There is limited safety experience of SIMPONI treatment in patients who have undergone surgical procedures, including arthroplasty. A patient who requires surgery while on SIMPONI should be closely monitored for infections, and appropriate actions should be taken.
The possibility exists for TNF-blocking agents, including SIMPONI, to affect host defenses against infections and malignancies. Treatment with SIMPONI may result in the formation of auto-antibodies and, rarely, in the development of a lupus-like syndrome.
There have been postmarketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers. Cytopenias including pancytopenia, have been infrequently reported with SIMPONI in clinical trials. Discontinuation of SIMPONI should be considered in patients with significant hematologic abnormalities.
The concurrent administration of TNF-antagonists with anakinra or abatacept is not recommended. Concurrent administration has been associated with increased infections, including serious infections without increased clinical benefit. The concomitant use of Simponi with other biological therapeutics used to treat the same conditions as Simponi is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions. Patients should continue to be monitored when switching from one biologic to another.
Patients treated with SIMPONI may receive concurrent vaccinations, except for live vaccines. In postmarketing experience, serious systemic hypersensitivity reactions have been reported following Simponi administration. Allergic reactions may occur after first or subsequent administration of SIMPONI. If an anaphylactic reaction or other serious allergic reactions occur, administration of SIMPONI should be discontinued immediately and appropriate therapy initiated.
The needle cover on the syringe in the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex. SIMPONI also contains sorbitol; patients with rare hereditary problems of fructose intolerance should not take SIMPONI.
Patients should be given detailed instructions on how to administer SIMPONI. After proper training, patients may self inject if their physician determines that this is appropriate. The full amount of SIMPONI should be administered at all times.
Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last SIMPONI treatment. Women must not breast feed during and for at least 6 months after SIMPONI treatment.
The most common adverse drug reaction reported in the controlled portion from clinical trials was upper respiratory tract infection (12.6 percent of SIMPONI-treated patients compared with 10.7 percent in control-treated patients). In the controlled periods of pivotal trials, 5.1 percent of SIMPONI-treated patients had injection site reactions compared with 2.0 percent in control-treated patients. The majority of the injection site reactions were mild and moderate, and the most frequent manifestation was injection site erythema.
The SIMPONI Patient Alert Card provides safety information to the patient. It should be given and explained to all patients before treatment. Patients must show the Alert Card to any doctor involved in his/her treatment, during and up to 6 months after SIMPONI treatment.
For complete EU prescribing information, please visit www.ema.europa.eu.
About Janssen Biologics B.V. and Janssen Research & Development, LLC
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 with serious diseases throughout the world. Beyond its innovative medicines, Janssen is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.
Janssen Biologics B.V. and Janssen Research & Development, LLC are two of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com for more information.
[1] European Federation of Crohn's and Ulcerative Colitis Associations. What is IBD? http://www.efcca.org/index.php/about-efcca/what-are-ibd. Accessed August 14, 2013.
[2] World IBD Day. About us. http://worldibdday.org/aboutus.html. Accessed August 6, 2013.
[3] SIMPONI [Summary of Product Characteristics]. Leiden, The Netherlands: Janssen Biologics B.V.; September 2013.
[4] Crohn's & Colitis Foundation of America. What is ulcerative colitis? http://www.ccfa.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis. Accessed August 6, 2013.
[5] Crohn's & Colitis Foundation of America. Colitis treatment options. http://www.ccfa.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/colitis-treatment-options.html. Accessed August 6, 2013.
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Rep. Dana Rohrabacher's Wife Took 50% of Congressional Campaign Contributions
Costa Mesa Congressman Dana Rohrabacher gave his wife more than 50 percent of the campaign contributions he raised mostly from corporate sources during July, August and September, according to recently filed records at the Federal Election Commission (FEC) in Washington.
The Committee to Re-Elect Congressman Dana Rohrabacher reported raising $21,925 during the three-month period and then paying Rhonda Rohrabacher $11,026.
Though Rohrabacher's Democratic Party challenger, Jay Shah, has more than two dozen spelling, typo and grammar errors on his campaign homepage along with zero contributions, the 12-term congressman from a historically solid Republican district pays his wife about $4,000 a month under the ruse that he needs a full-time campaign manager.
Since 2006, Rhonda has collected more than a quarter of a million dollars from her husband's campaign coffers, according to FEC records.
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(Many of the contributions, er, income came from corporate entities--especially defense and space-exploration companies--that financially benefit from Rohrabacher's D.C. maneuverings.)
During that same period--and while most of the rest of the nation suffered economically, Dana gave his wife a whopping 40 percent in raises.
The congressman, a notorious cheapskate and rambling oddball who skipped Vietnam War military service but became a chicken hawk after he exceed the draft age, doesn't care how the money grab looks. It only inflates his own bank account.
Rohrabacher--who grabs about $13,400 a month in public pay (not including generous free benefits)--originally ran for Congress in 1988 adamantly espousing the necessity of six-year term limits.
The anti-government, career politician found he couldn't leave the nation's capital once he got there or keep his promises.
He is presently campaigning for his 25th and 26th years in Washington.
--R. Scott Moxley / OC Weekly
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May heat drives season's first ozone alert for Wasatch Front
SALT LAKE CITY — Temperatures anticipated to inch toward the 90s Tuesday prompted Utah air quality regulators to issue the summer season's first ozone alert for the Wasatch Front, as well as Tooele, Washington and Box Elder counties.
The "yellow" alert means ozone levels are building and residents should take steps to curb activities that could aggravate the situation.
"We are seeing moderately high pollution levels, which is a reminder that everyone needs to be mindful that summer pollution has arrived," said Bryce Bird, director of the Division of Air Quality.
The summer ozone alert program generally begins in June and runs through September when hot temperatures combine with pollutants to create smoggy conditions. Those conditions can threaten health by causing lung damage or other respiratory complications.
Donna Kemp Spangler, Department of Environmental Quality spokeswoman, said it is not necessarily uncommon to have an alert at this time in the season, but it may feel especially early given last year's wet weather pattern.
"It was unusually wet last year and we're starting to pick up those warmer temperatures," she said. "Hopefully, this is not a foreshadow of a difficult summer with poor air quality."
Scientists at Utah's Air Monitoring Center say ways to reduce ozone include limiting driving, avoiding idling in cars or mowing the lawn during the middle of the day.
A three-day forecast is available at airquality.utah.gov. "Green" means conditions are good and people are encouraged to make clean air choices to keep pollution levels low. "Yellow" means the pollution is building and people are encouraged to take proactive steps. "Red" means pollution levels are critically high and potentially unhealthy.
State air quality regulators were recently lauded by Gov. Gary Herbert after the Environmental Protection Agency said Utah had successfully reduced ozone for a three-year period to come into compliance with national standards along the Wasatch Front.
In tandem with the Utah Department of Transportation, the division has launched a public education campaign with highway signage to warn that conditions are approaching unhealthy levels and driving should be curtailed. On "red" days, motorists are encouraged to refrain from driving at all if possible.
Spangler said Utahns are being encouraged to visit ucair.utah.gov and pledge to do something to improve air quality.
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Thorncroft Inn, Martha's Vineyard
- Free full breakfast, free WiFi, and free parking
Main amenities
- 8 smoke-free guestrooms
- Near the beach
- Room service
- Air conditioning
- Daily housekeeping
- Garden
- Hair salon
- Concierge services
- Luggage storage
- Limited hour front desk
- Tour/ticket assistance
What's around
- Tisbury Town Beach (0.4 mi / 0.7 km)
- Vineyard Haven Public Library (0.6 mi / 0.9 km)
- Vineyard Playhouse (0.9 mi / 1.4 km)
- West Chop Light (1 mi / 1.5 km)
- Martha's Vineyard Chamber of Commerce (1 mi / 1.6 km)
Thorncroft Inn, Martha's Vineyard
Hotel Info: 866-266-9798
- Superior Room, 1 Queen Bed, Hot Tub
- Deluxe Room, 1 Queen Bed, Fireplace
- Standard Room, 1 Queen Bed
- Superior Room, 1 Queen Bed, Hot Tub
- Signature Room, 1 King Bed, Fireplace
Also popular with travellers from Canada
At a glance
Key facts
Hotel size
- This hotel has 14 rooms
- Check-in time 3 PM-9 PM
- Check-out time is 11 AM
- Express check-out
Required at check in
- Credit card or cash deposit required
- Government-issued photo ID required
- Minimum guest age is 21
- Minimum check-in age is 21
Travelling with others
- Children (18 years old and younger) not allowed
- No cribs (infant beds)
- Pets not allowed
- Free WiFi and wired Internet access in public areas
- Free WiFi in rooms
- Free self parking
Other information
- Smoke-free property
- No alcohol served onsite
- Caters to adults only
Nearby Three Star Martha's Vineyard hotels
In the hotel
- Free full breakfast
- Room service (during limited hours)
- Bicycle rentals nearby
- Front desk (limited hours)
- Concierge services
- Tours/ticket assistance
- Hair salon
- Luggage storage
- Year Built 1918
- Garden
- Accessible bathroom
- In-room accessibility
In the room
- Air conditioning
- Bathrobes
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Top Martha's Vineyard hotels
Recently reviewed hotels in Martha's Vineyard
- Anchor In Distinctive Waterfront LodgingFrom
"We stayed at the Anchor In Hotel for 2 nights. They were very welcoming, and the facilities are excellent (it was still late April so the pool was closed). The location is…"Apr 26, 2016
- International InnFrom
"Went to JFK museum, within walking distance of hotel.Being on the main drag, everything was within walking distance. Harbour close also. And Hyannis is a good starting point to…"Apr 23, 2016
- The Club at New SeaburyFrom
- Hyannis Travel InnFrom
"Hotel staff all friendly and helpful. Told us about 2 for 1 ferry to Martha's Vineyard and other specials int eh area. Breakfast was sufficient. Could be expanded. Hotel itself is…"Oct 6, 2015
Nearby hotels
Thorncroft Inn, Martha's Vineyard's small print
This property's policy is to refuse certain bookings for the purpose of group events or parties, including pre-wedding stag/bachelor and hen/bachelorette parties.
The name on the credit card used at check-in to pay for incidentals must be the primary name on the guestroom reservation.
We have included all charges provided to us by this hotel. However, charges can vary, for example, based on length of stay or the room you book.
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Don't-Miss Stories
The Android TV remote app for iOS is as bare-bones as the Android version
Tap, swipe, type: Android TV gets an iOS app for when your hardware remote goes missing.
Podcast 505: MacBook and Apple Watch backlash blues
Glenn and Susie discuss Macworld's review of the new MacBook, people dissing the Apple Watch on its anniversary, the missing iPhone SE, and if Apple's services can save it.
Hackers can track your whereabouts with Waze vulnerability
Researchers from UC-Santa Barbara were able to reproduce the hack by creating thousands of ghost drivers to monitor the whereabouts of the target.
FBI discloses iOS security flaw, but not the one used to crack the San Bernardino iPhone
Apple already knew about the vulnerability, which doesn't affect devices running iOS 9 and OS X El Capitan.
India makes it compulsory for phones to have 'panic buttons'
India has mandated that starting next year mobile phones in the country should have buttons that can be quickly used by women to alert police and close relatives if they are in distress.
Pizza Hut turns to algorithms and GPS tracking to increase sales
Yup, it's the 'Uber-ization' of pizza, as Pizza Hut joins the wave of chain restaurants embracing tech.
Intel calls for the end of the headphone jack with USB-C replacement
USB-C may not only lead a revolution in PC design, it may also change our smartphones and tablets forever.
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Everything about the Solartab is fine, but it's in search of a solution as a combination product.
The problem with deleting photos from your device with iCloud Photo Library enabled
The sync service puts photos everywhere—or nowhere at all.
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Apple made $10 billion last quarter, but the rapid growth of 2015 has slowed, and Q2 2016 saw the first decline in year-over-year revenue in 13 years.
First Look: Macphun's new Filters for Photos app works as an Apple Photos extension
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Apple reports first drop in iPhone shipments
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Through May 7, Amazon has discounted various models of Kindle and Fire Tablets.
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Microsoft has launched a new beta of Skype for Business that runs on Mac, following its launch of a revamped work communication product last year.
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Discussing shopping trends, and favorite retail stocks to bet on, with Randy Konik, Jefferies, and Roxanne Meyer, MKM Partners. » Read More
Wall Street analysts are adjusting their 2014 forecasts for retail, and although they're generally cautious, they do see some positive signs.
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U.S. stocks finished lower on Thursday.
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The "Fast Money" traders share their final trades of the day.
Lululemon announced Laurent Potdevin will take over as the new CEO. FMHR trader Mike Murphy and Jon Najarian take their positions on the stock.
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Vocabulary Word
Word: perfidious
Definition: treacherous; disloyal; N. perfidy: treachery
Definition: treacherous; disloyal; N. perfidy: treachery
Sentences Containing 'perfidious'
So of the subtile and crafty, so of the perfidious, so of every one that offendeth, must thou ever be ready to reason with thyself.
Traitor, cruel, vindictive, and perfidious, wherein had this poor wretch failed in his fidelity, who with such frankness showed thee the secrets and the joys of his heart?
I myself have written this: have a care to whom thou givest it to read: trust no Moor, for they are all perfidious.
Rather Cape Tormentoto, as called of yore; for long allured by the perfidious silences that before had attended us, we found ourselves launched into this tormented sea, where guilty beings transformed into those fowls and these fish, seemed condemned to swim on everlastingly without any haven in store, or beat that black air without any horizon.
In a few minutes the scuttle was opened, and, bound hand and foot, the still struggling ringleader was shoved up into the air by his perfidious allies, who at once claimed the honour of securing a man who had been fully ripe for murder.
It has been asserted that this incident, along with many other perfidious actions of the Japanese throughout the Pacific War, led to an American tendency to shoot the dead or wounded Japanese soldiers and those who were attempting to surrender and not take them as POWs easily.
Despite the fact that Nietzsche expressed his disgust with plebeian-volkist anti-Semitism and supremacist German nationalism in the most forthright terms possible (e.g. he resolved "to have nothing to do with anyone involved in the perfidious race-fraud"), phrases like "the will to power" became common in Nazi circles.
The senate blamed Pompey for the perfidious act. John Leach in his biography of Pompey defends his subject by arguing that Brutus "presumably began to whip up further support for Lepidus (the name of the town suggests that there were hereditary clients of his there)" and so Pompey was "forced" to send Geminius to Regium Lepidi to recapture and execute him.
More Vocab Words::: secular - worldly; not pertaining to church matters or religion; temporal
::: stipple - paint or draw with dots or short strokes
::: grotesque - fantastic; comically hideous; strange and unnatural (causing fear or amusement)
::: emaciated - thin and wasted (from hunger or illness)
::: rubric - title or heading (in red print); directions for religious ceremony; protocol
::: recline - lie down
::: acknowledge - recognize; admit
::: brazen - insolent; without shame; bold; Ex. brazen lie; V: face with bold self-assurance or with unshamed confidence
::: dowry - money or property brought by a bride to her husband at marriage
::: agitate - stir up; disturb


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Popey24 has won 7,854 Achievements and 7 Challenges in 272 games and 4 apps
Registered on 01 Nov 09
| Last visited 24 May 16 | Last scanned today at 04:33 by TA Pro Scanner
Wasn't Goat Simulator already free at one time?
I don't think so. I bought it on the 360 for cheap and don't have it on the X1, and I grab every GWG.
It was free in the US for some time...randomly...
35 achievements out of 35 won | 34,593 tracked gamers have this game | Last played 22 May 16
431 achievements out of 600 won | 138,851 tracked gamers have this game | Last played 14 Apr 16
56 achievements out of 65 won | 113,662 tracked gamers have this game | Last played 28 Mar 16
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I would like to present an overview of Red Hat Virtualization and Management solutions primarily on the upstream projects oVirt, Spacewalk, Katello, and Aeolus and how they can be utilized to create a private cloud and how the management pieces also help manage public cloud resources. I have been involved in Open Source in one form or another since I was 14 years old. I started my career at Novell in 2005 as a member of the desktop migration team. That team was responsible for moving the entire company off Windows onto Linux. Following Novell I worked at Ingenix (United Health Group) as a Linux Support and Pre-Sales Engineer. I was also an Open Source Evangelist attempting to promote the value of open source technologies in health care in United Health Group. I started my own company called Open Management after leaving United Health Group. I worked with several companies to migrate their applications to a complete or partial Open Source stack. I worked with various open source virtualization technologies during this time and I worked heavily with Amazon AWS. I'm now a Pre-Sales Engineer and Open Source Solutions Architect for one of the largest value added resellers in the country. I help customers leverage their existing open source environments and help them build new solutions to replace a proprietary stack. I'm focusing on Unix to Linux and Vmware to RHEV migrations. I have my RHCE and I'm working toward my RHCA.


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22 Aug 2006 // 12:00 AM
The gritty, seedier side of power punk... straight out of Cleveland.READ more
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The UK singer-songwriter continues to find her own voice on the follow-up to the impressive The Disconnection.READ more
21 Aug 2006 // 8:00 AM
The epilogue to the band with the ridiculous name is an engaging enough remix EP.READ more
21 Aug 2006 // 6:00 AM
While Substance Abuse have something to say, they may need a little more than flow to do it right.READ more
21 Aug 2006 // 4:00 AM
Upbeat, but with a blue-toned soul, Prince Diabaté's latest CD is well worth hunting down.READ more
21 Aug 2006 // 2:00 AM
While a two-gendered duo might look suspiciously calculated at first glance, the Dagons have been plying their trade for the better part of a decadeREAD more
21 Aug 2006 // 12:00 AM
"It was Christophe's vision that Rose is very much a normal person in this un-normal world," says Radha Mitchell.READ more
21 Aug 2006 // 12:00 AM
When the Levees Broke, elegant and anguished, encourages you to see, and more importantly, to care about and act on what you see. It is political in the most significant sense, and won't let you forget it.READ more
21 Aug 2006 // 12:00 AM
When F.X. Toole went into the hospital for heart surgery in 2002 with 900 pages of the unfinished manuscript that would become Pound for Pound, he said, 'Doc, get me just a little more time, I gotta finish my book.' He didn't get it.READ more
21 Aug 2006 // 12:00 AM
Well crafted, gruesomely violent, and genuinely fun tales about some of the darker sides of our society.READ more
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Obie goes all-the-way gangsta in an attempt to add a minute or two onto his rapidly expiring 15.READ more
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Discover this Supreme Black Bean Soup Recipe, ideal for your next meatless meal.
Pick over and wash 1 pound of black (or turtle) beans, soak them overnight, and then cook the legumes about 1 1/2 hours (until they're soft but not mushy). Add 1 medium-sized carrot, cut into thin strips 1 inch long; 2 finely chopped medium-sized onions; 2 well-chopped stalks of celery; 2 minced cloves of garlic; about 1 1/2 cups of tomato puree; 1 teaspoon of sweet basil and about 1 tablespoon of vegetable salt (Vegesal is one available brand). Allow the soup to simmer until the vegetables lose most of their crunch. If the beans haven't broken up and the soup seems thin, add 1 tablespoon of arrowroot starch — stirred into a little water — to thicken it. Serve with a slice or two of fresh lime (lemon will do in a pinch).
Read more about vegetarian meals: Hearty Vegetarian Vegetable Soups.
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Jeff Vidler's Vision Critical research on Pandora users' use of and opinions about broadcast radio should serve as a wake up call for broadcast audio (the service formerly known as "radio").
Michael O'Malley highlighted with a red circle yesterday what we need to do in order to keep things that way.
And, they expect us to do those same things on every digital platform.
Business cycles teach lessons, and what we're going through right now isn't new.
The courageous invest to gain market share when others are cutting back.
Infographic: How to Create Amazing Content for Every Show, Every Day In Seven Steps - Facts are forgettable. Stories are sticky. But going from that knowledge to daily creation can be challenging. Here are seven steps to help you create and...
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Camp visiting weekend brings business to Northwoods
Submitted: 07/11/2014
Story By Lauren Stephenson
- You may notice more people on the roads, lakes, at restaurants, and in stores the next few weekends. Many overnight camps in the Northwoods host a visiting weekend for their campers' families, and that means big money for local businesses.
"We're talking thousands of parents invading Minocqua, and Rhinelander and Eagle River throughout the weekend," said Camp Kawaga Director Matt Abrams.
There are more than 20 overnight camps in Vilas and Oneida Counties, and at least half host a visiting weekend. That's when parents come up to visit their kids spending the summer at an overnight camp. Though they visit camp, parents and campers spend a lot of time in the community.
"Really, most of the time they're out," added Abrams. "They're going to dinner. They're going go-carting."
"Camp weekend really is a special weekend. We can count on the store being packed to the walls with people. And they're a very good crowd," said Michael Johnson, manager of Dan's Minocqua Fudge.
The store has been welcoming campers and their families for 47 years.
"Every year we have people that stop in here at the store and will tell us a nice story of how they came here when they were a camp kid or when they came here with their grandparents and now they're bringing their grandchildren here," Johnson added.
Like Dan's Minocqua Fudge, The White Stag Inn in Sugar Camp also sees a larger crowd on visiting weekend. The owners say they'll serve more than 500 people in just a five hour period. It's a popular restaurant among visiting families and camp alumni.
"We are seeing multi-generations. So my brothers and I are now the third generation here at the White Stag and we're seeing the third and fourth generation of campers. So it's really kind of a unique experience to have grown up not only with the parents, but now having their kids and grandkids here," said White Stag Inn co-owner Anissa Widule.
Restaurants and shops aren't the only businesses that get a boost from visiting weekend.
"These parents are booking the hotels a year ahead because they know they're coming the next year so this is a consistent boon for the Minocqua area," Abrams said.
But the business boom doesn't necessarily end on Sunday.
"We've had families that have ended up buying second homes up here," Abrams added. "The other thing that a lot of them do is they rent homes."
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Mel's Trading Post holds Paddle Sport Demo Day
Submitted: 05/29/2016
Play Video
- In between the rain Sunday, people got outside and on the water.
Mel's Trading Post in Rhinelander held its annual Paddle Sport Demo Day at Hodag Park.
People were able to test out kayaks, canoes, and paddle boards for free.
The owner of Mel's trading post, Mitch Mode, likes this day not only try and sell some equipment but to also get feedback from people about the different boats.
+ Read More
Tomahawk holds annual car show
Submitted: 05/29/2016
Play Video
- Car enthusiasts flocked to Tomahawk Sunday for the Main Street Memories car show.
The 22nd annual car show attracted cars and visitors from all over.
The streets of Tomahawk were filled with more than 200 cars of all different kinds. Main Street Memories car show is a Memorial Day tradition.
"You know 22 years going strong, and we're proud of it," said Tomahawk Main Street director Christine Vorpagel. "Tomahawk Main Street, we're all about historic preservation and sustainable development."
For many spectators, car shows are another way of learning about American history.
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One dead in ATV accident in Marinette County
Submitted: 05/29/2016
- A 90-year-old man died in an ATV crash in Marinette County late Saturday afternoon.
According to the Marinette County Sheriff's Office, it happened private property north of Newton Lake in the Town of Athelstane.
90-year-old James Bosanny was driving the ATV with his 64-year-old son, James Bosanny, Jr., on board. He lost control on a small hill after hitting a plow before the ATV accelerated and hit a tree. They both were thrown off the ATV. The 90-year-old died at the scene.Crews took the son first to Bay Area Medical Center in Marinette and then later taken to a hospital in Green Bay for serious injuries.
The sheriff's office says neither was wearing a helmet. Police don't think alcohol or speed played a part in the crash.
Crews are still investigating. James Bosanny, Sr., was from Monroe, Wisconsin, and his son, James Bosanny, Jr., was from Hortonville, Wisconsin.
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First part of Conover-Phelps trail opens
Submitted: 05/29/2016
Play Video
- The rain fortunately stayed away in Conover for a part of Sunday afternoon just in time for the grand opening of the Conover-Phelps bike trail.
The project has been years in the making, and now it's ready to ride. A couple hundred people and local leaders came out in support of it.
"There's a real feel for people being enthusiastic about this," said Jeff Currie, the President of Great Headwaters Trails, which helped lead the bike trail project.
It's supposed to connect Conover to Phelps through nearly 11 miles of paved trail. The first part is open and goes from Conover Community Park to Muskrat Creek Road.
"3.2 miles on the ground and ready to be ridden on biked or hiked," said Brian Blank, the chairman of the Conover-Phelps Trail Capital Campaign.
"When people hear about a town and then when people say, have you seen their bike trail, it's just, right away it's like there's more to that town than I thought there was," Currie said.
While not yet complete, project leaders are hopeful the trail will be finished soon. Project leaders say the second part of the trail, about five miles long, is fully engineered but about 60 percent funded.
"We're about $200,000 away from completing the remaining five miles," Blank said.
"You know that funding could come, and when it does, five miles of trail in two or three months will be on the ground," Currie said.
"I have no doubt in the next couple years this trail will be completed all the way to Phelps," said Gary Meister, the vice president of Great Headwaters Trails.
The trail is non-motorized so, no ATVs allowed, but it will be a snowmobile trail in the winter.
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Fire destroys Town of Berlin home
Submitted: 05/29/2016
- Firefighters call a Town of Berlin house a total loss after a fire destroyed it early Sunday morning.
According to the Marathon County Sheriff's Office Facebook page, crews got a call around 1:40 a.m. to the 11,000 block of Naugart Drive. When they got there, the house was totally up in flames.Several surrounding fire departments were called in to help.
No one was hurt. The house is valued at more than $100,000.
Investigators don't think the cause of the fire was anything suspicious, but they are still investigating.
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Memorial Day Weekend brings tourists to the Northwoods
Submitted: 05/29/2016
Play Video
- Memorial Day Weekend means the return of snowbirds and tourists.
Tourism is a big industry here in the Northwoods.
Many businesses have reopened for the summer, but the people coming to the Northwoods aren't just from the surrounding states.
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Sgt. Ryan Jopek Ruck Run reminds people the meaning of Memorial Day
Submitted: 05/29/2016
Play Video
- Steven Jopek carries a number of memories with him on Memorial Day.
"This will be our 9th Memorial Day where he hasn't been here," said Steven.
This weekend marked the 10th anniversary of the last time he saw his brother, Ryan, in person.
"He would be 30 on June on 1st," said Ryan's sister Jessica Holmgren.
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25th Anniversary Screening of Scrooged, With Bobcat Goldthwait
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It's time for some nostalgic holiday laughs as SF Sketchfest presents a 25th Anniversary screening of Scrooged, the dark comedy update of Dickens' A Christmas Carol. The film stars Bill Murray as Frank Cross, a cynical television programming executive whose cutthroat business practices have made him rich and powerful, but left him a coldhearted, lonely cynic. His ruthless nature inspires a supernatural intervention when he callously fires his long-suffering yes man Elliot (Bobcat Goldthwait) on Christmas Eve. That night, he is visited by three eccentric ghosts (played by John Forsythe, David Johansen and Carol Kane), who force him to look back on the life choices that led him to his present state and the grim future that awaits if he doesn't change his ways. Special guest Bobcat Goldthwait will be on hand for a discussion and audience Q&A session.
* Additional fees apply. No coupon or promo codes necessary to enjoy the displayed discount price.
All offers for Scrooged 25th Anniversary Screening have expired.
The last date listed for Scrooged 25th Anniversary Screening was Saturday December 22, 2012 / 5:30pm.
Currently at The Castro Theatre
The Drag Queens of Comedy Crack Wise at the Legendary Castro
- Full Price:
- $45.00 - $350.00
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- $22.50 - $200.00
With drag-royalty superstars including contestants of RuPaul's Drag Race, many Legendary Queens and… More
Venue Details
Typical movie theater concessions available plus alcohol. Prices are great. No real food just popcorn and candy. Plenty of places to eat in the area. Concessions and drinks are cash only, no ATM inside.
Whatever Happened To Bianca Del Rio?star this tip starred
Slurp is right down the street, their ramen noodles are really good!star this tip starred
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Quotes & Highlights
Watch the trailer for _Scrooged. _
The film is rated PG-13.


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How Do You Spell Chanukah?? Comedy, Music and More
* Additional fees apply. No coupon or promo codes necessary to enjoy the displayed discount price.
The last date listed for How Do You Spell Chanukah?? was Sunday December 2, 2012 / 7:00pm.
Most Popular Comedy Event Nearby
Booze-Fueled Comedy in Bye Bye Liver: The Twin Cities Drinking Play
- Full Price:
- $24.50
- Our Price:
- $12.25
Drunken friends, overserved basket cases, pushy bouncers and all the other hallmarks of bar culture… More
Venue Details
About the Ticket Supplier: Sabes Jewish Community Center
The Sabes JCC is a multifaceted organization servicing the entire community. We provide programs and services in many areas including our early childhood center, health & fitness, recreation, Jewish arts & humanities, senior services, afterschool programs, day camp, special events and so much more.
The Sabes JCC is dedicated to the production of innovative, provocative and entertaining professional theatre, music, dance and collaborative arts that explore, celebrate and illuminate Jewish identity, history and culture.