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Designed specifically for the experienced regulatory professional, the RAPS Executive Development program builds key management, business and leadership skills through intense discussions with some of the world's best business professors in an intimate learning environment at the Kellogg School of Management.
Rockville, MD6/2/2016 - 6/3/2016
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It's well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What's less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.
The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations.
The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration's (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better.
R. "Ray" Wang, principal analyst, founder, and chairman of Silicon Valley-based Constellation Research will deliver the opening keynote Sunday evening, 18 September, at RAPS' 2016 Regulatory Convergence conference in San Jose, CA.
More than 35 medical professors and experts have criticized the US Food and Drug Administration's (FDA) review of a Duchenne Muscular Dystrophy (DMD) drug, citing errors in the agency's advisory committee meeting briefing documents.
At issue is Sarepta's drug eteplirsen, which the company is seeking approval as the world's first treatment for DMD, a rare and fatal genetic disorder afflicting about 15,000 boys in the US. The drug was initially supposed to go before the Peripheral and Central Nervous System Drugs Advisory Committee in January, though that meeting was postponed because of snow until 25 April.
The initial release of the advisory committee documents in January was viewed by nearly every onlooker to be extremely negative, causing Sarepta's stock to be cut in half, resulting in at least one investor lawsuit and pushing the company to file additional clarifications of "key inaccuracies in the FDA briefing document."
In the statistical review section of the briefing documents, FDA officials said at the outset that the data on just 12 subjects "overall, did not provide statistical evidence to support the efficacy of eteplirsen."
But now, according to DMD experts from UCLA, Stanford University, Harvard Medical School and other top medical schools, "errors" in some of the agency's briefing documents "may lead to a false perception that there is little evidence that eteplirsen has any effect at slowing the progression of DMD."
While recognizing that the company conducted a small study, creating "some uncertainty as to whether the findings will accurately represent subsequent observations in larger study groups," the experts say that "the only way to address that uncertainty is to expose more individuals to the drug and assess efficacy on the overall amenable population over even longer periods of time. The excellent safety profile of eteplirsen makes this strategy reasonable."
In addition, the academics are echoing what many of the mothers of the boys in the trial have been saying about their sons' continued ability to walk.
"In these additional data (Sarepta Addendum), loss of ambulation data at 4 years of eteplirsen administration indicates that 4 of 4 (100%) boys on study 201/202 remained ambulant past the age of 14y, while only 2 of 10 (20%) in the Belgian/Italian external control group remained ambulant past age 14y," the academics say. "Other available natural history data from United Dystrophinopathy Project, CINRG, and Duchenne Connect are consistent with the external control group supporting that on average only 20-30% of long-term steroid treated DMD patients remain ambulatory past age 14y."
The academic experts also said the briefing documents contain "some scientifically questionable comparisons," and that given "the relative paucity of patients with amenable mutations, the flexibility afforded by FDASIA [the Food and Drug Administration Safety and Innovation Act], and the fact that many of the boys between the ages of 4 and 21 years with relevant mutations are already receiving eteplirsen in the context of these trials, it would be difficult to conduct a large placebo controlled study in the near future."
The professors, who call on Billy Dunn, FDA's director of the Division of Neurology Products, to pass along their comments to the advisory committee, also contend that "it would be dubiously ethical to veer from the currently recommended study path at this point. In keeping with the criteria imposed by FDASIA for accelerated approval for rare disease with unmet need, we conclude that the aggregate data, described in the briefing documents, are providing substantial evidence of efficacy and use in the greater population of boys amenable to exon 51 skipping is appropriate. These three-year data alone are clearly supportive of accelerated approval, however the new 4-year data regarding age at loss of ambulation now provide even more compelling data for accelerated approval based on an irreversible morbidity."
The drug's PDUFA date has been extended by three months to 26 May to allow time for FDA to consider additional data including loss of ambulation and six-minute walk distance (6MWD) at four years, which were included in the Sarepta addendum.
Categories: Drugs, Clinical, Crisis management, US, CDER
Tags: DMD, Sarepta, eteplirsen, advisory committee briefing documents
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The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing. View More
The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations. View More
The US Food and Drug Administration (FDA) on Thursday issued new draft guidance meant to establish the necessary performance characteristics for genetic sequencing tests used to diagnose infectious diseases. View More
The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration's (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better. View More


text:
Google Technology News
Updated: 1 hour 14 min ago
Google files appeal in France opposing an order to apply Right to be Forgotten globally - TechCrunch
New York Times
Google files appeal in France opposing an order to apply Right to be Forgotten globally
While Google shows off its latest developments at the I/O event in California, there's been another development in the ongoing legal fallout from the 2014 Right to be Forgotten ruling in Europe. Today, Google said that it has filed an appeal in France ...
Google challenges French fine for not being forgetful enoughPCWorld
Google Appeals French 'Right to Be Forgotten' OrderWall Street Journal
Google takes right-to-be-forgotten fight to France's highest court to avoid 'global race to the bottom'VentureBeat
New York Times -Bloomberg -Reuters -The Hill
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Google patents pedestrian flypaper for self-driving cars - The Verge
Google patents pedestrian flypaper for self-driving cars
The Verge
Google knows that its self-driving cars are going to get into accidents — maybe even accidents involving pedestrians — and so the company has patented a unique solution to minimize injuries if this happens: human flypaper. The patent, granted earlier ...
Google patents 'sticky car' to reduce crash injuriesBBC News
Google's driverless cars may use human flypaper in road accidentsZDNet
Run down by a Google car? You could be sticking to the hoodCNBC
CNET -International Business Times -Washington Post -Gizmodo
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Google dives into the future with a focus on AI - Computerworld
Google dives into the future with a focus on AI
MOUNTAIN VIEW, Calif. -- With much of what Google announced during the first day of its I/O developer conference focused on helping users answer questions before they even think of them, artificial intelligence is proving critical for the company's ...
Here's how Google Home could be Amazon Echo's worst nightmareThe Verge
Google Home vs. Amazon Echo: Why Home could winCNET
Google Home Is Cool, But It's Got to Catch Up to Amazon EchoWIRED
InformationWeek -Macworld -Search Engine Land -New York Times
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Nintendo has a new game plan - Engadget
Master Herald
Nintendo has a new game plan
In case you didn't get the message yet, Nintendo is trying lots of new things. To that extent, it's formalizing some of that in its official charter next month. While most of it is rewording in places, the updated charter includes new references the ...
Nintendo eyeing new business ventures in medicine, restaurants, and IPDigital Trends
Nintendo proposes changes to the company's purpose as business broadensPolygon
all 88 news articles »Google News
Facebook's new Live Video map lets you drop in on strangers around the world - Digital Trends
Digital Trends
Facebook's new Live Video map lets you drop in on strangers around the world
Digital Trends
Facebook continues to add new features to Live Video, on Wednesdays rolling out an interactive map to users around the world. Here you can peer into the lives of some of Facebook's global community of 1.65 billion users. But don't expect too much – a ...
Facebook Live Map gives unusual look at the world11alive.com
Social Video Has Entered Its Body Horror PhasePopular Science
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SlashGear -Digiday -Business 2 Community -ModernSalon.com (blog)
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Facebook's Zuckerberg makes plea for conservatives' 'trust' - Politico
Facebook's Zuckerberg makes plea for conservatives' 'trust'
Facebook CEO Mark Zuckerberg on Wednesday personally extended an olive branch to conservatives still reeling from charges that the social media giant has suppressed news from right-leaning media outlets. At a roughly 90-minute, closed-door meeting at ...
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Facebook and Google are destined to become Apple and Microsoft - Business Insider
Business Insider
Facebook and Google are destined to become Apple and Microsoft
Business Insider
People don't always remember this, but when Microsoft first started, one of its biggest partners was Apple — manufacturer of the Apple II, the gold standard for early PCs. That partnership, always tenuous, didn't last. Microsoft would go on to partner ...
UK VR Studio nDreams To Make 2 Apps For DaydreamAndroid Headlines
all 31 news articles »Google News
The end of small talk is coming - Quartz
The end of small talk is coming
That may sounds like an abstract, farfetched question. But consider Google's announcement today of its new Allo chat app. Google's Erik Kay explained how users can ask the app to perform simple tasks like making restaurant reservations. In addition:.
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Here's how Google Home could be Amazon Echo's worst nightmare - The Verge
The Verge
Here's how Google Home could be Amazon Echo's worst nightmare
The Verge
Google jumped into the smart assistant game today with its new Google Home device: an answer to Amazon's Echo and the rise of personal-assistant things that sit in your kitchen and listen to everything you do. Amazon had a breakout hit with Echo, and ...
Google Home vs. Amazon Echo: Why Home could winCNET
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Nvidia Shield update brings Netflix HDR, Vudu, Spotify and HDR games - CNET
Nvidia Shield update brings Netflix HDR, Vudu, Spotify and HDR games
In my updated Nvidia Shield review I called it a powerful but niche product that appeals primarily to tech geeks. A software update aims to broaden its appeal, while also increasing its already substantial geek cred. Coming soon with a free update to ...
Xiaomi's 4K Mi Box is Google's newest Android TV deviceThe Verge
With HDR Gaming And More 4K Content Incoming, Nvidia's Shield Is More Appealing Than EverForbes
NVIDIA Confirms Homefront: The Revolution Coming Soon To SHIELDAndroid News | Androidheadlines.com
Digital Trends -Mashable -AnandTech -Gizmodo
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Google's Allo runs on the same encryption tech that powers WhatsApp - The Verge
The Verge
Google's Allo runs on the same encryption tech that powers WhatsApp
The Verge
Earlier today at the I/O conference, Google announced a new chat app called Allo, complete with an "incognito" mode that boasts full end-to-end encryption. But the technology powering that encryption is more familiar than many Google fans may realize.
Google's Allo won't include end-to-end encryption by defaultTechCrunch
With Allo and Duo, Google Finally Encrypts Conversations End-to-EndWIRED
Google Allo is the Hangouts killer we've been waiting forTechnoBuffalo
Engadget -The Hill -Phone Arena -Inverse
all 9 news articles »
Google's Tensor Processing Unit said to advance Moore's Law seven years into the future - PCWorld
Google's Tensor Processing Unit said to advance Moore's Law seven years into the future
Forget the CPU, GPU, and FPGA, Google says its Tensor Processing Unit, or TPU, advances machine learning capability by a factor of three generations. "TPUs deliver an order of magnitude higher performance per watt than all commercially available GPUs ...
Google Isn't Playing Games With New ChipWall Street Journal
Google built its own chips to expedite its machine learning algorithmsTechCrunch
Google Built Its Very Own Chips to Power Its AI RobotsWIRED
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Xiaomi's 4K Mi Box is Google's newest Android TV device - The Verge
The Verge
Xiaomi's 4K Mi Box is Google's newest Android TV device
The Verge
Today's announcement of Google Home is likely to be the most exciting "living room" news that comes out of the company's annual developers conference, but that doesn't mean TV has been completely forgotten. Google today announced a bunch of new ...
Android TV lands in more TVs, adds HDR support, snags lots of new appsDigital Trends
Xiaomi States 'Global Ambitions' By Launching Android-Powered Set-Top Box In US MarketInternational Business Times
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TechCrunch -Gizmodo -Engadget -9 to 5 Google
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Acura's New Self-Driving Car to Hit the Test Track - PC Magazine
PC Magazine
Acura's New Self-Driving Car to Hit the Test Track
PC Magazine
Acura has a new self-driving car, which the car maker says will "support more complex testing scenarios." "The RLX has been fitted with a new suite of radar, Lidar, camera and GPS sensors, complemented by higher performance CPUs and GPUs, and ...
Acura's sleeker 2nd-gen self-driving car hides sensors for better aestheticsAppleInsider (press release) (blog)
Acura's new autonomous test car to lead to automated driving by 2020Mashable
Acura's self-driving RLX prototype gets a major upgradeDigital Trends
PR Newswire (press release) -Motor Authority -Car and Driver (blog) -Engadget
all 13 news articles »Google News
PornHub launches BangFit so you can bang to get fit - TechCrunch
PornHub launches BangFit so you can bang to get fit
In seemingly bizarre news out of the porn industry, PornHub is launching a new fitness system (wearable + workout videos) called BangFit. As its name suggests, it helps you bang to get fit. Here's how it works: Users can join the game at this website ...
Pornhub's Bangfit 'sexercises' the idea behind the Wii FitVentureBeat
Pornhub wants to help you lose weightCNET
Pornhub wants to help you get fitEngadget
Refinery29 -New York Daily News -STASHED -Huffington Post
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Yahoo Mail mobile apps get extra sharing and sync features - Engadget
Yahoo Mail mobile apps get extra sharing and sync features
Yahoo continues to improve its Mail app for mobile devices. After adding support for Google Drive files and GIFs last month, the company is bringing more sharing and sync features to iOS and Android users. If you're on Apple's platform, Yahoo Mail now ...
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NetEase to Commit to Making Virtual Reality Game Twilight Pioneers for Google's Daydream Platform - PR Newswire (press release)
PR Newswire (press release)
NetEase to Commit to Making Virtual Reality Game Twilight Pioneers for Google's Daydream Platform
PR Newswire (press release)
MOUNTAIN VIEW, Calif., May 18, 2016 /PRNewswire/ -- NetEase (NASDAQ: NTES)'s virtual reality game Twilight Pioneers was revealed at Google I/O 2016 as one of the first games to commit to Google's new high quality mobile VR platform built on top of ...
and more »
I/O 2016: Google Allo smart messenger and Duo video calling coming to iOS, Android this summer - AppleInsider (press release) (blog)
AppleInsider (press release) (blog)
I/O 2016: Google Allo smart messenger and Duo video calling coming to iOS, Android this summer
AppleInsider (press release) (blog)
Google hopes to shake up the mobile communications landscape this summer with a cross-platform release of both Allo, a new smart messenger, and Duo, a simplified one-to-one video calling service. Designed with the goal of making conversations "easier ...
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Google turns Firebase into its unified platform for mobile developers - TechCrunch
Google turns Firebase into its unified platform for mobile developers
Google offers a plethora of cloud services that mobile developers can use to power their apps. With Firebase, which it acquired in 2014, it already offered developers a dedicated platform and SDK for building mobile apps; today it is greatly expanding ...
Google expands Firebase with analytics, remote config, crash reporting, and dynamic linksVentureBeat
Google's Firebase cleans up the mess Facebook left by killing ParseThe Verge
Google Is Expanding Universal App Campaigns to iOS DevelopersAdweek
Business Insider -Android News | Androidheadlines.com -Engadget -Marketing Land
all 21 news articles »Google News
Google Assistant will talk to your favorite services - Engadget
Google Assistant will talk to your favorite services
Google Assistant won't just be helpful for talking to Google itself: It'll tap into a wide array of services, too. The search giant has revealed that it's working on a "comprehensive way" for third parties to tap into the AI-powered, conversation ...
and more »

subset: commoncrawl


text:
This is the true story of a 24-hour period on Everest, when members of three separate expeditions were caught in a storm and faced a battle against hurricane-force winds, exposure, and the effects of altitude, which ended the worst single-season death toll in the peak's history. In March 1996, Outside magazine sent veteran journalist and seasoned climber Jon Krakauer on an expedition led by celebrated Everest guide Rob Hall. Despite the expertise of Hall and the other leaders, by the end of summit day eight people were dead. Krakauer's book is at once the story of the ill-fated adventure and an analysis of the factors leading up to its tragic end. Written within months of the events it chronicles, Into Thin Air clearly evokes the majestic Everest landscape. As the journey up the mountain progresses, Krakauer puts it in context by recalling the triumphs and perils of other Everest trips throughout history. The author's own anguish over what happened on the mountain is palpable as he leads readers to ponder timeless questions.
Guardian reviews
Customer reviews
Product details
Additional Info
|Publication date
|1 Jul 2011
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patricia merritt
patricia merritt (December 24,1942 / Maryland)
Spirit Of A Child - Poem by patricia merritt
A Mother holds her son close
to her chest.
Tears role down her cheek,
knowing he will be at rest.
Her son looks up at her sad
face, don't cry mom, I'm going
to a unpainful place, I won't suffer
anymore. As he said with his last
She rocks her son, his arm falls
to his side.
A warm glow passes over her
as his spirit lifts to the heavens
with the angels at his side.
Moms love is for eternety, not
just for awhile.
Love you son.
Comments about Spirit Of A Child by patricia merritt
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Poem Submitted: Friday, June 2, 2006
Poem Edited: Friday, June 2, 2006


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Monthly Archives: April 2012
Parting Words
Many people ask me about the words I say at the end of every class. They are not a quote from a spiritual leader or a learned person. They come from no one but myself and they are truly a … Continue reading
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Partner Yoga
In any relationship, trust and communication are key. Partner Yoga utilizes both, building a stronger bond between people. Because you know your partner, you're able to truly relax and go deeper in the poses. Partners can be significant others, friends or … Continue reading
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- Rocklin, CA
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Looking for a law enforcement career? The Army National Guard is looking for dedicated team members to serve their community, state, and nation as Military Police (MPs). MPs support battlefield operations through circulation control, providing area security, conducting prisoner of war operations, supervising civilian internee operations, and carrying out law and order operations. MPs also support the peacetime Army community protecting critical resources, implementing crime prevention...
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Playstation Vita Games
Unlock red brick for Lego Batman 2: DC Super HeroesHome / Playstation Vita /
This page contains Lego Batman 2: DC Super Heroes Unlockables for Playstation Vita called "Unlock red brick" and has been posted or updated on Jun 24, 2012 by hourie56.
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Boxshot & Details
- Developer: Tt Games
- Publisher: Warner Bros. Interactive Entertainment
- Genre: Action Adventure
- Release: Jun 19, 2012
- ESRB: Everyone 10+
Unlock red brick
On the second level just destroy the nine gargoyles and this unlocks the red brick.
Report Problem
Please Submit a Problem for any incomplete, non-working or fake cheat listed above.
More Unlockables
From: qwert
From: hourie56
Back to all Cheats
From: hourie56
Stuck in this game? Set a specific, clearly defined question and let other gamers answer your question or view answers to previously asked questions. If you think you are an expert then please try to help others with their questions.
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Vermin Country is a little slice of the park, with nothing but anthropomorphic critters.
When this land was created in 1981, it was called Bear Country. Its single attraction was the Country Bear Shindig. The land was renamed Vermin Country when Splash Ride opened, replacing the Bear Country "facilities".
You shouldn't try Pirate Mode
© copyright 2011–2016
A Pants Aflame production


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Children's menu
Location:Frankie & Benny's
Starts: Thu February 05 2015
More details and offers from Frankie & Benny's
Starts: Thu February 05 2015
More details and offers from Frankie & Benny's
Children's menu fo up to 11 years with a main course, dessert and refillable soft drink from £4.25
All meals come with an option of side vegetables, side salad or Heinz bake beans and a free fun pack with games and puzzles
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SANTA CLARA (AP) - Jim Harbaugh has the utmost respect for a guy who dislocates his finger and pops it back in on his own. Harbaugh once did so himself during his 15-year NFL career as a quarterback.
ALAMEDA (AP) - Oakland Raiders receiver Rod Streater returned to practice Monday for the first time since breaking his left foot two months ago.
CLEVELAND (AP) - A Browns fan who says he wanted to give Johnny Manziel "a hug" was struck by the rookie quarterback's entourage at a downtown hotel and was left with a swollen eye and lip, police said.
UNIONDALE, N.Y. (AP) - Frans Nielsen and John Tavares finally solved Philadelphia's Steve Mason in a shootout, and the New York Islanders outlasted the Flyers 1-0 on Monday night to post the best 21-game start in franchise history.
CLEVELAND (AP) - LeBron James scored 29 points, including 16 in the first quarter, and the Cleveland Cavaliers broke a four-game losing streak with a 106-74 win over the Orlando Magic on Monday night.
BOSTON (AP) - The Red Sox are hoping to spend their way out of the AL East cellar with two big free agent signings.
NEW YORK (AP) - The star of USA Swimming's annual Golden Goggles banquet was a record-breaking prodigy from Maryland.
DETROIT (AP) - The Buffalo Bills had plenty of support at their temporary "home" stadium.
NEW YORK (AP) - A full postseason share for the World Series champion Giants was worth a record $388,606, topping the previous mark of $370,873 set by San Francisco two years ago.
CLEVELAND (AP) - The Cleveland Cavaliers are struggling, and then some. LeBron James believes he's a major reason for their early failures.
CHARLOTTE, N.C. (AP) - An apologetic Jeffery Taylor said he will not appeal the NBA's 24-game suspension following his guilty plea on domestic violence charges.
SEATTLE (AP) - Kyle Seager has cashed in on the best season of his young career, becoming the third Seattle Mariners player to reach the $100 million threshold.
NEW YORK (AP) - Will Katy Perry be a firework at the Super Bowl? Will she show them what she's worth? Will she let her colors burst?
The Associated Press
SANTA CLARA (AP) - Anquan Boldin knew it would take one big play by San Francisco's offense, and he delivered it - along with a helmet-cracking hit that left his defender down.
Page 234 of 761
BALTIMORE (AP) - Let it rain again on the Preakness. Team Nyquist doesn't seem concerned.
MIAMI (AP) - Zhou Qi needs someone to help him communicate at workouts with NBA teams, simply because he does not speak English well enough to ...
ANAHEIM (AP) - Ravaged by injuries, the Los Angeles Angels are taking a chance on Tim Lincecum, the two-time NL Cy Young Award winner who is ...
CLEVELAND (AP) - Overshadowed as Golden State shot down history during the regular season, the Cavaliers are making this postseason their own.
PARIS (AP) - Roger Federer pulled out of the French Open on Thursday, ending his record streak of appearing in 65 consecutive Grand Slam tournaments - every ...
OAKLAND (AP) - Josh Reddick was trying to make something happen, hoping to put himself into position to score. He's likely going to miss a ...
RIO DE JANEIRO (AP) - The head of security for the state of Rio de Janeiro wants soldiers to start policing the city immediately, 2 ½ months ...
IRVING, Texas (AP) - Jordan Spieth covered his mouth in disbelief on the 16th green when his long eagle putt stopped short of falling in for ...
LAKE TAHOE (AP) - Toms Skujins delivered his U.S.-based team another win in the nation's highest-profile race.
OAKLAND (AP) - A far cry from his brash, former basketball-playing father, Klay Thompson is perfectly content to be the soft-spoken, second superstar behind MVP Stephen ...
SAN DIEGO (AP) - Jeff Samardzija pitched eight strong innings, Joe Panik had four hits and Brandon Crawford homered for the NL West-leading San Francisco Giants ...
SAN JOSE (AP) - Martin Jones made 22 saves in his second straight shutout and Tomas Hertl scored twice to give the San Jose Sharks a ...
JACKSON - Ripon Christian proved it can hang in Division VI on Wednesday.
BALTIMORE (AP) - Doug O'Neill couldn't have done any better if he picked Nyquist's post position himself.
TAMPA, Fla. (AP) - Sidney Crosby and Co. kept pressing and shooting until the Pittsburgh Penguins finally imposed their will.
Page 5 of 31
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Silent Scope (PlayStation 2)
Screenshot 8 of 17
Mission One: Downtown and providing police backup. Everything is timed. Bad guys are identified by a red flash over their heads, good guys by a blue one
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Contributed by piltdown_man (105675) on Jun 04, 2014.


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MJ12, featuring Brand X bass legend Percy Jones, will be releasing their eagerly awaited debut album on Gonzo Multimedia UK on June 24, 2016. (more...)
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The 11th Annual ASCAP 'I Create Music' EXPO announces its full conference schedule today, jam-packed with inspiring and informative sessions for music creators of all levels, no matter what genre or medium they write for. (more...)
California Shakespeare Theater marks the beginning of its 25th season at the glorious Bruns Amphitheater with Shakespeare's sassiest battle royale, Much Ado About Nothing, in a newly-minted adaptation by Kenneth Lin and Jackson Gay, with additional text by Lin, and directed by Gay in her Cal Shakes debut. Much Ado About Nothing plays from May 25 through June 19; for tickets and information, contact the Cal Shakes Box Office at 510.548.9666 or visit www.calshakes.org (more...)
Lincoln Center announces Lang Lang's 'New York Rhapsody,' a special one-night only live concert featuring the internationally acclaimed pianist Lang Lang. This exclusive multi-genre concert event-Tuesday, May 3, 2016 at 8:00 pm, in the Rose Theater at Jazz at Lincoln Center-pairs one of the world's greatest virtuosos with a star-studded list of guest artists. The 'Lang Lang's New York Rhapsody' event, which benefits Lincoln Center's community engagement initiatives, is produced by Live From Lincoln Center and will be filmed for a national television broadcast on PBS later this year. (more...)
The Security Project, featuring members of King Crimson, Shriekback and Peter Gabriel's original band bring the genre-less masterpieces of Peter Gabriel into the 21st Century on their new live album Live 1. (more...)
In her latest intimate and in-depth conversation with a New York cabaret star, BWW reviewer/writer Remy Block learns more about veteran singer/performer Meg Flather, who has just won a 2016 MAC Award for Best Original Song and is currently performing a critically acclaimed show PORTRAITS at Don't Tell Mama. (more...)
Quantum Collective has added 13 new acts to the lineup for their 5th Annual Southwest Invasion concert series, held from March 17-19 in Austin, TX. Third Eye Blind will kick off their North American tour with a special performance at Southwest Invasion, joined by Made of Oak (Nick Sanborn of Sylvan Esso), Paper Lions, POWERS, Yuck, Little Hurricane, The Young Wild, Bee's Knees, Transviolet, Great Caesar, Stolar and Austin's Los Coast. Other acts confirmed for the series include Talib Kweli, MSTRKRFT, Deap Vally, Arkells, Green River Ordinance, Jamie Kent, Into It. Over It, Lucky Chops, Night Beats, Overcoats, Quiet Company, Gingger Shankar, The Wild Feathers and Wintersleep. Along with over 25 concerts, Southwest Invasion creates a village of artists, goods, non-profit organizations and services for an audience of 15,000 people throughout the three day event on the rooftop and in the courtyard of the Whole Foods flagship store in Austin. (more...)
This spring, New York City's Ballets with a Twist brings a fresh floorshow-to-stage experience to Bucks County Playhouse (70 South Main Street) with four performances of Cocktail Hour: The Show: (more...)
Quantum Collective has unveiled the lineup for their 5th Annual Southwest Invasion concert series, held from March 17-19 in Austin, TX. (more...)
The Inwood Film Festival has just announced the jury for its Short Shorts program as part of its inaugural Short Film Festival in Inwood, NYC, on March 2 and 3, 2016 at Casandra Hall. In a neighborhood bereft of cinemas or theaters, the small but mighty Inwood Film Festival is honored to have such a revered, diverse, and accomplished collection of storytellers on its first jury. (more...)
?Cornelia Street Cafe has a long history of jump starting many careers. Eve Ensler's Vagina Monologues began there and Suzanne Vega began her ascent there. JD Cerna hopes to follow in those famous footsteps with Problem Cat: A Love Story. (more...)
Joe's Pub at The Public has announced its nightly performances from January 6-17, 2016. Scroll down for details or visit www.joespub.com for a complete list of shows! (more...)
The Night Fires are being lit once more! Performance dates are December 18-20 at Town Hall Theater in Middlebury. (more...)
New Yorker Rachael Sage will herald the holiday season with her charming new holiday song 'Hanukkah in the Village.' (more...)
Visionary director Julie Taymor curates and hosts the first National Sawdust+ concert tonight, November 6 at 7:30pm. MADE IN BROOKLYN, an evening inspired by that artistically fertile corner of New York City, will feature music by Brooklyn-born composers including the great George Gershwin and Oscar-winners Aaron Copland, John Corigliano and Elliot Goldenthal. The concert will feature the world concert premiere of Goldenthal's String Quartet No. 1 'The Stone Cutters' performed by Flux Quartet, the 'Chaconne' from Corigliano's Academy Award-winning score for The Red Violin, performed by Tim Fain & Stephen Gosling, and much more. (more...)
The performance will be held on Sunday, November 15 at 3pm. Cabaret on the Hudson is a series that features three outstanding cabaret performers or small groups, each bringing a 25 minute sampling of their New York City cabaret shows to Westchester, NY. (more...)
With a goal of topping last year's record-breaking half million dollars raised in its ongoing battle against Parkinson's disease, LIGHT OF DAY 'SWEET LITTLE 16' CELEBRATION, presented by the Asbury Park Press, the 16th anniversary edition of the anchor event for the world-renowned Light of Day Foundation, will bring over 150 music acts to 30 venues over 10 days in three New Jersey cities, New York City, and Philadelphia, in January, following holiday season tours of Europe and Canada. (more...)
The WFUV Live at Zankel concert series, presented by Carnegie Hall in partnership with WFUV 90.7 FM, kicks off its eleventh annual series on Saturday, November 21 at 10:00 p.m. with a performance by Tony Award-winning singer-songwriter Duncan Sheik. (more...)
While working on a play at Rattlestick Playwrights Theater in 2014, Scott Haze and Broadway veteran James Franco decided to join forces with David Van Asselt, Artistic Director of Rattlestick, to create Rattlestick West. Rattlestick, known for its work with emerging American artists, has produced over 90 world premieres in its 20 year history. Haze, founder of The Sherry Theater in Los Angeles, brought in his producing partner Lukas Behnken and the Sherry team with over 10 years of doing theater in LA to form this new bi-coastal collective. (more...)
1 2 3 4 … 17 next »
New Spock and Chekov Posters for STAR TREK BEYOND!
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MUSIC - VIDEO: Gwen Stefani Shares First Look at New 'Misery' Music Video
CLASSICAL - Review: The Clarinet Factory Performs at Prague Spring Festival
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DANCE - Review: AMERICAN BALLET THEATRE's 'La Fille mal gardee' Revives The Spirits With Bucolic Charm
COMEDY - Photo Flash: Comedians Lewis Black, Kathleen Madigan and More in The 52nd Street Project's LAUGHING MATTERS Benefit


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Gainesville's manager of code enforcement wants to make sure that, come September, it's not open season on Riverside Drive with lines of pickup trucks leaving with deer strapped to the top.
Donna Alexander's Pall Mall cigarettes might have indirectly led to her death, but a working smoke alarm could have saved her.
The Greater Hall Chamber of Commerce Agribusiness Committee will be accepting 2010 agribusiness award nominations through March 26.
Hall County firefighters spent a few anxious moments searching the burned remnants of a mobile home Tuesday before determining no one was home.
Spring Street in the New Holland area will be closed to through traffic due to storm drain repair beginning at 9 a.m. today. It should reopen at 4 p.m. Friday.
JEFFERSON - During a joint meeting Thursday, members of the Jefferson City Council and the Jackson County Board of Commissioners will be hashing out the details of a possible Special Purpose Local Option Sales Tax V.
Alina Fernandez, daughter of Cuban leader Fidel Castro, shared personal stories of her life in Cuba on Tuesday, including her escape nearly 20 years ago and memories of the father she said she wouldn't care to meet again.
Hall County Sheriff's officials on Tuesday announced several recent arrests in five unrelated cases.
A proposal by Atmos Energy to raise Georgia customers' rates by about $4 a month has been met with opposition by state Rep. Carl Rogers, R-Gainesville, who says the timing is poor.
The brightest high school seniors from 10 Gainesville and Hall County public and private high schools were honored Tuesday at a Kiwanis Club luncheon for the Student Teacher Achievement Recognition program.
Winter still isn't through with North Georgia.
Without a driver's license and a permanent job, Dolores Victor relies on Hall Area Transit for most of her errands.
The Hall County Board of Commissioners held a special workshop Monday to discuss plans for the North Hall park and library.
Page 1270 of 1816
Much like a wine that has been aged, Sweet Acre Farms Winery is finally ready.
As his officers resurface from the dark depths of Lake Lanier, the hardest call Corey Gilleland has to make is the one to call it ...
The safety advisories are flashing this weekend as Hall County residents head out in remembrance and celebration of Memorial Day and the unofficial kickoff to ...
When his four boys were born on Aug. 27, 1944, Charles Lee joked with a newspaper reporter he would need a bigger farm to be ...
Twenty-five miles outside of Gainesville stands a house with a past.
A body was found in Lake Lanier just off shore at Lanier Point Park on Saturday afternoon, according to Gainesville police spokesman Sgt. Kevin Holbrook.
Two people were injured Saturday afternoon when a motorcycle struck a van on Queen City Parkway, according to Post Commander Richard Harper from Georgia State ...
Hall County Fire Services crews battled a residential fire Friday night in the 3900 block of Falcon Parkway in South Hall County.
A Gainesville High School alumnus will be one of four drum majors for the Georgia Tech marching band this fall.
The American Legion Women's Auxiliary provided flags Friday as about 45 people showed up to place flags on veterans' graves at Alta Vista Cemetery ...
A Gainesville man was charged with possession of synthetic marijuana after a raid Thursday and was later changed with rape in a Gainesville case, a ...
Authorities say they have exhausted their ground and water search at Lanier Point Park for Lizeth Ruby Ruiz, a Gainesville woman who has been missing ...
At least one of the six people injured in Thursday's two-vehicle wreck on Dawsonville Highway remains hospitalized.
Murder charges against three men in an alleged drive-by shooting at Orchard Brook Apartments off McEver Road have been forwarded to Hall County Superior Court.
Three people escaped a fire Friday morning, but the mobile home was destroyed.
Page 2 of 9
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Lady Gaga reveals she is bisexual but her boyfriends never want a threesome
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Reader comments
Another irrelevant, boring story of a heterosexual woman trying to titillate straight men by pretending to be bisexual. Tourism does not make you bisexual.
Here's a plea to sexy, young female stars (and I'm thinking here of Megan Fox, Katy Perry, Lady Gaga, Pink etc etc etc). Unless you are in a same sex relationship (or at least have experienced a same-sex relationship longer than the duration of a same-sex kiss in front of a a straight male audience) then please shut the f*ck up about your 'bisexuality'. It is boring, irrelevant and inspiration to no-one (except perhaps for particularly needy, boring people). Are these women really so insecure about their appeal as singers or actresses that they have to invent an imaginary bisexual side.
' "They're like 'I don't need to have a threesome. I'm happy with just you'." '
I'm tempted to say something very rude about her and her name, but I'll stick to STFU.
Absolutely right, Simon Murphy. And your adjective 'insecure' is perfect. It's another pathetic attempt to appeal to a male audience.
I agree with the first 2 comments, and I'll also add: She's lying on all points.
What the hell, guys? Awesome, stylish, inspirational, sexy people can't be bisexual? I'm not the only one, you know! STFU back to you, my friends: STFU.
Normally, I would be defensive if faced with somebody trying to use sexuality in a cynical way, but Lady Gaga blatantly is bisexual. Should she be demure about it? She's not our bloody PR lady. Some of us bisexuals ARE "sexually liberated", you know – why should we have to reign in our behaviour just to avoid giving other bisexuals a bad name?
There's a little saying I like to use on occasions like this:-
"Bisexuals are not sluts. I am, but not because I'm bisexual."
P.S.: Fair point about Katy Perry and Pink, but Megan Fox definitely sounded genuine to me.
AAAAHHH! I agree with Simon Murphy (Do I??) yea! yea! Indeed I do! I have never heard of or want to hear again these idiots jumping on the I'M BI band-waggon. Although Simon, I think RobN is a king-size pratt. But, 'Are you voting BNP?' is below the belt and, I would have thought, beneath Simon Murphy.
I'm surprised with all the biphobic comments on here. What a load of terrible, hate filed diatribes. You should be ashamed of yourselves. I expect it from The Sun not Pink News
I think they mean she is USING bisexuality to appeal to the male audience.
I don't think they're bashing bisexuality as such.
I totally understand what they mean, Lezabella, and I was trying to be humourous in my post, but there is a nasty unintended flip-side to such comments.
From what I know of Lady Gaga, she clearly is bisexual for real. Gaga is a very liberated person, from her sexuality to her delightful fashion sense – her "coming out" was not a cynical exploitation of sexuality, it just so happens to be sexy because that's the way she does things. And let's not forget that she was talking to Rolling Stone and not some seedy lads mag.
I do appreciate it when people stand up for us bismexual peeps, but the danger of over-zealous protection is that it creates an atmosphere where we feel like we're expected to be respectable role models all the time and speak of our sexuality in dry language. That's boring! Some of us just like to flirt and be silly. And someone so willing to challenge people's perceptions as Lady Gaga is a fantastic role model. I, for one, am glad that she's "part of the club".
Thankyou for your reply….Pupmkin Pie! Oooh what a rhyme! :)
I adore Gaga, I had her album on repeat driving around Australia-love it.
But in all seriousness I agree she IS bisexual, and is herself no matter what.
But bring back Kate Bush that's what I say lol
I do hope Simon's as dismissive of people who come out as gay but say they've not had a same-sex encounter yet?
I'm not bashing bisexual people. I'm bashing people who claim to be bisexual but are NEVER seen with a same sex partner and who never seem to be in a same sex relationship and who only seem to be 'bisexual' when promoting their careers. Pumpkin Pie – you claim that Gaga is 'clearly bisexual'. Why? She claims to be bisexual but then says that 'none of her boyfriends ever want a 3-some.'
Interesting that 'bisexual' Gaga associates bisexuality mainly with 3-somes. None of this 'I love the person, not their gender' for Gaga. For her bisexuality is about 3-somes. For sure some bisexuals have 3-somes but it is interesting that in Gaga's so-called 'coming out' interview she merely panders to the old cliche about bisexuals being sluts.
As for other notable 'bisexuals' – namely Megan Fox; Katy Perry, Pink, Lily Allen etc etc – just how many of them have EVER been in a same sex relationship? Considering that their heterosexual relationships are splashed all over the papers you'd think their same sex relationships would enjoy the same treatment as Lindsay Lohan's relationship.
And Jen no – I am not as dismissive of people who come out as gay but say they've not had a same sex relationship yet. Usually because those people don't come out in lads mags; wearing no clothes while promoting their new album. In other words it's not a blatantly cynical career move.
The only way she could possibly out herself without "promoting her career" would be via something like Twitter. I don't know about you, but if I was a pop-star with an ambiguous sexuality, I'd certainly rather address the issue in one of the most famous pop culture magazines in the entire world, rather than meekly whispering it on a micro-blogging site.
As for her being "clearly bisexual", I just always got that vibe from her songs and acts. She's also a very open person who isn't bothered by taboos, and is always herself no matter what others think and no matter how mainstream culture thinks she should act or dress. So, if she says she is, I have no reason not to believe her.
Then, we've got the fact that bisexuals come in a range of flavours. Not everyone's attracted to men and women equally. Some don't see gender as a factor and others do, in that they specifically like different things about either sex. Heteronormativity is a huge deal. One of my best pals is a bisexual woman in her mid-twenties. Since I've known her, she's only ever had occasional sexual flings with women, but has always sought serious relationships only with men (and is now married to one). Apparently, it's because her same-sex relationships always ended up being really competitive and bitchy – she needed that gender barrier for a relationship to work, some of that good ol' yin and yang. Not being a competitive businesswoman like my friend, I doubt Gaga has exactly this problem. Thing is, there's plenty of other things that could not be to her liking. Being sexually attracted to a certain type of person, but not liking the dynamics such a relationship would present is perfectly understandable.
Another issue is age. I don't know about those other women, but I have read that Megan Fox apparently has tried dating another woman before. She's about the same age as me – that's more than I've done! My record as a similarly aged bisexual male is – girls: not a whole lot; boys: zero. Alright, the problem with me is that I've only fully accepted my bisexuality for about 2 years now, and these last two years have been a rough time in which I haven't had the time to date anyone. I'm not the only one, though – it's very difficult to get used to the concept of liking both men AND women. I've always been very accepting of sexuality, so I had no problem with being bisexual, it's just that I was genuinely confused as to whether I was or not. I definitely want to pursue relationships with other guys, but for some people it's so much easier to stick to what they know, especially if the alternative doesn't work exactly the way they like it. Hey, and let's not forget the fact that it will always be FAR easier (and, for people who don't even recognise sex, more likely) for a bisexual person to hook up with someone of the opposite gender just based on the sheer likelihood of bumping into a straight person rather than a gay/bi person.
As for threesomes, if Lady Gaga is only romantically interested in women in a sexual sense, then that sounds like a sensible idea. I don't think she's saying that that's the only way she'd sleep with women. I think she is in fact commenting on exactly the cliche you're talking about: "guys love girl-on-girl action, I like girls, so why the hell aren't they happy for me to bring along a playmate?". She makes an interesting point: that when such fantasies become reality, the men whose fantasies they were no longer have control. Just because she admits she likes threesomes doesn't mean she's pandering for attention.
Likewise, name one thing she does that ISN'T sexy. This girl's had a career in burlesque and go-go dancing. She LOVES sex and sexuality, and is very open and proud about it. I very much admire her for that, in fact. The only reason her coming out looks so sexual is because SHE is sexual. Frankly, I'd be very, very suspicious that something was going on if she came out in a magazine that didn't feature her wearing kinky outfits or showing some flesh.
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Moroder?! Warp heroes Darkstar, Autechre, Plaid, Bibio, patten?! Tron!? Playstation Soundtrack?! Yes. Yes it is. For those gamers out there, TRON RUN/r is a crazed driver pitched in the same hi-tech roller-space as Wipeout (c.1995) on the PS1 all those moons ago (which also featured music form electronic luminaries of the day Leftfield, The Chemical Brothers, and Orbital). Inspired by game and movie, Moroder and co. drop us into a 14 track ride of original electronic cyber-moves, glitched-out techno, pumped out tempo and science-fictions to get the pulses racing – playing the game or not.