Tag Archives: NICE

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8 Ways To Skip Your Friends' Stupid Shit Now That It's Warm Out

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Friends: They're always inviting you to their stupid shit. Birthday drinks, improv shows, parties that aren't within 200 feet of your bed — you name it! Fortunately, when it's cold and terrible outside during winter, it's easy to skip this shit, because you can just text your friend “sorry, it sucks outside” and miss their thing and they have to be cool with it because they'd totally skip your thing too if the situation were reversed.

When it's NICE outside, however, skipping your friends' shit becomes much more difficult. So difficult, in fact, that many people simply give up and actually attend the shit. This is a classic amateur mistake, and one that, after reading this post, you'll never have to make again! Here are 8 Surefire Ways To Skip Your Friends' Stupid Shit Now That It's Nice Out:

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Source: FULL ARTICLE at College Humor – Articles

Business, Finance, Occupation & Industry

U.K. Regulators Sour on Novartis Breast Cancer Drug Afinitor

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By Dan Carroll, The Motley Fool

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The U.K.’s National Institute for Health and Clinical Excellence, or NICE, has decided not to recommend Novartis‘ Afinitor for treating advanced breast cancer in draft guidance it released yesterday.

NICE turned away the drug in the treatment of HER2 negative, hormone-receptor-positive forms of the cancer due to questions over its cost-effectiveness, a major hurdle for the U.K. as it deals with rising health care costs and tightening budgets.

The decision isn’t set in stone, since it is draft guidance, but Novartis and cancer patient groups expressed disappointment at NICE‘s decision. This isn’t the first time the U.K. agency has turned away a breast cancer treatment; NICE has also given the thumbs-down to therapies from big pharma rivals, such as Roche‘s Avastin.

NICE has yet to come up with final guidance on Afinitor, although the agency’s Chief Executive, Sir Andrew Dillon, was quoted in NICE‘s statement as saying, “While the independent Appraisal Committee acknowledged that everolimus [Afinitor] may offer a step change in treatment by restoring sensitivity of the tumour to hormone therapy, the evidence highlighted uncertainty relating to how much the treatment extends overall survival. Using the most appropriate estimates, the committee concluded that everolimus is not a cost-effective treatment option for the NHS.”

While the ruling could hurt Novartis’ goals, Afinitor is still expected to hit blockbuster status, with one analyst last year projecting peak sales exceeding $2 billion by 2017.

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The article U.K. Regulators Sour on Novartis Breast Cancer Drug Afinitor originally appeared on Fool.com.

Fool contributor Dan Carroll has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

pSivida Reports Updates on ILUVIEN® for Planned Resubmission to FDA and European Launch

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By Business Wirevia The Motley Fool

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pSivida Reports Updates on ILUVIEN® for Planned Resubmission to FDA and European Launch

WATERTOWN, Mass.–(BUSINESS WIRE)– pSivida Corp. (NAS: PSDV) (ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported a number of updates with respect to ILUVIEN® for chronic diabetic macular edema (DME).

Alimera announced that it intends to resubmit its New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration (FDA) by the end of March 2013. Using data from Alimera’s two previously completed pivotal Phase III clinical trials (FAME™ Study), the resubmission will focus on the safety aspects of ILUVIEN and the population of patients with chronic DME considered insufficiently responsive to available therapies, the same group for which marketing approval for ILUVIEN has been granted in various EU countries, according to Alimera. Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera.

Alimera also announced that shipments of ILUVIEN to the German market are expected to begin in the second quarter of 2013 upon acceptance from the Medicine and Health products Regulatory Agency of the intended commercial batch size, a delay from Alimera’s previous expectation that this would occur in the first quarter of 2013. Alimera further reported that it also expects to begin shipments to the U.K. in the second quarter of 2013 for treatment of privately insured patients.

Alimera reported the submission of a patient access scheme (PAS) for ILUVIEN for DME has been agreed to by the UK’s Department of Health and is now under consideration by NICE for inclusion in its rapid review facility. NICE had previously issued final guidance that ILUVIEN is not a cost-effective treatment for chronic DME considered insufficiently responsive to available therapies. Alimera reported that under the review facility, NICE is expected to assess the impact of the PAS on ILUVIEN‘s cost effectiveness and determine whether an update to the final guidance is warranted.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Why InterMune Shares Popped

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By Brian D. Pacampara, The Motley Fool

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Although we don’t believe in timing the market or panicking over market movements, we do like to keep an eye on big changes — just in case they’re material to our investing thesis.

What: Shares of biotechnology company InterMune climbed as high as 11% today after announcing plans to launch its lung disease treatment Esbriet in the U.K.

So what: The U.K.’s National Institute for Health and Clinical Excellence (NICE) recommended Esbriet to treat patients with idiopathic pulmonary fibrosis, or IPF, reigniting investor optimism over the drug’s sales potential going forward. However, a few Wall Street analysts believe that Esbriet’s global acceptance still rests heavily on its approval in the U.S. — it was initially rejected by the FDA in 2010 — so Fools should be cautious about getting too excited over today’s news.

Now what: Management expects to launch Esbriet in England and Wales by the end of June.

“The positive recommendation by NICE means that patients in England and Wales and their families living with IPF will now have access to the only approved treatment for this unpredictable and fatal lung disease,” said Chairman and CEO Dan Welch. “This is an important step forward for patients, clinicians and the IPF community in England and Wales and we look forward to beginning the launch of Esbriet there this summer.”

Of course, with late-stage U.S. trial data still about a year away, there might be plenty of better opportunities to buy into the stock.

Interested in more info on InterMune? Add it to your watchlist.

The article Why InterMune Shares Popped originally appeared on Fool.com.

Fool contributor Brian Pacampara has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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Source: FULL ARTICLE at DailyFinance