FDA approves new use for Roche's Avastin in colon cancer treatment

Jan 23 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved the use of Roche's Avastin for patients whose colorectal cancer has worsened despite previous treatment with the drug.

The new use will allow patients first treated with Avastin plus chemotherapy to be treated again with the biotechnology drug in combination with a different chemotherapy regimen.

A pivotal clinical trial showed that such a treatment strategy improved survival.

"The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," Hal Barron, chief medical officer at Roche's Genentech unit, said in a statement. "These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."

Avastin, also known as bevacizumab, is an antibody that blocks vascular endothelial growth factor, or VEGF, a protein tumors need to grow nutrient-providing blood vessels.

The drug is approved in the United States for treating glioblastoma, a brain tumor, and colorectal, lung and kidney cancers.

Worldwide Avastin sales totaled $5.3 billion Swiss francs ($5.5 billion) in 2011.

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FDA approves Novartis drug for rare iron disorder

WASHINGTON -- The Food and Drug Administration has approved a Novartis drug to treat a rare genetic disorder that causes an overload of iron in the blood.

The FDA cleared Novartis' drug Exjade to treat patients 10 and older with a form of thalassemia, which affects about 1,000 people in the U.S. The disorder can lead to internal organ damage.

Patients with traditional thalassemia often require red blood cell transfusions to replace the protein that carries oxygen throughout the bloodstream.

Novartis' drug is for patients with a milder form of the condition known as non-transfusion-dependent thalassemia. These patients do not require frequent blood transfusions.

The FDA approved the drug in combination with a diagnostic test that measures iron concentration in the liver.

Novartis is headquartered in Basel, Switzerland with U.S. offices in East Hanover, N.J.

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The time bomb in Obamacare?

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Health Law Pinches Colleges

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Obamacare A Tempting Target For Cuts

Republicans never got their chance to chop down President Barack Obama’s health care law, but that doesn’t mean it’s safe from the clippers as Congress looks for solutions for tough fiscal times.

The Affordable Care Act brings in a lot of new taxes and savings, but it also dishes out as much as $1.7 trillion in new spending over the next decade — money that looks awfully tempting to lawmakers scrounging around for ways to fund other projects or pay down the deficit.

Continue Reading And even Democrats may be forced to take a look as battles over the debt limit, deficit reduction and entitlement reform heat up. Obama and Senate Democrats have already reluctantly tapped into the law for revenue for things they want to get done.

Twice, as part of bipartisan deals, they agreed to increase the amount Americans must pay if they get too generous a subsidy in the insurance exchanges. The first time was to pay for the 2010 doc fix to avoid deep physician fee cuts under Medicare, and the second time was to offset the cost of repealing new 1099 tax reporting requirements that both parties considered burdensome on businesses.

Last February, Obama signed legislation slashing $5 billion from the Prevention and Public Health Fund to help pay for a continuation of payroll tax breaks and other initiatives. The health care law gave the fund $15 billion in its first 10 years.

And just a few weeks ago, lawmakers agreed to cut funding for nonprofit health insurance cooperatives to help pay for another one-year doc fix. That was in the last-minute fiscal cliff deal.

Although the White House takes issue with the Congressional Budget Office’s $1.7 trillion estimate for 2012to 2022, there are still plenty of funds and juicy options on the shelf if lawmakers get hungry enough — that is, if Democrats would agree to them. Here are some potential targets:

Reclaim excess subsidies

One option is to require insurance subsidy recipients to pay back 100 percent of overpayments, which would raise $44 billion over 10 years, according to CBO.

The law provides lower-income Americans tax credits to help them buy insurance, but if their earnings change midyear, putting them in a different income bracket, they can end up pocketing more than they’re eligible for. So-called clawbacks would require them to return those subsidies down to the last dime.

House Republicans voted for that option last spring, but Democrats said the proposal would go too far, because poor Americans might end up owing the government thousands of dollars at the end of the year. Liberal health care advocates are already unhappy Congress increased the clawbacks — so increasing the amount low-income people would have to repay could be a hard sell.

“The fact that it was made even more rigorous, it has the potential of being an enormous problem,” said Ron Pollack, executive director of Families USA, which strongly supports the health law. “This clawback affects people even if they were trying to do all the right things.”

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Remarks by the President at Staff Inaugural Ball

The White House

Office of the Press Secretary

Washington Convention Center
Washington, D.C.

9:00 P.M. EST

THE PRESIDENT:  Hello, everybody!  (Applause.)  You all clean up pretty good.  (Applause.)  You are looking good. 

Couple of acknowledgements I want to make -- first of all, please give it up for DJ Mel Sandico.  (Applause.)  The U.S. Army Band is in the house.  (Applause.)  We're so proud -- they can play anything -- anything.  Go ahead and make a request, they’ll play it.  They are outstanding.  And we are so grateful for their service to our country each and every day. 

Now, this is just a little gathering, little party among friends.  (Applause.)  Represented here are our outstanding OFA staff and volunteers.  (Applause.)  Our amazing PIC -- that would be Presidential Inaugural Committee Team.  (Applause.)  

MRS. OBAMA:  This has been a great inauguration.  They've done a great job. 

THE PRESIDENT:  Michelle just said this has been a great inauguration, and you've done a great job. 

We've got the DNC convention team that did an amazing job.  (Applause.)  We've got the DNC team that did an amazing job.  (Applause.)  And we've got the White House team, which is pretty good.  (Applause.)  They did an amazing job.

AUDIENCE MEMBER:  And you!

THE PRESIDENT:  I'm here, too.  (Applause.)  That’s true.  And the First Lady of the United States -- (applause) -- bangs and all -- (applause) -- looking very sparkly and twinkly.  (Laughter.)   

Now, I'm not going to speak long, mainly because I've been speaking a lot and you all have heard me before.

MRS. OBAMA:  And the entertainment is pretty good.

THE PRESIDENT:  And, more importantly, we've got a couple of people who are pretty good musicians named Lady Gaga and Tony Bennett in the house.  (Applause.)  This is like my -- Michelle is like doing interpretive dance of everything I say.  It's been a long weekend -- she's getting a little silly now.  (Laughter.) 
But my main job here tonight is real simple, and it's just to say thank you.  (Applause.)  You know, some of you were involved the very first time I ran, back in 2007, 2008.  (Applause.)  Some of you were 14 at the time, and so just got involved this time out.  (Applause.)  You know who you are.  (Applause.)

MRS. OBAMA:  That’s right.  

THE PRESIDENT:  But regardless of whether you got involved six years ago or you got involved six months ago, what is true is that all of you have come to represent for me and Michelle our deepest hopes for America. 

The average age here is probably around 20-something -- (applause) -- and that’s only because I'm here, which brings the average age up quite a bit.  But when I think about traveling around the country during the course of the campaign and getting to know some of you and meeting some of you and seeing the work you do in the White House or the work that you did during the convention, and I meet young people who are so much smarter and more thoughtful and more caring about the future than I ever was at your age, so much more capable, so much more serious, so much more poised, it makes me know that America’s future is in good hands.  (Applause.)

As long as all of you understand the immense and incredible power that you possess when you work together, when you join voices, when you extend yourselves not just on behalf of your own ambitions but on behalf of a larger cause, you cannot be stopped. And part of the reason I know that America will succeed is when I look at how you work together, what I saw in offices from Vegas  -- (applause) -- to Richmond -- (applause) -- to Colorado Springs -- (applause) -- to Manchester, New Hampshire -- (applause) -- to Orlando, Florida -- it didn’t matter -- (applause) -- it didn’t matter where I was, I'd walk into a volunteer office and what you saw was people from every walk of life -- black, white, Hispanic, Asian, Native American, young, gay, straight -- it didn’t matter where you came from, you came together with a mission in mind and a vision in mind.  And you were willing to set aside whatever surface differences you had because you understood you were working on behalf of an America that was a little more just and a little more fair and a little more compassionate, and better stewards for our environment.  (Applause.)

And seeing that kind of spirit operate day in, day out, no matter how hard the work, no matter how little you got paid, no matter how bad your candidate screwed up, it didn’t matter, you just kept on going.  And there were times during the course of this year where I might have gotten down, but you picked me back up.  (Applause.)  You lifted me up on your shoulders.  And you said, yeah, we know he’s gotten kind of old and gray-haired, and we know sometimes he stumbles.  But we are going to carry him across the finish line.  (Applause.)  Because this is not about him; this is about us.  This is about America.  This is about what we believe.  This is about what our values are.  (Applause.) This is what our ideals are all about.  We are going to go out there and change America.  (Applause.)

That's what you did every single day.  And so this weekend belonged to you.  (Applause.)  To you.  (Applause.)

So my final message -- because I'm already breaking my promise; I said I wasn’t going to talk long -- is to say that you can't stop now.  I know some of you have got to go back to school.  I know some of your parents are all like, okay, you did your little thing, but now you’ve got to go back and get your degree.  I know some of you’ve got some rent to pay, so you’ve got to --

MRS. OBAMA:  Some loans.

THE PRESIDENT:  -- get some loans to repay.  You may be making a whole range of career choices and decisions right now.  And, look, not all of you will end up staying in politics.  Not all of you will end up pursuing professionally public service.  But every single one of you, in your communities, in your neighborhoods, in your workplaces, wherever you decide to put down roots, wherever you decide to make a difference, as long as you retain that spirit that you’ve shown during the course of these campaigns -- the idea that you’re a citizen, that America only works when you make it work -- (applause) -- that you have the power to move this country and, as a consequence, the world  -- if you retain that sense and never lose it, then I tell you, not only is America going to be in good hands, but what’s going to happen is you’re going to influence your peers and your friends and the folks you live next to and your neighbors and people in your workplace.  And suddenly, like Robert Kennedy described, you’re like a stone thrown in a pool and it starts rippling out.  And you don’t know where those ripples are going to go, and that’s the future that I see for you. 

I know that every single person here donated $10 to a memorial on behalf of Alex Okrent Memorial.  (Applause.)  And Alex was one of you -- this incredibly thoughtful, talented, compassionate, caring young person who decided to get involved because he thought he could make a difference.  And tragically, he ended up leaving us while working in the campaign -- some of the people here were there when it happened.  And it was heartbreaking, and it reminded us of how precious our time on this Earth is. 

We don’t have a lot of time.  I know when you’re young it seems like it goes on forever.  It turns out things are fragile. And yet, the thing that outlives each of us is what we do for somebody else, what difference did we make.  And we know Alex made a difference.  (Applause.)  And so his impact outlives him. And that means -- that’s all right -- somebody is over there and they probably fainted because they’ve been standing too long.  Many of you have been at rallies -- there’s one over here, we’ve got EMS folks here.  People, bend your knees while you’re here.  (Laughter.)  And try to get hydrated as well.

MRS. OBAMA:  You know you’ve got to drink some water!

THE PRESIDENT:  Drink water is what I mean.  (Laughter.)  Juice is okay, too.  (Laughter.)

But in the same way that Alex left this indelible mark on my life and Michelle’s life, and many of your lives, you will leave an indelible mark as well, as long as you decide that you’re going to spend your life giving something back. 

You’ve already given me an incredible gift.  You’ve given America an incredible gift.  Don’t stop.  Keep on going.  (Applause.)  Don’t stop.  Stay fired up.  (Applause.) 

Are you fired up?

AUDIENCE:  Fired up!

THE PRESIDENT:  Are you ready to go?

AUDIENCE:  Ready to go!

THE PRESIDENT:  Fired up!

AUDIENCE:  Fired up!

THE PRESIDENT:  Ready to go?

AUDIENCE:  Ready to go!

THE PRESIDENT:  Fired up!

AUDIENCE:  Fired up!

THE PRESIDENT:  Ready to go!

AUDIENCE:  Ready to go!

THE PRESIDENT:  Fired up!

AUDIENCE:  Fired up!

THE PRESIDENT:  Ready to go.

AUDIENCE:  Ready to go!

THE PRESIDENT:  I think Lady Gaga is fired up, too. 

God bless you, guys!  (Applause.)  I love you!  Thank you!  God bless you.  God bless the United States of America.  (Applause.) 

END 
9:16 P.M. EST

Watch the full video of a Google+ Hangout with Vice President Joe Biden.

President Obama renominates Richard Cordray as Director of the Consumer Financial Protection Bureau.

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GOP Bill Would Repeal Health Law's Individual Mandate

Republican senators introduced a bill Tuesday to repeal the unpopular individual mandate in President Obama's signature healthcare law.

Sens. Orrin Hatch (R-Utah) and Lamar Alexander (R-Tenn.) introduced the measure, dubbing it the "American Liberty Restoration Act." They said the mandate is an assault on constitutionally protected freedoms — despite the Supreme Court's ruling last year that upheld the mandate as constitutional.

"This legislation we are introducing today is simple: it strikes the individual mandate, so we can instead find ways of providing people with health care, but in a manner that doesn’t run counter to our constitutional framework of limited government," Hatch said in a statement.

The individual mandate requires most taxpayers to either purchase insurance or pay a penalty. There are exceptions for people who are too poor to buy coverage or for whom insurance would be too expensive (defined as costing more than 8 percent of annual income).

“Congress should repeal the law, especially the individual mandate, and then proceed step by step to reduce the cost of health care so more Americans can afford to buy insurance," Alexander said.

Hatch and Alexander's bill is unlikely to go anywhere.

The Supreme Court represented conservatives' best chance to get rid of the mandate, and the prospect of legislative repeal was taken fully off the table once President Obama won a second term and Democrats expanded their majority in the Senate.

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