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BioWorld - Monday, April 20, 2026
Home » Authors » Mari Serebrov

Articles by Mari Serebrov

ODAC Takes AVEO to Task over Single Phase III Trial

May 2, 2013
By Mari Serebrov
Despite moving testimony from patients stressing the need for more options to treat advanced kidney cancer, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 13-1 Thursday against the adequacy of AVEO Oncology Inc.'s single Phase III trial to support the approval of tivozanib.
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SEC Adcom Struggles with the Slow Pace of Reform

May 2, 2013
By Mari Serebrov
The slow pace of progress is wearing on the SEC's Advisory Committee on Small and Emerging Companies as it waits for the commission to move on recommendations it's suggested to help small companies get the capital they need to grow and create jobs.
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AVEO Drops on Possibility of Second Phase III Trial

May 1, 2013
By Mari Serebrov
Shares of AVEO Oncology Inc. plummeted to historic lows Tuesday with the realization that the company may have to conduct a second Phase III trial before the FDA considers approving tivozanib to treat advanced renal cell carcinoma (RCC).
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Where’s Superman When He’s Needed?

April 30, 2013
By Mari Serebrov
Look! Up in the sky! It’s a bird! It’s a plane! It’s . . . another superbug. The invasion of the multidrug-resistant superbugs is not a nightmare in the making. It’s already here. And it could be years before a new superhero lands in Metropolis to knock out the worst of the worst of these villains that are set on world domination. In a twist on the usual comic book tale, the super-resistant strains of CRE, malaria and tuberculosis threatening the world today are not the work of a mad scientist scheming away in a remote underground lab. They are...
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Alzheimer's Continues to Get Short End of the Budget Stick

April 26, 2013
By Mari Serebrov
As advocates for Alzheimer's research swarmed Capitol Hill this week, they told lawmakers, in polite terms, to put federal funding where their mouths are.
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CBO: Key to Innovation is Making it a National Priority

April 25, 2013
By Mari Serebrov
To spur innovation in biopharma and other industries, Congress must make it a national priority, according to the Congressional Budget Office (CBO).
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Pace of Biosimilar Race Is Just a Matter of Location

April 24, 2013
By Mari Serebrov
While the development and approval of biosimilars, especially monoclonal antibodies (mAbs), are moving at a snail's pace in developed countries, the copycat drugs are racing forward in Asia and Latin America.
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Pace of Biosimilar Race Is Just a Matter of Location

April 23, 2013
By Mari Serebrov
While the development and approval of biosimilars, especially monoclonal antibodies (mAbs), are moving at a snail's pace in developed countries, the copycat drugs are racing forward in Asia and Latin America.
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Bigger Arsenal Needed to Fight Drug-Resistant Superbugs

April 22, 2013
By Mari Serebrov
Superbugs are staging a global onslaught that will only get worse with time unless a modernized arsenal is developed to stop them. But an inventory of new weapons under development doesn't look like enough is being done to turn the tide anytime soon.
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SEC Tries Congressional Patience on JOBS Act Delays

April 18, 2013
By Mari Serebrov
Congress is running out of patience with the SEC's continued delay in implementing part of the Jumpstart Our Business Startups (JOBS) Act that was supposed to be in place last year.
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