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BioWorld - Friday, January 16, 2026
Home » Authors » Mari Serebrov

Articles by Mari Serebrov

Is IPAB the Right Rx for What Ails Medicare?

July 14, 2011
By Mari Serebrov
Medicare needs fixing. That much everyone agreed on at a House subcommittee hearing on the Independent Payment Advisory Board (IPAB) created by the Affordable Care Act as a way to contain "excessive cost growth" in Medicare.
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Putting Overseas Earnings to Work

July 13, 2011
By Mari Serebrov
It doesn’t take a PhD in economics to come up with practical solutions to jumpstart our economy and create jobs. But it does take guts – and real-world vision – to implement change that makes a difference. One simple solution would be a tax break on overseas profits. As we have reported in BioWorld Today, the Freedom to Invest Act, H.R. 1834, would do just that. The bill, introduced in May, allows the repatriation of more than $1 trillion in overseas earnings at a 5.25 percent tax rate. But the Joint Committee on Taxation pooh-poohed the idea, saying it could...
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Seattle Genetics Aims at Accelerated Approval Bar

July 13, 2011
By Mari Serebrov
A lot is on the line Thursday when the FDA's Oncologic Drugs Advisory Committee (ODAC) reviews Seattle Genetics Inc.'s Adcetris as a treatment for relapsed or refractory Hodgkin lymphoma and for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).
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Titan Flexes its Muscle Against Opioid Dependence

July 12, 2011
By Mari Serebrov
Titan Pharmaceuticals Inc. is a step closer to filing a new drug application (NDA) for its Probuphine as a weapon to fight opioid dependence.
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New Fentanyl Approvals Hint At Track for Class-Wide REMS

July 11, 2011
By Mari Serebrov

PDUFA V Strives to Balance Safety with Timely Approvals

July 11, 2011
By Mari Serebrov
WASHINGTON – Amid criticism that the FDA has yet to strike the right balance between risk and benefit, the agency's Janet Woodcock gave a House subcommittee a sneak peak of proposed PDUFA V enhancements that would address those concerns.
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Idera Weathers Big Pharma Partner's Shift in Priorities

July 8, 2011
By Mari Serebrov
Like many biotechs these days, Idera Pharmaceuticals Inc. is feeling the pinch as a big pharma partner shifts its pipeline priorities, leaving the future of Idera's lead TLR9 compound up in the air.
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Archimedes Breakthrough Pain Drug Gets Pain-Free REMS

July 6, 2011
By Mari Serebrov and Nuala Moran
Archimedes Pharma Ltd.'s Lazanda isn't the first fentanyl product to get the FDA's nod for breakthrough cancer pain, but its pain-free risk evaluation and mitigation strategy (REMS) and intranasal delivery could give it an edge in the U.S. market once it launches in the fall.
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Will Comparative Effectiveness Drive Biopharma Competition?

July 6, 2011
By Mari Serebrov
Comparative-effectiveness research (CER) is a C-suite issue that is already reshaping how some biotechs do business.
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Many Biotechs Shying Away from Social Media World

July 5, 2011
By Mari Serebrov
When it comes to the virtual world, a number of biotechs are downright antisocial.
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