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BioWorld - Monday, February 6, 2023
Home » Authors » Mari Serebrov

Mari Serebrov

Articles

ARTICLES

FDA, Biopharma Prepare for First Wave of Biosimilars

July 21, 2011
By Mari Serebrov
No Comments
With the first wave of biosimilars about to hit, it could be sink-or-swim time for both the FDA and industry as they prepare to dive in.
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Biopharma Mapping Through Social Media No Man's Land

July 20, 2011
By Mari Serebrov
No Comments
Caught in a regulatory no-man's land for social and digital media, biopharma will get little help from a new draft guidance on mobile medical apps.
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Deficit Tremors Put Health Care Costs on Shaky Ground

July 18, 2011
By Mari Serebrov
No Comments
Medicare, and the cost of health care in general, has become the epicenter in the debate over the federal deficit as the administration and Congress look for ways to control the budget.
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Seattle Genetics Gets ODAC Vote, Another Trial Looms

July 15, 2011
By Mari Serebrov
No Comments
WASHINGTON – An advisory committee voted unanimously for accelerated approval for two lymphoma indications for Seattle Genetics Inc.'s Adcetris, but the company has its work cut out for it if it hopes to get FDA approval by its Aug. 30 PDUFA date.
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Is IPAB the Right Rx for What Ails Medicare?

July 14, 2011
By Mari Serebrov
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments

PDUFA V Strives to Balance Safety with Timely Approvals

July 11, 2011
By Mari Serebrov
No Comments
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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View All Articles by Mari Serebrov

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