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.
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.
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.
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...
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).
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.
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.
