Tag Archives: generics

CDER Runs into Trouble with Generic Drug Reorg Plan

After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).
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The Strange Twists and Turns of 'Pay for Delay'

In the arcane world of patent litigation, the term ‘pay for delay’ can be misleading, and as the Washington debate to restrict these deals unfolds, it is becoming apparent that a  ban on such settlements may serve to delay generics even further.  Is the fresh grass of reform really always greener than the well-seeded status […]
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Spanish Generics Industry to Government: "Leave Branded Pharma Alone"

Just days before the reports that R&D investment in Spanish pharma had fallen to below EUR1 billion ($1.3 billion) in 2011 for the first time since 2007, the country’s generic manufacturers association, AESEG, offered some unexpected support for the branded industry. In comments to APM Health Europe described as “rare”, AESEG chief Ángel Luis Rodríguez […]
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Drug Reimbursement and the "New Medicaid"

by Tom Norton A lot has been written about the “state option” created by the Supreme Court ruling on HCR, and what it means to American medicine. Sorting out an opinion will, to a degree, depend on whom you read and what you believe. But regardless of where you come out on this issue, there […]
Posted in Guest Blog, healthcare, Legal, Market Access, R&D, Regulatory | Also tagged , , , , , , , | 1 Comment

Supreme Court Considers the Affordable Care Act

Posted in Corporate Responsibility, healthcare, Legal, Regulatory, Strategy | Also tagged , , , , , , , | Leave a comment
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